China Health Labs is a leading provider of total lab solutions for medical diagnostics and food safety testing in China. It has experienced strong revenue growth of 41% in 2010 to $33.7 million due to increased sales of its total lab solutions. The company expects continued growth in 2011 as it leverages its track record to gain market share in rural hospitals, military/emergency services, and food safety testing - sectors with large market potential and limited competition. China Health Labs is well positioned for growth with a comprehensive suite of products, established customers and relationships, and sufficient funding to support its expansion plans.
The document provides summaries of regulatory updates from 2015, including:
- New and revised FDA, Eudralex, WHO, and Indian Gazette guidelines.
- ICH announced organizational changes to become more globally inclusive.
- FDA released a new method validation guideline for biologics and updated requirements for quality metrics reporting.
- Eudralex provided new guidance on excipient GMP and prevention of cross-contamination in facilities and production.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
Webinar presentation: Consultation on reforms to the generic medicine market ...TGA Australia
The TGA is consulting on reforms to streamline the generic medicine market authorisation process. The proposed reforms include: 1) Reducing regulatory barriers such as relaxing requirements for dissolution data and reference products in bioequivalence studies. 2) Providing more certainty on data requirements through early advice on biowaiver justifications. 3) Supporting international work sharing by using common templates for bioequivalence studies and biowaiver justifications. 4) Prioritizing applications for generic medicines that address shortages or high expenditure to encourage more competition. Feedback is sought through an online consultation closing March 21. The reforms aim to enhance supply of affordable generic medicines in Australia.
Presentation: Update from the Complementary and OTC Medicines Branch: Listed ...TGA Australia
This session will provide an overview of the status of reform initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to complementary medicines
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
The document provides summaries of regulatory updates from 2015, including:
- New and revised FDA, Eudralex, WHO, and Indian Gazette guidelines.
- ICH announced organizational changes to become more globally inclusive.
- FDA released a new method validation guideline for biologics and updated requirements for quality metrics reporting.
- Eudralex provided new guidance on excipient GMP and prevention of cross-contamination in facilities and production.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
Webinar presentation: Consultation on reforms to the generic medicine market ...TGA Australia
The TGA is consulting on reforms to streamline the generic medicine market authorisation process. The proposed reforms include: 1) Reducing regulatory barriers such as relaxing requirements for dissolution data and reference products in bioequivalence studies. 2) Providing more certainty on data requirements through early advice on biowaiver justifications. 3) Supporting international work sharing by using common templates for bioequivalence studies and biowaiver justifications. 4) Prioritizing applications for generic medicines that address shortages or high expenditure to encourage more competition. Feedback is sought through an online consultation closing March 21. The reforms aim to enhance supply of affordable generic medicines in Australia.
Presentation: Update from the Complementary and OTC Medicines Branch: Listed ...TGA Australia
This session will provide an overview of the status of reform initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to complementary medicines
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
TGA Presentation: Legislative framework and Commonwealth access schemes relev...TGA Australia
The document discusses the legislative framework and Commonwealth access schemes for medicinal cannabis in Australia. It covers the current scheduling of cannabis and THC, which were added to Schedule 8 in November 2016. It also describes the Therapeutic Goods Administration (TGA) pathways of Special Access Scheme Category B and Authorized Prescriber that doctors can use to access unapproved medicinal cannabis products for patients. The criteria for approval through these schemes include details on the patient, product, and prescribing doctor. Additionally, the document outlines the interface between Commonwealth and state/territory regulations regarding medicinal cannabis.
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
China diagnostic reagent industry report, 2010ResearchInChina
The document discusses China's diagnostic reagent market in 2009-2010. It notes that in 2009, China's market represented 5% of the global market and focused on low-end products. There were over 70 Chinese producers generating $4 billion in sales, with immune and nucleic acid reagents growing. Da An Gene was a leading producer of nucleic acid reagents, which accounted for over 50% of its revenue and 60% of the domestic market. The document also provides an overview of the industry structure and major Chinese companies.
- The document discusses Antares Pharma, a pharmaceutical company focused on developing drug-device combination products. It provides an overview of Antares' approved and in-development products, including Gelnique gel for overactive bladder which was recently approved by the FDA. It also summarizes partnerships with companies like Teva and Watson, the financial position and growth of the company, and potential milestones in the next 12-18 months including product launches.
Manufacturing Quality Branch – 2015 Achievements and ChallengesTGA Australia
In 2015, the Manufacturing Quality Branch achieved improvements in GMP clearance times and inspection performance while also facing ongoing challenges. Key accomplishments included:
- Reducing median GMP clearance processing times from 18.8 weeks to 4.1 weeks through process improvements and increased communication.
- Completing 92% of domestic initial inspections and 94% of domestic reinspections within target timelines.
Looking ahead to 2016, plans include further streamlining the GMP clearance and inspection processes through application improvements, clearer sponsor expectations, and rewarding consistent compliance through less frequent inspections for high-performing facilities. The goal is more predictable timelines and reduced regulatory burden.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
Regulatory affairs is a profession that has developed to ensure the safety and efficacy of regulated products like pharmaceuticals, medical devices, and cosmetics. Regulatory affairs professionals are responsible for understanding and complying with regulations, collecting scientific data, and submitting applications to regulatory agencies to obtain approval to market products. They provide strategic guidance to companies on navigating the regulatory process from product development through marketing approval and post-market compliance. Ensuring compliance with regulations governing manufacturing, quality management systems, advertising, and other areas is important for regulatory affairs.
Dear all,
I have tried putting down my view-points on benefits of Project Management system in Pharmaceutical Industry...
Please let me know what do you think.
Regards,
Megha Thakkar
Best Practices - Injectable Packaging LinesManish Bhatkar
In the past couple of years we have seen many companies recalling sterile products, primarily due to the problems related to particulate matter and/ or sterility assurance. These problems are not only a potential threat to the patient health, but also lead to short supply due to contamination, manufacturing problems, or product discontinuation. Sterile dosage forms are vulnerable to both microbial and particulate contamination, which has been traced to glass and packaging materials, problems such as leaching and sorption and moreover the manufacturing/ operating practices.
Recently, in an industry workshop I had shared my thoughts, views, experiences and study findings on this topic and I am happy to share the same with you. I hope this will be useful…
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
UBI Group of Companies is a privately held global biopharmaceutical group established in 1985 with 7 operating entities and over 950 employees worldwide. The group has three proprietary technology platforms and has generated over $250 million in self-funded revenue reinvested in R&D. UBI Group has a diverse pipeline of vaccines and biologics across human and animal health with global operations in the US, China, Taiwan, and Ireland. The group has a track record of partnerships with multinational companies and awards for its innovative research.
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The Therapeutic Goods Administration provides updates on several pathways for new medicine approvals in Australia, including standard, priority, provisional, comparable overseas regulator, and orphan drug pathways. It discusses key issues for the priority and provisional pathways, such as eligibility criteria and timelines. The TGA also provides an overview of its orphan drug program and discusses emerging trends toward more expedited drug approvals globally and in Australia.
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
This document discusses project management in the pharmaceutical industry. It covers topics such as the importance of planning, types of planning, steps involved in planning, elements of planning, challenges, project implementation, and measuring project success. It also provides a case study on Eli Lilly and how the company overcame challenges through increased R&D spending, collaborations, and implementing open innovation strategies.
Regulatory Reform - Are we heading in the right direction?TGA Australia
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
The document provides an overview of common issues seen by regulators in evaluating bioequivalence studies from the perspective of a regulatory evaluator. It discusses key aspects of study design, clinical conduct, analytical methods, pharmacokinetic analysis, and statistical analysis that are evaluated. Examples of specific studies that were not accepted due to issues such as analytical problems, clinical inconsistencies, and use of an inappropriate reference product are also provided. The evaluator emphasizes that justification for exclusion of data and consideration of outliers is important in statistical analysis.
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
This presentation by Advantagewon Oil Corp discusses the company's operations and future plans. It acquired properties in Texas that hold proven oil reserves worth over $40 million. The company drilled two successful wells in 2014 and plans 1-2 more in 2015. It also acquired land in another area of Texas with over $119 million in estimated oil reserves. Advantagewon aims to lease additional land and eventually drill up to 300 wells across its properties. The presentation introduces the management team and their experience in the oil industry. It provides an overview of the company's assets and development plans to continue growing production and reserves.
TGA Presentation: Legislative framework and Commonwealth access schemes relev...TGA Australia
The document discusses the legislative framework and Commonwealth access schemes for medicinal cannabis in Australia. It covers the current scheduling of cannabis and THC, which were added to Schedule 8 in November 2016. It also describes the Therapeutic Goods Administration (TGA) pathways of Special Access Scheme Category B and Authorized Prescriber that doctors can use to access unapproved medicinal cannabis products for patients. The criteria for approval through these schemes include details on the patient, product, and prescribing doctor. Additionally, the document outlines the interface between Commonwealth and state/territory regulations regarding medicinal cannabis.
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
China diagnostic reagent industry report, 2010ResearchInChina
The document discusses China's diagnostic reagent market in 2009-2010. It notes that in 2009, China's market represented 5% of the global market and focused on low-end products. There were over 70 Chinese producers generating $4 billion in sales, with immune and nucleic acid reagents growing. Da An Gene was a leading producer of nucleic acid reagents, which accounted for over 50% of its revenue and 60% of the domestic market. The document also provides an overview of the industry structure and major Chinese companies.
- The document discusses Antares Pharma, a pharmaceutical company focused on developing drug-device combination products. It provides an overview of Antares' approved and in-development products, including Gelnique gel for overactive bladder which was recently approved by the FDA. It also summarizes partnerships with companies like Teva and Watson, the financial position and growth of the company, and potential milestones in the next 12-18 months including product launches.
Manufacturing Quality Branch – 2015 Achievements and ChallengesTGA Australia
In 2015, the Manufacturing Quality Branch achieved improvements in GMP clearance times and inspection performance while also facing ongoing challenges. Key accomplishments included:
- Reducing median GMP clearance processing times from 18.8 weeks to 4.1 weeks through process improvements and increased communication.
- Completing 92% of domestic initial inspections and 94% of domestic reinspections within target timelines.
Looking ahead to 2016, plans include further streamlining the GMP clearance and inspection processes through application improvements, clearer sponsor expectations, and rewarding consistent compliance through less frequent inspections for high-performing facilities. The goal is more predictable timelines and reduced regulatory burden.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
Regulatory affairs is a profession that has developed to ensure the safety and efficacy of regulated products like pharmaceuticals, medical devices, and cosmetics. Regulatory affairs professionals are responsible for understanding and complying with regulations, collecting scientific data, and submitting applications to regulatory agencies to obtain approval to market products. They provide strategic guidance to companies on navigating the regulatory process from product development through marketing approval and post-market compliance. Ensuring compliance with regulations governing manufacturing, quality management systems, advertising, and other areas is important for regulatory affairs.
Dear all,
I have tried putting down my view-points on benefits of Project Management system in Pharmaceutical Industry...
Please let me know what do you think.
Regards,
Megha Thakkar
Best Practices - Injectable Packaging LinesManish Bhatkar
In the past couple of years we have seen many companies recalling sterile products, primarily due to the problems related to particulate matter and/ or sterility assurance. These problems are not only a potential threat to the patient health, but also lead to short supply due to contamination, manufacturing problems, or product discontinuation. Sterile dosage forms are vulnerable to both microbial and particulate contamination, which has been traced to glass and packaging materials, problems such as leaching and sorption and moreover the manufacturing/ operating practices.
Recently, in an industry workshop I had shared my thoughts, views, experiences and study findings on this topic and I am happy to share the same with you. I hope this will be useful…
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
UBI Group of Companies is a privately held global biopharmaceutical group established in 1985 with 7 operating entities and over 950 employees worldwide. The group has three proprietary technology platforms and has generated over $250 million in self-funded revenue reinvested in R&D. UBI Group has a diverse pipeline of vaccines and biologics across human and animal health with global operations in the US, China, Taiwan, and Ireland. The group has a track record of partnerships with multinational companies and awards for its innovative research.
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The Therapeutic Goods Administration provides updates on several pathways for new medicine approvals in Australia, including standard, priority, provisional, comparable overseas regulator, and orphan drug pathways. It discusses key issues for the priority and provisional pathways, such as eligibility criteria and timelines. The TGA also provides an overview of its orphan drug program and discusses emerging trends toward more expedited drug approvals globally and in Australia.
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
This document discusses project management in the pharmaceutical industry. It covers topics such as the importance of planning, types of planning, steps involved in planning, elements of planning, challenges, project implementation, and measuring project success. It also provides a case study on Eli Lilly and how the company overcame challenges through increased R&D spending, collaborations, and implementing open innovation strategies.
Regulatory Reform - Are we heading in the right direction?TGA Australia
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
The document provides an overview of common issues seen by regulators in evaluating bioequivalence studies from the perspective of a regulatory evaluator. It discusses key aspects of study design, clinical conduct, analytical methods, pharmacokinetic analysis, and statistical analysis that are evaluated. Examples of specific studies that were not accepted due to issues such as analytical problems, clinical inconsistencies, and use of an inappropriate reference product are also provided. The evaluator emphasizes that justification for exclusion of data and consideration of outliers is important in statistical analysis.
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
This presentation by Advantagewon Oil Corp discusses the company's operations and future plans. It acquired properties in Texas that hold proven oil reserves worth over $40 million. The company drilled two successful wells in 2014 and plans 1-2 more in 2015. It also acquired land in another area of Texas with over $119 million in estimated oil reserves. Advantagewon aims to lease additional land and eventually drill up to 300 wells across its properties. The presentation introduces the management team and their experience in the oil industry. It provides an overview of the company's assets and development plans to continue growing production and reserves.
South American Silver Corporate Presentationsoamsilver
The document is a corporate presentation for South American Silver Corp., which is focused on advancing its two large undeveloped silver resources in South America. The presentation highlights that:
1) South American Silver's flagship project, Malku Khota in Bolivia, is one of the world's largest silver-indium resources and a recent update doubled estimated annual production to over 13 million ounces of silver and 80 tonnes of indium for the first five years.
2) Malku Khota has potential for further resource expansion through additional drilling and represents an opportunity for future production of one of the world's largest amounts of indium and gallium, critical metals with growing industrial demand.
3) The project
South American Silver Corp. is a growth focused exploration and development company advancing one of the world's largest undeveloped silver and indium resources. It has two large scale projects in South America - Malku Khota in Bolivia, which has one of the world's largest silver-indium resources, and Escalones in Chile, a high potential copper-gold deposit. The company plans to drive shareholder value through advancing these projects, leveraging its exposure to silver and the indium market.
The corporate presentation provides the following information about Romarco Minerals' Haile Gold Mine project:
1) The feasibility study completed in February 2011 found the project would have a capital cost of $292 million, operating cost of $379 per ounce, and average grade of 2.06 g/t gold, making it one of the lowest cost and highest grade open pit gold projects.
2) Measured and indicated resources at the project total 71.1 million tonnes at 1.77 g/t gold containing 4 million ounces at a gold price of $1200, while proven and probable reserves at $950 gold are 20.1 million tonnes at 1.24 g/t containing 801
Oremex Gold Inc. is a Canadian gold exploration company focused on projects in Mexico. It has a portfolio of 5 gold projects located in prolific mining regions of Mexico, including Cerro del Oro in Zacatecas and Santa Catarina in Sinaloa. The company has 35 million shares issued and management with a track record of success in Mexico. Oremex plans to advance its projects through exploration drilling and develop new discoveries within the emerging Sierra Rosario Gold Belt.
El documento habla sobre el cibercrimen, que involucra el uso indebido de computadoras e internet para cometer una variedad de delitos, engaños y malas prácticas. Describe algunos tipos de cibercrimen como la intoxicación online para desprestigiar a personas u organizaciones, y delitos cometidos por placer personal en lugar de por dinero. También menciona varios artículos del código penal relacionados con delitos informáticos.
This document provides an overview of China Health Labs & Diagnostics Ltd., a leading provider of total lab solutions in China. It discusses the company's business units, growth strategy, financial performance, management team, and investment highlights. China Health Labs generates revenue from the sale and servicing of diagnostic equipment and reagents across multiple business units, and is well positioned to benefit from trends of increasing healthcare spending and policy support in China.
This document provides an overview and disclaimer for an investor presentation about China Health Labs & Diagnostics Ltd. It notes that the presentation should not be distributed without consent and that investing involves risks outlined in other documentation. The presentation is not an advertisement or public offering. It has been prepared to assist investors and contains forward-looking statements involving risks and uncertainties. Market and industry data comes from third parties and management estimates.
China Health Labs is a leading provider of total lab solutions and diagnostic equipment and reagents in China. It has four business units focused on rural hospitals, military and emergency services, food safety labs, and large urban hospitals. The company has experienced strong revenue growth in recent years and has a large addressable market supported by Chinese government policies. It has proprietary technology, partnerships with government agencies, and a strategy focused on expanding into new geographic areas and developing new solutions.
China health presentation_dec_2011_v2__compatibility_mode_healthchina
China Health Labs is a leading provider of total lab solutions and diagnostic equipment and reagents in China. It has several business units serving various sectors such as rural hospitals, the military, and food safety. The company is well positioned to benefit from China's growing healthcare demand driven by factors like increasing wealth and an aging population. It has a first mover advantage in its total lab solutions approach and proprietary technologies.
1. introduction to industrial pharma 5 8-2020shravyalakshmiS
This document provides an overview of industrial pharmacy and the various departments within a pharmaceutical industry. It discusses the manufacturing department including the dispensing, production, and packaging/labeling units. It also describes the research and development, marketing, quality control, engineering, and accounting departments. The document outlines some key aspects of industrial pharmacy like pilot plant scale up techniques, technology development and transfer, regulatory affairs, regulatory requirements for drug approval, quality management systems, and Indian regulatory requirements.
The document provides a market analysis for an analytics company called AlphaMD to enter the pharmaceutical market in the UAE. It includes a literature review on the pharmaceutical sector in UAE, identifying key parameters and needs of target companies through interviews. Based on a decision matrix, marketing pharmaceutical companies were identified as the top target. Recommendations include providing competitive intelligence and contracting services at affordable prices while maintaining quality. Limitations include lack of financial data from SMEs and limited interviews.
This document provides an overview of the Indian pharmaceutical industry, Biocon India Group, and a case study they are considering. It discusses the political, economic, demographic, and technological factors shaping the Indian pharmaceutical industry. It also summarizes India's patent regime and how it has evolved over time. The document then provides background on Biocon Group, including their culture and business units. It outlines the broad questions Biocon is considering regarding their growth strategy and whether to expand their Clinigene clinical trials segment. Potential short and long-term strategies for expansion are discussed.
This document discusses Antares Pharma, a pharmaceutical company developing drug delivery systems. It provides an overview of the company's technology platforms, product pipeline, partnerships, and financial status. Key points include that Antares has three FDA-approved products, multiple products in development through partnerships with companies like Teva and Pfizer, and is focusing on developing self-injection products like its Vibex methotrexate auto-injector to treat conditions like rheumatoid arthritis.
This presentation provides an overview of Antares Pharma and highlights several key points:
1) Antares has three FDA-approved products, two products filed with the FDA, and five additional products in development across various therapeutic areas including self-injection technology.
2) Antares has a broad collaboration with Teva to develop five injectable products using Antares' proprietary injection devices, with multiple products already filed or approved.
3) Antares has demonstrated success in developing, gaining approval for, and commercializing products using its transdermal gel and needle-free injection technology platforms. Its approved products address large markets and have strategic partners.
Cortellis Clinical Trials Intelligence is a powerful resource for accelerating clinical trial development decisions and portfolio strategy. It covers drugs, medical devices, and biomarkers from clinical trials around the world. As the industry's leading provider of high-quality life sciences content, Thomson Reuters can integrate Cortellis Clinical Trials Intelligence with their other offerings and a customer's own information. The solution provides an affordable and accessible way to access clinical trials intelligence that is integrated and easy to use.
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
This presentation discusses Antares Pharma, a pharmaceutical company focused on developing drug delivery products. It highlights Antares' approved and in-development products, including auto-injectors and pen injectors being developed through a partnership with Teva. Key points made include: Antares having FDA-approved products and a diverse pipeline, including a methotrexate auto-injector entering late-stage development; growing revenues and partnerships with major pharmaceutical companies; and proprietary injection technology being important for commercial success of biologics and biosimilars.
This presentation provides an overview of Antares Pharma and its product pipeline. It summarizes that Antares has developed proprietary drug delivery systems, including auto-injectors and transdermal gels. It has several FDA-approved products and partnerships with major pharmaceutical companies. Its pipeline includes additional self-injection products in development, including products for rheumatoid arthritis and biosimilars, which represent large market opportunities.
This document summarizes key information about the medical device industry in the US and challenges facing a company called MTC. It discusses proposals to address MTC's challenges, including implementing lean manufacturing, establishing strategic supplier relationships, rationalizing sales commissions, building hospital partnerships, and acquiring other companies to increase capacity and product variety. Risks of the proposals are also summarized along with mitigation strategies.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
Major developments in point-of-care (POC) testing were highlighted at the 2015 American Association of Clinical Chemistry Annual Meeting:
1) Several companies announced new POC devices, including a low-cost, battery-powered molecular diagnostics platform from Cepheid and a smartphone-based chlamydia test.
2) Existing POC tests for influenza, diabetes, kidney disease, liver disease, and pregnancy from companies like Alere, DiaSys Diagnostics, and Abbott were demonstrated.
3) The large POC diagnostics market, estimated at $17 billion globally, was a focus for many exhibitors given the potential for rapid results at the point of care.
Elan Drug Technologies is celebrating 40 years of leadership in drug delivery and innovation. In 2010, they achieved several major milestones including helping partners receive FDA approval for new drugs and expanding their technology research. Looking ahead, they expect additional approval milestones and advancements in clinical trials. Elan also formally launched a new manufacturing services business to provide scale-up and commercial manufacturing. They hope to sign new deals and continue helping clients deliver clinically meaningful benefits to patients through proprietary drug delivery technologies.
GE Healthcare Systems is evaluating four new ultrasound products: HepEcho, Omega, TEEmax, and UltraLipo. The team recommends introducing HepEcho and Omega first. HepEcho addresses liver cancer detection needs in Japan. Omega increases prenatal care access in Indonesia by enabling midwives to detect birth defects. Both products improve healthcare quality, access, or costs by over 15% to align with GE's Healthymagination initiative. The team proposes delaying TEEmax and not introducing UltraLipo, as they do not as clearly meet Healthymagination goals. Risks include distribution challenges, competition, and buyer resistance. The team outlines execution plans focusing on targeted markets.
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2. Disclaimer
Neither this presentation nor any of its contents are to be distributed to third parties without the prior written consent of China Health Labs & Diagnostics Ltd.
(“China Health Labs”). This presentation supersedes and replaces any and all material s which may have been provided to potential investors. There are certain
risks inherent in an investment in the securities of China Health Labs, which prospective investors should carefully consider before investing in the securities of
China Health Labs. Reference is made to the section entitled “Risk Factors” in the draft Filing Statement of China Health Labs dated May 30, 2010, which section
is incorporated by reference into this investor presentation, for a discussion of the risks inherent in an investment in the securities of China Health Labs. The draft
Filing Statement is available on SEDAR at www.sedar.com under China Health Labs’s profile.
This presentation is not, and under no circumstances is it to be construed as, an advertisement or a public offering of these securities. This presentation is
personal to each offeree and does not constitute an offer to any other person or to the public generally to subscribe for or otherwise acquire any of the securities
referred to herein. No securities regulatory authority or similar authority has reviewed or in any way passed upon the presentation or the merits of these securities
and any representation to the contrary is an offence. This presentation has been prepared for information purposes only in order to assist prospective investors in
evaluating an investment in China Health Labs.
Except for the statements of historical fact, the information contained herein may be of a forward-looking nature. Such forward-looking information involves
known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of China Health Labs to be materially
different from any future results, performance or achievements expressed or implied by statements containing forward-looking information. Although China Health
Labs has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as
anticipated, estimated or intended. There can be no assurance that statements containing forward looking information will prove to be accurate as actual results
and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on statements
containing forward looking information.
The information contained herein includes market and industry data that has been obtained from third party sources, including industry publications, as well as
industry data prepared by China Health Labs management on the basis of its knowledge of and experience in the industry in which China Health Labs operates.
Third party sources generally state that the information contained therein has been obtained from sources believed to be reliable, but there is no assurance as to
the accuracy or completeness of included data. China Health Labs believes that its industry data is accurate and that its estimates and assumptions are reasonable,
but there is no assurance as to the accuracy or completeness of this included data. Although the data is believed to be reliable, China Health Labs has not
independently verified any of the information from third party sources referred to in this presentation or ascertained the underlying economic assumptions relied
upon by such sources.
2
3. Mission Statement
To be the leading provider of total lab solutions for
medical diagnostics and food safety in China
3
4. Company Overview
Who We Are
China Health Labs & Diagnostics is a leading provider of total lab solutions for medical
diagnostics and food safety in China
• We develop and sell proprietary total lab solutions to targeted sectors and sell diagnostic equipment & reagents to
large urban hospitals
• We generate revenues from the sale of solutions and equipment, and recurring revenues from reagents and service
• We manufacture our own propriety equipment and reagents in our Beijing facility
2010 Performance & Status
Revenue growth of 41% to 33.7 million
Net Income growth of 41% to $5.5 million equal to EPS of $0.10
Net income growth of 78% and EPS of $0.12 excluding one-time going public expense
Installed 124 rural labs to have total 210. Secured bid for 587 new locations in Jilin
More than doubled sales of POCT solutions to the Chinese military
Increased sales of food safety solution to Beijing municipal government by over 40%
Increased sales of equipment and reagents by 19% to large urban hospitals
4
4
5. Growth Strategy
• Only provider of total lab solutions to our targeted sectors, providing premium value
compared with individual products
Provide Solutions • Total lab solutions combines equipment, software, installation & training and ongoing
supply of reagents and service
• Building tremendous customer loyalty and multiple recurring revenue streams
• On solutions where we have competitive advantages in technology and relationships
Focus Resources • On sectors that have Chinese government policy and budget support
• On sectors where we have limited competition and large market potential
• Total rural hospital lab solution
Leverage Track Record • POCT solutions for military and emergency rescue applications
to Build Market Share • Food safety testing solutions
• Selected products for large urban hospitals
Collaborative Product • Developed rural lab solution with provincial and central government Ministry of Health
& Service • Joint R&D agreement with the Chinese military
Development • Developed food safety testing solution with the Beijing government
• Reagent technology that can enhance ongoing revenues to rural labs and urban hospitals
Acquisitions and • Small size medical equipment and manufacturers with established brands, high quality
partnerships products and complementary customers
5
6. China Market Size and Growth
• Large and growing market, driven by increasing Chinese wealth and growing
consumer demand for improved health care
• Trend towards universal health care system
• Chinese government policy and budget support for our key sectors: improved rural
health care, emergency and rescue services and food safety
China’s Medical Device Market China’s Per Capita Healthcare Expenditures (2006)
US$ Billions
Sources: China: Accessing the Medical Device Market. Espicom Business Intelligence, July 2007; Report of Chinese Medical Instrument Industry under International Financial Crisis, 2009;
The Red Hot Market for Medical Devices in China by: Evelyn Rubin September 08, 2006; How will China's healthcare reform affect the medical device sector in 2009? by Glenn Hou
6
7. Business Sectors
• Started business in 1993 by
importing equipment and
reagents for large urban hospitals
• 2010 growth driven by 100%
increase in sales of total lab
solutions to three new sectors
• In 2010 three new sectors
increased to 41% of revenues
from less than 30% in 2009, trend
to continue in 2011 and beyond
• Generate higher margins in new
sectors due to proprietary
solutions and limited competition
7
8. Products and Services
1) Rural hospital lab solution
5) Equipment & Reagents
2) Point-of-Care
Technology
Solution
4) Service, training and
support services 3) Food safety ‘quick-
test’ lab solution
Strong suite of complementary products
8
9. Large Urban Hospitals
Overview
• Large existing market served by many Chinese and international players
• Lower margins than for total lab solutions business
Competitive Advantages Photo
• Long term market presence, since 1993
• Strong market position with deliveries to
more than 500 of the 1000 biggest hospitals
• Competitive product range with a
combination of imported and locally made
products
• In 2010, revenues grew by 19% and accounted
for 59% of total revenues
• Opportunity to accelerate growth if we
localize production of high quality reagents
9
10. Rural Hospitals and Labs
Overview
• Turnkey package of diagnostic testing equipment, installation & training, hardware and software and
ongoing reagent supply & service
• Company estimates market opportunity is approximately $2 billion over next 5 years based on
50,000 existing and 40,000 new rural hospitals throughout China
Competitive Advantages Photo
• First-mover advantage to aggressively roll out
network of clinics before competition can
establish a comparable product
• Installed base of 210 rural hospitals plus new
bid to install 587 – at least 797 for 2011
• Initial revenues and profits from installation and
recurring revenues from reagents and service
• Currently no competitors due to high barriers to
entry: long certification process, requirement
for full suite of complementary products,
relationships with provincial governments
10
11. Military & Emergency Rescue Services
Overview
• Point of Care Technology (“POCT”) Dry-chemistry diagnostic solution for use in ‘out-of-lab’
environments where urgent diagnosis is required (natural catastrophes, military settings)
– Used in joint military exercises and disaster relief in China, Haiti, Pakistan, Peru and Indonesia
Competitive Advantages Photos
• China Health is the only supplier in China
• Closed system with exclusive reagent supply
• Patented system protected by registered
copyright
• Chinese military bought 17 systems in 2009 &
more than doubled order in 2010
• Developing full range of POCT products with
Chinese military in three year R&D
agreement
• 13 systems sold to NERT in 2011
• Appeals to international markets
11
12. Food Safety Testing
Overview
• Lab solutions for the PRC government to test the safety of food for public consumption
– Tests the chemical or biochemical index of food items similar to testing that of the human body
Competitive Advantages Photo
• Established market
– established business in 2008 for Beijing
Olympics, later set up 17 large food safety
testing labs for the Beijing government at food
distribution centers, mini-labs and mobile labs
– Beijing government increased order in 2010
• New LIS and mobile POCT products under
development
• Use “Beijing Model” as reference site to sell
solution to additional cities in China
• Company estimates that total Chinese
market opportunity is over $1 billion for 50
largest cities in China (660 cities in China)
12
13. Locations and Distribution
Facilities
• Beijing: HQ and 15,600 m2 production facility
Company facility Heilongjiang
• Guangdong: Sales and distribution hub Direct sales force presence
Planned sales force expansion Jilin
• Shanghai: Sales office
Liaoning
Direct Sales and distribution Beijing
• 58 person sales force, with direct sales in 12 Hebei
regions Shanxi Tianjin
• Direct sales of of total lab solutions Henan
• Third party wholesale distribution network, Shanghai
consisting of approximately 25 distributors for Jiangsu
large urban hospitals Sichuan
Jiangxi Zhejiang
Import business
• Typically highly advanced equipment
Guangdong
• Exclusive distributor in China for 3 European Guangxi
medical device manufacturers
• Partners include Trinity Biotech, Toshiba, Boule
Medical AB, Eschweiler, Maxmat, Abbott
Laboratories, and Elektronika 77
In-place manufacturing operating at 25% capacity to support internal growth
13
14. Management and Board
Management
• Founded Biochem Group in 1993
Shiping (Wilson) Yao
• 20 years experience in the medical equipment industry
President, CEO, Chairman and
• Member of China’s National Standardization Technical Committee
Director
• Member of the Board of Renmin University of China
Yuqiang Tang
• Over 15 years of managerial, sales and marketing experience
COO, Director
Bill Tunbrant • Wide range of experience in the medical equipment industry, as well as in international manufacturing
VP of Marketing, Director • Former director of Nibe Industrier AB (OMX: NIBE’B)
Adam Kniec • Founder of ArkOrion Enterprises Inc., a provider of accounting and financial reporting services to Canadian
CFO and US publicly traded companies
Chao Zhang
• 10 years financial management experience in the medical equipment and private health care industries
VP of Finance
Stephen D. Wortley
• Currently a partner at the law firm Lang Michener LLP
Secretary
Non-Executive (independent) Directors
• Deputy Dean of the School of Finance of Renmin University
Yumin Zhuang
• Independent supervisor with China CITIC Bank
Hong Chang • Physician with the University Health Network in Toronto
• Director of Migao Corporation (TSX: MGO)
Paul Haber
• Former Vice President, Chief Financial Officer and Corporate Secretary of QuStream Corporation (TSXV:QVC)
• Director of Zongshen PEM Power Systems (TSX: ZPP)
Kim Oishi • Former President and Director of Hanfeng Evergreen (TSX: HF); Senior Vice President of Hanwei Energy (TSX:
HE); Director of Cantronic Systems (TSX-V: CTS); and Grand Power Logistics (TSX-V: GPW)
14
15. Financial Highlights
000’s (except per share amounts)
2010 2009 Change
Revenue $33,705 $23,824 41%
Gross Margin 39.3% 34.7% 13%
Net Income $5,527 $3,914 41%
EPS - Diluted $0.10 $0.07 43%
WANS - Diluted 55,188 52,233 6%
Total Assets $37,081 $21,361 74%
Long Term Financial $Nil $Nil
Liabilities
• Strong revenue growth and margins drive earnings growth
• Net income growth of 78% and EPS of $0.12 in 2010, if one time QT expenses are excluded
• Sufficient funding to continue growth in 2011
• May need additional debt of equity to for acquisition or for large rural lab contract
15
16. Outlook
• Expect continued strong revenue growth in 2011 and beyond, driven by growth
of total lab solutions for three key sectors
• Expect growth of revenue from large urban hospitals to be lower, such that total
lab solutions to account for growing percentage of revenues
• Gross margins expected to be stable in 2011, supported by strong margins
from proprietary products and services
• Sufficient working capital and capacity to support 2011 growth
• Continued strong growth in net income and EPS expected for 2011
16
18. History of the Company
1993 • Company founded by Mr. Wilson Yao in Guangzhou
• Began by providing distribution and services for medical diagnostic equipment to hospitals
1995 • Begin geographic expansion within China
1998 • Established offices outside of Guangdong, forming the basis for a regional distributors and service network
2003 • Transformed from distributor to manufacturer
• Relocated head office to Beijing
2007 • Began construction of a new R&D and production facility
• Awarded PRC state level and military tenders for laboratory equipment
• Developed Biochem branded lab information hardware and software system
• Launched the total lab solution in rural areas of China (20 rural labs in Henan province)
2008 • Recognized as being compliant with the PRC’s “Good Manufacturing Practice” (GMP)
• Entered into agreement Liaoning province to implement 66 rural labs
• PRC government began using Biochem Group products in food safety testing
2009 • R&D and production centre was officially placed into operation
• First batch of point-of-care-technology products were used in military exercises
2010 • Accumulated 60 PRC government issued production licenses for medical diagnostic equipment and reagents
• Focus on growth opportunities in rural diagnostic facilities, point-of-care-technology, and food testing
18
18
19. State of the Chinese Healthcare Industry
• Old system (pre 2009): Market-oriented (hospitals run as profit centers)
– Resulted in higher medical fees, making medical services less affordable to ordinary citizens
– Large development gap between urban and rural areas
– Low government funding
– Weak rural healthcare facilities
– Increasing disease burdens
• New system (post 2009): Universal health care
– Investment of RMB 850 billion (US$125 billion) over the next three years
– Focus on improving rural hospitals, public emergency rescue forces and good safety controls
– Expanding coverage of basic medical insurance from 30% today to 90% in 2011
China’s Health Care Expenditure as a % of GDP vs. G8 Nations (2006) China’s Hospital Beds per 10,000 Citizens vs. G8 Nations (2004-2006)
Source: OECD
19
20. Recent Sweeping Healthcare Reforms
• In April 2009, the Chinese government announced plans to reform China’s healthcare
system into a universal healthcare system
• The plan involves the following commitments:
– An investment of RMB 850 billion towards healthcare reform over the next three years;
– Prioritized development of small, rural hospitals and clinics
– Implement a diversified medical insurance system targeting coverage of over 90% of the
population by 2011
• The government has committed to undertake the following improvements:
– Upgrade basic treatment and diagnostic equipment at 50,000 existing township clinics
– Build 39,400 new diagnostic facilities, health clinics, hospitals and service centers primarily in
rural areas
– Train 1.37 million village doctors and 160,000 community doctors
Massive government reforms targeted at improving healthcare for rural citizens
Source: JP Morgan’s Hands-on China Report – March 9, 2009
20