Zhejiang Qiming Biotech Co., Ltd. Generic API Manufacturer G i API M f t Custom Process Development Contract Manufacturing
History• Qiming Biotech was formed in 2010 from the merger of Eastbound Synopharma and the API division of Qiming Pharma• Eastbound was a company established in 2002 in Shanghai and well known for custom process development of key pharmaceutical intermediates• Qiming Pharma is a long term manufacturer of both APIs and intermediates for the pharmaceutical industry with di t di t f th h ti l i d t ith more than 17 years of experience.
Organizations Qiming Biotech Eastbound Synopharma Qiming Pharma (HK) Holdings Ltd Financial Non‐cGMP Manufacturing Shangyu Process Process Shangyu Development Manufacturing Institute cGMP Manufacturing g Process Development p Quality Assurance Technology Transfer
Management TeamManagement Team Dr. Leo Lin VP Quality and Regulatory Affairs Chris Vance Michael Zhang VP Sales, Marketing and President & CEO Business Development Dr. Yuan Li VP Process Development VP Process Development Operations Dr. Young Lo Research Fellow R h F ll Linzhong Zhou Over 100 years of Western Over 100 years of Western Finance Director Finance Director Pharmaceutical Business Experience
Our Advantages• cGMP and non‐cGMP manufacturing of APIs and GMP d GMP f t i f API d intermediates for pharmaceutical and veterinary industry• Sophisticated development and manufacturing capability p p g p y offers custom solutions to complex problems• Frequent communication with clients; no surprises • Broad technology platform with niche capabilities on commercial scale • Experienced team of managers with western Experienced team of managers with western pharmaceutical experience
Business FocusB i F cGMP and Non‐GMP Manufacturing APIs and IntermediatesCustom Solutions to Complex Problems
Qiming Biotech Manufacturing Qiming Biotech Manufacturing• Shangyu site is 43,000 m2 (10+ acres) located in Hangzhouwan Industrial Industrial Park in Shangyu, Zhejiang • Plant 1 certified by China’s SFDA for APIs and inspected by major pharma by major pharma companies • Plant 2 installation underway. Designed for ICH Q7A level cGMP compliance
APIs ListAPIs ListNo. API CAS # Pharmaceutical Status US DMF filed. Inspected by US customer and waiting non‐steroidal anti‐inflammatory for FDA inspection at 2Q 2012. ANDA approval is driving FDA 1 Mefenamic acid 61‐68‐7 61 68 7 drug (NSAID). drug (NSAID) schedule. Commercial production presently for non‐ Tradename: PONSTEL regulatory market Anitinflammatory, mucoregulator. No SFDA file, but in commercial production for non‐2 Talniflumate 66898‐62‐2 Tradename TALMAIN (Korea), regulatory market LOMUCIN non‐steroidal anti‐inflammatory drug (NSAID). Tradename: No SFDA file, but in commercial production for non‐3 Tolfenamic acid 13710‐19‐5 CLOTAM regulatory market Calcium 4 51828 93 4 51828‐93‐4 Phenylpyruvate5 α‐Ketovaline Calcium 51828‐94‐5 Combination of amino acids for 6 α‐Ketoleucine Calcium 51828‐95‐6 use in managing protein Product licenses approved by SFDA. Final documentation D,L‐α‐Ketoisoleucine metabolism during renal underway. SFDA inspection expected in 3Q 2012 with 7 66872‐75‐1 Calcium insufficiency. Tradename: approval thereafter. y y 2‐Hydroxy‐4‐ Ketosteril8 (methylthio)butyric 4857‐44‐7 acid calcium salt Antihistamine, In commercial production for non‐regulatory market.9 Fexofenadine HCl 15439‐40‐8 Tradename: Allegra US DMF will be filed in Q3, 2012 Antidepressant10 Venlafaxine 93413‐69‐5 In commercial production for non‐regulatory market. Tradename: Effexor Tradename: Effexor Stroke recovery Process development completed, documents will be filed 11 Edaravone 89‐25‐8 Traded by Mitsubishi with SFDA in Q4 2012 Respiratory stimulant. Process development completed and US DMF will be filed 12 Doxapram 7081‐53‐0 Tradename: Dopram with FDA in Q4 2012
Q Qiming Biotech Manufacturing g otec a u actu g• cGMP Production in two multi‐purpose manufacturing units. – I l t d Isolated areas for finishing final API steps including drying, milling, blending f fi i hi fi l API t i l di d i illi bl di – Wide range of vessels, glass and SS, to permit flexible process arrangements – Solid procedures and training programs to assure cGMP quality adherence• Experienced QC and QA team to review and audit manufacturing Experienced QC and QA team to review and audit manufacturing procedures – On site analytical laboratories assure timely data for manufacturing and validated procedures for regulatory filing.• Western pharma audited facilities – Major pharma inspections – PAI inspection by US FDA completed. Facility approved with no 483• Non‐GMP Production partnerships with Qiming Pharma and Dafeng Eastbound – Large scale facilities permit easy scale‐up and supply of critical intermediates – Wide range of chemistry practiced••
Key TechnologiesKey Technologies• Oxidation with various oxidants O id ti ith i id t• Halogenation including Br, I and Cl• Heterocyclic chemistry: indoles, pyridines, piperidines, etc. Heterocyclic chemistry: indoles pyridines piperidines etc• Grignard reactions• Sandmeyer Reactions y• Nitration using nitric acid• Hydride reactions• Other chemical reactions such as acylation, esterification, condensation, cyclization, sulfonation, polymerization etc.
Plant 1: cGMPPlant 1: cGMP Plant• B ilt i 2005 t Built in 2005 to produce API and d API d late stage intermediates• Certified by SFDA in 2006• Five additional APIs developed for Five additional APIs developed for SFDA and western regulatory approval Vessels 11.0 m3 Glass lined Stainless• US DMF submitted for mefenamic US DMF submitted for mefenamic 2000 liter 2000 lit 2 2 acid; awaiting FDA inspection and 500 liter 4 2 certification Centrifuge flatbed 2 stainless Dryer Tray dryer 1 500 liter Double cone vacuum 1 1000 liter Double cone vacuum 1 Purified Water System Mill HVAC class 100,000 rated FDA rating: D 15 Pa ±1°C, ±10% RH
Facilities and UtilitiesFacilities and Utilities• Total area: 43,000 m2• Total reactor volume: Plant 1: 11 m3 Plant 2: 17 m3• Reactors: Glass, Stainless Glass Stainless• Total employees: 70• Reaction Temperature Range: ‐30 to 150 °CUtilities:• Po er Power: Total capacity 800 kw Total capacit 800 k• Steam: 10 bar max• Refrigeration: g 120,000 kCal ,
Shangyu Process Development Institute• More than 300 projects completed in the past 7 years;• Over 15% of developed projects moved into pilot or p p j p commercial scale;• Professional R&D team with western pharma working experience;• Long term business relationship with big pharmas and western CMO companies.
Shangyu Process Development Institute Process Development Institute
Shangyu PSh Process Development Institute D l t I tit tProcess Development, Analytical Method p , y Development and Production Support• 20 Chemists & Engineers including Dr Young Lo and Dr Yuan Li• 1400 m2 modern development and analytical laboratory• 24 fume hoods for bench development• 3 walk‐in hoods for cGMP kilo lab• State of the art analytical capability – HPLC, GC, UV, FT‐IR, etc – Easy access to AA, LC‐MS, TGA, DSC, NMR, EA, X‐ray, etc• Onsite access to chemical research Onsite access to chemical research resources – SciFinder, Reaxys
Development Laboratory& Kilo LabDevelopment LaboratoryBench LabsBench Labs 7 350 m2 350 m Fume hoods 24 Each lab air controlled independentlyKilo Lab Vessels Glass 50‐200 liters Capacity 1‐5 kg p y g cGMP finishing section tray dryer filter press HVAC class 100,000 Kilo labAnalytical LabAnalytical Lab 7 700 m2 700 m HPLC GC IR Microbiology Stability y
Development Laboratory& Kilo LabDevelopment LaboratoryBench LabsBench Labs 7 350 m2 350 m Fume hoods 24 Each lab air controlled independentlyKilo Lab Vessels Glass 50‐200 liters Capacity 1‐5 kg p y g cGMP finishing section tray dryer filter press HVAC class 100,000Analytical LabAnalytical Lab 7 700 m2 700 m HPLC GC IR Microbiology Stability y
No SurprisesN S i Reply to inquiry Project evaluation within 3 days Detailed proposal Project preparation presented within 10 days Frequent progress reports; Project execution j no surprises no surprises Project completion Campaign reports and Campaign reports and analytical documentation
Thank You Visit us in Shangyu, ZhejiangDr. Yuan Li Chris VanceVP Process Development Operations VP Sales, Marketing Business Dev Sales Marketing,email@example.com firstname.lastname@example.org+86 (575) 8272 6990-8011 +1 (804) 601-2760