MasterLink Investor Conference November 25, 2019

1. 免疫與標靶抗癌療法
全球創新者
董事長 張念慈
2019.11.25

2. Safe Harbor Statement
This presentation contains certain forward-looking statements.
These forward-looking statements may be identified by words such as ‘believes,’ ‘expects,’ ‘anticipates,’ ‘projects,’ ‘intends,’ ‘should,’ ‘seeks,’ ‘estimates,’ ‘future,’ or similar
expressions or by discussion of, among other things, strategy, goals, plans, or intentions. Various factors may cause actual results to differ materially in the future from
those reflected in forward-looking statements contained in this presentation, among others:
1. Pricing and product initiatives of competitors
2. Legislative and regulatory developments and economic conditions
3. Delay or inability in obtaining regulatory approvals or bringing products to market
4. Fluctuations in currency exchange rates and general financial market conditions
5. Uncertainties in the discovery, development, or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials
or research projects, unexpected side effects of pipeline or marketed products
6. Increased government pricing pressures
7. Interruptions in production
8. Loss of or inability to obtain adequate protection for intellectual property rights
9. Litigation
10. Loss of key executives or other employees
11. Adverse publicity and news coverage
OBI Pharma cautions that this foregoing list of factors is not exhaustive. There may also be other risks that management is unable to predict at this time that may cause
actual results to differ materially from those in forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date on which they are made. OBI undertakes no obligation to update publicly or revise any forward-looking statements.
Any statements regarding earnings growth is not a profit forecast and should not be interpreted to mean that OBI’s earnings or earnings per share for this year or any
subsequent period will necessarily match or exceed published earnings or earnings per share forecasts of OBI Pharma, Inc.
2

3. Agenda
3
Novel
Cancer
Pipeline
Company
Introduction
Key
Milestones
and Inflection
Points
Globo Series
Science
Leadership
1 2 3 4

4. 4
San Diego
USA
Shanghai
CHINA
Global HQ
Taipei
TAIWAN
Hong Kong
CHINA
Melbourne
AUSTRALIA
“
設立日期： April 29, 2002
上櫃日期： March 23, 2015
市值 (Nov. 22, 2019)： ~US$833M (~NT$25B)
上櫃募資金額： ~US$200M (~NT$6.2B)
帳上淨現金： ~US$154M
員工人數： 117
台灣浩鼎生技股份有限公司 (TPEx: 4174.TWO)
www.obipharma.com

5. 張念慈 博士
創辦人暨董事長
黃秀美
總經理
具豐富國際經驗的管理團隊
5
Kevin Poulos
Chief Commercial
Officer
Mitch Che
Chief Operating
Officer
David Hallinan,
PhD
VP Regulatory
Affairs
賴建勳 博士
VP Research
蔡承恩 醫師/博士
VP Medical and
Clinical Development
賴明添 博士
Chief Science Officer
Tillman Pearce, MD
Chief Medical Officer
陳志全
Chief Financial
Officer

6. 科學與醫學顧問群
6
Stephan Landisch, MD
石全, PhD 陳鈴津, PhDRussell Greig, PhD 陳紹琛, MD, PhD
翁啟惠, PhD 閻雲, MD, PhD 楊泮池, MD, PhD

7. OBI 站在癌症創新治療最前線
7CAR T, chimeric antigen receptor T-cell therapy; IV, intravenous; MOA, mechanism of action; PD-1, programmed death 1; PD-L1, programmed death ligand 1.
Explosion in
Immunotherapy
Driven by PD1/PD-L1 and
Novel Antigens/MOAs
Continued Growth of
Targeted Therapy
Driven by CAR T
Improved
Chemotherapies
Tumor-Specific
Improved Formulations
創新驅動力
INNOVATION DRIVERS
Targeted Prodrugs
IV Oral Therapy
Synergistic
Combinations
Anchored by PD-1/PD-L1
Antibody-Drug
Conjugates (ADCs)
Bispecific Antibodies
創新趨勢
INNOVATION TRENDS
OBI Pharma is
Focused on:
Novel Antibodies
Innovative
Technologies
Synergistic
Combinations
Tumor-Specific
Chemotherapy
浩鼎創新
OBI INNOVATION

8. OBI轉型為癌症創新療法多元產品組合的醫藥公司
8
mAb, monoclonal antibodies; GSL, glycosphingolipid.
GSL mAb
GSL Vaccine Targeted
Prodrug
Antibody-Drug
Conjugate
Bispecific
mAb
Targets:
Assays:
Globo H (+), SSEA-4 (+), AKR1C3 (+) Tumors
Globo H, AKR1C3

9. Agenda
9
Novel
Cancer
Pipeline
Company
Introduction
Key
Milestones
and Inflection
Points
Globo Series
Science
Leadership
1 2 3 4

10. 目前全球唯一
開發Globo H和SSEA4醣分子免疫療法
進入中後期臨床階段的生技公司
10
OBI台灣浩鼎

11. Globo Series: 獨特的醣鞘脂類 (GSLs)
11
Zhang et al. Frontiers in Immunology 2019;10
Globo Series發生於胚胎早期的特異
性表達，為多能胚胎SC標誌，與上
皮細胞的間質轉化（EMT）相關。
GSL在分子信號傳導、細胞串擾和細胞粘附中的作用

12. Globo Series 抗原表現於多種上皮細胞癌
12
* >50% expression highlighted.
Note: Expression of Globo Series was determined by flow cytometry; More than 15% is regarded as positive.
Lou YW, et al. Proc Natl Acad Sci U S A. 2014;111(7):2482-2487.
Cancers Globo H* SSEA-3 SSEA-4*
Esophagus 食道癌 100% 0% 50%
Stomach 胃癌 100% 50% 67%
Pancreas 胰臟癌 75% 38% 100%
Prostate 攝護腺癌 25% 25% 100%
Liver 肝癌 90% 40% 60%
Ovary 卵巢癌 56% 22% 89%
Colon 大腸癌 86% 0% 71%
Kidney 腎癌 86% 0% 83%
Mouth 口腔癌 85% 15% 62%
Cervix 子宮頸癌 25% 50% 75%
Breast 乳癌 61% 26% 74%
Brain 腦癌 35% 53% 71%
Lung 肺癌 65% 25% 65%
Bile duct 膽管癌 60% 20% 40%

13. Globo H 對腫瘤存活扮演必要角色
13
Cancer Res. 2016.
AACR Special Conference Abstract A20.
Cheng JY, et al. Cancer Res. 2014;74(23):6856-6686.
J Cancer Sci Ther. 2013;5(7):264-270.
OBI Data on File.
促進免疫抑制
Tumor Shedding of
Globo H Ceramide
TRAX
Ca2+ 
Endothelial Cells
Notch1
Ub
Ub
Degradation
Tumor Cells
Lymphocytes
Kinase
Tumor Survival
Kinase
Kinase
促進血管新生
促進腫瘤存活訊號傳導

14. 透過增加存活率和減少凋亡途徑，來促進腫瘤細胞存活。
Chuang, PK. et al, PNAS, 2019, p. 3518-3523
14
Globo Series GSL

15. Agenda
15
Novel
Cancer
Pipeline
Company
Introduction
Key
Milestones
and Inflection
Points
Globo Series
Science
Leadership
1 2 3 4

16. 浩鼎的多元化抗癌新藥研發產品線
ALL, acute lymphoblastic leukemia; CRPC, castration-resistant prostate cancer; HCC, hepatocellular carcinoma; TNBC, triple-negative breast cancer.
16
作用靶點 潛在適應症 新藥探索 臨床前研究 臨床一期 臨床二期 臨床三期
OBI-833
OBI-888
OBI-999
OBI-866
OBI-898
Globo H
三陰性乳癌
肝癌
Globo H
Globo H
Globo H
SSEA-4
SSEA-4
數種癌症
數種癌症
數種癌症
數種癌症
數種癌症
OBI-3424 AKR1C3
肝癌
攝護腺癌
白血病
Adagloxad
Simolenin
疫苗
疫苗
單株抗體
抗體小分子藥
物複合體
單株抗體
疫苗
小分子化
療前驅藥
類型抗癌新藥

17. Adagloxad Simolenin
誘導產生Globo H抗體的首創型主動免疫療法新藥
First-in-Class Active Immunotherapy Inducing Globo H Antibodies
17

18. APC, antigen-presenting cell; CTL, cytotoxic T-lymphocyte; KLH, keyhole limpet hemocyanin; MHC, major histocompatibility complex; TCR, T-cell receptor..
Adagloxad Simolenin
引發ADCC & CDC 促使腫瘤細胞死亡
18
MHC
Adagloxad
Simolenin
T Cell
TCR
ADCC
Antibody-Dependent
Cellular Cytotoxicity
Tumor cell
B
Anti-Globo H
IgM
Anti-Globo H
IgG
Globo H
KLH
IgG
IgM
Complement
CTL
Antigen-Presenting Cell
CDC
Complement-Dependent
Cytotoxicity

19. Adagloxad Simolenin 二期試驗重要發現
（以轉移性乳癌患者為受試對象）
PFS, progression-free survival.
Clinicaltrials.gov. Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects. NCT01516307
19
腫瘤的Globo H表現量
與無惡化存活期(PFS)
相關
接受完整9次注射的受試
者有較佳的無惡化存活期
疫苗引發 抗Globo H的
IgG抗體濃度與無惡化存
活期(PFS)正相關

20. Adagloxad Simolenin 全球臨床三期試驗
（以早期高復發風險之三陰性乳癌病患為受試對象）
ECOG PS, Eastern Cooperative Oncology Group Performance Status.
Clinicaltrials.gov. Study of Adagloxad Simolenin (OBI-822) and OBI-821 Versus Placebo Treatment for High Risk Early Stage Triple Negative Breast Cancer
Patients (TNBC) Following Neoadjuvant or Adjuvant Chemotherapy. NCT03562637
20
主要試驗指標：無「侵襲性疾病」存活期 (Invasive Disease-Free Survival, IDFS)
次要試驗指標：整體存活期、生活品質、安全性、耐受性
期中分析：「侵襲性疾病」發生的個案數達預估數的70%時進行評估
預估試驗期間：兩年受試者給藥期、三年無侵襲性疾病存活期評估，加上兩年整體存活期評估
主管機關核准進行：美國、澳洲、台灣、香港、俄國、烏克蘭
下一目標：歐盟、中國、韓國
R
1:1
實驗組
Adagloxad Simolenin
(Adagloxad Simolenin 30 μg + OBI-821 100 μg)
334位受試者
對照組
安慰劑 (phosphate-buffered saline)
334位受試者
用藥期間約兩年（共21針）
早期高復發風險之三陰性乳癌
共 668 位受試者
Neoadjuvant patients with
residual disease, or
Adjuvant patients with
4 axillary nodes
Globo H positive
ECOG PS 0-1

21. OBI-888
作用於Globo H之首創單株抗體
21

22. 癌症種類 動物模型 劑量 (mg/kg) 給藥方式
在最高劑量之腫瘤生長
抑制 (TGI), %
乳癌 MCF7 1, 3, 10 Q2W x 6 85
乳癌 HCC-1428 3, 10, 30 Q2W x 6 55
胰臟癌 HPAC 5, 20, 80 Q2W x 5 47
直腸癌 SW480 100 Q2W x 4 49
肺癌 NCI-H526 10, 30, 100 Q2W x 5 43
OBI-888 五種動物模型顯示抑制腫瘤生長之效果
Q2W, every 2 weeks; TGI, tumor growth inhibition.
OBI Data on File.
22

23. OBI-888 具高度腫瘤特異性
（Highly Tumor Specific）
23
OBI Data on File.
MCF7-TUMOR BEARING MICENORMAL MICE
標記Globo H mAb（OBI-888）
在MCF7小鼠腫瘤的分佈
Eppendorf 試管
僅供參考

24. OBI-888 保護T細胞免於Globo H抑制
aAPC, artificial antigen-presenting cells; CHO-K1, Chinese hamster ovary K1 cells.
PD-1 effector cells were pretreated with 40 µM Globo H Ceramide for 20 hours in the presence or not of 10 µM OBI-888, and then incubated with
aAPC/CHO-K1 cells for 6 hours. The RLU signal was determined after 10 minutes developing with Bio-Glo™ Luciferase Assay Reagent.
Each treatment was performed in quintuplicate. RLU shown as mean ± standard deviation (SD).
OBI Data on File.
24
0
10000
20000
30000
40000
IntensityofT-cell's"Glo"(RLU)
aAPC/CHO-K1 Cell
T-cell activity with Globo H Ceramide
OBI-888
Globo H Ceramide
OBI-888
+
-
-
-
+
+
4-fold increase
aAPC/CHO-K1 Cells

25. OBI-888與Anti-PD-L1單株抗體併用
顯示保護T細胞活性之加乘效果
OBI Data on File.
PD-L1 aAPC/CHO-K1 Cell
T-cell activity in PD-L1(+) cells with
Globo H Ceramide
8-fold increase
2-fold increase
OBI-888 and a-PD-L1 mAb
a-PD-L1 mAb
Globo H Ceramide
a-PD-L1 mAb
OBI-888
- + - + +
- - + + +
- - - - + 25
aAPC/CHO-K1 Cells

26. OBI-888 具發展合併療法之潛力
ADC, adenocarcinoma; EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer; PI3K, phosphatidylinositol-4,5-bisphosphate 3-kinase;
SqCC, squamous cell carcinoma.
Yang CY, et al. Cancer Biomark. 2017;21(1):211-220.
21%
Dual
Expression
N = 228 patients with Stage 1 NSCLC, including both ADC and SqCC
在第一期非小細胞肺癌（Stage 1 NSCLC），Globo H的表現不但與PD-L1表現
相關 (P=0.021)，亦與 EGFR (ADC, P=0.026) 及 PI3K 的現相關 (SqCC, P<0.001)
PD-L1 overexpressed
in 46% of patients with
Stage 1 NSCLC
26
Globo H overexpressed
in 38.6% of patients with
Stage I NSCLC

27. OBI-888一期臨床試驗
27IDE, Investigational Device Exemption.
Clinicaltrials.gov. Study to Evaluate the Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. NCT03573544.
多種固體腫瘤
胰臟癌、乳癌、胃癌、食道癌、
大腸直腸癌、肺癌
Part 1
劑量遞增階段
(DOSE ESCALATION)
OBI-888
Part 2
族群擴增階段
(COHORT EXPANSION)
OBI-888
Apostolia M Tsimberidou, MD, PhD
Department of Investigational Cancer Therapeutics
Division of Cancer Medicine
以IDE-Approved Assay量測Globo H表現量

28. OBI-888 臨床一期安全性試驗摘要
• 未發生與該藥品相關之嚴重不良事件(SAE)。
• 未發生劑量限制毒性(DLT)。
• OBI-888顯示耐受性良好。
28
OBI Data on File.

29. OBI-999
作用於Globo H之抗體小分子藥物複合體
(Antibody-Drug Conjugate, ADC)
29

30. OBI-999 以腫瘤特異之Globo H抗原為作用標的
對癌細胞具特異性之細胞毒素於
Globo H高表現之癌細胞釋放
特殊之連接技術 (linker technology)
能維持抗體的安定性以及一致的
drug-to-antibody ratio (DAR)
全球獨家授權 使用ThioBridge® 技術
於Globo Series抗體小分子藥物複合
體(ADC)
ThioBridge® is the registered trademark of Abzena
30
ADC Utilizing Novel Site-Specific Linker
Technology ThioBridge®

31. OBI-999 四種動物模型顯示抑制腫瘤生長之效果
PDX, patient-derived xenograft; TGI, tumor growth inhibition; QW, every week; Q3W, every 3 weeks.
OBI Data on File.
癌症種類 動物模型
劑量
(mg/kg) 給藥方式
在最高劑量之腫瘤反應或腫
瘤生長抑制 (TGI), %
乳癌 MCF7 1, 3 QW x 6 or Q3W x 2 完全反應
胃癌 NCI-N87 1, 3,10 QW x 4
完全反應
(CR achieved at both 3
and 10 mg/kg)
胰臟癌 HPAC 10 QW x 4 完全反應
肺癌PDX LU-01-0266 1, 3, 10 QW x 4 完全反應
完全反應
腫瘤消失
(Tumor Free)
31
=

32. 32

33. OBI-999 第一期臨床試驗
33
IDE, Investigational Device Exemption.
Clinicaltrials.gov. A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of
OBI-999 in Patients With Advanced Solid Tumors. NCT04084366.
多種固體腫瘤
胰臟癌、乳癌、胃癌、食道
癌、大腸直腸癌、肺癌
Part 1
劑量遞增階段
(DOSE ESCALATION)
OBI-999
Part 2
族群擴增階段
(COHORT EXPANSION)
OBI-999
Apostolia M Tsimberidou, MD, PhD
Department of Investigational Cancer Therapeutics
Division of Cancer Medicine
以IDE-Approved Assay量測Globo H表現量

34. OBI-898
以腫瘤SSEA-4抗原為作用標的之單株抗體

35. SSEA-4 抗原高度特異表現於多種癌細胞
(Highly Specific to Cancer Cells)
35Note. Expression of Globo Series Antigens was determined by flow cytometry; >15% expression was regarded as positive.
Lou YW, et al. Proc Natl Acad Sci U S A. 2014;111(7):2482-2487.
Cancers Globo H* SSEA-3 SSEA-4*
食道癌 Esophagus 100% 0% 50%
胃癌 Stomach 100% 50% 67%
胰臟癌 Pancreas 75% 38% 100%
攝護腺癌 Prostate 25% 25% 100%
肝癌 Liver 90% 40% 60%
卵巢癌 Ovary 56% 22% 89%
大腸直腸癌 Colon 86% 0% 71%
腎癌 Kidney 86% 0% 83%
口腔癌 Mouth 85% 15% 62%
子宮頸癌 Cervix 25% 50% 75%
乳癌 Breast 61% 26% 74%
腦癌 Brain 35% 53% 71%
肺癌 Lung 65% 25% 65%
膽管癌 Bile duct 60% 20% 40%

36. SSEA-4 的表現與癌症不良結果相關
36
1. Eur Respir J. 2013 Mar;41(3):656-63.
2. OBI data on file.
3. Aloia et al. Breast Ca Res 2015;17:146
肺癌
食道癌
• SSEA-4 表現與類基底肺癌的不良預後有關1。
• SSEA-4表現與同時接受放療、化療的食道癌患者
預後（OS和PFS）較差有關2 。
三陰性乳癌
TNBC
• 接受化療的TNBC患者，其SSEA-4和ST3GAL2表
現與不良預後（未轉移存活期）相關； SSEA4也與
EMT3相關。

37. 37
PNAS (2015) 112: 6955-60. Fig S8.
SSEA-4 is up-regulated in the EGFR
mutants of lung cancer cell lines
OBI-898 對TKI具抗藥性的肺癌顯現治療潛力
Expression of SSEA4 on the surface of lung cancer cells
SSEA-4 highly expressed in lung tumor cells,
and enhanced with the progression of lung
adenocarcinoma.
EGFRL858R/T790M double mutation
induced Greater SSEA-4 expression

38. 38
EGFRL858R/T790M mice were used. ** EGFR L858R Western Blot was highly correlated to hematoxylin and eosin stain; P<0.01.
OBI data on file.
OBI-898
在EGRF雙突變模型所表現的抗腫瘤作用
PBS
OBI-898
3mg/kg
OBI-898
30mg/kg
EGFR Protein Expression

39. Major TKI Products and Companies
PRODUCT GENERIC NAME COMPANY FIRST APPROVAL
First
Generation
Iressa® Gefitinib AstraZeneca 2003
Tarceva® Erlotinib
Genetech (Roche)/
Astellas
2004
Second
Generation
Gilotrif® Afatinib Boehringer Ingelheim 2013
Vizimpro® Dacomitinib Pfizer Sept 2018
Third
Generation
Tagrisso® Osimertinib AstraZeneca 2015
因應TKI治療出現抗藥性
提供EGFR突變癌症療法新策略
Table summarized by OBI.
39

40. 40
OBI-3424
以表現AKR1C3的腫瘤為標的之小分子化療前驅藥

41. 具腫瘤特異性(Tumor-Specific)之小分子化療前驅藥(Prodrug)
OBI-3424經腫瘤內AKR1C3酵素活化後 會釋放出細胞毒殺劑
OBI-3424
NADPH, nicotinamide adenine dinucleotide phosphate.
41
OBI-3424
Tumor Cells
Killed
Tumor
Cell
AKR1C3
Enzyme
Present
AKR1C3
Active
drug
Prodrug
No AKR1C3
Minimal Impact
on Healthy Cells
Healthy
Cell
O2N
O
O
NMe2
O
P
O
N
N
OBI-3424
AKR1C3
NADPH
HOHN
O
O
NMe2
O
P
O
N
N
HO
P
O
N
N
Active
Crosslink DNA
Cell Death
O2N
O
O
NMe2
O
P
O
N
N
OBI-3424
AKR1C3
NADPH
HOHN
O
O
NMe2
O
P
O
N
N
HO
P
O
N
N
Active
Crosslink DNA
Cell Death

42. 以未被滿足之醫療需求 & AKR1C3酵素高表現之癌症為目標
開發OBI-3424潛在適應症
癌症 臨床發展進度 AKR1C3表現 * %
肝癌 Liver Ongoing 89
對去勢療法產生抗性之
攝護腺癌 CRPC
Ongoing 58
T細胞急性淋巴性白血病
T-ALL
P1 IND planned in Q2/2019
(NCI funded PPTC)
86
腎癌 Kidney n/a 64
膀胱癌 Bladder n/a 66
胃癌 Stomach n/a 59
** AKR1C3 Expression: Guise CP, et al. Cancer Res. 2010;70(4):1573-1584.
CRPC, castration-resistant prostate cancer; IND, Investigational New Drug Application; n/a, not applicable; NCI, National Cancer Institute;
PPTC, Pediatric Preclinical Testing Consortium; T-ALL, T-cell acute lymphoblastic leukemia.
42

43. 以肝細胞癌(Hepatocellular Carcinoma, HCC) & 對去勢療法
產生抗藥性之攝護腺癌(Castrate-Resistant Prostate Cancer,
CRPC)患者為受試對象
43Clinicaltrials.gov. This Study is to Evaluate OBI-3424 Safe and Effective Treatment Dose in Subjects With Hepatocellular Carcinoma or Castrate Resistant
Prostate Cancer. NCT03592264
局部晚期或已轉移
HCC, CPRC
Part 1
劑量遞增階段
OBI-3424
Part 2
族群擴增階段
OBI-3424
以IDE-Approved Assay量測AKR1C3酵素的表現量
OBI-3424臨床試驗

44. OBI-3424
在PDX動物模型(T-ALL 31)明顯降低白血病之骨髓浸潤
PB, peripheral blood; PDX, patient-derived xenograft.
OBI Press Release 30 Oct 2017: OBI Pharma announces OBI-3424 results from the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics.
Days post-treatment initiation
%huCD45+inthePB
Prof Richard B. Lock
Head of the Leukemia
Biology Program
Children’s Cancer Institute
in Australia
Control
Group
OBI-3424
Group
Significant
Difference in
Event-Free
Survival
(EFS)
OBI-3424 is one of the most effective
drugs we have ever tested against T-ALL
in over 12 years of evaluating drugs at the
Children’s Cancer Institute using
preclinical models of childhood ALL
“
“
44

45. Globo Series 腫瘤醣抗原具備與其他抗癌標靶結合
開發創新雙特異抗體(Bispecific Antibody)之潛力
45
VEGF, vascular endothelial growth factor.
+
創新之
雙特異性抗體
SSEA4
Globo H
GLOBO SERIES
腫瘤醣抗原
VEGF
OX-40
PD-L1
CD-137
CD-40
其他抗癌靶點

46. Agenda
46
Novel
Cancer
Pipeline
Company
Introduction
Key
Milestones
and Inflection
Points
Globo Series
Science
Leadership
1 2 3 4

47. 47
Includes Patents Held By Licensors.
Approved Patents Patents in Review
49
63
109
158
2017 20182017 2018
浩鼎研發中產品全球智財權保護

48. 2019達成之研發里程碑
48
Clinicaltrials.gov. This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. NCT03573544
Clinicaltrials.gov. This Study is to Evaluate OBI-3424 Safe and Effective Treatment Dose in Subjects With Hepatocellular Carcinoma or Castrate Resistant Prostate Cancer. NCT03592264
Clinicaltrials.gov. Study of Adagloxad Simolenin (OBI-822) and OBI-821 Versus Placebo Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients (TNBC) Following
Neoadjuvant or Adjuvant Chemotherapy. NCT03562637
獲美國FDA核准
進行I / II期臨床
試驗，針對適應
症癌症進行抗體
小分子藥物複合
體研究
已獲美國FDA核准針對有
AKR1C3表現的實體腫瘤展開
I / II期臨床試驗
FDA並授予用於治療急性淋巴
性白血病(Acute Lymphoblastic
Leukemia, ALL)和肝細胞癌
(Hepatocellular Carcinoma,
HCC)孤兒藥資格
已獲美國FDA核
准進行臨床一期
試驗，並獲FDA
授予治療胰臟癌
(Pancreatic
Cancer)之孤兒
藥資格
啟動以三陰性乳
癌(TNBC) 患者
為受試對象之全
球三期臨床試驗

49. 研發里程碑與價值轉折點2019-2023
49
IDFS, invasive disease-free survival.
以三陰性乳癌（TNBC）為適應症
啟動第三期全球臨床試驗
2018 2020 2021 2022 20232019
Part 2Part 1
臨床試驗
啟動
期中分析收案完成Adagloxad
Simolenin
Part 1
Data
Part 2
Data
Part 2
族群擴增階段
Part 1
劑量遞增階段
Part 2
Data
Part 1
Data
OBI-888
OBI-999
Phase
1
Part 2
族群擴增階段
Part 1
劑量遞增階段
臨床試驗
啟動
Part 2
Data
Part 1
Data
OBI-3424

50. 浩鼎創新多元的抗癌產品線
50
1
全球Globo Series
醣新藥研發的領導
者，研發領域包括
以Globo H以及
SSEA-4為作用標的
之治療性疫苗、單
株抗體，以及抗體
小分子藥物複合體。
4
量測腫瘤抗原表現
之檢驗試劑
全球智財權保護
數個研發里程碑與
價值轉折點
(2019-2020)
3
被腫瘤內AKR1C3
酵素活化之首創小
分子化療前驅藥
(prodrug)
2
Globo Series具備
與其他抗癌標靶結
合，開發具綜效之
雙特異性抗體
(Bispecific
Antibodies)潛力

51. THANK YOU
Please visit our website:
www.obipharma.com