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1 台灣東洋藥品法人說明會蕭英鈞董事長 March 26th, 2015 ( 註 ) 此資料內容並非隸屬財務預測, 僅供參考此資訊內容之財務數字應以公司財報為準

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; and 11 adverse publicity and news coverage. TTY Biopharm 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 forwardlooking 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. TTY Biopharm 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 TTY Biopharm 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 TTY Biopharm Company Limited. 2

3 Mission Become one of the world s most innovative biopharmaceutical companies, devoted to drug development and international marketing. Specialize in oncology business development in the global market; continue to develop and market Critical Infectious disease drug portfolios. Commit to the development and manufacture of Specialty Pharma (patentable or high-barrier products), Biologics and New Medical Entities. Be the best partner for leading pharmaceutical companies who excel in sales and marketing in target markets. Be the best partner for globally innovative pharmaceutical companies to develop and market drug portfolios in Asia-Pacific region. 3

4 Company Overview Founded in 1960, restructured in 1996 Traded in the Taiwan TPEx (2001, Code: 4105); Shares outstanding: 248 Million Shares (December, 2014) TTY Biopharm consolidated sales as 2013: NTD 3.11 Billion, USD 104 Million Headquarters: Taipei, Taiwan; Number of employees: 484; Group: 1000 Major Investments PharmaEngine Inc. Taiwan, 智擎生技 (19.54%)- Market cap( 約 )US$841mn. TSH Biopharm Co. Ltd., 東生華製藥股份有限公司 (56.48%)- Market cap( 約 )US$96mn. CY Biotech 創益生技 (30.98%) Acquisition of Shionogi s Factory in Taiwan( 六堵廠 ), 2011 Mainland China WorldCo., Beijing 北京榮港公司 (100%) TOT Biopharm, China 東曜藥業 (40.91%) XDHP, Shanghai 上海旭東海普公司 (22%) TOT Shanghai R&D Center 東源生物醫藥科技 ( 上海 ) 有限公司 (40.91%) Philippines 菲律賓子公司 (87%) Thailand 泰國子公司 (40%) Vietnam 越南辦事處 (100%) 4

5 Growth Story 公司沿革 Est. Repositioned Growth TTY s injection formulation for cancers officially certified for EMEA,2008 Traded on the Taiwan GTSM (4105), 2001 New anti-cancer drugs Lipo-Dox & UFUR launched, 2000 New oncology (injection) factory established (Chung- Li, Taiwan), 2007 Taiwan Biotech Industry Golden Medal Award, 2013 Started business in Shanghai, China (1993) 5

6 Major Operation Sites 主要營運據點 All Across the World 6

7 Major Investments 轉投資主要架構 22% 旭東海普 XDHP 特色藥 ( 血管急救重症與呼吸道 ) 生產製造暨業務推廣 100% 榮港生技 WORLDCO 藥物開發 (Liver/ID/CNS) 行銷暨業務推廣台灣東洋 TTY 40.91% 56.48% 東曜 TOT CHINA 東生華製藥 TSH 大陸癌症藥廠慢性病領域 (CV/GI/Immune) 之藥物生產製造暨行銷業務推廣 19.54% 智擎生技 PharmaEngine 新藥開發公司 Spinning out Non-Oncology Biotechnology projects as new companies for minimum risk / maximum return 30.98% 100% 創益生技 CY Biotech 泰 / 越 / 菲辦事處益生菌及減肥藥開發行銷暨業務推廣 7

8 Entry Barrier (Profit) Product Strategy 產品策略 New Entity New Derivatives Special Formulation (Technology Platform) New Combination New Indication New Formulation Generic Market Scope (Risk) 8

9 TTY 個體 2013/2014 全年比 ( 億元 ) 單位 : 億元 2014 全年 2013 全年差異數差異 % 營業收入 % 營業成本 % 營業毛利 % 毛利率 59% 61% 營業費用 % 營業淨利 (0.15) -5% 營業外收 ( 支 ) 處分投資利益投資 ( 損 ) 益 ( 註 ) (3.41) -86% 其他 % 營業外收 ( 支 ) 小計 % 稅前淨利 % 稅後淨利 % ( 註 ) 含 2013 年第一季旭東 ( 開曼 ) 處分台灣東洋國際股份 60% 之持股所產生之處分投資利益 4.78 億元, 餘為投資損失 0.84 億元 9

10 TTY 個體 2013/2014 全年比差異 ( 億元 ) 單位 : 億元稅前 2014 全年稅前淨利出售投資利益不含智擎出售之淨利出售投資利益 : 2014 年係出售智擎持股 2.17% 單位 : 億元稅前 2013 全年稅前淨利出售投資利益不含東洋國際出售之淨利年係出售台灣東洋國際 ( 香港 ) 持股 60% 單位 : 億元稅前差異數稅前淨利稅後稅後稅後出售投資利益 (0.51) (0.24) 不含出售之淨利

11 TTY 個體 2014 上 / 下半年比 ( 億元 ) 單位 : 億元 2014 全年 2014 下半年 2014 上半年差異數差異 % 營業收入 % 營業成本 % 營業毛利 % 毛利率 59% 60% 58% 0 3% 營業費用 % 營業淨利 % 營業外收 ( 支 ) 處分投資利益投資 ( 損 ) 益 % 其他 % 營業外收 ( 支 ) 小計 % 稅前淨利 % 稅後淨利 % 11

12 癌症新藥上市時程 ( 台灣 ) 產品代號適應症上市時間 TS-1 胰臟癌 2014 ( 已上市 ) Painkyl 癌症突發性疼痛 2014( 已上市 ) Ivic 血液癌症 2015( 已上市 ) TS-1 大腸直腸癌 2015( 已上市 ) Pexeda 肺癌 2015( 已上市 ) ES0013 口腔炎 2015 LN9012 血液癌症 2015 FR8013 多種固體腫瘤

13 外銷新藥證取得時程產品代號適應症預估上市時間 / 目標市場 Folina 葉酸拮抗劑 2015 /Asia Ivic 血液癌症 2016/Asia Pexeda 肺癌 2016/ Asia, global LN9012 血液癌症 2017/Asia, global FR8013 多種固體腫瘤 2017/Asia, global 13

14 Global Presence of TTY Oncology Products TTY has successfully registered 67 oncology product licenses in 18 countries. Country URUR Oxalip Lipo-Dox Irino Asadin Gemmis Tyxan Tynen Epicin Thado Anazo Folina Total Germany 1 1 Sweden 4 4 EU Portugal UK 1 1 Spain 2 2 Thailiand Philippines Vietnam Hong Kong Malaysia Asia Singapore India 1 1 Sri Lanka Pakistan 1 1 Jordan 1 1 Austria 1 1 America Costa Rica Africa Nigeria Total

15 Product Pipeline CDMO/Super Generic (Specialties 特色藥品 ) Products 產品組合 Indication(s) 適應症 World Market (USD) Core Technology 核心技術 Advantages 產品優勢 LDIA09 (Caelyx Ⅱ) Ovarian Cancer( 卵巢癌 ) Breast Cancer( 乳癌 ) 卡波西氏瘤多發性骨髓瘤 6.7 億 Pegylated Liposome Technology High technology/ manufacturing barriers Worldwide patent (In-House) LAIA98 (LIPO-AB) Systemic Fungal Infection ( 全身性黴菌感染 ) 9 億 Liposome Technology High technology/ manufacturing barriers Worldwide patent (In-House) Leuprolide Prostate Cancer( 前列腺癌 ) 子宮內膜異位症子宮肌瘤中樞性性早熟 20 億 Lupron Depot Microsphere Formulation High technology/ manufacturing barriers Worldwide patent Risperidone Schizophrenia( 精神疾病 ) 45 億 Microsphere Formulation High technology/ manufacturing barriers Worldwide patent 15

16 Super GenericⅠ- Lipo-Dox & CaelyxⅡ Lip-Dox (Doxorubicin HCl Injection 2mg/mL) Liposome: A tiny bubble that can be filled with drugs and carry drugs into tissues. How does liposome treat cancer? Healthy human blood vessels are encapsulated by endothelial cells which are bounded by tight junctions (BBB->Blood Brain Barrier). Tight junctions will stop large particles like liposome leaking out of the vessel. Tumor vessels do not have tight junctions. Therefore, liposomes can penetrate tumor cells from the blood but blocked out by endothelial wall of healthy cells. In another word, liposome can target tumors by nature Caelyx (Doxorubicin HCl Injection 2mg/mL) Source: Asia Pacific Equity Research, March 4 th, 2011, JP Morgan Doxorubicin 100 nm PEG Source: Asia Pacific Equity Research, March 4 th, 2011, JP Morgan 16

Market Overview of Lipo-Dox & Caelyx Ⅱ Oncology market- WW: USD$60 Billion Growth +7.1%(2010) Taiwan: NTD$14 Billion Global Demand (regulatory countries): 2~2.

New patients: 1,200,000 a year. Worldwide +1,500,000 people died in a year. New patients: 1,500,000 a year.

17 Market Overview of Lipo-Dox & Caelyx Ⅱ Oncology market- WW: USD$60 Billion Growth +7.1%(2010) Taiwan: NTD$14 Billion Global Demand (regulatory countries): 2~2.5 Million vials/year Metastatic (stage IV) breast cancer BC ( 轉移性乳癌 ) AIDS-related Kaposi s sarcoma in patients ( 愛滋病引發之卡波西氏肉瘤 ) Worldwide +400,000 people died in a year. New patients: 1,200,000 a year. Worldwide +1,500,000 people died in a year. New patients: 1,500,000 a year. Multiple myeloma, MM ( 多發性骨髓瘤 ) Worldwide +16,900 people died in a year. New patients: 32,000 a year. Ovarian cancer ( 卵巢癌 ) Worldwide +125,000 people died in a year. New patients: 225,000 a year. Source: 2011 Evaluate Pharma report; WHO report 17

18 Super GenericⅡ Liposome Technology AmBisome (Amphotericin B) 18

TTY 目標 :50% 全球市佔率 (by 2015) Concurrent renal toxicity invasive bacterial infection ( 骨髓移植後併發腎毒性侵入性細菌感染 ) New patients: 500,000 a year.

19 Market Overview of LIPO-AB Global Revenue Estimate: USD$1 Billion Global Demand (regulatory countries): USD$1.5~2.5 Million vials/year Leishmaniasis ( 利時曼氏病, 又稱 Kala-azar 黑熱病 ) Worldwide +50,000 people died in a year. New patients: 300,000 a year. TTY 目標 :50% 全球市佔率 (by 2015) Concurrent renal toxicity invasive bacterial infection ( 骨髓移植後併發腎毒性侵入性細菌感染 ) New patients: 500,000 a year. The infected bursa meningitis HIV patients ( 愛滋病患者腦膜炎 ) Worldwide +5,625 ~ 150,000 people died in a year. New patients: 375,000 a year. Systemic fungal infection ( 腎功能不全之菌種感染病患 ) A retrospective study of 462,293 adult physical examination data from 2008 chronic kidney disease, one to five was 11.9%. The study estimated that 2.73 million people have chronic kidney disease. The world CKD prevalence of about 10-14%. 19

20 Super GenericⅢ Leuprolide Depot Introduction 產品簡介 20

Management of Endometriosis ( 子宮內膜異位症 ) Depending on the epidemiological estimate the global women of childbearing age prevalence was 10% (approximately 32.

21 Market Overview of Leuprolide Depot World Hormone Therapy market (2008): USD$4 Billion Global 2011 Lupron/Leuprolide Revenue Estimate: USD$2.3 Billion TTY 目標 : 35% 全球市佔率 (by 2015) Prostate Cancer ( 前列腺癌 ) Worldwide +900,000 people died in a year. New patients: 72,000 a year. Management of Endometriosis ( 子宮內膜異位症 ) Depending on the epidemiological estimate the global women of childbearing age prevalence was 10% (approximately 32.3 million people) Uterine Fibroids ( 子宮肌瘤 ) In women of reproductive age, and its incidence is approximately 20 percent, before and after menopause, the incidence rate of about forty to fifty percent. Central Precocious Puberty ( 中樞性性早熟 ) Depending on the epidemiological estimate the global children of both sexes the prevalence of approximately 0.6%. 21

22 Leuprolide Depot Schedule for launch: EU USA mg 3.75mg Diluent 3-Month 1-Month 資料來源 : Kalorama Information: (Cancer Therapeutics and Biotherapeutics 2009) 22

23 Leuprolide Depot 1 month PK Study 3 month PK Study Mean value of Leuprolide concentration of Leuplin or TTY products in beagles after a single intramuscular administration. 23

24 Super Generic Ⅳ- Risperidone Indication: Schizophrenia( 精神分裂 ) It may suffer life in all stages. Depending on the epidemiological estimate, the global incidence is of about 1% 70 million people. RISPERDAL CONSTA (Risperidone) Long-Acting Injection is a combination of extended release microspheres for injection and diluent for parenteral use. (CONSTA 利培酮長效注射針劑是由緩釋微球注射劑及非腸道使用的稀釋劑所組合而成 ) The extended release microspheres formulation is a white to offwhite, free-flowing powder that is available in dosage strengths of 25, 37.5, or 50mg risperidone per vial. Risperidone is micro-encapsulated in 75/25 polylactide-co-glycolide (PLGA) at a concentration of 381mg risperidone per gram of microspheres. Ref. Insert of RISPERDAL CONSTA 24

25 2010 年全球銷售額前十大中樞神經用藥 (Schizophrenia) ( 注意力缺陷過動症 ) 25

26 Category: Oncology Existing Core Products 現有核心產品 Products 產品名稱 Indications 適應症 Market(s) 行銷地區 Asadin( 伸定注射劑 ) Acute promyelocytic leukemia, APL( 急性前骨髓細胞白血病 ) Taiwan( 台灣 ) Thailand( 泰國 ) Malaysia( 馬來西亞 ) Philippines( 菲律賓 ) Vietnam( 越南 ) (2004) Gemmis( 健仕注射液 ) Lipo-Dox ( 力得微脂體注射劑 ) inoperable, locally-advanced(stage IIIa or IIIb) or Metastatic(stage IV) Non-small cell lung cancer( 非小細胞肺癌 ) Inoperable(stage II or III) or metastatic(stage IV) Pancreatic cancer, PC( 胰臟癌 ) Metastatic(stage IV) Urinary bladder cancer, UBC( 膀胱癌 ) Metastatic(stage IV) breast cancer, BC( 轉移性乳癌 ) Recurrent(stage IV) Ovarian cancer, OC( 卵巢癌 ) AIDS-related Kaposi s sarcoma in patients with low CD4 counts and extensive mucocutaneous or visceral disease.( 愛滋病引發之卡波西氏肉瘤 ) Metastasis carcinoma of the ovary with recurrent to both first line platinum- and paclitaxel-based chemotherapy regimens( 復發性卵巢癌 ) Metastatic(stage IV) breast cancer, BC( 轉移性乳癌 ) Combination with bortezomib in 2 nd line Multiple myeloma, MM( 多發性骨髓瘤 ) Taiwan( 台灣 ) Vietnam( 越南 ) Malaysia( 馬來西亞 ) Sri Lanka( 斯裡蘭卡 ) Nigeria( 奈及利亞 ) (2000) Taiwan( 台灣 ) Thailand( 泰國 ) Vietnam( 越南 ) Sri Lanka( 斯裡蘭卡 ) (2006) 26

27 Category: Oncology Existing Core Products 現有核心產品 Products 產品名稱 Indications 適應症 Market(s) 行銷地區 Oxalip ( 歐力普注射劑 ) Tyxan( 汰杉注射劑 ) Colorectal cancer, CRC( 結腸直腸癌 ): stage III colon cancer adjuvant treatment; metastatic colorectal cancer(stage IV) Gastric cancer, GC( 胃癌 ): Advanced gastric cancer(stage IV) Adjuvant & metastatic(lymph node positive) (stage II~IV ) Breast cancer, BC( 乳癌 ) Metastatic(stage IV) Non-small cell lung cancer( 非小細胞肺癌 ) Hormone refractory metastatic prostate cancer, PC( 前列腺癌 ) Locally advanced(stage III~ stage IVB) squamous cell carcinoma of the head and neck( 局部晚期頭頸部癌 ) Metastatic(stage IV) Gastric gland cancer( 胃腺癌 ) Taiwan( 台灣 ) Thailand( 泰國 ) Vietnam( 越南 ) Singapore ( 新加坡 ) Nigeria( 奈及利亞 ) Sri Lanka ( 斯裡蘭卡 ) (2005) Taiwan( 台灣 ) Austria( 奧地利 ) Germany( 德國 ) Sweden( 瑞典 ) Other EU members( 其他歐盟會員國 ) (2007) Thado( 賽得膠囊 ) Newly diagnosed multiple myeloma, MM( 多發性骨髓瘤 ) Erythema Nodosum Leprosum, ENL( 痲瘋性結節性紅斑 ) Taiwan( 台灣 ) Philippines( 菲律賓 ) Malaysia( 馬來西亞 ) (2009) UFUR( 友復膠囊 ) Gastric cancer, GC( 胃癌 ) Adjuvant Treatment for stage IB, II, III patients after curative surgery; advanced gastric cancer(stage IV) Colorectal cancer, CRC( 大腸結腸直腸癌 ) Stage II & III colorectal cancer; metastatic colorectal cancer(stage IV) Breast cancer, BC( 乳癌 ), stage II breast cancer; metastatic breast cancer(stage IV) Lung cancer, LC( 肺癌 ) stage IB; metastatic lung cancer(stage IV) Head & Neck cancer( 頭頸癌 ), Stage I to IV Taiwan( 台灣 ) Thailand( 泰國 ) Vietnam( 越南 ) Malaysia( 馬來西亞 ) India( 印度 ) Pakistan( 巴基斯坦 ) (2008) 27

28 Category: Oncology Products 產品名稱 Indications 適應症 Market(s) 行銷地區 TS-1( 愛斯萬膠囊 ) Zobonic( 抑骨凍晶靜脈注射劑 ) Painkyl Fentanyl ( 平舒疼口頰溶片 ) Existing Core Products 現有核心產品 Gastric cancer, GC( 胃癌 ): Stage II & III gastric cancer adjuvant treatment; Advanced gastric cancer(stage IV); Pancreatic cancer, PC( 胰臟癌 ) Multiple myeloma, MM( 多發性骨髓瘤 ) Hypercalcemia of malignancy( 惡性腫瘤之高血鈣併發症 ) Breakthrough Pain( 癌症突發性疼痛 ) Taiwan( 台灣 ) China( 中國大陸 ) (2012) Taiwan( 台灣 ) (2012) 2013/Q4 Launch Taiwan ( 台灣 ) Restricted Drug Episil Oral Mucositis( 頭頸癌 &HSCT 患者口腔潰爛疼痛 ) 2014/Q3 Launch Taiwan ( 台灣 ) Restricted Drug Lvic ( 癌微可 ) CML( 慢性骨隨性白血病 ) 2014/02 Launch Taiwan 28

29 Products 產品名稱 Indications 適應症 Market(s) 行銷地區 Cubicin( 救必辛注射劑 ) LIPO-AB C+S( 博益欣 ) Existing Core Products 現有核心產品 Category: Infection Diseases 1. Complicated Skin and Skin Structure Infections caused by susceptible isolates of the following Gram-positive bacteria( 治療下列感受性革蘭氏陽性菌引起的複雜性皮膚和皮膚組織感染 (csssi) 如下 ): Staphylococcus aureus(including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis(vancomycin-susceptible isolates only) 2. Staphylococcus aureus Bloodstream Infections(Bacteremia), Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates( 引起之血液感染 ( 菌血症 ) 包括由具 methicillin 感受性及抗藥性菌株造成之右側感染性心內膜炎 ) 1. 利時曼氏病 leishmaniasis 又稱黑熱病 Kala-azar 2. 骨髓移植後併發腎毒性侵入性細菌感染 Concurrent renal toxicity invasive bacterial infection 3. 感染囊球菌腦膜炎的 HIV 患者 The infected bursa meningitis HIV patients 為一抗感染新療效複方新藥對鮑氏不動桿菌 (AB 菌 ) 治療效果更佳, 目前市場尚無 cefoperazone/sulbactam 複方製劑, 上市後可實際提供臨床用藥選擇性實際藥價低於單方用藥, 減低醫療浪費 Taiwan( 台灣 ) (2009) Global( 全球 ) (2014) Taiwan( 台灣 ) (2013) Taiwan( 台灣 ) (2013) 29

30 重症醫療事業群致力於重症及感染症產品開發及行銷成軍六年, 近年銷售淨額成長每年皆超過 8%, 去年更超過 20% 未來 5 年將以每年 30-50% 成長目前主力產品包括 Cubicin Colimycin Brosym Lipo-AB 等, 提供病患對抗細菌及黴菌的高品質產品未來 2-3 年將有新抗生素 4-5 年將有抗病毒新藥陸續上市 30

31 Product Portfolio (TIT) 類別產品適應症開發階段抗細菌 Cubicin G (+) 現有產品 CMS G (-) 現有產品 Exacin G (-) 現有產品 Brosym Broad spectrum 現有產品 New formulated colistin Anti-carbapenem resistant Formulation New cephalosporin Broad spectrum 評估授權抗黴菌 Lipo-AB Broad spectrum 現有產品 Flusine Cryptococcus and Candida 現有產品 Anti-HIV AL7012 HIV Formulation Niche generic and TNCE DL7014 and TL7014 HIV Formulation Antibiotics, antifungals, anti-virus TBD 爭取經銷及自行開發 31

32 Current Status of Licensing Late Stage Pipelines (TIT) Brosym Lipo-AB ( 內湖 ) AL7012 DL7014 TL7014 New formulation of colistin Licensing-in finished products License-in License-out TFDA NIH price Formulation or study 32

State of the Art Manufacture Facilities 臻藝術等級之生產設施 ( 中壢, 六堵 ) The only PIC/S GMP certified manufacture sites for high potency oncology, 2008/2013 EMA, 2010 Japan, 2013 US FDA, 2013 Brazil, Australia

33 State of the Art Manufacture Facilities 臻藝術等級之生產設施 ( 中壢, 六堵 ) The only PIC/S GMP certified manufacture sites for high potency oncology, 2008/2013 EMA, 2010 Japan, 2013 US FDA, 2013 Brazil, Australia High standard Validation of Equipment qualification/ Laboratory instruments qualification/ HVAC system/ Water system/ Compressed air system/ Nitrogen system/ Cleaning/ Analytical method/ Process/ Computer/ Logistic Individual flow management Air flow/ Man flow/ Material flow/ Product flow/ Waste flow To prevent cross contamination and environmental pollution 微脂體 / 微球體 / 重症抗生素藥物產能擴廠, /Q4 年全部竣工 HVAC System Work Safety Environmental Protection Fine Manufacturing Process 33

34 廠區照片 A C B D A-B 圖為中壢癌症針劑廠區圖 C-D 圖為六堵廠新針劑廠示意圖 34

35 Subsidiary- TOT BIOPHARM 蘇州 Suzhou 東曜藥業有限公司總部及專業抗癌藥廠蘇州工業園區 Suzhou TOT Biopharm China 上海 Shanghai 上海行銷總部上海普陀區長城大廈 Shanghai Marketing 上海研發中心上海張江高科園區孵化基地 Shanghai R&D Center 35

36 高端研發項目 Category Product Feature Indication Biologics TAB008 TAD011 治療性單抗治療性單抗結直腸癌, 非小細胞肺癌, 實體腫瘤腦瘤, 頭頸部癌, 結直腸癌, TAA013 抗體交聯藥實體腫瘤 TAT014 治療性單抗乳癌, 胃癌 TLD208 脂質體細胞毒抗腫瘤藥乳癌, 卵巢癌 Specialty TLL209 新一代靶向性脂質體細胞毒抗腫瘤藥乳癌, 實體腫瘤 TID214 白蛋白細胞毒抗腫瘤藥實體腫瘤 Innovation TVL111 修飾型溶瘤病毒實體腫瘤 TVP211 溶瘤痘苗病毒實體腫瘤 36

37 一期工程介紹一期工程主廠房占地 4,620 平方米共二層樓, 約 10,000 平方米 2012 年完成第一期工程, 包括 : 癌症口服製劑廠一期廠房癌症針劑廠生物藥中試廠 37

38 Production 生產狀況 Subsidiary XDHP Shanghai Jin Qiao Plant Small-volume injection(including antieoplastic drugs) 小容量注射劑 ( 含抗腫瘤類 ) 2000/8 GMP 認證 ;2005/7 GMP 複證 Small-volume injection(including hormonal contraceptives) 小容量注射劑 ( 賀爾蒙類避孕藥 ) 2004/2 GMP 認證 ;2005/7 GMP 複證 Large-volume injection 大容量注射劑 2004/2 GMP 認證 ;2005/7 GMP 複證 Plant Space( 占地面積 ): 17,500m 2 Annual Production Capacity( 年生產規模 ): 250 million vials Jia Ding Plant Solid dosage form( 固體製劑 )- tablet( 錠劑 ), capsule( 硬膠囊劑 ) 2002/2 GMP 認證 ;2006/11 GMP 複證 Oral solution, suspension( 口服溶液劑, 混懸劑 ) 2003/1 GMP 認證 ;2006/11 GMP 複證 Active pharmaceutical ingredient( 原料藥 ) 2004/6 GMP 認證 ;2009/04 GMP 複證 Plant Space ( 占地面積 ):14,800m 2 Annual Production Capacity( 年生產規模 ) Tablet( 錠劑 ):100 million;capsules( 膠囊 ):50 million Oral Solution( 口服液 ):20 million;suspension( 混懸劑 ):20 million 38

去乙醯毛花苷射液 Deslanoside Injection 抗腫瘤 Antieoplastic 氟尿嘧啶注射液 Fluorouracil Injection 造影劑 Imaging Agents 泛影葡胺注射液 Diatrizoate Meglumine Injection 釓噴酸葡胺注射液 Gadopentetate Dimeglumine Injection 抗感染 Antibiotics

39 Subsidiary- XDHP Product Portfolios 上海旭東產品組合 Main Products ( 主要產品 ) 10.4% 4.2% 2.7% 3.7% 0.7% Source: 2008 sales 78.3% 针剂片剂胶囊混悬剂口服液其它心血管 Cardiovascular 單硝酸異山梨酯緩釋膠囊 Isosorbide Mononitrate Slow Release Capsule 胞磷膽鹼鈉注射液 Citicoline Sodium Injection 甲磺酸酚妥拉明注射液 Phentoliamine Mesylate Injection 卡托普利片 Captopril Tablet 去乙醯毛花苷射液 Deslanoside Injection 抗腫瘤 Antieoplastic 氟尿嘧啶注射液 Fluorouracil Injection 造影劑 Imaging Agents 泛影葡胺注射液 Diatrizoate Meglumine Injection 釓噴酸葡胺注射液 Gadopentetate Dimeglumine Injection 抗感染 Antibiotics 鹽酸林可黴素注射液 Lincomycin Hydrochloride Injection 硫酸阿米卡星注射液 Amikucin sulfate Injection 消化系統 Gastrointestinal 硫糖鋁混懸液 Sucralfate suspension 其他 Others 鹽酸溴己新注射液 Bromhexine Hydrochloride Injection 醋酸曲安奈德注射液 Triamcinolone Acetonide Acetate Injection 鹽酸曲馬多 Tramadol Hydrochloride 氯解磷定注射液 Pralidoxime Chloride Injection 39

40 Our Dream We strive to improve health and quality of life through innovative, cost-effective therapeutics and specialty drugs. Our focus is on the Unmet Medical Needs in challenging diseases throughout the world, such as Cancer & Infectious Diseases. ( 註 ) 此資料內容並非隸屬財務預測, 僅供參考此資訊內容之財務數字應以公司財報為準 Thank you for being all the way with us! 40

网易介绍

网易介绍 2005 Safe Harbor This presentation contains statements of a forward-looking nature. These statements are made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.