台灣東洋藥品法人說明會 - ttyeng.tty.com.tw/rwd1181/store/f3/tty company profile... ·...
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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。
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 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. 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
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
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
Growth Story 公司沿革
Started business in Shanghai, China (1993)
New anti-cancer drugs– Lipo-Dox & UFUR launched, 2000
Traded on the Taiwan GTSM (4105), 2001
New oncology (injection) factory established (Chung-Li, Taiwan), 2007
TTY’s injection formulation for cancers officially certified for EMEA,2008
Est. Repositioned Growth
1960 1996
Taiwan Biotech
Industry Golden
Medal Award, 2013
5
Major Operation Sites 主要營運據點 All Across the World
6
Major Investments 轉投資主要架構
台灣東洋 TTY
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
榮港生技 WORLDCO 藥物開發(Liver/ID/CNS)
行銷暨業務推廣
東曜 TOT CHINA 大陸癌症藥廠
東生華製藥 TSH 慢性病領域(CV/GI/Immune)之
藥物生產製造暨行銷業務推廣
智擎生技 PharmaEngine 新藥開發公司
創益生技 CY Biotech 益生菌及減肥藥開發
泰/越/菲辦事處 行銷暨業務推廣
Spinning out
Non-Oncology
Biotechnology projects
as new companies
for minimum risk /
maximum return
56.48%
40.91%
19.54%
30.98%
22%
100%
100%
7
Product Strategy 產品策略 E
ntr
y B
arr
ier
(Pro
fit)
Market Scope (Risk)
New
Entity
New
Derivatives
Special Formulation
(Technology Platform)
New
Indication
New
Formulation
Generic
New
Combination
8
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 23.84 22.92 0.92 4%
營業成本 9.72 8.88 0.84 9%
營業毛利 14.12 14.04 0.08 1%
毛利率 59% 61%
營業費用 11.44 11.22 0.22 2%
營業淨利 2.67 2.82 (0.15) -5%
營業外收（支）
處分投資利益 4.84 0.00 4.84
投資（損）益 0.54 3.95 (註) (3.41) -86%
其他 0.59 0.19 0.40 216%
營業外收（支）小計 5.97 4.14 1.83 44%
稅前淨利 8.64 6.96 1.68 24%
稅後淨利 7.80 5.87 1.93 33%
(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
TTY個體2013/2014全年比差異 (億元)
單位: 億元 2014全年
稅前 稅後
稅前淨利 8.64 7.80
出售投資利益 4.84 4.55
不含智擎出售之淨利 3.80 3.25
出售投資利益: 2014年係出售智擎持股2.17%
單位: 億元 2013全年
稅前 稅後
稅前淨利 6.96 5.87
出售投資利益 5.35 4.79
不含東洋國際出售之淨利 1.61 1.08
2013年係出售台灣東洋國際(香港)持股60%
單位: 億元 差異數
稅前 稅後
稅前淨利 1.68 1.93
出售投資利益 (0.51) (0.24)
不含出售之淨利 2.19 2.17
10
單位: 億元 2014全年 2014下半年 2014上半年 差異數 差異％
營業收入 23.84 12.01 11.84 0.17 1%
營業成本 9.72 4.80 4.92 -0.12 -3%
營業毛利 14.12 7.21 6.91 0.29 4%
毛利率 59% 60% 58% 0 3%
營業費用 11.44 5.50 5.94 -0.44 -7%
營業淨利 2.67 1.70 0.97 0.73 75%
營業外收（支）
處分投資利益 4.84 4.84 0 4.84
投資（損）益 0.54 0.55 -0.01 0.56 -5461%
其他 0.59 0.60 -0.02 0.61 -3983%
營業外收（支）小計 5.97 5.99 -0.03 6.02 -23350%
稅前淨利 8.64 7.70 0.95 6.75 714%
稅後淨利 7.80 7.05 0.75 6.30 843%
TTY個體2014上/下半年比 (億元)
11
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 2015
12
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
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
Portugal 2 1 1 4
UK 1 1
Spain 2 2
Thailiand 1 1 1 1 1 1 6
Philippines 1 1 1 1 4
Vietnam 1 1 1 2 1 2 1 1 10
Hong Kong 1 1 1 2 2 3 10
Malaysia 1 1 1 1 1 1 6
Singapore 1 1 2
India 1 1
Sri Lanka 1 1 1 1 1 5
Pakistan 1 1
Jordan 1 1
Austria 1 1
America Costa Rica 1 1 1 3
Africa Nigeria 1 1 2 1 5
Total 6 7 4 14 4 10 6 3 6 3 3 1 67
EU
Asia
14
Product Pipeline
CDMO/Super Generic (Specialties特色藥品)
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
Products
產品組合
Indication(s)
適應症
World
Market
(USD)
Core
Technology
核心技術
Advantages
產品優勢
15
Super GenericⅠ- Lipo-Dox® & CaelyxⅡ®
100 nm Doxorubicin
PEG
Caelyx® (Doxorubicin HCl Injection 2mg/mL)
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.
Source: Asia Pacific Equity Research, March 4th, 2011, JP Morgan
------------------------------------------------------------------------------------------------------------------------
Source: Asia Pacific Equity Research, March 4th, 2011, JP Morgan 16
Oncology market- WW: USD$60
Billion
Growth +7.1%(2010)
Taiwan: NTD$14 Billion
Global Demand (regulatory
countries): 2~2.5 Million vials/year
Market Overview of Lipo-Dox® & Caelyx Ⅱ®
Source: 2011 Evaluate Pharma report; +2008 WHO report
• Worldwide +400,000 people died in a year.
• New patients: 1,200,000 a year.
• Worldwide +16,900 people died in a year.
• New patients: 32,000 a year .
• Worldwide +1,500,000 people died in a year.
• New patients: 1,500,000 a year.
• Worldwide +125,000 people died in a year.
• New patients: 225,000 a 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)
Multiple myeloma, MM (多發性骨髓瘤)
Ovarian cancer (卵巢癌)
17
Super GenericⅡ Liposome Technology– AmBisome® (Amphotericin B)
18
Global Revenue Estimate: USD$1
Billion
Global Demand (regulatory
countries): USD$1.5~2.5 Million
vials/year
TTY目標：50%全球市佔率(by 2015)
Market Overview of LIPO-AB
• Worldwide +50,000 people died in a year.
• New patients: 300,000 a year.
• Worldwide +5,625 ~ 150,000 people died in a year.
• New patients: 375,000 a year.
• New patients: 500,000 a year.
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%.
Leishmaniasis (利時曼氏病，又稱Kala-azar黑熱病)
Concurrent renal toxicity invasive
bacterial infection (骨髓移植後併發腎毒性侵入性細菌感染)
Systemic fungal infection (腎功能不全之菌種感染病患)
The infected bursa meningitis HIV
patients (愛滋病患者腦膜炎)
19
Super GenericⅢ Leuprolide Depot Introduction 產品簡介
20
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)
Market Overview of Leuprolide Depot
Worldwide +900,000 people died in a
year.
New patients: 72,000 a year.
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.
Depending on the epidemiological
estimate the global women of
childbearing age prevalence was 10%
(approximately 32.3 million people)
Depending on the epidemiological
estimate the global children of both
sexes the prevalence of approximately
0.6%.
Prostate Cancer
(前列腺癌)
Management of Endometriosis
(子宮內膜異位症)
Central Precocious Puberty
(中樞性性早熟)
Uterine Fibroids (子宮肌瘤)
21
Leuprolide Depot
11.25mg 3.75mg Diluent
3-Month 1-Month
資料來源: Kalorama Information: (Cancer Therapeutics and Biotherapeutics 2009)
Schedule for launch:
EU---2014
USA---2018
22
Leuprolide Depot
3 month PK Study
Mean value of Leuprolide concentration of Leuplin® or TTY products in beagles after a single
intramuscular administration.
1 month PK Study
23
Super Generic Ⅳ- Risperidone
It may suffer life in all stages. Depending on the epidemiological estimate, the global incidence is of about 1% →70 million people.
Indication: Schizophrenia(精神分裂)
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 off-white, 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
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
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) 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)
Taiwan(台灣)、Vietnam(越南)、Malaysia(馬來西亞)、Sri Lanka( 斯裡蘭卡)、Nigeria( 奈及利亞) (2000)
Lipo-Dox
(力得微脂體注射劑)
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 2nd line Multiple myeloma, MM(多發性骨髓瘤)
Taiwan(台灣)、Thailand(泰國)、Vietnam(越南)、Sri
Lanka(斯裡蘭卡) (2006)
Category: Oncology
26
Category: Oncology
Products 產品名稱 Indications 適應症 Market(s) 行銷地區
Oxalip
(歐力普注射劑)
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)
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)
Tyxan(汰杉注射劑) 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)、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)
Existing Core Products 現有核心產品
27
Category: Oncology
Products 產品名稱 Indications 適應症 Market(s) 行銷地區
TS-1(愛斯萬膠囊) Gastric cancer, GC(胃癌): Stage II & III gastric cancer adjuvant
treatment; Advanced gastric cancer(stage IV); Pancreatic cancer,
PC(胰臟癌)
Taiwan(台灣)、China(中國大陸) (2012)
Zobonic(抑骨凍晶靜脈注射劑)
Multiple myeloma, MM(多發性骨髓瘤)
Hypercalcemia of malignancy(惡性腫瘤之高血鈣併發症)
Taiwan(台灣) (2012)
Painkyl Fentanyl
(平舒疼口頰溶片)
Breakthrough Pain(癌症突發性疼痛) 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
Existing Core Products 現有核心產品
28
Products 產品名稱 Indications 適應症 Market(s) 行銷地區
Cubicin(救必辛注射劑)
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)
Taiwan(台灣) (2009)
LIPO-AB 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
Global(全球) (2014)
Taiwan(台灣) (2013)
C+S(博益欣) 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) (2013)
Category: Infection Diseases
Existing Core Products 現有核心產品
29
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。
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重症醫療事業群
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
DL7014 and TL7014 HIV Formulation
Niche generic and
TNCE
Antibiotics, antifungals, anti-virus TBD 爭取經銷及自行開發
Product Portfolio (TIT)
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2015 2016 2017 2018 2019 2020
Brosym
Lipo-AB (內湖)
AL7012
DL7014
TL7014
New formulation of
colistin
Licensing-in finished
products
License-in
License-out
Formulation or study
NIH price
TFDA
Current Status of Licensing Late Stage Pipelines
(TIT)
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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，2014-2015/Q4年全部竣工
Work Safety HVAC System Environmental Protection
Fine Manufacturing Process
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廠區照片
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
A B
C D
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Subsidiary- TOT BIOPHARM
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
上海研發中心 上海張江高科園區
孵化基地 Shanghai R&D
Center 上海行銷總部
上海普陀區長城大廈 Shanghai Marketing
蘇州Suzhou
上海
Shanghai
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高端研發項目
Category Product Feature Indication
Biologics
TAB008 治療性單抗 結直腸癌,非小細胞肺癌,實體腫瘤
TAD011 治療性單抗 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
Specialty
TLD208 脂質體細胞毒抗腫瘤藥
乳癌, 卵巢癌
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
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一期廠房
2012年完成第一期工程，
包括：
癌症口服製劑廠
癌症針劑廠
生物藥中試廠
一期工程主廠房占地4,620平方米
共二層樓，約 10,000平方米
一期工程介紹
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Subsidiary XDHP Shanghai
Production 生產狀況
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
Annual Production Capacity(年生產規模): 250 million vials
Plant Space(占地面積): 17,500m2
Jin Qiao Plant
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
Plant Space (占地面積)：14,800m2
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
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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
Main Products (主要產品)
Subsidiary- XDHP Product Portfolios 上海旭東產品組合
78.3%
10.4%
4.2% 2.7% 3.7% 0.7%针剂
片剂
胶囊
混悬剂
口服液
其它
Source: 2008 sales
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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.
Thank you for being all the way with us!
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(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。