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SPT Investor Presentation 2016

Sep 26, 2016

51922_rns_2016-09-26_47f074c4-981d-47cb-a451-af5370bfd7a4.pdf

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TWSE 1789

ScinoPharm

Corporate Presentation

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Disclaimer

This material has been prepared by ScinoPharm Taiwan, Ltd. (“ScinoPharm”).

Any opinions expressed in this material are subject to change without notice as a result of using different assumptions. ScinoPharm is under no obligation to update or keep current the information contained herein.

The information contained in this presentation is ScinoPharm’s confidential information. Any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it is prohibited and may be unlawful.

No representation or warranty , express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company as to , the accuracy or completeness of this material and any liability therefore is hereby expressly disclaimed.

Statements made in this presentation include forward-looking statements, which include, without limitation, statements about the issues, plans and expectations of ScinoPharm. Without limiting the foregoing, statements including the words “believes”, “anticipates”, “plans”, “expects” and similar expressions are also forward-looking statements. Forward-looking statements reflect, among other things, management’s plans and objectives for future operations, current views with respect to future events and future economic performances and projections of various financial items. These forward-looking statements involve known and unknown risks , uncertainties and other factors which may cause actual results to differ materially from those implied by such forward-looking statements.

1

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Overview of ScinoPharm

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32

Confidential

Business Overview

  • Company specializes in high potency (steroid/cytotoxic) APIs and is expanding into sterile/aseptic injectable formulations

  • Facility & organization built in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai

  • 70 generic APIs in current portfolio with 25 APIs launched; 51 US DMFs filed (741 DMFs WW), 30 US DMFs in oncological APIs. 100+ NCE CRAM projects, with 5 APIs launched and 5 in phase III for NDA filing in 2-3 years

  • Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, Australian TGA, Japanese PMDA, etc.

3

World Class API Facilities

Taiwan

China

  • 6.6 hectares of land, 330K sqft facilities with >200M[3] reactor volume

  • 5 of 16 production lines equipped with high potency capabilities for cytotoxic/steroids

  • Passed US FDA, EMA, Australian TGA, Japanese PMDA inspections & 300+ cGMP customer audits

  • Provides comprehensive contract research & manufacturing services for Brand drug companies

  • 6.5 hectares of land with > 250M[3 ] reactor volume

  • 3 of 7 production lines equipped with high potency capabilities for cytotoxics

  • US FDA approved cGMP facility for intermediates & high potency APIs

  • Full scope capabilities in developing and producing APIs from small to large scale for generic & CRAM markets

  • Global market served including China

  • Global Market served

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4

Strong Generics Product Portfolio

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40
36
35
30
25 23
20
unlaunched
15
11
launched
10 7
5 6
13 4
2 2
5 6 2 2
6
4 3
2 2 2
1 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
11
5
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ScinoPharm - Oncology API Leader

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Stand-Alone API Companies
ScinoPharm 30 20
Shilpa 12 11 2
Polymed 10 2 3
MacChem Products 7 5 2 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Laurus Labs 7 7 11
# Other DMFs
Sichuan Xieli 6 8 13
Chemwerth 3 5 32
Apicore 5 6 23
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 30 20
Teva 15 26 247
Dr. Reddy's 15 13 189
Cipla 11 16 128
Sun 17 11 170
Hisun 11 19 48
# Oncology DMF Overlap with SPT
Qilu 8 3 8
# Non-overlapping Oncology DMF
Hengrui 3 3 9 # Other DMFs
0 50 100 150 200 250 300
Source: US FDA DMF Q1 2016 database
6
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We are Transforming our Company

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synergy of our API business,
to maximize ROI
Positioning as a Transforming into a
Tightening cost control,
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Tapping into formulation
scope based on our core
competencies into high-
entry-barrier APIs
7
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Keys to Generic Formulation Business

Opportunity

Strategy

Tactics

  • Already the leader in providing oncological APIs to regulated markets worldwide

  • Already the leader in � Developing dossiers per our � Expanding formulation providing oncological APIs difficult-to-make APIs to portfolio

  • to regulated markets increase value proposition � Building on-site worldwide in the supply chain oncology injectable

  • � Injectable CMOs are in � Targeted delivery & facility and establishing undersupply condition extended release of proven an integrated supply

  • � Can be customer’s APIs via 505(b)2 fast track chain

  • injectables provider by � Collaborating with start-ups � promoting our developing formulations & research institutes, formulations via using our own oncological focusing on un-met strategic alliances, APIs or others’ APIs, up to oncology medical needs of especially in China and and including filing for high prevalence in Asia US/EU ANDA with FDA

    • Expanding formulation portfolio

    • Building on-site oncology injectable facility and establishing an integrated supply chain

  • 2 US ANDAs

  • 11 co-developing and cost/profit sharing products with various partners

8

Strategic Alliance Highlights

*** Already launched**

Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product

Indications

Region

Launch
Year(E)

Remarks
Genovate Entecavir Hepatitis B Viral Taiwan 2013* 1st co-developed formulation product launch
Sagent Oncology
Injectable
Myeloid Leukemia US 2017 1st US ANDA filing, triggered US FDA
inspection in Changshu site
Foresee Leuprolide Prostate cancer US 2018 505(b)2 NDA CRAM + Equity
Coland Bortezomib Multiple
Myeloma
China 2020 1st co-developed drug in China to trigger
CFDA inspection in Changshu site
Azacitidine MDS China 2021 Co-developed formulation in China
Lee’s
Pharma
Fondaparinux Anti-thrombotic China 2021 Co-development collaboration
Travoprost
Bimatoprost
Glaucoma China 2020
Nanjing
King
Friend
Regadenoson Stress agent for
heart scan
China 2020 Co-developed formulation in China
9
US
partner
Project A
non-small cell
lung cancer
US
2020
US NDA 505(b)2 with Paragraph IV filing /
The estimated launch year is subject to
litigation results
US &
China
partners
Project B
imaging agent
US
2020
ANDA with Paragraph IV filing /
The estimated launch year is subject to
litigation results
US
partner
Project A non-small cell
lung cancer
US 2020 US NDA 505(b)2 with Paragraph IV filing /
The estimated launch year is subject to
litigation results
US &
China
partners
Project B imaging agent US 2020 ANDA with Paragraph IV filing /
The estimated launch year is subject to
litigation results

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Operating Results & Outlook

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10

Historical Performance

Unit: In NT$ million

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5,088
4,572
5,000
4,098
3,887 3,953 3,955
3,791
4,000
3,145
2,494
3,000
2,000 1,463
613 1,273
1,000 872 1,170
1,041 1,040 484
143 961
635
484
0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
11
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Recent Financial

Unit: In NT$

Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year 2013 2014 2015
Total assets 11,484 M 11,372 M 12,222 M
Shareholders’ equity 9,643 M 9,380 M 9,857 M
Sales 5,088 M 4,098 M 3,955 M
Net profit after tax 1,273 M 484 M 635 M
Earnings per share 1.88 0.69 0.87
Cash dividends 1.2 0.2 0.3
Stock dividends 0.4 0.4 0.4
Pay-out ratio 85% 87% 80%

Note : All of the above figures represent consolidated information

12

Quarterly P&L - Consolidated

In NT$ million, except for
EPS
2Q,’16
(Reviewed)
1Q,’16
(Reviewed)
2Q,’15
(Reviewed)
QoQ YoY
Operating Revenue 1,015 1,022 963 -1% 5%
Gross Profit 465 431 365 8% 27%
Gross margin 46% 42% 38%
Operating Expenses (236) (236) (239) 0% -1%
Operating Income 229 195 126 17% 82%
Operating margin 23% 19% 13%
Other Rev.(Exp.) (29) (4) 106 625% -127%
Net Income before Tax 200 191 232 5% -14%
Net Income after Tax 174 172 132 1% 32%
13
Net margin after tax
17%
17%
14%
EPS (after tax)
0.24
0.24
0.18
0%
33%
Net margin after tax 17% 17% 14%
EPS (after tax) 0.24 0.24 0.18 0% 33%

Half Year P&L - Consolidated

In NT$ million, except for EPS
1H,’16
(Reviewed)
1H,’15
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’16
(Reviewed)
1H,’15
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’16
(Reviewed)
1H,’15
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’16
(Reviewed)
1H,’15
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’16
(Reviewed)
1H,’15
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’16
(Reviewed)
1H,’15
(Reviewed)
YoY



In NT$ million, except for EPS 1H,’16
(Reviewed)
1H,’15
(Reviewed)
YoY
Operating Revenue 2,037 1,942 5%
Gross Profit 896 709 26%
Gross margin 44% 37%
Operating Expenses (471) (442) 7%
Operating Income 425 267 59%
Operating margin 21% 14%
Other Rev.(Exp.) (34) 99 -134%
Net Income before Tax 391 366 7%
Net Income after Tax 346 245 41%
14
Net margin after tax
17%
13%
EPS (after tax)
0.47
0.34
38%
Net margin after tax 17% 13%
EPS (after tax) 0.47 0.34 38%

Balance Sheet - Consolidated

In NT$ million 2016/6/30
(Reviewed)
2016/6/30
(Reviewed)
2015/6/30
(Reviewed)
2015/6/30
(Reviewed)
Cash and Cash Equivalents 2,964 24% 2,410 20%
Accounts Receivable 678 5% 568 5%
Inventories 2,062 16% 2,315 19%
Long-Term Investments 364 3% 339 3%
Property, plant & equipment 5,355 43% 5,142 43%
Other assets 1,122 9% 1,100 10%
Total Assets 12,545 100% 11,874 100%
Current Liabilities 2,248 18% 2,333 19%
L-T Liabilities and Others
339
3%
91
1%
Stockholders’ Equities
9,958
79%
9,450
80%
L-T Liabilities and Others 339 3% 91 1%
Stockholders’ Equities 9,958 79% 9,450 80%

15

Cash Flows - Consolidated

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1H 2016 1H 2015
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
2,336 1,928
beginning of period
Cash flows from operating activities 826 589
CAPEX (371) (345)
Short-term borrowings (241) 212
-
Long-term borrowings 255
Others 159 26
Cash and cash equivalents at
2,964 2,410
end of period
16
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Sales by Business

2016 1H

CRO CMO BD 4% 1% <1%

2015 1H

CMO BD CRO 2% 2% 7%

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Generics
89%
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17

Sales by Indications

2016 1H

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Others
CNS
12%
14%
2015 1H
Oncology
74%
CNS Others
14% 7%
Oncology
Oncology60%
79%
18
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Sales by Region

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2016 1H
JP
AU+NZ ROW
6%
3% 7%
India
2015 1H
9%
AU+NZ ROW
JP
US+CAN
EU
5% 7%
7%
52%
23%
India
US+CAN
19%
43%
EU
19%
19
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ScinoPharm Changshu Operationg Update

20

Short-Term Goal

To provide API contract development and manufacturing services for both multinational and China domestic pharmas

  • Major base for large volume API with regulatory supports

  • To be able to produce high value added intermediates for SPT

21

The Completive Advantages

  • Process Development Capability

Collaborating with a partner specialized in enzymatic technology to integrate with ScinoPharm in-house strong chemical synthesis capabilities for providing services to develop greener, safer, and more cost-effective API manufacturing processes

  • GMP Production Capability

Knowledge to design, develop, and test parameters of spray drying process for APIs which are difficult-to-dry, are sensitive to long drying residence time, or require uniform particle size distribution

Regulatory Compliance Capability Fully compliant with the most advanced guideline published by EMA in 2014 to set the standards for production line segregation and equipment cleaning criteria

22

Operating Progress

  • Actively implementing more than 20 contract research or manufacturing projects every year

  • 9 US/EU customers and 3 of them are top 10 big pharmas

  • Strategically partnership with Lee’s Pharma in China to provide API process development and manufacturing services for more than 15 projects

Successfully passed 14 GMP and 2 EHS audits conducted by customers

23

Selected List of CRAM Projects at Changshu

Customer
Project
Type
Product Indication/stage
Product
Type
Remarks/
Market
Passed Mexican
Customer
Project
Type
Product Indication/stage
Product
Type
Remarks/
Market
Passed Mexican
Customer
Project
Type
Product Indication/stage
Product
Type
Remarks/
Market
Passed Mexican
Customer
Project
Type
Product Indication/stage
Product
Type
Remarks/
Market
Passed Mexican
Customer
Project
Type
Product Indication/stage
Product
Type
Remarks/
Market
Passed Mexican
Customer
Project
Type
Product Indication/stage
Product
Type
Remarks/
Market
Passed Mexican
Customer
Project
Type
Product Indication/stage
Product
Type
Remarks/
Market
Passed Mexican
Customer Project
Type
Product Indication/stage Product
Type
Remarks/
Market
Passed Mexican
Top 10 global pharma CMO Approved antidepressant drug in US GMP
Intermediate

authority (APIF)
GMP inspection
Top 5 global pharma CMO Approved African sleeping disease drug API Site transfer
from Taiwan
Lee’s Pharma CRO +15 items including topical anesthetic,
brain tumor, antibiotic, hypertension, eye
drop, etc.

API
China
China pharm company CRO Phase II/ III clinical trial for cancer API China
China pharm company CRO Phase IIb for age-related macular
degeneration
API US/China
Taigen Biotech CRO Phase II clinical trial for myocardial
infarction
API China/Taiwan
US-based new drug company CRO Phase II clinical trial for prevention of HIV
infection

API
US
Top 5 global pharma CRO Phase II clinical trial for diabetes Intermediate US
24





Top 5 global pharma
CRO
Phase I clinical trial
API
NA
US NASDAQ listed pharma
CRO
Phase III clinical trial for opioid-induced
constipation
Crude API
US
Top 5 global pharma CRO Phase I clinical trial API NA
US NASDAQ listed pharma CRO Phase III clinical trial for opioid-induced
constipation
Crude API US

Key Progress for China Market

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ScinoPharm
Taiwan
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Submitted drug import license applications for 12 APIs (anti-cancer, cardiovascular, Alzheimer's disease, benign prostatic hyperplasia, hepatitis B, etc. )

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ScinoPharm
Changshu
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  • Obtained drug production permits for 11 APIs for anti-cancer, anti-viral, glaucoma, etc. )

  • Submitted 5 drug license applications for USFDA, 1 for EDQM and 2 for CFDA

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Strategic
Alliance
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5 formulation development and 1 new drug projects smoothly undergoing. Expected to be commercially available in 2019-2022

25

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Business Updates

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26

Injectable Plant Progress

  • Entire facility includes space for R&D, quality control, washing, sterilization, manufacturing, filling, lyophilization, packaging, and storage

  • Granted building use permit at the end of 2015. To complete registration batch production by 2017. Expected to submit the 1st home-made ANDA in 2018 and pass US FDA inspection in 2019

  • Target is injectables with high entry barrier/ high unit-priced generics like oncologicals and peptides. Will offer CMO services for brand drugs and self-developed drug

  • 10 drugs planned with the indications of cancer, diabetes, osteoporosis, multiple sclerosis and antinauseant

27

Aseptic Fill & Finish Service

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Vial
Product Line
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28

Diversified CRAM Portfolio

Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage First Launch Year Indication Location
Commercial 2005 Eluting Stent US
Commercial 2009/2013 Skin Infection/HAP US/EU
Commercial 2011 Depression US
Commercial 2012 Obesity US
Commercial 2013 Seizure US
Stage Est. NDA Filing Year Indication Location
Phase III 2016 Infections US / EU / Asia
Phase III 2017 Ovarian Cancer US / EU
Phase III 2017 Prostate Cancer US
11
Phase III
2017
Ovarian Cancer
CN
Phase III
2018
Parkinson’s Disease
US
29
Phase III 2017 Ovarian Cancer CN
Phase III 2018 Parkinson’s Disease US

2016 1H Major Products - account for 60% of total sales

API
Idii
2015 MKT
# of US DMF/EDMF &
API
Idii
2015 MKT
# of US DMF/EDMF &
API
Idii
2015 MKT
# of US DMF/EDMF &
API
Idii
2015 MKT
# of US DMF/EDMF &
API
Idii
2015 MKT
# of US DMF/EDMF &
API
Idii
2015 MKT
# of US DMF/EDMF &
API Idii 2015 MKT # of US DMF/EDMF &
ncatons Share other Filings
Irinotecan
HCI
Antineoplastic 64% 62
Docetaxel
Anhydrous
Antineoplastic 33% 68
Paclitaxel Antineoplastic 31% 57
Exemestane Antineoplastic 18% 44
Galantamine
HBr
Antipsychotic 12% 38
Gemcitabine
Antineoplastic
8%
76
Gemcitabine Antineoplastic 8% 76

*Source: IMS data from Newport

30

2016 API Product Launch Plan

API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API Region Indication Brand
Marketer
Regional
Sales
WW Sales
Azacitidine USA Myelodysplastic
syndromes (MDS)
Celgene US$248.1M US$751.6M
Desmopressin
Acetate
USA Polyuria Ferring US$150.1M US$395.8M
Entecavir USA
Singapore
Hepatitis B
Virus (HBV)
Bristol-
Myers
US$262.5M
(USA only)
US$1,576.6M
Australia
Flumazenil Korea Reversal of the
sedative effects of
benzodiazepines
Roche N/A US$84.0M
Gemcitabine
HCl
Middle
East
Pancreas, Lung,
Ovary, Breast
Cancers
Eli Lilly N/A US$547.9M
.
Tamsulosin
HCl
USA
Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$410.0M
US$1,818.4M
.
Tamsulosin
HCl
USA Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$410.0M US$1,818.4M

Launched Source: IMS Data (2014Q4-2015Q3) 31

Pipeline

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� 4-6 new launches � 5-6 new launches � 5-6 new launches
� 1 [st] co-developed US � 1 [st ] home-made drug US � 3 drug products launched in China
ANDA launched ANDA filing � 1st home-made drug launched in US
2016 2017 2018 2019 2020
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� 3-5 new launches � 6-8 new launches
� Chinese CFDA inspection at SPC
� 1 [st] self-developed US � US FDA inspection at INJ
ANDA launched
32
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Brand Quality with Asian Advantages www.scinopharm.com

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33