Sihuan Pharmaceutical Holdings Group Ltd. 四环医药控股集团有 …
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2018 Annual Results Presentation
Sihuan Pharmaceutical Holdings Group Ltd.
四环医药控股集团有限公司
1
Disclaimer
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Pharmaceutical Holdings Group Ltd. (the “Company”) and it is not intended to form the basis of any decision to purchase securities, interests or assets in or of the
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in or of the Company and neither this document nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment
whatsoever. Any decision to purchase or subscribe for securities in any offering must be made solely on the basis of the information contained in the prospectus or offering
circular issued by the company in connection with such offerings.
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will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company or any of its subsidiaries as to the appropriateness, accuracy,
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2
R&D Progress3
目录
Sales Performance
2
1 Performance Review
4R&D Platform
5 Financial Review
6Future Strategies
7 Appendix
Performance Review1
• Revenue of the Group increased by 6.2% to RMB2,917.4 million in 2018
• Profit attributable to owners of the Company increased by 11.8% to RMB1,620.0 million in 2018
• R&D expenditure increased by 48.3% to RMB533.2 million, accounting for 18.3% of total revenue
• Net Cash Flows reached RMB1,792.8 million
• Gross profit margin increased from 72.4% to 81.5%; Net profit margin increased from 53.9% to
57.6%
• Proposed final cash dividend per share is RMB1.3 cents
4
RevenueRMB2,917.4
million
Profit Attributable to
OwnersRMB1,620.0
million
Net Cash Flows
RMB1,792.8million
R&D ExpenditureRMB533.2
million
Maintaining Healthy Financial Standing
A number of major products, which includes Oudimei, Yuanzhijiu/Xingwei, Jie’ao,
Huineng and Mainokang, have been included in the Clinical Pathways Interpretation
and the Interpretation of Clinical Pathways for Therapeutic Drugs. Huineng has been
included in the Rheymatology Section in the guideline’s 2018 edition.
Troxerutin and Cerebroprotein
Hydrolysate Injection
(Yuanzhijiu/Xingwei/Xinshengtong)
Danshen Chuanxiongqin Injection
(Wei'Ao)
Roxatidine Acetate Hydrochloride
for Injection
(Jie'Ao)
Monoammonium Glycyrrhizinate
and Sodium Chloride Injection
(Huineng)
+39.3% +53.7% +71.4% +131.2%
Mature Products Fast-growth Products
Efficient Market Management to Realize Product Potential
6
Commenced Phase Ⅱ clinical trials in China of three innovative drugs, which includes 1)digestive system drug Anaprazole Sodium 2)China’s first independently patented innovative cabapenem
antibiotic Benapenem 3) innovative oncology targeted drug Pirotinib.
Antihypertensive drug Tylerdipine Hydrochloride has finished Phase Ⅰ studies in healthy invididuals and has initiated trials in patients. Besides, another three innovative drugs have commenced Phase Ⅰ clinical
trials respectively. They are 1) selective CDK4/6 inhibitor Birociclib 2) a third generation irreversible tyrosine kinase inhibitor XZP-3621 3) PDE-5 inhibitor Fadanafil.
Metformin Hydrochloride Tablets obtained consistency evaluation approval.
Exclusive product and paediatric medicine Midazolam Oromucosal Solution has been included in the Priority Review Process.
The Company is the first in China with the drug registration approval for Compound Electropyte Injection (Ⅱ) (500mL). Compound Amino Acid Injection (20AA) granted approval for drug registration.
Production approval has been obtained for Octreotide Acetate Injection, Ambroxol Hydrochloride Injection and Buflomedil Hydrochloride Injection.
Breakthroughs of Multiple R&D Projects
The Group’s first anti-diabetic innovative patented new drug Janagliflozin commenced Phase Ⅲ clinical trials in China.
“Non-PVC solid-liquid double chamber infusion soft bag”(including Ceftazidine,Cefuroxime, Cefodizime has passed on-site assessment.
• Global Business Development Department is established with officeslocated in China and US.
• Team is comprised of experts with extensive experience in domestic andoverseas pharmaceutical industry.
• Focus on the development of cutting-edge drugs in oncology and other majortherapeutic areas.
Global BD Expansion—Established to Enrich Product Portfolio
8
M&A and International Collaborations
重庆派金生物科技有限公司
Croma-Pharma
GmbH
2017 Set up joint
venture
• Expanded to aesthetic medicine business
• First product Princess® VOLUME dermal filler was
granted approval and has been launched to market
PharmaDax
Foshan
2017 Staged
investment
• Subscribe for 19.99% equity interests and corporate
bonds issued by PharmaDax Foshan at the
consideration of RMB200 M
• Equipped with FDA approved production line
Medifood
GmbH
2017 Acquisition • Acquired 50% equity in U.S. Foods for Special
Medical Purposes (FSMP) manufacturer Medifood
GmbH
• Obtained exclusive manufacture, marketing and
distribution rights in Greater China
Medtrition Inc. 2017 Acquisition • Acquired FSMP manufacturer Meditrition Inc.
• Obtained exclusive distribution rights in Greater
China
Covance 2015 Reached joint
agreement
• Reached long-term partnership agreement to support
the pre-clinical and clinical development of new drug
pipeline
Hugel Inc. 2014 Reached joint
agreement
• Joint R&D of Botulinum toxin and Hyaluronic acid
• Clinical trials in China have been completed
Chong Qing
Paijin Biotech
2014 Reached joint
agreement
• Reached agreements on 5 projects including Insulin
Degludec and Insulin Aspart
Ambest
Pharmaceutical
2017 Acquisition • Acquired 100% equity at a consideration of RMB1.1B
• Sales of “Huienng” and “Mainuokang” have recorded
high growth rate
Company Initiation
Date
Partnership Other Information
Sales Performance2
10
8.30%
6.96%
5.89%
4.81%
3.34%
Sihuan
Pfizer
Sanofi
AstraZeneca
CSPC
Leading Market Position
Source:IMS
Top 5 Coporations
in China’s CCV
Prescription Drug
Market in 2018
(Market Share)
Top 10 Corporations
in Domestic Hospital
Market in 2018
Ranking Corporations Market Share in 2018
1 Pfizer Group 3.04%
2 AstraZeneca Group 2.82%
3 YangZiJiang FTY 2.80%
4 JS. HengRui 2.19%
5 Sanofi Group 1.89%
6 Bayer Schering Pharma 1.65%
7 Qilu Pharm Group 1.64%
8 ChiaTai TianQing 1.62%
9 Roche 1.59%
10 Fosun Pharma 1.51%
11 Sihuan Pharmaceutical 1.42%
11
Sales & Marketing
Conduct evidence-based research on main products to extend their life span
• Conducted evidence-based research to reinforce the clinical efficacy, safety and indications of major products;
• Promoted inclusion of major products in official clinical guidelines, expert consensus and interpretation of clinical pathways. All major products have been successfully listed in the county-level Interpretation of Clinical Pathways and the Interpretation of Therapeutic Drugs for Clinical Pathways.
Strengthened academic promotions to enhance marketing capabilities
• Sped up national academic promotions, resulting in improved market recognition and coverage;
• Enhanced the efficiency of sales system by providing systematic trainings to sales specialists and distributors, so that marketing activities are more efficient at all level.
Deepen penetration in existing first-tier market of mature products and accelerate development in low-end market
• Dedicated efforts in deepening penetration of mature products in first-tier markets where there is extensive coverage, targeting at exploiting untapped hospital resources, with the aim to stabilize sales and achieve stable growth;
• Concentrated effort on directing resource to primary healthcare institutions, while accelerating the development in small- and medium-sized hospitals and community medical institutions in third- and fourth-tier cities.
Promote high-growth products
• Increased the number of hospital coverage for products that have been included in the medical insurance catalogue;
• Achieved further growth winning bids to incorporate more provincial medical insurance catalogues
12
Sales Performance of Main Products
Revenue of Key CCV Products
Product NamesYear of 2017 Year of 2018
Change(RMB’000) (RMB’000)
Cerebroside-kinin Injection686,909 749,710 9.1%
(Oudimei/Aofutai/Weitong/Jielixin) *Troxerutin and Cerebroprotein
Hydrolysate Injection 463,879 645,958 39.3%(Yuanzhijiu/Xingwei/Xinshengtong) *
Danshen Chuanxiongqin Injection (Wei’Ao)
216,549 332,880 53.7%
Cinepazide Maleate Injection389,969 314,547 -19.3%
(Kelinao/Anjieli)
Alprostadil Lipid Emulsion Injection216,460 154,056 -28.8%
(Yimaining/Yikangning)
Compound Trivitamin B for Injection(II)(Yeduojia) *
126,487 141,865 12.2%
GM1 Injection(Aogan/Xiangtong) 151,400 153,516 1.4%
Floium Ginkgo Extract and TertramEthypyrazine Sodium Chloride Injection
(Mainuokang) *65,774 59,667 -9.3%
Cerebroprotein Hydrolysate(Qu’Ao)
78,909 29,076 -63.2%
Nicotinamide Injection 9,458 42,284 347.1%
▪ Revenue of CCV products increased by 4.0% to RMB2,685.7 millions, accounting for 92.1% of the total revenue. The increase was mainly attributable to effective targeted market management.
▪ Main products won 25 to 30 provincial tenders with stable bidding prices.
▪ Yuanzhijiu/Xingwei/Xinshengtong and Wei’Ao achieved sustainable growth since the increasing nationwide hospital coverage.
*Exclusive Product
13
▪ Revenue from non-CCV products increased 42.2% to RMB231.7 million, accounted for 7.9% of the Group’s total revenue.
▪ By the end of 2018, Jie’Ao and Huineng have won tenders in 29 and 28 provinces, respectively. Both of the products have been included in 11 Provincial Reimbursement Drug Lists (PRDL).
▪ Along with the tender progress, chances are the new products get included in the updated version of PRDLs, leading to more shares and generating more revenue.
Revenue of Key Non-CCV Products
Therapeutic Area
Product NamesYear of 2017 Year of 2018
Change(RMB’000) (RMB’000)
GastroinestinalRoxatidine Acetate Hydrochloride for
Injection (Jie’Ao)35,269 60,457 71.4%
HepatitisMonoammonium Glycyrrhizinate and
Cysteine and Sodium Chloride Injection(Huineng)*
19,289 44,604 131.2%
Vitamins Nicotinic Acid Injection 989 27,866 2,718.0%
CNS Oxcarbazepine(Ren’Ao) 28,079 22,436 -20.1%
Anti-infection Clindamycin Injection(Xinnuoao) 17,534 15,324 -12.6%
Sales Performance of Main Products
*Exclusive Product
14
Mainuokang(Floium Ginkgo Extract andTertram Ethypyrazine SodiumChloride Injection)
Huineng(Monoammonium Glycyrrhizinate and Cysteine and Sodium Chloride Injection)
Jie’Ao(Roxatidine Acetate Hydrochloridefor Injection)
New Products Seizing Opportunities in the Drug Reimbursement Reform
Launching Year 2015
Therapeutic Area CCV
PRDL 10
Tenders Won 24 Provinces
Hospital Coverage 423( 176)
Launching Year 2015
Therapeutic Area Gastraintestinal Disease
PRDL 11
Tenders Won 29 Provinces
Hospital Coverage 477( 314)
Launching Year 2015
Therapeutic Area Liver Disease
PRDL 11
Tenders Won 28 Provinces
Hospital Coverage 471( 322)
The following recently launched products are expected to be included in more PRDLs and win more tenders.
• Surgery section of the 2017 edition of the Interpretation of Clinical Pathway
• General medicine section of the 2017 edition of the Interpretation ofClinicalPathway and Therapeutic Drugs (county-level)
• Digestive disease section of the 2018 national-level edition of the Interpretation of Clinical Pathway
• Rheumatology section of the 2018 national-level edition of the Interpretation of Clinical Pathway
• Digestive disease section of the 2018 national-level edition of the Interpretation of Clinical Pathway
• Exclusive Product
• Floium ginko and ligustrazine are included in NRDL and has been widely used in clinical practice.
• Exclusive Product
15
Source: IQVIA China’s Hospital Prescription Drug Data Report (>=100beds), MAT2018Q4
55.3
47.5
40.6 38.7 38.3
33.8
29.2 28.8 28.1 27.4
25.5 24.9
22.2 20.8
17.5 15.1 14.7 14.2 14.1 13.2
0
10
20
30
40
50
60
RMB/100 millions
MAT 2018Q4 Ranking of County-level Hospital Exploiting Status
Lower-end Market Expansion - Outstanding Performance in Expansion in County-level Market
16
▪ Fundamental Research:3 completed, 1 in progress• Research on cerebroside-kinin as treatment for cerebral infarction and inhibition of neuronal apoptosis in rats
(Tiantan Hospital)• Study of cerebroside-kinin’s neuroprotective effect on cerebral trauma in rats(The Army’s General Hospital)• Fundamental research on cerebroside-kinin as treatment of brain/subarachnoid hemorrhage(The Army’s
General Hospital)• Fundamental research on cerebroside-kinin’s effect on regeneration of neurons(Tiantan Hospital)(Undergoing)
▪ Clinical Research: 1 completed, 1 in progress• Randomized double-blind multi-centered clinical studies on Cinepazide Maleate Injection in acute ischemic stroke
• Leading institute: Beijing Union Medical College Hospital• 65 clinical centers• Completion of recruitment of 1301 patients• Currently at the stage of assorting data, results are expected to come out in 2019
• Safety Research:ADR automatic monitoring and evaluation on 19487 patients treated with Cinepazide Maleate Injection across 5 hospitals;to prove the safety and reliability of Cinepazide Maleate Injection’s clinical use.(With as leading institute, 5 clinical centers, 19487 patients)
Post-launching Re-evaluation of Key Products
CinepazideMaleate Injection(Kelin’ao/Anjieli)
Cerebroside-kinin Injection
(Oudimei/Aofutai/Weitong/Jielixin)
▪ Publications: 1 published• ADR automatic monitoring and evaluation on 19487 patients treated with Cinepazide Maleate Injection across 5
hospitals. Drug Application and Surveillance in China 2017(4)
▪ Clinical Research:1 completed, 2 in progress• Cerebroside-kinin as treatment of hypertensive intracerebral hemorrhage
• Led by The Army’s General Hostpital, 14 centers nationwide, planning to recruite 422 patients and completed in 2022
• Curative effect index includes degree of white matter fiber bundle damage under MRI; to prove the effectiveness of cerebroside-kinin in clinical use
• Cerebroside-kinin as treatment for acute cerebral infarction (319 patients) (Beijing University Third Hospital, 16 clinical center, publication submitted)
• Cerebroside-kinin as treatment of cognitive impairment after acute cerebral infarction(60 patients)(The First Affiliated Hospital of Anhui Medical University,planning to be completed in 2022)
▪ Publications:4 published, 3 submitted• Cattle encephalon glycoside and ignotin injection promoted synthesis of glial cellline-derived neurotrophic factor
by astrocytes that protected against neuronal damage induced by AAPH. Int J Clin Exp Med 2016;9(2):1794-1800• Cattle encephalon glycoside and ignotin reduced white matter injury and prevented post-hemorrhagic
hydrocephalus in a rat model of intracerebral hemorrhage. Sci Rep.2016 Oct 26;6:35923• Cattle Encephalon Glycoside and Ignotin Reduce Early Brain Injury and Cognitive Dysfunction after Subarachnoid
Hemorrhage in Rats. Neuroscience 2018 Sep 15;388:181-190• Systematic Evaluation and Meta Analysis of Cerebroside-kinin Injection as treatment for cerebral hemorrhage.
Clinical Medicine of China 2017(33)4:317-323.
17
▪ Clinical Research: Exploratory clinical trial on efficacy and safety of Danshen Chuanxiongqin Injection in randomized, double-blind, controlled, multicentered research
• Initiated on April, 2017• Leading institute: Beijing University First Hospital• 22 clinical centers, 240 patients are expected to be recruited• Expected to be completed in 2021
▪ Foundamental Research: 4 completed, 1 in progress• Troxerutin and cerebroprotein hydrolysate’s protective effect on neurovascular unit in rats after middle cerebral
artery embolization(The Army’s General Hospital)• Research on troxerutin and cerebroprotein hydrolysate’s protective effect on neurovascular units deprived of
oxyglucose(The Army’s General Hospital)• Research on troxerutin and cerebroprotein hydrolysate’s protective effect on neurovascular unit in traumatic
brain injury (The Army’s General Hospital)• Research on troxerutin and cerebroprotein hydrolysate’s neuroprotection and restoration of spinal cord injury in
rats (The Second Affiliated Hospital of Harbin Medical University) • Research on mechanism of troxerutin and cerebroprotein hydrolysate injection as treatment of cerebral
hemorrhage(Tiantan Hospital)
▪ Clinical Research:3 completed• Troxerutin and cerebroprotein hydrolysate as treatment of acute cerebral infarction(Beijing Hospital as leading
institute, 13 clinical centers, publication released)• Research on troxerutin and cerebroprotein hydrolysate as treatment of craniocerebral injury (Beijing Hospital, 10
clinical centers, publication released)• Research on troxerutin and cerebroprotein hydrolysate’s protective effect on children’s neurological injury
induced by febrile convulsion in children(Zhejiang University Children’s Hospital,publication submitted)
Troxerutin and Cerebroprotein
Hydrolysate Injection
(Yuanzhijiu/Xingwei/
Xinshengtong)
DanshenChuanxiongqin
Injection(Wei’Ao)
▪ Publications:7 published, 1 submitted• Randomized, single-blind, placebo controlled research on troxerutin and cerebroprotein hydrolysate as treatment
for acute cerebral infarction [J].Chinese Journal of Immunology and Neurology, 2016,7(23)4:251-255• Randomized multicenter controlled clinical study on troxerutin and cerebroprotein hydrolysate as treatment of
craniocerebral trauma[J].Chinese Journal of Neurosurgery, 2017,7(33):669-672• Protective effect of troxerutin and cerebroprotein hydrolysate neurovascular unit in rat after middle cerebral
artery embolization[J]. Chinese Journal of Stroke, 2017,12(12):1097-1103• Systematic evaluation on troxerutin and cerebroprotein hydrolate as treatment of acute cerebral infarction. World
Clinical Drugs, 2017,38(1),28-35• Research on troxerutin and cerebroprotein hydrolysate protective and restoring effect of rat’s neural function
after spinal cord injury [J]. Chinese Journal of Neurotrauma Surgery, 2018,4(6)• Troxerutin and Cerebroprotein Hydrolysate Injection Protects Neurovascular Units from Oxygen-Glucose
Deprivation and Reoxygenation-Induced Injury In Vitro. Evidence-Based Complementary and Alternative Medicine. Volume 2018 May 2,10 pages
• Troxerutin Cerebroprotein Hydrolysate Injection Ameliorates Neurovascular Injury Induced by Traumatic Brain Injury – via Endothelial Nitric Oxide Synthase Pathway Regulation. Int J Neurosci. 2018 Dec;128(12):1118-1127.
Post-launching Re-evaluation of Key Products
R&D Progress3
19
R&D Progress and Strategies
Innovative Drug
Dedicated in
Major Therapeutic
Areas
Established a clear R&D pipeline, increased R&D investment and allocated resources intherapeutic areas with major unmet clinical needs, such as oncology/immuno-oncology, diabetesand non-alcoholic steatohepatitis(NASH).
Patented innovative diabetic drug Janagliflozin has commenced Phase Ⅲ clinical trial. CommencedPhase Ⅱ clinical trials in China of three innovative drugs, which includes digestive system drugAnaprazole Sodium, China’s first independently patented innovative cabapenem antibioticBenapenem and innovative oncology targeted drug Pirotinib.
Three innovative drugs initiated their Phase Ⅱ clinical trial:Anaprazole Sodium, Benapenem andPirotinib. Four innovative drugs have commenced their Phase Ⅰ clinical trial-antihypertensivedrug Tylerdipine Hydrochloride, selective CDK4/6 inhibitor Birociclib, a third generationirreversible tyrosine kinase inhibitor XZP-3621and PDE-5 inhibitor Fadanafil.
Generic Drugs
Achieved
Progress
The generic drug R&D platform have the first-mover advantage. Bioequivalent test project has been deployed for 8 products and is progressing as scheduled. Metformin Hydrochloride Tablet has obtained consistency evaluation approval. A number of products in the generic drug pipeline are expected to be the first to pass or be considered to pass consistency evaluation in the second half of 2019. This include Capraplatin Tartaric Acid Capsule, Azithromycin Capsule; Ibuprofen Injection and Octraotide Acetate Injection.
Pediatric medicine Midazolam Oromucosal Solution has been Included in the Priority Review Process.
Business
Expension
M&A
BD Overseas
One of the subsidiaries – PharmaDax Foshan, equipped with manufacture and quality control system certified by U.S. FDA, in synergy with the R&D Centre in San Francisco, have become asignificant component in our strategic layout and will drive the frontier of market globalization.
Beijing Ruiye Drugs Manufacture Co. Ltd. (“Beijing Ruiye”), in which Sihuan Pharmaceuticalholds a 44% stake, is dedicated to the R&D of the “non-PVC solid-liquid double chamberinfusion soft bag” (including Ceftazidime, cefuroxime, cefodizime. The product is expected tolaunch in the first half of 2019.
20
*
Innovative Drug Pipeline
*哌罗替尼在美国和中国的I期临床试验已完成,并获得中国食品药品监督管理局I/II/III期临床试验批件,国内Ⅱ期临床试验已启动
Project atClinical Stage
TherapeuticArea
PhaseⅠClinical Trial Phase Ⅱ Clinical Trial Phase Ⅲ Clinical Trial
Janagliflozin Diabetes
CP001 Long-acting Basal Insulin
Diabetes
Insulin Aspart Diabetes
Insulin Aspart 30 Diabetes
Insulin Aspart 50 Diabetes
Birociclib Oncology
Pirotinib* Oncology
XZP-3621 Oncology
Benapenem Anti-infective
Anaprazole SodiumGastrointestinal
Disease
TylerdipineAnti-
hypertension
Fadanafil BPH-LUTS/ED
Project atPreclinical Stage
Therapeutic Area
Target Validation LI/LO Preclinical IND
XZP-5809 Oncology
XZP-P009 NASH
XZP-P135 NASH
XZP-P118 Oncology
XZP-P179 Oncology
XZP-P183 NASH
XZP-P107 Oncology
XZP-P215 Oncology
XZP-P223 Oncology
Monotherapy
Combined Regiment with Metformin
**
21
Janagliflozin—Anti-diabetic BlockbusterDiagnosed/No
Treatment4%Diagnosed/
UnderTreatment
26%
Undiagnosed70%
DM Diagnosis and Treatment in China
10.6%Prevalence in China
RMB44 billionDomestic
Market Potential
Source: IMS, IDF 7th Edition
▪ Category 1 innovative drug;
▪ Highly potent and selective SGLT-2 inhibitor. Based
on data from preclinical in-vitro research,
Janagliflozin demonstrates better SGLT-2 receptor
selectivity than marketed Canagliflozin and
Dapagliflozin;
▪ Pronounced anti-hyperglycemic effect and dosage-
efficacy correlation, proved by clinical research;
▪ Based on the clinical research, the new drug features
good safety profile, good pharmacokinetics data, a
long half-life, convenience (oral regiment once a
day), good bioavailability, and is not easily affected
by food consumption;
▪ Two separate Phase Ⅲ clinical trial currently
undergoing (monotherapy/combined regiment
with Metformin), with Ji Linong from Beijing
People’s Hospital leading the research;
▪ Targeting to be amongst the country’s top two
domestically-produced SGLT-2 inhibitors.
Innovative Drug—Diabetic Drug SGLT-2 Inhibitor
22
▪ The first type of basal Insulin that can be injected anytime
during the day with adjustable injection time;
▪ Lower risk of hypoglycemia compared with Insulin Glargine,
especially during the night;
▪ Features the half-time of appx. 25h, which doubled that of
Insulin Glargine, making it a super long-acting basal insulin
with stable control of blood glucose;
▪ Flexible to pair with rapid-effect insulin and Liraglutide—
Biphasic Insulin (Insulin Degludec/Insulin Aspart), and
Liraglutide/Insulin Degludec premixed preparation.
▪ The first domestic enterprise that submitted application and granted approval for clinical trials
(Category 7 Biological Products);
▪ Filled in the blank of biological products line and established the foundation of subsequent products
development;
▪ Global basal insulin market has great growth potential. This product could become a blockbuster with
the fastest growth rate.
Insulin Degludec Biosimilar Product
Advantages of Insulin Degludec
Mechanism of Insulin Degludec
Innovative Drug—Long Acting Basal Insulin
Binds to
Albumin
Cyto-
membrane
Insunlin Degludec
in the BloodBlood
Capillary
Subcutaneous
TissuePolymers
Monomer
Insulin
Receptor
23
Innovative Drug—Insulin Aspart potentially become the biosimilar product with market volume over RMB1 billion
359,826
417,623443,731
503,34927.72%
16.06%6.25%
13.44%
0%
10%
20%
30%
0
200,000
400,000
600,000
2014 2015 2016 2017
Growth rateSales(RMB10k)Market Trend of Insulin Aspart in China’s Public Hospital Market
Product Name CompanyAnnual Sales Volume (RMB 10k)
2014 2015 2016 2017
Insulin Aspart 30 Injection
Novo Nordisk 297,183 338,078 350,418 397,508
Insulin AspartInjection
Novo Nordisk 61,069 75,700 88,781 100,612
Insulin Aspart 50Injection
Novo Nordisk 1,576 3,844 4,531 5,227
Sihuan Pharm ranks in top 5 in domestic Insulin Aspart Clinical Research Progress
Sales of original Patented Insulin Aspart reached RMB5 billion in 2017
24
Innovative Drug—CDK4/6 Inhibitors Combetting Breast Cancer
▪ Category 1 innovative drug;
▪ Highly selective CDK4/6 inhibitor for ER+ breast cancer;
▪ PhaseⅠclinical trial in progress, POM(proof of Mechanism) has been
proved in research conducted on cancer patients, the new drug
demonstrates inhibiting activity on CDK4/6 with good pharmacokinetics
attributes based on current clinical research;
▪ Compared with globally marketed Palbociclib and Ribociclib, Birociclib
has potential advantages—1) effective Blood Brain Barrier (BBB)
penetration, potential to treat malignant brain cancer or malignant brain
metastasis, 2) single-agent activity, can be used as monotherapy, 3)
better safety profile with lower myelosuppression rate;
▪ Targeting to be amongst the country’s top two domestically
manufactured product.
来源:Datamonitor,Sammons SL, Topping DL, Blackwell KL. HR+, HER2– Advanced Breast Cancer and CDK4/6 Inhibitors: Mode of Action, Clinical Activity, and Safety Profiles. Current Cancer Drug Targets.;Nature Reviews Molecular Cell Biology
Birociclib – CDK4/6 Inhibitor
▪ Breast cancer has highest prevalence among all types of malignant tumor in female in
China, with appx. 70% of breast cancer patients exhibit ER+ status, and one of the most
promising target therapies – CDK4/6 inhibitor has no domestic manufacturer yet;
▪ In 2016, breast cancer treatment drugs recorded a total revenue of USD12.6 billion
globally, and the number is expected to double USD25 billion in 2024.
Market Demand
25
Innovative Drugs—EGFR-TKI Combatting NSCLC (Non-Small Cell Lung Cancer)
Pirotinib – NSCLC Patiens with EGFR Mutation
▪ Category 1 innovative drug;
▪ A novel irreversible tyrosine kinase inhibitor (TKI)
targeting EGFR mutation, effectively inhibiting targeting
receptors resistant to current marketed EGFR TKI;
▪ Demonstrated potential treating activity to squamous
cell lung carcinoma (no treatment method accessible
currently), potentially to be first-in-class drug
▪ International multi-centered PhaseⅠclinical trials have
already been completed in China and US. Phase Ⅱ
clinical trials in progress in China.
Market Performance
▪ Sales volume of EGFR-TKI increase from RMB1.03 billion
in 2013 to RMB 1.17billion in 2016,Sales volume of
EGFR-TKI is predicted to reach RMB1.56 billion.
Source:IMS CHPA ; EGFR Diagnostic Navigator
26
Anaprazole Sodium – Acid Suppressant of PPI Category
▪ Category 1 Innovative Drug;
▪ Inhibits gastric acid secretion and eliminates Helicobacter pylori rapidly and with high efficiency;
▪ Preclinical studies have demonstrated distinctive features including rapid onset and longer duration of
acid suppression. Composed of singer isomers, the new drug also features enzyme-free metabolism
and multi-enzyme metabolism, which mitigates the risk of drug-drug interactions. Thus the drug is
potentially to be the best-in-class attributable to its good safety properties and efficiency;
▪ Phase Ⅱ clinical trial progressing well, conducted in multiple clinical institutions across China.
Market Prospect
▪ Prevalence of digestive system diseases
accounts for 10%-20% of the population
with the recurrence rate of digestive
ulcers exceeding 75%;
▪ The market volume of PPIs reached
RMB18.8 billion in 2017, demonstrating
the extensive demand and promising
market potential.
图片来源:Mount Sinai Health System
Innovative Drug—Proton Pump Inhibitor Category
27
Benapenem – Carbapenem, Broad-spectrum Antibiotics
▪ Category 1 Innovative Drug;
▪ Carbapenem antibiotic which has strong antibacterial activity against G+/G- and anaerobic bacteria
that it can be widely used in patients with severe infection;
▪ Features longer half-life period and safety profiles compared with other drugs in the same
category;
▪ Commenced Phase Ⅱ clinical trial for complicated urinary tract infections is being conducted in
multiple clinical institutions in China and progressing well.
Innovative Drug—Broad-spectrum Antibiotics
Market Review
▪ Market volume of anti-infective drugs has reached RMB192.0 billion in 2017, with the growth rate of
4.0%;
▪ Carbapenem ranked as the 5th in the antibacterial drugs with the sales volume of almost RMB9.7 billion,
with its market share increased from 4.4% in 2013 to 6.2% in 2017.
28
Current Market
▪ The blood pressure control rate of hypertensive
patients after treatment is 29.6%, among which 50%
of patients are often accompanied with certain
organ damage and 49% of patients accompanied
with hypertension-related symptoms ;
▪ CCB has the highest prescription rate for Asian
patients among other anti-hypertension drugs.
▪ Existing CCB drugs are associated with side-effect
such as renal failure and peripheral edema.
▪ Category 1 innovative drug;
▪ Innovative dual inhibition of L-/T-type calcium channels;
▪ Compared with marketed CCB, pre-clinical study suggests that Tylerdipine not only effectively lowers blood
pressure, but also reduces the incidence of edema and provides additional organ protection like kidney and
heart protection;
▪ PhaseⅠclinical trial on healthy volunteers is completed and that on patients is currently being conducted.
Clinical trial data demonstrated that the anti-hypertensive effect of Tylerdipine was comparable to the marketed
CCB drugs.
Tylerdipine – L/T Dual Calcium Channel Blocker
31%
37%
11%
7%
3%
11% CCB
ARB
β receptor inhibitor
ACEI
Diuretic
Others
Innovative Drug—L-/T- Dual Calcium Channel Blocker Anti-hypertension Drug
Domestic Market Share of Anti-hypertension Chemical Drugs in 2015
29
Bioequivalence
Test and post-
launching re-
evaluation
Potential First-to
market Generic
Drug in China
Products
submitted to both
CFDA and FDA
Generic Drugs
Submitted for
Production
Approval
• Entecavir Tablet
• Metoprolol Succinate ER
Tablet
• Olanzepine Orally
Disintegrating Tablet
• Esomeprazole Magnesium
(Pellet) Tablet
• Venlafaxine
Hydrochloride Sustained-
Release Tablet
• Nifedipine Controlled
Released Tablets
• Sitagliptin Phosphate/
Metformin Hydrochloride
Tablet
• Capraplatin Tartaric Acid Capsule
• Ibuprofen Injection
• Levetiracetam Injection
Concentrated Solution
• Levamlodipine Besylate Tablet
• Levetiracetam Tablet
• Eslicarbazepine Acetate Tablet
• Ticagrelor Tablet
• Clopidogrel Hydrogen Sulphate
Tablets
• Gabapentin Capsule
【Priority Review】
• Midazolam Oromucosal Solution
• Quetiapine Fumarate ER Tab
(PharmaDax)
• Glyburide Tablet (PharmaDax)
• Midazolam Oromucosal
Solution
• Eslicarbazepine Acetate
Tablet
• Roxatidine Acetate
Hydrochloride Sustained-
release Capsule
• Tedizolid Phosphate Tablet
▪ By the end of 2018, there are 99 projects ongoing on the generic drug R&D platform with
31 projects under review by CFDA/CDE. Involving therapeutic areas include CNS,
endocrine system, digestive system, anti-viral and anesthesia.
▪ Bioequivalence Test for 7 products have been deployed while 3 of them have the
application submitted according to the bioequivalence test application requirement. 1
consistency evaluation approval has been acquired.
Bioequivalent Test
• Metformin Hydrochloride
Tablet
• Azithromycin Capsule
• Octreotide Acetate Injection
• Oxcarbazepine Tablet
• Roxatidine Hydrochloride
Injection
• Pantoprazole Sodium Injection
• Alprostadil Injection
• Ozagrel Sodium Injection
Post-launching Re-evaluation
• Cinepazide Maleate Injection
• Salviae Miltiorrhizae and
Ligustrazine Hydrochloride
Injection
▪ Cerebroside-kinin Injection
▪ Troxerutin Cerebroprotein
Hydrolysate Injection
Generic Drug R&D Progress
30
▪ Treatment of partial epileptic seizures in patients aged 4 years andabove;
▪ Currently the first and the only domestic enterprise that submitted application and received acceptance applied for production approval for this drug in China;
▪ Features good tolerance with higher efficacy and safety for long-termtreatment, the drug is expected to be the first-line clinical drug in thefuture;
▪ Epilepsy is one of the three major CNS diseases. There are currentlyappx. 9 million epilepsy patients in China, with more than 400 thousandnewly diagnosed epilepsy patients every year. According to IMS, thedomestic antiepileptic drug market reached RMB2.42 billion in 2017.
▪ The first manufacturer to pass the Consistency Evaluation throughsupplementary application in China;
▪ As primary therapy to patients with diabetes , this drug is characterizedwith various beneficial effects, other than hypoglycemic effect,including cardiovascular protection and alleviating non-alcoholic fattyliver diseases;
▪ Acknowledged as a first-line medication for diabetes in guidance forType 2 diabetes prevention and treatment;
▪ The total revenue of metformin tablets in city- and county-level publichospitals in China reached RMB2.59 billion in 2017.
Anti-epileptic Drug
Eslicarbazepine
Acetate Tablet
Anti-diabetic Drug
Metformin
Hydrochloride Tablets
Key Generic Drugs
31
R&D Platform 4
32
Driving the Innovative Frontier—R&D Bases
Innovative Drug R&D center-Shandong Xuanzhu
Small molecule innovative drug development Center. Focuses on major disease areas with significant
clinical needs, including diabetes, oncology, anti-infective and non-alcoholic hepatitis, with appx.
200 experienced personnel with over 10 years of experiences working in multinational pharmaceutical
companies. Its Clinical Development Center is responsible for clinical
procedures including project management, clinical testing, data
management, biostatistics, medical science, registration, quality
assessment and quality control.
R&D Centre, CS-Bay Therapeutics
Primarily focuses on the development of
first-in-class immuno-oncology drugs, including
small molecule drugs and large molecule
biologics such as antibodies and fusion protein
drugs.
Beijing Aohe Research Institute
Focuses on the development of first-to-market
generic drugs, in relation to which we have
developed intellectual property rights concerning
formulation, production process, improved
chemical attributes or drug delivery system.
Financial Review5
34
Financial Highlights
Key Income Statements Items
2018 2017Change
(RMB’000) (RMB’000)
Revenue 2,917,405 2,745,809 6.2%
Gross profit 2,379,088 1,986,853 19.7%
Operating profit 2,025,943 1,688,256 20.0%
Profit attributable toowners of the Company
1,619,956 1,448,935 11.8%
Key Financial Ratios
2018 2017
Gross profit margin 81.5% 72.4%
Net profit margin 57.6% 53.9%
Basic EPS (RMB cents) 17.1 15.3
Receivable Turnover (days) 58 69
Inventory Turnover (days) 177 102
Proposed final cash dividend per share (RMB cents)
1.3 1.3
35
2,917.4 2,745.8
20182017
Overall Revenue Statistics
▪ Revenue of the Group increased by 6.2% to RMB2,917.4 million in 2018.
▪ Revenue from CCV products increased 4.0% to RMB2,685.7 million.
▪ Revenue from non-CCV products increased 42.2% to RMB231.7 million.
(RMB million)
+6.2%
Revenue
92.1%
7.9%
CCV Non-CCV
36
Profit Margin
1,986.9 2,379.1
72.4%
81.5%
1500.0
2000.0
2500.0
2017 2018
Gross profit(RMB million)
Gross profit margin
▪ Gross profit increased by 19.7% to RMB2,379.1 million, and gross profit margin rose from 72.4% to
81.5%. This was mainly attributable to the implementation of production cost control procedures
of the Group and higher sales from products with better profit margin during the year.
▪ Profit attributable to owners of the Company increased by 11.8% to RMB1,620.0 million, and net
profit margin rose from 53.9% to 57.6%.
Profit attributable to owners of the Company
Net profit margin(RMB million)
1,448.9 1,620.0
53.9%
57.6%
20%
60%
100%
1000.0
1500.0
2000.0
2017 2018
37
R&D Expenditure
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
14.0%
16.0%
18.0%
20.0%
0
100
200
300
400
500
600
2017 2018R&D expenditure
Percentage of revenue
533.2359.6
13.1%
18.3%
R&D expenditure(RMB million) Percentage of revenue
38
Net Cash Flows from Operating Activities—Solid Financial Standing
1,671.3
2,062.4
1,708.2
1,448.91,620.0
1,760.9
1,568.6
2,018.0 1,917.61,792.8
0.0
500.0
1000.0
1500.0
2000.0
2500.0
2014 2015 2016 2017 2018
2014-2018 net cash from operating activities
net profit operating cash flow
(RMB million)
39
Distribution Expenses
Distribution expenses(RMB million)
Distribution expenses of 2018 increased to RMB271.1 million compared with 2017, which
was mainly attributable to the Group’s enhanced academic promotion across the nation
aiming for brand strengthening.
Percentage of revenue
5.0%
6.0%
7.0%
8.0%
9.0%
10.0%
0
100
200
300
2017 2018
Distribution expenses Percentage of revenue
271.1227.6
8.3%
9.3%
40
Capital Expenditure
(RMB million)
406.3
710.8
58.6
107.4
22.2
19.7
0
100
200
300
400
500
600
700
800
900
2017 2018
Purchase or in-house development of intangible assets
Acquisition of land use rights
Property, plant, equipment & investment property
487.1
837.9
Future Strategies6
42
Growth Engines for Current and Future Stage
2019-2020
2020-2022
2022 and onwards
Innovative new drugs
Janagliflozin, Birociclib, Benapenem,
Anaprazole Sodium
Aesthetic medicine Generic drugsMetformin, Ibuprofen Injection, Rivastigmine Hydrogen Tartrate
Capsules, Levetiracetam Concentrated Solution for Injection,
Levamlodipine Besylate
Specialty medicine (PharmaDax)
Quetiapin Fumarate ER Tablet,
Glyburide Tablet
Aesthetic medicine
Hyaluronic Acid(Hugel Inc.)
Botulinum Toxin(Hugel Inc.)
Growth stage productsMainuokang, Roxatidine, Huineng
Aesthetic medicinePrincess Hyaluronic Acid
(Croma-Pharma GmbH )
Medical insurance of class A and B
Nicotinamide for Injection, Nicotinic Acid for Injection, Dopamine for
Injection, Diprophylline for Injection
The Group will continue M&A activity as a strategy to optimize
product portfolio, providing additional growth drive to the Group.
43
Future Strategies & Outlook
On its extensive experience builds Sihuan Pharmaceutical’s leadership position in the CCV drug market. With strong and stable fundamentals and excellent financial capability, the Group also seeks to increase the revenue from non-CCV drugs and the strategy is working out remarkably.
Strengthen marketing competency
The Group will maintain a diversified product portfolio and a sustainable product resources in the mid- to long-run. In terms of marketing, the Group will continue to increase penetration in lower-end markets for its mature products, and boost market coverage of its growth stage products by tender wins and inclusion in more provincial RDLs.
Going ahead, Sihuan Pharmaceutical’s vision in sales and marketing and business operation is precise, clear and determined. Eyeing the next page of development, the Group implemented a series of internal adjustments with the aim to “strengthen R&D capabilities, optimize product resources and accelerate market expansion”. the Group will strive for the sustainable development and better returns for its shareholders
Strategies
Optimize product portfolio
In the future, the Group will be investing significant resources into developing a sustainable pipeline of innovative and generic products, through in-house R&D, mergers and acquisitions and international cooperation..
Outlook
Appendix7
45
Digestive system drug Roxatidine and hepatitis drug Huinengachieved over 50% growth in revenue
Company Overview
Founded in 2001
Leading manufacturer and distributor of cardio-cerebral vascular prescription drug in China
Non-CCV drug portfolio exhibits high growth potential
Integrated conglomerate with well-established R&D, manufacturing and distribution platform
Strong financial standing
Robust environmental, social and governance system
• Ranks 1st in CCV drug market• Over 40 products marketed • Best-selling products Yuanzhijiu, Wei’Ao and maintain rapid
growth
• Over 18 innovative drug projects and 100 ongoing generics projects; first NDA to be submitted in 2021
• GMP certified production bases in Jilin and Liaoning• Over 410 in-house sales managers and 3000 distributors with established
hospital network
• Industry-leading gross profit margin; net profit margin stood at ~ 50%;
• Stable operating cash flow
• Low debt ratio (<1%)
46
With an average of 20 years experience in the industry, our core management leadthe company with expertise and dedication
Dr. Che Fengsheng
Co-founder,
Chairman &
Executive Director
✓ In-depth understanding of domestic pharmaceutical industry
✓ Proven R&D and drug acquisition track record
✓ Extensive clinical experience
✓ Proven entrepreneurship
✓ Expertise in managing growth-stage companies
✓ High standard of corporate governance
Mr. Choi Yiau Chong
Executive Director & Chief Financial Officer
Core Management Team
8 years of clinical
experience as a
neurologist
Over 20 years of
experience in sales and
marketing of
pharmaceutical products
and managing
pharmaceutical
companies
6 years of clinical
experience as a general
surgeon
Over 20 years of
experience in sales and
marketing of
pharmaceutical products
Extensive finance and
accounting experience
gained from a publicly-
listed company and
Deloitte & Touche
Member of the Chartered
Institute of Management
Accountants (UK) and the
Institute of Certified Public
Accountants of Singapore
Dr. Guo Weicheng
Co-founder, Deputy
Chairman, Chief
Executive Officer &
Executive Director
Dr. Shih Chengkon
Head of Xuanzhu
Well-known Pharmacologist
with extensive research
leadershipexperiences in
therapeuticareas of
cardiovascular, immunological,
anti-viral,etc.
Over 20 years of innovative
R&D experience in Boehringer
IngelheimPharmaceutical Inc.,
TaishanScholar Overseas
Specialist, Jinan Hight-level
Talents
Dr. Guo Feng
Vice President (R&D)
Nearly 20 years of
experiences in innovative
drug R&D and management
especially in oncology drug
R&D strategy making, clinical
development, registration etc.
A member of Merck
Healthcare Global Clinical
Development Executive
Leadership team; led team
conducted clinical
development and registration
of multiple well-known drugs
in China and Asia
47
Our History
• 2006 Acquired 100% interest of Beijing Sihuan,;
Hainan Sihuan was awarded “National high-tech enterprise”
• 2007 Listed on the main board of the SGX-ST on 23 March;
Acquired 100% interest of Shenzhen Sihuan
• 2008 Acquired 100% interest of Shandong Xuanzhu;
Aogan was launchedBeijing Sihuan was awarded “National high-tech enterprise”Hainan Sihuan was awarded “National high-tech enterprise”
• 2009 Qingtong was launched;
Established Langfang Gaobo, engaged in the production of
APIs and pharmaceutical intermediates;
Delisted from the SGXST
• 2010 Ranked No. 4 in the Forbes 2010 list of the most promising
enterprises in the PRC and No. 1 among pharmaceutical
companies
Listed on the Hong Kong Stock Exchange
Aquisition of Changchun Xiangtong and Duofei Pharm
Alprostadil, Oudimei, YuanzhijiuCompound trivitamin B for injection (II) was launched
• 2011 Acquisition of Wansheng, and cooperation with Shandong
buchang
• 2018 Establishment of Global Business Development Centre
Category 1 Innovative Drug Benapenem Commenced
Phase II Clinical Trial in China
Innovative Digestive System Drug Anaprazole Sodium
Commenced Phase II Clinical Trial in China
Innovative Oncology Drug Pirotinib Commenced Phase
II Clinical Trial in China
Metformin Hydrochloride Tablets Obtained Consistency
Evaluation Approval
Pediatric Medicine Midazolam Oromucosal Solution to
be Listed in the Priority Review Process
Rapid-acting Insulin Analogue Insulin Aspart Granted
Approval for Clinical Trials
Long-acting Insulin Degludec Granted Approval for
Clinical Trials
Compound Electrolyte Injection (II) Granted Drug
Registration Approval
• 2001 Hainan Sihuan was founded
• 2002 Exclusive drug Kelinao and Chuanqing
were launched
• 2003 Acquired 28% equity share of Beijing
• Sihuan
• 2004 Kelinao's synthetic process a 20-year
patent protection period; established
medical evaluation committee
• 2005 Cerebrovascular Medicine Research
Institute of Hainan Sihuan was founded
• 2012 The group won the top 100 listed companies in
Hong Kong in 2012;First generic drug Roxatidine obtained new drug
certificate and production approval;
Acquired remaining 40% equity interest of Xuanzhu Pharma;
Partnered with NeuroVive, the world's leading mitochondrial
technology pharmaceutical company
• 2013 3 Category 1.1 innovative drug were approved for clinica
trials;
First-to-market generic drug Roxatidine was launched
• 2014 Langfang Gaobo Jingbang received report from the US FDA;
Anti-hypertensive innovative drug “Telodipine Hydrochloride”
obtained clinical trial approval
• 2015 Acquired 39% interest of Beijing Ruiye;
Xuanzhu and Covance signed long-term partnership
agreement;
Entered into a research collaboration agreement in novel
analgesic drugs and ion channel technology development
• 2016 Inovative patent drug Imigliptin Dihydrochloride obtained
• approval for Phase II/III clinical trials granted by the CFDA,
• and entered phase II clinical trials;
Category 1.1 innovative drug granted approvals for Phase
I/II/III clinical trials : Janagliflozin, Fadanafil, and Sirotinib
2017 Acquisition of Ambest Pharmaceutical (Jilin Changchun)
48
Business Structure
Sihuan Pharmaceutical Group
BeiJing Siuan
Pharm
Business Department 1
Shenzhen Sihuan Pharm
Business Department 2XuanZhu
Pharma
(Innovative drug)
AoHe
Pharmaceutical
Research
Institute
(Generic drug)
LangFang
Gaobo Pharm
JiLin SihuanPharm
BenXi
HengKang
Pharm
JiLin SiChang
Pharm
ChangChunXiangTong
Pharm
JiLin JinSheng
Pharm
JiLin Zhen’Ao
Pharm
R&D Production Sales & Marketing
CS-Bay
Therapeutics
(Innovative Drug
R&D Centre)
JiLin JinShengmarketing
center
HongHe
marketing center
Consists of over ten pharmaceutical companies and research institutes, the Group has
established a complete industry chain encompassing R&D, manufacturing, and marketing &
sales.
JiLin Sihuan
Aokang Pharm
JiLin
ShengTong
Chem Pharm
JiLin HuiKang
Pharm
49
Drug R&DM i c r o s o f t P o w e r P o i n t 2 0 0 3 优 化 模 板
Among the 654 research
personnel, 33 have obtained
their Ph.D. while over 196 have
Master degree.
We dedicated appx. 18.3% of
the revenue to R&D, which is
above the domestic industry
average.
Over 117 projects under
development, including 18
innovative patent drugs and 99
generic drugs.
➢ Domestic team : We have two
leading R&D teams that focus on
innovative and generic drug R&D
respectively
➢ Foreign team:We established the
U.S Innovative Drug R&D Centre
which is a key component of the
Group’s global planning. The Centre
primarily focuses on first-in-class
immuno-oncology drugs, including
small molecule drugs and large
molecules such as antibodies and
fusion protein drugs.
50
Drug R&D
StrongR&D
Foundation
Innovative
patent
drugs
Science/Tech
Projects-New
Drug R&D
State
Torch
Program
Patent
The first-to-market generic drug Kelinao was granted“State Torch Program”by the Science and Technology Ministry, in addition to several national and regional awards.
We have applied for over 760 patents among which 235 were granted. The number of PCT granted over 50.
Innovative patent drugs—Benapenem, TylerdipineHydrochloride and Pirotinib have been entitled the National Science/Tech Projects-New Drug R&D (Major National Science and Technology Projects).
We have submitted IND applications for 12 innovative drugs, and all of them obtained approvals for clinical trials and have entered into different stages of clinical trial.
51
Unique and Outstanding Sales & Marketing Structure
Our Group
Product managers
Distributor
Patients
Distributor Distributor Distributor
• • •
Hospitals and physicians
Academic promotion Selecting and managing distributors
Sales managers
• • •
Product/marketing support; distributor
screening/selection and management
Organizing and supporting various types of pharmaceutical
academic conferences, visiting senior experts and key opinion
leaders
Sihuan’s in-house marketing & sales team:
Over 100 product managers
– devising marketing strategies
– organizing national, provincial and municipal conferences, as
well as hospital departmental seminars
– providing product knowledge training for distributors
Over 500 sales managers
– responsible for tendering, provincial RDL, EDL or NRCMSL
– screening/selecting distributors, and setting sales targets for
them
– closely monitoring distributors' performance
– providing necessary support and services for distributors
Over 3,000 distributors and their sales force:
– have deep understanding of the local markets, established sales
channels and good relationship with local hospitals
– responsible for hospital market development and sales to
hospitals
– responsible for the maintenance of the relationship with
hospitals
The sales & marketing network operates at high efficiency by specialization and a close cooperation between over 600 professional sales & product managers and 3000 distributors.
Our unique sales model has proved to be very successful, highly productive andcost-effective, and enable us to develop and penetrate the markets rapidly.
52
Therapeutic areas CCV CNSGastrointestinal
systemAnti-infective Others
Number of Products
39 9 6 15 30+
Main products Kelinao, Oudimei,
Yuanzhijiu, Yeduojia
Ren’ao Roxatidine Clindamyein
Azithromycin
Huineng
Product Portfolio of Abundance and Diversity
Kelinao
Chuanqing
Qu’Ao
Ren’Ao Anjieli Anjiejian GM1
Qingtong
Pojia
Yimaining
Oudimei
Yeduojia
Salivae
Miltiorrhizae
Liguspyragine
Hydrochloride
and Glucose
Injection
Danshen
Chuanxiongqin
2005 2006 2007 2008 2009 2010 2011
Roxatidine
2003 2004
Nalmefene
hydrochloride
Yuanzhijiu
Kanglixin
Zhuo’Ao/Bi
’Ao
2013 2014
Huineng
Clindamycin
2015 2016
Floium Ginkgo
Extract and
Tertram
Ethypyrazine
2017
Dopamine
injection
Nicotinamide
Cerebroprotein
hydrolysate
Verapamil
Nicotinic acid
injection
Dyphylline
injection
53
Main Products Introduction
Product Product Specifications
Kelinao/Anjieli
◼ Mature key product
◼ Therapeutic area: CCV
◼ Entered NRDL
◼ Number of provincial tenders
won by Kelinao and Anjieli are
29 and 30
• Generic Name: Cinepazide Maleate Injection
• Active Ingredients: Cinepazide Maleate
• Mechanisms of Action:
• Ca2+ blocker:dilates vessels and restores blood flow to the ischemic regions
• Stimulation of endogenous adenosine effects: blocks pathological cascades involved in the stroke at
various pathways by inhibiting the metabolism and uptake of adenosine, which is an endogenous
protector secreted in response to ischemia and hypoxia, thereby, protecting neurons from the ischemic
injury
• Improvements of hemorheological parameters:enhances the red blood cell deformability and reduces
blood viscosity, thereby improving microcirculation
• Indications:
• Cerebrovascular diseases: cerebral arteriosclerosis, transient ischemic attack, cerebral thrombosis,
sequelae of subarachnoid hemorrhage, intracerebral hemorrhage, and traumatic cerebral injuries
• Cardiovascular diseases: coronary artery diseases, angina pectoris; combination therapies with other
medicines are necessary for myocardial infarction
• Peripheral vascular diseases: lower extremity arteriosclerosis, thromboangiitis obliterans, arteritis,
Raynaud’s disease
Oudimei /Aofutai
◼ Relatively mature exclusive
product
◼ Therapeutic area: CCV
◼ Entered 24 provincial RDLs
◼ Number of provincial tenders
won by Oudimei and Aofutai
are 27 and 23
• Generic Name: Cerebroside-kinin Injection
• Active Ingredients: GM1 0.24 mg/mL, polypeptide 3.2 mg/mL、amino acids 1.65 mg/mL、hypoxanthine
≥12 μg
• Mechanisms of Action:
• Neuroregeneration: stimulates neural stem cell differentiation, axon growth, and synapse formation;
modulates activities of enzymes including adenylyl cyclase, ATPases, protein kinases, etc., and
therefore preserves neural metabolism and repairs nervous system
• Neuroprotection: prevents Ca2+ overload, and maintains the integrity of neuron membrane; inhibits lipids
peroxidation that generates free radicals, and therefore alleviates cerebral edema and neuron damage
• Nutrients supplementation:polypeptides, amino acids, etc. are able to cross the blood-brain barrier,
and stimulate protein synthesis. Also, they supply specific nutrients for neuron metabolism and recovery
• Indications:
• To treat central nerve injuries caused by stroke, Alzheimer’s disease, hypoxic-ischemic encephalopathy,
craniocerebral injury, spinal cord injury, and other relevant conditions
• To treat peripheral neuropathies including traumatic peripheral neuropathy, diabetic peripheral
neuropathy, and compression neuropathy, etc.
54
Main Products Introduction
Product Product Specifications
Yuanzhijiu /Xiongwei
◼ Promising exclusive product
◼ Therapeutic area: CCV
◼ Entered 21 provincial RDLs
◼ Number of provincial tenders
won by Yuanzhijiu and Xingwei
are 29 and 28
• Generic Name: Troxerutin and Cerebroprotein Hydrolysate Injection
• Active Ingredients: Troxerutin 40 mg/mL, polypeptides 1.91 mg/mL, amino acids, and nucleic acids
≥0.8 mg
• Mechanisms of Action:
• Promotes neural protein synthesis and nucleic acids metabolism, stimulates synapse formation
and neuron regeneration
• Enhance the glucose utility and improves metabolism, protects the brain from ischemia.
• Increases cAMP expressed in platelets, and thus inhibits platelet aggregation and prevents
thrombosis
• Modifies red blood cell deformability and enhances microcirculation
• Decreases capillary permeability and alleviates edema
• Indications:
• Acute and chronic cerebrovascular diseases such as cerebrothrombosis, cerebral hemorrhage,
cerebral vasospasm, etc.
• Sequelae of traumatic cerebral injury and cerebrovascular diseases (eg. insufficient cerebral blood
supply, stroke, and cerebral hemorrhage)
• Occlusive peripheral vascular diseases, thrombophlebitis, and edema caused by capillary bleeding
and increased vascular permeability
Weiao
⚫ Promising product
◼ Therapeutic area: CCV
◼ Entered 19 provincial RDLs
◼ Number of provincial tenders is
27
• Generic Name: Salvia Miltiorrhiza and Ligustrazine Hydrochloride Injection
• Active Ingredients: Salvia Miltriorrhiza 0.36-0.44 mg/mL、Ligustrazine Hydrochloride 18-22 mg/mL
• Mechanisms of Action: inhibits platelet aggregation, dilates coronary arteries, reduce blood viscosity,
accelerates blood flow, improves microcirculation, and also prevents cardiac ischemia and myocardial
infarction
• Indicatiosn:
• Treat occlusive cerebrovascular diseases, such as cerebral dysfunction, cerebrothrombosis, and
stroke
• Treat other ischemic cardiovascular diseases, such as coronary artery diseases, angina pectoris,
myocardial infarction, thromboangiitis obliterans, etc.
55
Main Products Introduction
Product Product Specifications
Yeduojia
◼ Promising exclusive product at
earlier stage of development
◼ Therapeutic area: nervous system
and metabolism
◼ Entered DRL of 16 provinces
◼ Entered NRCMSL of 3
provinces
• Generic Name: Compound Trivitamin B For Injection (II)
• Active Ingredients: Vitamin B1, B6, and B12
• Mechanism of Action: protects peripheral nerves via a synergistic action of these three compounds
• Promotes aerobic metabolisms of carbohydrates and provide energy for injured nerves
• Promotes the synthesis of GABA and the metabolism of homocysteinaemia, and improves the
microcirculation around peripheral nerves
• Participates in the transition of the methyl group, and maintains the integration of myelin sheath,
thereby promoting the recovery of damaged nerves
• Indications:
• Peripheral nerve injury, polyneuritis, trigeminal neuralgia, and sciatica
• Prevents vomiting caused by isoniazid poisoning, gestation, radiation, and antineoplastic drugs
• pernicious anemia and nutritional anemia; can also be used as nutrition supplements for patients
with Vitamin B intake disorders
Floium Ginkgo Extract and
Tertram Ethypyrazine
◼ Promising exclusive product at
earlier stage of development
◼ Therapeutic area: CCV
◼ Entered DRL of 10 provinces
◼ Number of provincial tenders is
24
• Generic Name: Floium Ginkgo Extract and Tertram Ethypyrazine Sodium Chloride Injection
• Active Ingredients: Floium Ginkgo Extract, Tertram Ethylpyrazine
• Mechanisms: Active ingredients of floium ginkgo (ginkgo flavone glycoside and ginkgolides) and
tertram ethylpyrazine generate synergy effects:
• Inhibit lipid peroxidation, suppress production of free radicals and accelerate free radical removal,
and prevent ischemia/reperfusion injury; improve microcirculation and promote energy supply;
• Anti-hyperlipidemia, reduce cholesterol level, prevent platelet aggregation, and reduce blood
viscosity
• Prevent release of allergic mediators and mast cell degranulation, antagonize contraction of
smooth muscle cells, therefore alleviate adverse effects related to solely use of tertram
ethypyrazine such as rash and asthma
• Indications:
• Treat ischemic cardio-cerebral vascular diseases, e.g. blood supply insufficient, cerebral
thrombosis, cerebral embolism, coronary heart diseases, angina, heart attack
• Cerebral dysfunction, Alzheimer’s disease
56
Product Product Specifications
Roxatidine
◼ First-to-market generic product
newly launched to the market
◼ Therapeutic area: digestive
system
◼ Entered 11 provincial RDL
◼ Number of provincial tenders is
29
• Generic Name: Roxatidine Acetate Hydrochloride For Injection
• Active Ingredients: Roxatidine Acetate Hydrochloride
• Mechanisms of Action:
• As a new generation of H2 receptor antagonist, it suppresses gastric acid secretion, prevents the
upper gastrointestinal bleeding, and moreover, protects gastric mucosa
• Indications:
• upper gastrointestinal hemorrhage caused by peptic ulcer, stress ulcer, and hemorrhagic gastritis,
especially for patients at low risks
• H2 antagonists are recommended for stress ulcer prevention by the American Society of Health-
System Pharmacist (ASHP) guidelines with a recommendation degree of A
Huineng
◼ Exclusive product newly
launched to the market
◼ Therapeutic area: hepatitis
◼ Entered 11 provincial RDLs
◼ Number of provincial tenders is
28
• Generic Name: Monoammonium Glycyrrhizinate and Cysteine and Sodium Chloride Injection
• Active Ingredients: ammonium glycyrrhizinate 0.6 mg/mL, Cysteine and Sodium Chloride 0.3 mg/mL
• Mechanisms of Action:
• Preserves hepatocyte membrane integrity, possesses abilities of anti-oxidation, anti-inflammation,
and anti-fibrosis; modifies immune function
• Inhibits virus proliferation and achieves virus inactivation
• Indications: chronic persistent hepatitis, chronic active hepatitis, acute hepatitis, hepatotoxicity, early-
stage cirrhosis, allergic diseases, etc.
Main Products Introduction