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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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



Launching Year 2015

Therapeutic Area Liver Disease

PRDL 11



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


(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


▪ 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


▪ 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.


▪ 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


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


◼ Entered 24 provincial RDLs


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


• 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



Yuanzhijiu /Xiongwei

◼ Promising exclusive product




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


• 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



◼ 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



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


◼ Entered DRL of 10 provinces


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


Roxatidine

◼ First-to-market generic product

newly launched to the market

◼ Therapeutic area: digestive

system

◼ Entered 11 provincial RDL


29

• Generic Name: Roxatidine Acetate Hydrochloride For Injection

• Active Ingredients: Roxatidine Acetate Hydrochloride


• 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



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


• 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.


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