Luye Pharma Group LtdLuye Pharma Group, Ltd.

We aim to be the leading specialty pharmaceutical group to improve the quality of human life

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Group Overview

• Founded in 1994 in China

• Listed on SGX main board since May 2004y

• 3500 employees in total, 1300 sales people and 300 R&D specialists

• Committed to R&D manufacturing and marketing of natural drugsCommitted to R&D, manufacturing and marketing of natural drugs, new formulations and biopharmaceutical products. 

• 50+ products in oncology, cardiovascular, orthopaedics, gastroenterology, endocrinology and CNS markets 

• 10% of the sales revenue invested to R&D as a strategy 

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Corperate Culture

Mission:Professional technology serves human health.

Operational Philosophy:Talents and science‐technology lead to perfection and sublime. 

Enterprise Vision:Being the most respectful and global leading pharmaceutical group

Strategic Goal:To be one of the global Top 100 pharmaceutical companies by 2020!

Core Value:Core Value:Innovation, Responsibility. Fairness. Integrity. Co‐operation. 

LUYE Pharma Group was honored to be the “Best companies to serve for in China" in p p2011 by the FORTUNE China. 

Major Milestones 

Group Establishment

Group Establishment

Listed on SGX

Listed on SGX

Acquisition of Nanjing SikeAcquisition of Nanjing Sike

Acquisition of Sichuan BaoguangAcquisition of 

Sichuan BaoguangAcquisition of Beida WeixinAcquisition of Beida Weixin

19981998 20042004 20052005 20072007 20092009 20102010 201120111998199819981998 2004200420042004 2005200520052005 2007200720072007 2009200920092009 2010201020102010 2011201120112011

Inauguration of  R&D and Inauguration of  R&D and  Acquisition of Acquisition of  Initiation of Phase II Initiation of Phase II Int’l Business Dept’sInt’l Business Dept’s

First exportation of formulation productFirst exportation of formulation product

Singapore WMBSingapore WMB

Acquisition of A‐Bio

Acquisition of A‐Bio

of Xuezhikang in USof Xuezhikang in US

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Locations & Facilities 

BeijingBeida WeixinSFDA GMP

Yantai, ShandongShandong LuyeTGA GMPTGA GMP 

Nanjing, JiangsuLuye SikeSFDA GMP  Luzhou, Sichuan

Luye BaoguangSFDA GMP 

SingaporeA‐BiocGMP

Domestic Market Coverage

Committed to quality services  for customers benefits.

Professional academic promotion by in‐house team since 1995

35 sale support offices

Sales network covering 30 provinces 

1300 sales professionals targeting 4000 hospitals

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Overseas Market

Formulation products registered and marketed in Europe and ASEAN countries, including Singapore, Malaysia, Philippines Vietnam Russia MongoliaPhilippines, Vietnam, Russia, Mongolia, Finland, Korea and Croatia and etc.

Therapeutic Areas Positioning

Leading position in Oncology & ImmuneLeading position in Oncology & Immune Market

3 000 000 000

3,500,000,000

2,500,000,000

3,000,000,000

ROCHE GROUP

JS.L.Y.G. HENGRUI

1 500 000 000

2,000,000,000SHANDONG QILU FTY

ASTRAZENECA GROUP

SANOFI GP.

JIANGSU HANSOH

1,000,000,000

1,500,000,000LVYE GROUP

PFIZER GROUP

NOVARTIS GROUP

ASTELLAS GROUP

0

500,000,000

9

0MAT ~ 06/2007 MAT ~ 06/2008 MAT ~ 06/2009 MAT ~ 06/2010 MAT ~ 06/2011

Quick growing in Oncology Market

COMPANY AGR* 2008 AGR 2009 AGR 2010 AGR 2011 CAGR

ROCHE GROUP 30.05 27.53 29.10 17.41 25.92

JS.L.Y.G. HENGRUI 25.63 23.01 13.26 12.78 18.53

SHANDONG QILU FTY 28.00 28.95 28.57 26.92 28.11

ASTRAZENECA GROUP 58 34 31 11 27 49 28 92 35 91ASTRAZENECA GROUP 58.34 31.11 27.49 28.92 35.91

SANOFI GP. 22.89 19.34 18.81 9.97 17.65

JIANGSU HANSOH 25.38 30.94 19.76 36.40 27.97

LUYE GROUP 39.62 32.31 28.52 20.45 30.04

PFIZER GROUP 31.37 26.75 16.02 23.84 24.37

NOVARTIS GROUP 13.73 17.34 20.77 24.13 18.93

ASTELLAS GROUP 14.19 35.21 16.32 8.68 18.20

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*AGR: annual growth rate

Oncology Products

CMNa希美纳®®(Sodium Glycididazole for Injection)

®®

The only approved sensitizer for radiotherapy of cancer treatment in the world

Lipusu力扑素® ® (Paclitaxel Liposome for injection)

Paclitaxel liposome formulation, for the treatment  of NSCLC, ovarian and breast cancer

The new biological response modifiers with anTiandixin天地欣®®(Lentinan Lyophilized powder for

injection)

The new biological response modifiers with an exact effect, to enhance cell immune systems of cancer patients

Tiandida天地达®®(Amifostine Injection )

Broad‐spectrum cytoprotection agent to protect normal cell tissues of patients during chemotherapy treatments

YITAIDA伊泰达®®(Arsenious Acid and Sodium

Chloride Injection）

Anti‐tumor medicine indicated for the acute promyelocytic leukemia (APL) and primary advanced liver cancer.

TIANDIPING奥沙利铂(Oxaliplatin for Injection)

Indicated for metastatic colorectal cancer  after  the fluorouracil failure, alone or with the fluorouracil.

The Best Seller– LI PU SU

Unlike other domestic companies, Luye mainly focus on brand drugsLIPUSU is liposome Paclitaxel , a novel DDS drug, developed by Luye  Contribute around 1/3 to whole company annual revenue in 2010

30.00600,000,000

Rank 8th among all the Oncology products launched in China

20.00

25.00

400,000,000

500,000,000

10.00

15.00

200,000,000

300,000,000

ANNUAL SALESShare of Paclitaxel (%)

0.00

5.00

0

100,000,000

12

MAT ~ 06/2007

MAT ~ 06/2008

MAT ~ 06/2009

MAT ~ 06/2010

MAT ~ 06/2011

Top 10 Oncology products in China

Product  COMPANY RANK MAT ~ 06/2011

MAT ~ 06/2010

MAT ~ 06/2009

MAT ~ 06/2008

MAT ~ 06/2007

XELODA (CAPECITABINE) ROCHE GROUP 1 958,785,207 841,095,102 624,503,267 479,351,300 384,797,376

AI SU (DOCETAXEL) JS.L.Y.G. HENGRUI 2 919,400,049 847,478,009 731,970,017 555,142,163 416,984,452

CELLCEPT(MYCOPHENOLATE 

MOFETIL)ROCHE GROUP 3 857,415,711 813,970,871 679,558,438 583,383,788 523,427,996

MOFETIL)

PROGRAF (TACROLIMUS) ASTELLAS GROUP 4 740,331,777 681,232,422 585,648,165 433,154,065 379,328,331

AI HENG (OXALIPLATIN) JS.L.Y.G. HENGRUI 5 661,427,617 580,038,594 523,834,387 457,546,507 386,764,860

ZADAXIN (THYMALFASIN) SCICLONE PHARM 6 627,330,312 617,970,828 501,523,085 411,800,845 302,177,412

ZE FEI (GEMCITABINE) JIANGSU HANSOH 7 619,928,575 493,180,764 404,596,942 297,441,976 198,283,542

S ( C )LI PU SU (PACLITAXEL) LUYE GROUP 8 519,944,408 401,130,300 302,570,475 194,916,778 106,664,815

MABTHERA (RITUXIMAB) ROCHE GROUP 9 494,466,368 402,638,800 306,030,429 235,722,380 150,412,205

RIBONUCLEIC ACID JL.AODONG YANJI PH

10 461,385,350 365,067,964 220,812,641 134,198,904 84,851,669

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PH

Cardiovascular Products

XuezhikangXuezhikangCapsule/TabletCapsule/TabletCapsule/TabletCapsule/Tablet• A worldwide recognized blood lipid regulator• Extract from “specially‐made red yeast rice”• Combination of modern high‐tech biotechnology 

ith t diti l Chi dwith traditional Chinese drug• Safely and effectively regulating blood lipid in a 

comprehensive way to effectively prevent the heart and cardiovascular diseasesN i l E i l D C l d• National Essential Drugs Catalogue product

SaitanSaitan赛坦赛坦®®

((TelmisartanTelmisartan Capsules)Capsules)• ARB 1st line depressurization drug

Endocrinology Products

Beixi贝希®® Exclusive capsule formulation ((AcarboseAcarbose Lower the blood sugar level after mealCaps lesCaps les)) P t t di b l lCapsulesCapsules) )  Protect cardio‐cerebral vascular  

Beitangning A Class 1 national new drug, the safest insulin sensitizer to improve贝唐宁®® the insulin resistance protecting the pancreas islet’s function and贝唐宁    the insulin resistance, protecting the pancreas islet’s function, and((PioglitazonePioglitazone adjusting grease metabolic disorder.HydrochlorideHydrochlorideTabletsTablets ))

Orthopaedics ProductsMaitongna麦通纳®®(Sodium Aescinatefor Injection)

Anti‐effusion and anti‐swelling, indicated for the cerebral edema and edema caused by trauma or surgery.

Okai欧开®®(Sodium Aescinate Tablet) Indicated for soft tissue swelling and vein edema.

Olai欧莱®®(Compound Sodium  Aescinate Gel)

Sidi 斯迪诺®®

Indicated for the local swelling caused by inflammation, degenerative disease and trauma.

Indicated for bone pain caused by osteoporosis and Sidinuo斯迪诺®®(Elcatonin for Injection)

Otong欧通®®(C i i G l)

p y pto prevent the osteoporotic fracture.

Indicated for the relief the pain of joints and muscle wound in clinic.

(Capsaicin Gel)

Glucosamine Hydrochloride Tablets盐酸氨基葡萄糖片

Indicated for the cartilage damaged, to prevent and suspend the occurrence and development of osteoarthritis.

Feng Shi Ye风湿液®( Rheumatism Treatment Liquid)

Indicated for nourishing liver and kidney, to nourish and circulate the blood, to expel wind and dampness, to achieve the complete treatment of rheumatic disease.

Hepatology and Gastroenterology Products

Lutingnuo 绿汀诺® (Reduced Glutathione for Injection)

Indicated for alcohol‐associated liver disease to remove the drug toxicity and to relieve the 

益肝灵® Yiganling Soft Capsule

radiation reaction and damage.

Indicated for acute and chronic hepatitis

Nuosen 诺森® (Sodium Pantroprazole for Injection)

hepatitis.

Indicated for duodenal ulcer, gastric ulcer and acute 

Nuosen诺森® ( Pantroprazole Pellets capsule)

ulcer, gastric ulcer and acutepathological changes of gastric mucosa, as well as compound gastric ulcer and acute hemorrhage of upper digestivecapsule)

Sailimai 赛立迈® (Smectite Dispersible Tablet)

hemorrhage of upper digestive tract.

Indicated for active peptic ulcer ( h d d d l

Weilikang Particle

(stomach and duodenal ulcer, reflux esophagitis and Zollinger‐Ellison Syndrome).

Central Nervous System Products

Jinsiping 金思平®p g

(Selegiline Hydrochloride Tablet) 

• Indicated for Parkinson's disease and senile 

dementia.

• Indicated for the tristimania.

Yikang Capsule益脑胶囊®®

• Indicated for neurasthenia and the bodyIndicated for neurasthenia and the body 

tired, dizziness, insomnia and hypomnesis

caused by cerebral arteriosclerosis.

Gynecology Products

Ximingting希明婷® (Extract of Chinese Cohosh)• Indicated for treating perimenopausal period 

climacteric syndrome. • More natural and safer than HormoneMore natural and safer than Hormone 

Replacement Therapy (HRT)

Fule Particles妇乐Th l l ti i bi l d ti• The only oral antimicrobial and anti‐inflammatory drug indicated for gynecological diseases in  medical insurance drugs list, named to be  Protected Chinese Medicine.

Fukangning Capsules妇康宁A classic prescription to smooth blood, regulate menstruation and nourish qi and vein 

h h i i

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to enhance the immunity system.

Product PipelineCode CMC Pre-Clinical IND Phase I Phase II Phase III NDA

LY03001

LY03002

LY03003

LY03004

LY03005

LYBBF

LYFSD

LY02001

LY04008

LY01609

LY01610

LY01611LY01611

LY01612

TS0802

TS0903TS0903

TS0904

TS0963

TS0901TS0901

CNS Cardiovascular Gastroenterology and Hepatology

Oncology Metabolism

Research and Development Center

• Establishment in 1998 with a dedicated team of more than 300 specialists 

• Focusing on the research and development of new formulations natural drugs and• Focusing on the research and development of new formulations, natural drugs and biotechnology products

• Platforms  for innovative drug screening and development, new formulation research, pharmacology, drug safety evaluation and etcp gy, g y

• China GLP Drug Safety Evaluation Center

• FDA cGMP Microsphere Pilot Workshop 

Diff ti t d R&D i t ti• Differentiated R&D orientation  

• A pipeline composing over 10 products with independent IP rights

Long‐acting Extended‐releasedLong acting Extended released Microsphere Technique • The first in the world to cure the neurodegenerative diseases with  long‐acting extended‐released 

formulation, which betters the clinical effect, reduces the side‐effect,  and  improve the patients compliance .

• The first in China to complete the research of pilot process & equipment and the preparation of pilot samples.

• The biweekly or longer administration frequency  significantly reduces the treatment cost,  lessen the family burden and improve the life quality which provides paradigm for the pharmaceutical economicsfamily burden  and improve the life quality, which  provides paradigm for the pharmaceutical economics study.

• 8 microsphere products in the pipeline, 5 of which will be launched in the coming 5 years.

• China  State Key Laboratory for Long‐acting and Targeting Drug Delivery Systemy y g g g g g y y

10 00

12.00

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0 00

2.00

4.00

6.00

8.00

10.00

Con

cent

ratio

n（ng

/mL

0.000 2 4 6 8 10 12 14 16 18 20

Time（d）

Liposome Technology Platform

Key Liposome Technology

• techniques for preparation of highly encapsulation efficient and stable liposometechniques for preparation of highly encapsulation efficient and stable liposome

• techniques for liposome releasing preparation  

• techniques for preparation of liposomal formulation of different physicochemical drugs

• core technical index and methodology for liposome drugs quality control 

• pharmacokinetics assessment system for liposome drugspharmacokinetics assessment system for liposome drugs

Major Project of the 11th 5‐year plan:  

Liposome Drug Process Engineering Technology Platform

6 liposome drugs in the pipeline 

Innovative R&D mode – integration ofInnovative R&D mode  integration of industry and academy

Shandong Luye Pharmaceutical Co., Ltd.    Yantai University

company 50% share holding 50% share holdingcompany president as the chairman of committee

College of Pharmaceuticals, Yantai University

50% share holding 50% share holding

Union School Management Committee

Yantai University 

Committee    

College of Pharmaceuticals being the major training base. 

Strategic R&D Alliance

Strategically allied with well‐known schools and institutes to make value for the core business . 

Clinical trial capability 

• 16 staff , with 2 PhD，2 MD and 4 Masters in Pharmacology

• handle phase I‐IV clinical trials in research centers around China; launch clinical trials in fields of Oncology, Gastroenterology, Hepatology, Neurology and Psychiatry, Orthopedics, Cardiology, Pulmonary Medicine and Critical Care, Gynecology and Surgery;Pulmonary Medicine and Critical Care, Gynecology and Surgery; 

• Collaborate with 100+ Top Hospitals and 200+ outstanding specialists, covering 30+ provinces;

• Setup partnership with several local and international CROs; 

• Successfully accomplish 30+ clinical trials; 3 staff have experience in y p ; pconducting international multi‐center clinical studies.

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Registration Capability 

10 staff, with 1 Ph.D and 4 Masters

have rich expertise in registration consulting, registration feasibility analysis, registration strategy analysis in China, registration classification, technical solutions and dossier preparation of drugs and medical devices; 

good at communication with government, international multi‐center clinical study application, import drug registration, supplemental 

li i f d i i i i f dapplication for drug registration, re‐registration of drugs etc.; 

successfully registered around 30 drugs/devices in China and 3 drugs abroadabroad 

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International partnership

• License‐in later stage products in Oncology, Gastroenterology, H l O h di C di l N lHepatology, Orthopedics, Cardiovascular, Neurology areas 

• Co‐develop drugs in pre‐clinical ( pharmacology and toxicology) and clinical stageclinical stage

• License‐out new formulations & NCE 

Global Strategic Partners

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h k ！Thank you！

Contacts

Cindy Cheng International BD Managerchengting@luye.cn 

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86 13564482649 (cell)