2011 china pharmaceutical newsletter

CHINA PHARMACEUTICAL NEWSLETTER

Volume III 2011

Published byChina Center for Pharmaceutical International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd.

surveillance, GMP inspection, combating counterfeit drugs and joining PIC/S, and signed the Minutes of the 2011 Bilateral Meeting. (Mar.22, 2011)

SFDA Deputy Commissioner Bian Zhenjia meets Indian Ambassador and IDMA delegation On the morning of March 16, 2011, Bian Zhenjia, Deputy Commissioner of SFDA, met the visiting Dr. Jaishankar S, Indian Ambassador to China, and Mr. N.R. Munjal, Vice Chairman of Indian Drug Manufacturers’ Association (IDMA), and their entourage. Both sides had a discussion on establishing bilateral cooperation and communication mechanism in the f ield of drug supervision and exchanged ideas on drug registration and regulation. (Mar.16, 2011)

SFDA Commissioner Shao Mingli meets Chairman of Hong Kong Hospital Authority On February 22, 2011, Shao Mingli, Commissioner of SFDA, met with the visiting Mr. Hu Dingxu, Chairman of the Hospital Authority of Hong Kong, and his entourage. Both parties exchanged views on further enhancing cooperation. (Feb.24, 2011)

N a t i o n a l F o o d a n d D r u g A d m i n i s t r a t i o n I n s p e c t i o n Wo r k Conference convened From March 16 to 17, 2011, the National Food and Drug Administration Inspection Work Conference was held to sum up the achievements of the inspection work during the "Eleventh Five-Year Plan period", and clarify the work ideas and goals during the "Twelfth

S F D A C o m m i s s i o n e r S h a o Mingli Inspects the Development of Bio-pharmaceutical Industry in Hubei Province On March 22, 2011 , SFDA Commiss ioner Shao Mingli inspected the development of biopharmaceutical industry in Hubei Province, Commissioner Shao Mingli fully affirmed and highly appraised the Food and Drug Administration work in Hubei Province. He said that the food and drug administration work of Hubei has, through its explorations, accumulated useful experiences for the whole country. He hoped that Hubei will inherit and carry forward these experiences and further improve food and drug administration. (Mar.28, 2011)

SFDA Commissioner Shao Mingli and Deputy Commissioner Wu Zhen separately meets with Chairman Director of ANVISA Upon the invitation of the SFDA, Dirceu Barbano, Chairman Director of Brazilian National Health Surveillance Agency (ANVISA), led a five-member delegation visited SFDA on March 15-18, 2011. SFDA Commissioner Shao Mingli and Deputy Commissioner Wu Zhen separately chaired the meeting with the delegation. Both sides made extensive and in-depth discussions on common concerns such as the registration and approval procedures for active pharmaceutical ingredients, generic drugs, biological products and medical devices, post-marketing

Five-Year Plan period". SFDA Deputy Commissioner Bian Zhenjia attended and spoke at the meeting.

The meeting clearly stated the main tasks for the national food and drug administration and inspection work in 2011, and determined the development objectives of food and drug inspection work during the "Twelfth Five-Year Plan period", namely: taking the scientific outlook on development as guidance, implement the scientific concept of regulation to strengthen the inspection work for drugs, medical devices, health foods, and cosmetics; taking institutional reform as an opportunity to further improve the regulatory and inspection m e c h a n i s m , p r o m o t e i n s p e c t i o n information technology; improve the working mechanism of inspection, standardize law enforcement procedures; upgrade inspection equipment, make efforts to build an inspection team with "Excellent politics quality, outstanding service, honest style, and quick action"; improve the drug sampling test system, scientifically analyze and evaluate the quality of marketed drugs, and improve drug safety early warning capacity; control illegal advertisements, promote the healthy development of internet information services and transaction services; severely crack down on illegal criminal activities of manufacturing and selling counterfeit and substandard food and drugs, to ensure drug and food safety for the public. (Mar.18, 2011)

Special Report

WHO2010 12 13 17 WHO

WHO

2011 3 1

WHO

·

WHOWHO

120

WHO

7 2100 5

WHO

30 10WHO

WHO

WHO

2011 3 1

Chinese Vaccine Regulatory System Accredited by WHO

From December 13 to 17, 2010, China's national regulatory system for vaccines was conducted by evaluation experts from WHO headquarters, WHO Representative

of Sanitary Safety of Health Products etc.

On March 1, 2011, SFDA held the Summing-up Teleconference on China’s vaccine regulation system complying with WHO evaluation standards in Beijing. SFDA Commissioner Shao Mingli, MOH Deputy Minister Yin Li, SFDA Deputy Commissioner Wu Zhen, WHO China Representative Dr Michael O'Leary, and Dr. Lahouari Belgharbi, an expert of the WHO Headquarters attended the meeting.

Dr. Belgharbi declared at the meeting: Chinese vaccine regulatory system has been assessed as qualified by the WHO. Chinese manufacturers can submit applications to have their vaccine pre-qualified by the WHO. Dr. Belgharbi said: "China could become, in a year or two, a major supplier of vaccines at affordable prices, and the exports of Chinese vaccines will undoubtedly make a significant contribution to the immunization programs of more than 120 developing countries and middle-income countries."

SFDA Commissioner Shao stated that the accreditation of the vaccine regulatory system in China with a high score is of

the World Health Organization carried out the assessment of 7 major parts of China’s vaccine regulatory system, of which 2 parts get full marks, and the

also excellent. These achievements have demonstrated that the drug regulatory

system in China has made great progress, and that the Quality Assurance of Chinese vaccine products is strictly regulated, these achievements have laid a foundation for vaccine manufacturers to enter the international market at an earliest date.

The successful qualification provides a proof that Chinese vaccine regulatory system has met the international standards, this could eventually open the door for vaccines produced in China to be supplied to the world. Passing WHO Evaluation denotes an important step forward for our vaccine industry to become bigger and s t ronger, to enhance indus t r ia l competitiveness, and implement the "going out" strategy. China is a world-leading superpower of vaccine production boasts of 30-plus vaccine manufacturers with an annual production capacity of nearly 1 billion doses. Passing WHO Evaluation also means that China’s vaccine companies can apply for WHO prequalification as of now, and its prequalified products can be incorporated into the United Nations vaccine procurement plans, or recognized by o ther coun t r i es and reg ions fo r procurement. Recently, the food and drug authorities have invited WHO experts to carry out preliminary training and guidance

aiming to support and guide enterprises to actively participate in international competition, and explore the international markets. (Mar. 1, 2011)

2 CHINA PHARMACEUTICAL NEWSLETTER

Volume III 2011 3

4 1China’s Electronic Supervision of essential drugs achieved substantive phrasal results: as of April 1st, all essential drugs successful won the bidding shall be “holders” of "electronic identity card"

4 1

3 20

1906

100%

3 30

4

1

4 1

2012 2

(2011 3 31 )

As of April 1st, all essential drugs successful won the bidding shall be “holders” of "electronic ident i ty card," and their production enterprises shall all be subjected to electronic supervision. For drugs that are enlisted in the essential drugs list but not included in the electronic supervision network, or without drug electronic supervision codes and unified labels, they are not allowed to participate in the bidding of essential drugs.

As of March 20, 1906 pharmaceutical manufacturers of all provinces (autonomous regions or municipalities) intending to participate in or already won the bidding of essential drugs have been fully incorporated into the electronic supervision network, and their production lines have been transformed in accordance with relevant requirements to achieve the targets of 100% network incorporation rate and 100% transformation rate.

On the Teleconference for Electronic Supervision of Essential Drugs held on March 30, SFDA Commissioner Shao Mingli fully affirmed the achievements of electronic supervision on essential drugs in the previous stage, and announced that, starting from April 1, the essential drugs participating in the tender have met the basic conditions for code assignment, and therefore are allowed to enter into the substantive code assignment management phase.

Commissioner Shao Mingli further defined the general idea of electronic supervision on drugs during the "Twelfth Five-Year Plan period", that is: on the basis of electronic

supervision on essential drugs to participate in the tender from April 1 this year, the ongoing effort to expand the scope of electronic supervision will be continued, to realize the goal that by the end of February 2012, all essential drugs (including bid-winning drugs and non-bid-winning drugs) shall be subjected to electronic supervision. With sustained effort, we strive to achieve an electronic supervision system with full coverage of all varieties of drugs and the whole process by the end of the "Twelfth Five-Year Plan period", to establish a more robust information network and management system, and achieve the full quality traceability and accountability for the whole process of the production and circulation of marketed drugs.

Current ly, SFDA has completed the construction of "database for essential drugs production enterprises within the electronic supervision network" and "database for enterprises with transformations on production lines", and has provided these data through the network for local enterprises to follow suit in the tender of essential drugs. The implementation of electronic supervision of drugs will help to effectively crack down on the illegal acts of manufacturing and selling counterfeit and substandard drugs, it is conducive to the accountable and traceable recall of defective products, to the protection of the interests of pharmaceutical manufacturers, to the effective protection of standard products, and will play a positive role for

administration, to ensure drug safety for the public to a greater degree. (Mar. 31, 2011)


National Teleconference on Strengthening the Quality Control of Essential Drugs Convened

National Teleconference on Special Campaign for Drug Safety Convened

2011 3 9

2010

2822

6413 17392

2010

(2011 3 9 )

2 28

2009 7

(2011 3 1 )

On March 9, 2011, SFDA convened a national Teleconference on Strengthening the Quality Control of Essential Drugs. At the meeting, SFDA Commissioner Shao Mingl i summarized the works on strengthening the quali ty control of essential drugs over the past year nationwide, and deployed four key tasks that need to be done this year: first, the full implementation of the new national essential drug quality standards; second, continue to perform the full coverage sampl ing tes t for the whole var ie ty of essential drugs; third, speed up the information system construction while promoting the electronic monitoring for a full variety of essential drugs, fourth, further improve the monitoring and evaluation system for adverse drug reactions. It is required that the whole system shall make real contributions to the further advancement of health care reform

O n F e b r u a r y 2 8 , t h e N a t i o n a l Teleconference on Special Campaign for Drug Safety was convened in Beijing, SFDA Commissioner and Convener of the National Special Campaign for Drug Safety, Shao Mingli chaired the meeting.

The meeting summarized and reviewed the work o f t he Spec i a l Campa ign for Drug Safety that had been jointly launched by Ministry of Health, Ministry of Public Security, Ministry of Industry and In fo rma t ion Techno logy, S ta t e Administration of Industry and Commerce, SFDA, and State Administration of TCM since July, 2009. It was noted that in the previous stage, the various departments have actively performed their regulatory

from a political perspective and profound unders tanding of the impor tance of ensuring the quality and safety of essential drugs.

In 2010, the whole system of SFDA has carr ied out a tota l of 6 ,413 on-s i t e superv i s ion and inspec t ion for 2,822 manufacturers of essential drugs nationwide, and has been completed to date the inspections on the prescription and production process of 17,392 varieties, effective measures such as mandated rect i f icat ion, suspended production, d e a d l i n e r e p o r t i n g , s u p p l e m e n t a r y application for registration, and classified handling etc. have been taken to address the

have achieved the full coverage sampling test for the whole variety of essential drugs in 2010, covering all varieties in the national essential drug list. (Mar. 9, 2011)

duties, and have done fruitful work in the aspects such as: severely crack down the misconducts and crimes of manufacturing and selling counterfeit and substandard drugs and medical devices; reinforce the investigation and punishment of illegal advertisements; adjust and optimize the structure of the pharmaceutical industry; strengthen drug safety supervision; promote the construction of essential drug system etc. The aforementioned six Ministries and Administrations shall establish, as a next step in the second half of this year, a joint inspection and evaluation team to conduct a comprehensive inspection and evaluation on the works of Special Campaign for Drug Safety nationwide. (Mar. 1, 2011)

CHINA-PHARM Exhibits of CHINA-PHARM

Volume III 2011 5

2010

SFDA Requires the Smooth Implementation of Good Manufacturing Practice for Pharmaceutical Products (2010 revised edition)

2010 79

793 1

2011 3 1

2013 12 31

2015 12 31

2011 3 1

GMP 2011 3 1

GMP(2011 2 25 )

For the smooth implementation of Good Manufacturing Practice for Pharmaceutical Products (2010 revised edition) (MOH No. 79) (hereinafter referred to as "GMP"), in light of the "Drug Administration Law" and MOH No. 79, SFDA issued a notice on the implementation procedures and relevant requirements on March 1.

The notice stressed the provincial food and drug administration departments must attach great importance to GMP implementation, fully understand the importance and complexity, as

ensuring drug safety, promoting pharmaceutical economic restructuring and industrial upgrading, and further enhancing the international competitiveness of China's pharmaceutical industry. The implementation of GMP should be included into the work priorities of food and drug administration departments at all levels in the Twelfth Five-Year Plan period, we should strengthen organization and leadership, implement work responsibilities in combination with the actual situation of the area, and formulate a detailed implementation plan to ensure the effectiveness of various work tasks.

The notice stated that since March 1, 2011, all newly-established drug manufacturers, newly-constructed (reconstructed or expanded) workshop of pharmaceutical manufacturers should meet the requirements of new GMP. The production of sterile products such as blood products, vaccines, injection etc. in existing pharmaceutical manufacturers should meet the requirements of GMP before December 31, 2013. The production of other types of drugs should meet the requirements of GMP before December 31 , 2015 . Manufac ture rs

( w o r k s h o p s ) t h a t f a i l t o m e e t t h e requirements shall not continue to produce

The notice requires that all provincial food and drug administration departments should effectively perform the publicity and training of GMP in the areas within their jurisdiction, reinforce the construction of drug inspection

and carry out evaluations on the inspection and certification capacity of drug inspection and

SFDA and the provincial food and drug administration departments shall accept the GMP certification applications of pharmaceutical manufacturers since March 1, 2011. All applications that accord with the requirements of the inspection cert i f icat ions shal l be issued with a Pharmaceutical GMP Certification with new codes. The certification applications that have been accepted before March 1, 2011 shall be issued with a Pharmaceutical

requirements. The validity period shall be maximally extended to the deadlines as stipulated by the notice. (Feb. 25, 2011)

SFDA Draws Attention to Safety Issues Concerning Orlistat

2011 3 436

On March 4, 2011, National Center for Adverse Drug Reaction Monitoring released the 36th Adverse Drug Reaction Information

Bulletin, which drew attention to safety issues concerning weight-loss drug orlistat. Orlistat capsule (120mg) is managed as a OTC drug

CHINA-PHARM Exhibits of CHINA-PHARM


5454 Varieties of Drugs including Corypalis Tablets Converted to Over-the-Counter (OTC) Drugs

SFDA Seeks Comments on "Management Guidelines for Phase I Clinical Trials of Drugs (Draft for Comments)"

( ) 10

2010 6454

9 44 1

2006 540

(2011 2 25 )

I

3 184 30

http://www.sda.gov.cn/syjzh1139/fj1.rar(2011 3 18 )

According to the Provis ions for the classified Management of Prescription Drugs and Over- the-Counter Drugs ( I n t e r i m ) ( S F D A N o . 1 0 ) , a n d t h e requirements of the Notice on performing the conversion of prescription drugs into Over-the-Counter drugs and related

[2010] No.64), and with the approval o f SFDA, 54 va r i e t i e s o f d rugs (9 chemicals, 44 Chinese patent drugs, 1 biological products) including Corypalis tablets shall be converted to Over-the-Counter drugs. SFDA requires that food

To s t r eng then t he managem en t f o r phase I clinical trial of drugs, improve the analytical quality of clinical trial laboratories for the analysis of biological samples, effectively protect the rights and safety of subjects in clinical trials, ensure that the data and results generated b y t h e c l i n i c a l t r i a l s a r e r e l i a b l e , integrated and scientific, according to "Qual i ty Management Standards for Cl in ica l Tr ia ls of Drugs" , the Drug

and drug administration departments in all provinces (autonomous regions and municipalities) to inform the relevant drug manufacturers in the area to conduct modifications of the instructions and labels for these varieties since the date of issuance of this notice, in accordance with the instructions Notice on the issuance of performing the conversion of prescription drugs into Over-the-Counter drugs and related issues (SFDA Department of Drug Registration [2006] No.540) and relevant provisions of SFDA. (Feb. 25, 2011)

R e g i s t r a t i o n D e p a r t m e n t o f S F D Adrafted the "Management Guidelines for Phase I Clinical Trials of Drugs (Draft fo r Comments )" , and "Management Guidel ines for Labora tor ies for the Analysis of Biological Samples in Clinical Trials of Drugs (Draft for Comments) ", to solicit public comments from March 18, to April 30 2011. Related links: http://www.sda.gov.cn/syjzh1139/fj1.rar

(Mar. 18, 2011)

120mg

242010 12 31

120

(2011 3 4 )

in China, for the treatment of obesity or

As of December 31, 2010, National Center for Adverse Drug Reaction Monitoring database has collected over 120 cases reports on the adverse reactions of orlistat mainly manifested as constipation, abdominal pain, diarrhea, dizziness, menstrual disorders, and skin rash. SFDA warned consumers, doctors, pharmacists and drug manufacturers to pay close attention to the safety issues of orlistat, strengthen the monitoring of adverse reactions, and take effective risk

management measures to minimize the incidence. (Mar. 4, 2011)

Volume III 2011 7

Center for Drug Evaluation of SFDA Published the "Evaluation Principles and Procedures for Pharmaceutical Technology"

2011 3 23

INDNDA

ANDA

GRP(2011 3 24 )

On March 23, 2011, Center for Drug Evaluation of SFDA (CDE) published the "Evaluation principles and procedures for pharmaceutical technology."

A c c o r d i n g t o t h e c l a s s i f i c a t i o n o f evaluation tasks and risk levels, and focusing upon the technical evaluation science, legal, and ethical aspects, the newly published "Evaluation principles and p rocedures fo r pha rmaceu t i ca l t e c h n o l o g y " h a s e s t a b l i s h e d t h e appropriate evaluation and decision-making processes, in an open, fair and impart ia l manner, for c l inical t r ia ls of Investigational New Drugs (IND),

New Drug Appl ica t ion (NDA) , and Abbrevia ted New Drug Appl ica t ion (ANDA) respectively. The Principles and procedures also identified the competent evaluation departments’ role in task management, enhanced the transparency and openness, and took the communication and exchanges as an important work measure for the evaluation of new drugs, so as to improve the eff ic iency and decision-making for drug evaluation. Meanwhile, the Principles and Procedures also set forth requirements to establish the Good Review Practice (GRP) for the evaluation quality of CDE. (Mar. 24, 2011)

Center for Drug Evaluation of SFDA Issues Real-time

for all Departments

National Institute for Food and Drug Control Initiates the Information Disclosure Section for "Inquiry of the Registration and Evaluation of Drug Packaging Materials"

(2011 3 10 )

, 2011 323www.nicpbp.org.cn

After the institutional reform of Center for Drug Evaluation of SFDA (CDE), the evaluation tasks for all CDE departments shall be publicized through the public notification of evaluation tasks for all departments section on the official Web site in chronological order by received tasks. Applicants for registration evaluation can, according to the classification of

In light of the "Open, fair, standard and transparent", since March 23, 2011, the National Institute for Food and Drug Control shall initiate the Information Disclosure Section for "Inquiry of the reg is t ra t ion and eva lua t ion of drug packaging materials" in the "Inspection

applications, search for information of various CDE departments including the special review procedures, new drugs, generic drugs, and dosage alterations, supplementary applications, imports and re-registration for imports, supplementary material for the feedback of manufacturers, re-evaluation, general information of the reports to be evaluated. (Mar. 10, 2011)

Work Publicity" column of its website (www.nicpbp.org.cn). The Website information includes two aspects: 1. Inquiry of the information of received mails, once inquirers fill in the mail number and the sender unit, they can check the status whether the


2011 3 23 28

1621300

21%100

(2011 3 7 )

National Development and Reform Commission Lowers the Prices of Drugs in Some CategoriesO n M a r c h 2 , 2 0 1 1 , t h e N a t i o n a l Development and Reform Commission issued a notice that resolves to reduce the maximum retail price of certain antibiotics and circulatory system drugs for the treatment of infections and cardiovascular diseases from March 28, involving a total of 162 varieties and nearly 1300 formulation

in average chopped off 21% of the current prices, and an estimated 10 billion yuan reduction of the people’s disease burden is expected.

Relevant NDRC leaders pointed out that the price adjustment has taken into account the factors such as the cost of drug production and the actual transaction price in the market, and distinguished between different situations, highlighted the key factors for price reduction. High price-cut is imposed on drugs with high per diem price, low price-reduction or no price-cut is imposed on drugs with low per diem price, so as to ensure the production and supply of relatively inexpensive drugs, at the same time, burden on patients is relieved; appropriately control the price-cut rate on patent drugs and other innovative drugs to encourage pharmaceutical research and innovation; further narrow the price gaps between separately priced drugs and

uniformly priced drugs, so as to maintain the fair competition environment of the market.

Relevant leaders from NDRC also stated that it is a generally adopted measure for the governments of different countries to implemen t necessa ry d rug p r i ce regulation. It is an important part of deepening health care system reform to reasonably control the medical expenses, reduce the pharmaceutical burden of patients, rectify pharmaceutical market order, and adjust drug prices in a planned and systematic way. In the wake of the announcement of this price-cut program, the National Development and Reform Commission will also reduce in stages the drug prices within the government’s price-setting range in accordance with established work plans. The drug price adjustment will be based on the average social cost of production and management, t ak ing i n to accoun t marke t supp ly and demand and other factors. Further narrow the price gap between originally developed branded drugs that has passedthe patent protection period and regular generic drugs. Explore the development of uniform price for drugs newly added into the list of insurance system as a basis for the calculation of reimbursement by medical insurance. (Mar. 7, 2011)

Pharmaceutical excipients and Packaging M a t e r i a l s M a i l R o o m o f N a t i o n a l Institute for Food and Drug Control has received the mails or not; 2. Inquiry of the phases of the technical review status, once inquirers fill in the drug packaging

evaluation application acceptance No. and the check code generated after they f i l led in drug packaging evaluat ion application form, they can check all status of the technical review phase.

(Mar. 23, 2011) (2011 3 23 )

Exhibits of CHINA-PHARM

Meeting Brief

Volume III 2011 9

The Training on New Version of GMP for Pharmaceutical ProductsOn March 16, a 4-day training class in

version of Pharmaceutical GMP kicked off in Beijing, which marks the beginning of a round of training in the new version of Pharmaceutical GMP nationwide.

At the meeting, Director General Sun Xianze of Department of Drug Safety and Inspection of SFDA stated the background and significance of the new version of Pharmaceutical GMP, and put forward clear requirements for its implementation. Sun Xianze stressed that provincial Food and Drug Administration Depa r tmen t s shou l d a t t a ch g r ea t importance to the study and training of the new Pharmaceutical GMP, and unify related thinking and standards. Fully implement the publicity and education work of the new Pharmaceutical GMP in areas within jurisdiction, institutions

establish and improve the drug quality control system to ensure the quality of certification and inspection, which must also have uniform standards and criteria. For drugs failing to meet the requirements of the quality control and management system, they may not be subjected to the certification and inspection of new pharmaceutical GMP.

Relevant personnel from food and drug administration authorities of Provinces (autonomous regions and municipalities)

attended the training. (Mar. 17, 2011)

" T h e S e c o n d S i n o - J a p a n e s e P h a r m a c e u t i c a l E x c h a n g e Symposium" held in BeijingOn March 29, 2011, China Center for Pharmaceutical International Exchange (CCPIE), Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, and Japan Pharmaceutical Manufacturers Association (JPMA) jointly organized the "Second Sino-Japanese Pharmaceutical Exchange Symposium." The two sides held in-depth discussions and exchanges with respect to the Investigational New Drug Applicat ion (IND) system and the ex ante consultation mechanism, Good manufacturing practices (GMP) for Pharmaceutical Products and Drugs Master File (DMF) system and other aspects.

Relevant leaders and experts of Dept. of Drug Registration, Dept. of Drug Safety and Inspection and Center for Drug Evaluation of SFDA attended the meeting and delivered speeches. Officials from PMDA, JPMA and China Association of Enterprises with Foreign Investment (CAEFI), R&D-based Pharmaceutical Association Committee (RDPAC) made wonderful speeches.

The success of "The Second Sino-Japanese Pharmaceutical Exchange Symposium" serves to further strengthen pharmaceutical exchanges between China and Japan, promote the exchanges and communication between Chinese and Japanese drug administrat ion authorit ies, academic institutions and enterprises, and enhance mutual understanding. (Mar. 29, 2011)

GMP

3 16 4 GMP

GMP

GMP

GMP

GMP

GMP

(2011 3 17 )

2011 3 29

(IND)

GMP

DMF

IND

GMP DMF

RDPEC

(2011 3 29 )CHINA-PHARM Exhibits of CHINA-PHARM CHINA-PHARM Exhibits of CHINA-PHARM


2010 8500

1400 12002010

118-

90

RA (UC)(CD) (Ps)

(PsA) (AS)2010

2010

In 2010, global pharmaceutical market sales hit 850 billion U.S. dollars, of which biotechnology drugs and generic drugs reached their record highs of 140 billion and 120 billion U.S. dollars respectively.

The top three bestselling enterprises in 2010 are Pfizer, Johnson & Johnson and Novartis Pharma AG. While the top three best-selling drugs are: Pfizer’s Atorvastatin Calcium, which is used tolower cholesterol, has reaped a top sales volume of 11.8 billion U.S. dollars; clopidogrel bisulfate, which is jointly developed by Bristol-Myers Squibb of the United States and Sanofi-Aventis of France and used to inhibit coronary artery disease, peripheral vascular disease, and thrombosis formation in patients with

2010Sales rankings of well-known pharmaceutical enterprises in Europe and America in 2010

Special Focus

cerebrovascular disease, has struck a sales volume that exceeded 9 billion U.S. dollars, ranking second; and infliximab,which is jointly developed by U.S. Johnson & Johnson, Merck & Co. and Mitsubishi Tanabe Pharma Corporation of Japan for the treatment of rheumatoid arthritis (RA), Ulcerative Colitis (UC), Crohn's disease (CD), psoriasis (Ps), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) ranked third with its annual global sales in 2010. The top-three best-selling drug categories in 2010 are drugs for central nervous sys tem, card iovascular drugs and anticancer drugs; for biological agents, the top-three best-selling drug categories are monoclonal antibodies, vaccines, and tumor necrosis factor (TNF) inhibitors.

Sales rankings of well-known pharmaceutical enterprises in Europe and America in 20102010

Name of CompanyRevenue

Million Dollars

Compared withlast year

%Common name of the product Indications

P zer Pharmaceuticals Limited 67809 36 Atorvastatin Calcium Tablets hyperlipidemia, arteriosclerosis

Johnson & Johnson 61587 0 In iximab ulcerative colitis

Novartis 50624 14 Valsartan Capsules hypertension

Merck & Co Inc 45987 68 Singulair asthma, hypersusceptibility

Roche47473 million

CHF 45498 USD -3 Bevacizumab cancer of colon

GlaxoSmithKline28392 million

GBP 43882 USD 0 uticasone propionate sal- meterol xinafoate asthma

-Sano -Aventis

30384 millionEUR 40281 USD 4 LANTUS insulin glargine injection diabetes

Abbott Laboratories 35167 14 adalimumab rheumatoid arthritis

AstraZeneca 33269 1 Quetiapine fumarate tablets schizophrenia

Eli Lilly and Company 23076 6 Olanzapine schizophrenia

Bayer16913 million

EUR 22422 USD 6 Drospirenone and ethinylestradiol tablets oral contraception

Volume III 2011 11

Bristol-Myers SquibbCompany

19484 4 Clopidogrel hydrogen sulfate myocardial infarction,arteriosclerosis

Teva PharmaceuticalIndustries Ltd

16121 16 Copaxone multiple sclerosis

Amgen 15053 3 Etanercept rheumatoid arthritis

Merck Drugs &Biotechnology

5754 millionEuro 7628 USD 8 Rebif multiple sclerosis

The above data is calculated according to the average rate of 2010.2010

1 Euro=1.3257 USD 1 CHF=1.0434 USD 1 GBP=1.545 USD

O s s e o r ® ( s t r o n t i u m r a n e l a t e ) h a s s ign i f i can t ly g rea t e r bone - fo rming activity than the commonly prescribed bisphosphonate, alendronate, according to results of the largest-ever biopsy study in post-menopausal women presented at the European Congress on Osteoporosis and Osteoarthritis (ECCEO011-IOF) in Valencia. Through its unique dual impact on both bone formation and resorption, Osseor®

substantially reduces fracture risk, the primary goal of osteoporosis treatment.

Bone biopsy is the gold standard technique used to examine the effect of osteoporosis t r ea tmen t s on bone . Bone b iops ie s involve taking a cylindrical sample of real bone from the upper part of the pelvis called the iliac crest. Biopsies allow the

tissue) and mineralized subparts of the bone matrix and can be used to measure bone formation rates and other parameters. Bone formation is measured by examining mineralizing surface, the proportion of bone surface on which new mineralized

bone is being deposited.

In this international, double blind study of 268 women, Osseor® has a significantly greater effect on mineralizing surface compared to a lendrona te . Af te r s ix months, mineralizing surface, expressed as a percentage of bone surface (the study's primary endpoint) was 2.94% in Osseor® patients compared to 0.20% in patients receiving alendronate (p<0.001). This superior effect on bone formation was further amplified after 12 months of treatment. Osseor® also significantly increased both the bone formation rate and the mineral apposition rate compared to alendronate over six and 12 months of treatment. The superior bone-forming eff icacy of Osseor ® i s l inked to i t s innovative dual mechanism of action which

®Largest-Ever Biopsy Study In Osteoporosis Demonstrates Superior Bone Forming Activity With Osseor® (Strontium Ranelate) Versus Bisphosphonates

(ECCEO011-IOF)

® ()

()

268®

6

2.94%0.20% p<0.001 12

MS/BS6

12

Special column

Provided by Servier (Tianjin) Pharmaceutical Co., Ltd.


China Center for Pharmaceutical International Exchange (CCPIE)

Address: Room 1106, 11th Floor, Office Building B, Maples International Center, No. 32, Xizhimen North Street, Haidian District, Beijing, 100082, P.R.C.

32 B 11 1106100082

Tel: 010-8221 2866 Fax: 010-8221 2857Email: [email protected]: www.ccpie.org

Servier (Tianjin) Pharmaceutical Co., Ltd.

Address: 6 Floor, West Building, World Financial Center, No.1, East 3rd Ring Middle Road, Chaoyang District, 100020 Beijing, China

Tel: 010-6561 0341Fax: 010-6561 0348E-mail: [email protected]: www.servier.com.cn

Notes: All Chinese information in Newsletter extracted from Newspapers and Internet. AllEnglish articles are the translations from the Chinese version.Read the electronic version of the newsletter please visit http://www.ccpie.orgNewsletter

Newsletter http://www.ccpie.org

rebalances bone turnover in favour of the formation of newer and stronger bone. This is not the case with bisphosphonates as they have been shown to actually suppress the bone forming-surface.

"The results of the study show that Osseor®

preserves a higher bone forming activity compared with alendronate", notes study investigator Professor Roland Chapurlat from the Hôpital Edouard Herriot, Service de Rhumatologie et Pathologie Osseuse, Lyon, France.

"The bone-forming activity seen here can be attributed to strontium ranelate's unique mechanism of action which, unlike bisphosphonates that block bone resorption and formation, combines the dual effects of increasing or maintaining bone formation and decreasing bone resorption", points out study investigator Professor PG Ste- Marie from the Centre Hospitalier de l'Université de Montréal, Canada.

This new trial conducted in 268 post-menopausal women with osteoporosis is the largest biopsy study ever. It sets a new standard in the assessment of the effects of different osteoporosis treatments on bone. It is also the second head to head study in which Osseor® demonstrates superiority versus alendronate. In the previous trial,

which used a non-invasive technique (High Resolution peripheral Quantitative Computerized Tomography), Osseor® was shown to be more effective than alendronate on bone microarchitecture at both cortical and trabecular level.

Over the course of both studies, the occurrence of adverse events was similar for each treatment group.

Anti-fracture efficacy sustained over 10 years

Osseor® was developed independently by Les Laboratoires Servier. It has awarded the imported drug certification issued by State Food and Drug Administration on Jun. 16th, 2008. Better efficacy on bone formation and bone quality are the key determinants for Osseor® and explain its well demonstrated efficacy against vertebral, non vertebral and hip fractures. It is also the key determinant explaining why Osseor® is the unique treatment which has recently been shown to have sustained anti-

osteoporotic women.

Source: European Congress on Osteoporosis and Osteoarthritis (ECCEO011-IOF)

(Mar. 25, 2011)

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PG Ste- Marie

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2011 china pharmaceutical newsletter

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