China -  Chinese law firm

Vol.2, No.32

CHINA LEX PHARMA LAW NEWSLETTER

Vol. 2 , No.32 - December 4, 2001

TOPICS THIS ISSUE:

  • Foreign Companies to Enter China's Retail Pharmacy Market in 2003
  • China's First Methadone Project Launched in Response to Growing AIDS Concerns
  • Two Chinese Pharmaceutical Companies Hope to Produce Cheap Anti-HIV Drugs
  • China Prohibits Mass Advertising Of Prescription Products
  • List of China GMP Facilities (Continued)

Foreign Companies to Enter China's Retail Pharmacy Market in 2003

In 2003, foreign companies will be granted the right to operate retail and wholesale pharmaceutical businesses with no geographical or capital restrictions. This comes as part of China's commitment to broaden market access after it joins the World Trade Organization, claims the State Economic and Trade Commission.

The China Daily reported, citing Yu Mingde, the deputy director of the State Economic and Trade Commission's Economic Operation Department, that prior to 2003, Sino-foreign joint venture trials will be held in key cities such as Beijing, Shanghai and Guangzhou.

Under the joint venture regulations, it is required that foreign partners must have annual sales exceeding US $2 billion for three consecutive years before applying to set up the venture and they should also have total assets exceeding US $200 million.

China Daily also cited SETC sources as saying that negotiations to permit foreign pharmaceutical retailers to set up joint ventures in Beijing and Shanghai has been occurring for many years.

(Source: AFX, China Daily)

China's First Methadone Project Launched in Response to Growing AIDS Concerns

China is planning to launch its first project using methadone in an attempt to help drug users fight their addictions. This comes as a further sign that China is finally beginning to take its AIDS crisis more seriously.

The experiment will be expected to begin next year, Li Jianhua, deputy director of southwest China's Yunnan Institute for Drug Abuse, told reporters on the last day of a conference on HIV/AIDS in Beijing.

Held behind closed doors, this four-day national conference was the first event dealing with HIV/AIDS that China has ever staged. Li said that methadone is a synthetic opiate-type drug that is widely used in other countries to wean addicts off heroin. The drug can be ingested orally as well as injected. However, taking the drug orally could prevent HIV from being transmitted through needle sharing.

The conference also debated on possibility of distributing clean syringes to addicts in efforts to prevent infection. Such discussions illustrate how China's official attitude towards AIDS looks to be changing slowly but surely.

In previous years, Chinese authorities have openly shown their disdain for anti-AIDS measures, which was stemmed largely from their impression that the disease was associated with "social evils," such as drug users and homosexuals.

At the opening of the AIDS conference, the head of the United Nations AIDS organization (UNAIDS), Peter Poit, praised China for its increased efforts to stem the epidemic. However, he also warned that "if there is no change to the intensity of the response to AIDS, then the epidemic will inevitably grow." It is believed that the epidemic will spread to 10 million over the next decade.

Experts have said that although intravenous drug usage is a significant factor in the widespread transmission of the epidemic, official efforts to counter this have fallen behind efforts to counter other areas such as contaminated blood supplies.

Earlier this week, Charles Rycroft, the spokesman for the United Nations children's fund UNICEF in Beijing, singled out China's refusal to use methadone therapy as a mistake, saying, "They don't want to work with people who use drugs because they don't want to give the impression that they are too permissive."

According to the official assessment, there are more than 600,000 people with HIV in China. However many experts outside of China regard this figure as a great understatement, especially given the number of people who may have become infected through selling their blood to mercenary collectors using unsanitary practices.

(Source: Agence France Presse)

Two Chinese Pharmaceutical Companies Hope to Produce Cheap Anti-HIV Drugs

Two Chinese drug companies have recently applied to the State Drug Administration in hopes of producing two generic anti-HIV drugs. They are hoping that these applications will take advantage of domestic patent laws which allow generic drug makers to copy and sell medicines alongside patented versions. Shanghai Desano Biopharmaceutical Co, a privately-owned company, claimed that it has applied to the State Drug Administration to produce two generic anti-HIV drugs, to which Bristol-Myers Squibb holds patents, and it also plans to apply to make AZT, the first drug recognized to treat HIV, to which GlaxoSmithKline holds the patent.

Northeast General Pharmaceutical Factory, a State-owned company, said it too has applied to the government to make and domestically sell HIV drugs.

These two companies already manufacture and export raw materials to markets such as Brazil and India. There, these raw materials are used to make AIDS drugs. The two companies could benefit from the loopholes in Chinese law, which allow for generic drug makers to copy and sell medicines alongside the patented versions.

They see a market opportunity in China due to the rising number of HIV infected, which is estimated at 600,000 nationwide and growing at a rate of 30% per year. Most of the infected cannot afford patented versions of the medicines, which could cost them US $10,000 a year.

Li Jinliang, deputy general manager of Shanghai Desano, was quoted saying, "We can produce everything an HIV person needs for US $400 a year". He is expecting a decision on this matter sometime around June of next year.

Foreign drug makers maintain that the law contains loopholes which allow domestic pharmaceutical companies to reproduce medicines through paltry changes in Formulation. It also allows domestic companies to register to sell a drug in China while its foreign developer is still in the process of applying for administrative protection for it.

Dr. Shen Jie, the director of the National center for AIDS Prevention and Control told reporters the government has been in negotiations with both GlaxoSmithKline and Bristol-Myers Squibb to try to reduce the price of their HIV drugs in China.

(Source: AFX)

China Prohibits Mass Advertising Of Prescription Products

Advertisements for prescription medicines which can be seen virtually anywhere in China due largely to the media, will cease to exist starting from December 1. This announcement comes after the issuance of a new set of regulations by the State Drug Administration (SDA).

According to this new regulation, the manufacturers of prescription medicines for cardiac disease, angina, hypertension, hepatitis and diabetes, as well as those for non-antibiotics and hormonal medicines, will be required to limit their advertisements to professional medical media only starting from February 1, 2002. Commercials or advertisements of any sort for medicines that do not meet national standards can not be promoted in any type of media.

Sources say that medicines which have been available to the public for a duration of five years can be advertised on public media, subject to approval by relevant departments.

(Source: Asia Pulse)


VISITING US IN BEIJING?

Turn Your PDA Into A Tour Guide
Beijing City guide for Palm OS 3.5
1000 Chinese Character TAXI Cards
1000 Super descriptions ONLY US $18.95

www.redBANG.com

NEVER EVER LOST

What the professionals have said:
I tried the redBANG application,
It is the most thorough guide I've seen!

Ava Mason
Handango Business Development


List of China GMP Facilities (Continued)

Name of Enterprise

Certified Scope

451. Xiangbei Willman Pharmaceutical Co., Ltd.

Powder-injection (Cephalosporin)

452. Zhunzhou Qianjin Pharma Co., Ltd. by Shares

Tablet

453. Tianjin Huajin Pharmaceutical Factory

Powder-injection (Penicillin), High dose injection

454. Tianjin Nanhua Pharma Co., Ltd.

Powder-injection (Penicillin)

455. Tianjin Hualida Bio-engineering Co., Ltd.

Recombinant human interferon-a2b

456. Shanghai Wanxing Bio-pharma Co., Ltd.

Recombinant human interferon-a2a, a2b

457. Chongqing Yaoyou Pharma Co., Ltd.

Bulk drug (Penicillin), Powder-injection (Penicillin, Cephalosporin)

458. Shanghai Livzon Pharmaceutical Co., Ltd.

Bulk drug (Bio-products and polypeptide), Tablet, Capsule

459. Shanghai Changzheng Pharma Co., Ltd.

High dose injection

460. Longyan Tianquan Bio-chem Pharma Co., Ltd.

High dose injection

461. Shandong Dayin Sea-biological Pharma Co., Ltd

Capsule

462. Shanghai Medical University Hongqi Pharma Factory

Freeze-dried powder-injection

463. Anhui Anke Bio-tech Co., Ltd.

Injected recombinant human somatotrophin

464. Chongqing Yaoyou Pharma Co., Ltd.

Bulk drug (Penicillin), Powder-injection (Penicillin, Cephalosporin), High dose injection

465. Zhangjiakou Pharmaceutical Factory

Powder-injection (Penicillin)

466. Qingdao Guofeng Group Huayang Pharmaceutical Co., Ltd.

Powder-injection (Penicillin)

467. Chongqing Daxin Pharma Co., Ltd by Shares

High dose injection

468. Guangzhou Nanxin Pharma Co., Ltd.

Tablet, Capsule

469. Southwest Synthetic Pharma Co., Ltd. by Shares

Powder-injection (Cephalosporin)

470. Guangzhou Baiyunshan Pharma Factory

Powder-injection (Cephalosporin)

471. Weilun Bio-product Company

Freeze-dried powder-injection

472. Guangzhou Baiyunshan Chemical Pharma Factory

Bulk drug (Cephalosporin)

473. Shenzhen Haibin Pharma Co., Ltd.

Powder-injection (Penicillin)

474. . Guangdong Liguo Pharma Co., Ltd.

Bulk drug (Cefazolin Na)

475. Livzon Synthetic Pharma Factory

Bulk drug (Cephalosporin)

476. Shandong Zibo Xinda Pharma Co., Ltd.

Capsule, Granule (Cephalosporin)

477. Sanyan Delin Pharma Co., Ltd.

Powder-injection, Capsule, Granule (Penicillin)

478. Shantou Pinjiang Pharma Factory

Powder-injection (Cephalosporin)

479. Shandong Huaifang Pharma Co., Ltd.

Powder-injection (Penicillin), bulk drug

480. Sanyan Delin Pharma Co., Ltd.

Bulk drug (Tazobactam)

481. Qilu Pharma Factory

Bulk drug (Penicillin), Powder-injection (Penicillin, Cephalosporin), Freeze-dried powder-injection

482. Eisia (Suzhou) Pharma Co., Ltd.

Tablet

483. Yongxin (Kunshan) Pharma Co., Ltd.

Tablet, Capsule

484. Kunming Jida Pharma Co., Ltd.

Powder-injection (Cephalosporin)

485. Ningxia Pharma Factory

Powder-injection (Penicillin)

486. Yingxin Pharma (Kunshan) Co., Ltd.

Plaster

487. Qilu Pharma Factory

Low dose injection, Tablet, Capsule

488. Shenzhen Huashenyuan Gene-Engineering Co., Ltd.

Recombinant human growth factor liquid

489. Kunmin Pharma Co., Ltd. by Shares

Powder-injection

490. Anhu Longkema Bio-pharma Co., Ltd.

Freeze-dried cow mycobacterium

491. Yongguang Pharma Co., Ltd.

Eye-drops, bulk drug

492. Beijing Tiantan Bio-product Co., Ltd.

Recombinant hepatitis B Vaccine

493. Chengdu Daxinan Pharma Co., Ltd.

Tablet, capsule, granule

494. Chengdu TCM University Huashen Pharmaceutical Co., Ltd.

Tablet, capsule, granule, oral liquid

495. Shanghai Roche Pharma Co., Ltd.

Recombinant human interferon a2a, low dose injection

496. Yancheng Shengyuan Pharma Co., Ltd.

High dose injection

497. Shenzhen Taitai Pharma Co., Ltd by Shares

Tablet, granule, oral liquid

498. Jibiai Bio-tech (Beijing) Co., Ltd.

Diagnose agent

499. Shanghai Taicifu Bio-engineering Co., Ltd.

Tablet

500. Jiangsu Suzhong Pharma Factory

Tablet, capsule, granule

 


Lehman Lee & Xu

China Lawyers, Notaries, Patent, Copyright and Trademark Agents

http://www.chinalaw.cc/

Beijing Office

Shanghai Office

6th floor, Dongwai Diplomatic Office Building
23 Dongzhimenwai Dajie
Beijing 100600 China
Tel.: (86)(10) 8532-1919
Fax: (86)(10) 8532-1999
Email: mail@chinalaw.cc

 

Suite 5107, Plaza 66
No. 1266, West Nanjing Road
Shanghai 200040 China

 

Tel:

(86)(21) 6375-8240
(86)(21) 6288-1635/6

Fax:

(86)(21) 6375-8705
(86)(21) 6288-1635/6

 

Email: shanghai@chinalaw.cc

 

Shenyang

Hong Kong

Guangzhou

Chengdu

To unsubscribe from this newsletter send an email to unsubscribe_lp@chinalaw.cc Please include the email address to which the newsletter is being sent (not a forwarded address) in the body of the email.

The China Lex Pharma Law Newsletter is intended to be used for news purposes only. It should not be taken as comprehensive legal advice, and Lehman, Lee & Xu will not be held responsible for any such reliance on its contents.

RSS Feeds