World's first gene therapeutic medicine approved for market in China

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Last updated at: (Beijing Time) Thursday, March 04, 2004

World's first gene therapeutic medicine approved for market in China

Chinese State Food and Drug Administration (SFDA) approved on Jan. 20 the recombined human p53 adenovirus injection for production, marking it China's and also the world's first gene therapeutic medicine approved for entering into the market.

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Chinese State Food and Drug Administration (SFDA) approved on Jan. 20 the recombined human p53 adenovirus injection for production, marking it China��s and also the world��s first gene therapeutic medicine approved for entering into the market.

As learned at an exhibition on achievements by returned overseas students started on Feb.29 and according to requirements of departments concerned, scientists will next put the medicine into use in grade-3 A-level hospitals all over the country and probe further for its functions. ��Father of gene therapy�� US scientist Dr. W. French Anderson sent his congratulations to domestic scholars for the achievement. Expert said this milestone of biological hi-tech development would help push the development of the research on gene therapy and the entire industry forward, thereby making contribution to the health of human beings.

Clinical experiments on gene therapy started in 1990. It is to inject gene into a specific carrier and introduce in human cells to cure diseases. Up to now, there are nearly hundred companies dedicated to gene therapy and clinical programs of gene therapy have come to more than 700. However, there has been no safe and effective gene therapy medicine approved so far in the world as new medicine.

The United States approved clinical experiments of products on recombination p53 adenovirus. Through tumor local injection, intravenous injection, interposing medicine supply and thoracic and stomach infusion etc. US, Japanese, Canadian and European scientists started gene therapy on dozens of kinds of tumors such as head and neck squamous cell carcinoma, breast cancer, esophageal cancer through recombined adenovirus p53 products.

China is one of the pioneers in the research on gene therapy. With the support of the National 863 Program, national significant scientific and technological project and local governments and approved by State Food and Drug Administration (SFDA), Professor Peng Zhaohui etc. with Shenzhen SiBiono GeneTech Co., Ltd, China's first specialized company of its kind started in 1998 clinical experiment on recombination of human p53 adenovirus injection for therapy and established in Shenzhen production lines and factory as certified by state GMP (Good Manufacturing Practice or Good Practice in the Manufacturing and Quality Control of Drugs).

To date, over 300 people at home and abroad have received treatment with recombined human p53 adenovirus injection. The gene therapy medicine has shown generality in tumor-resistance, marked coordinated effect with traditional radiotherapy and great effect in curing head and neck squamous cell carcinoma such as nasopharyngeal cancer.

Peng Zhaohui remains sober though the medicine has gone into the market, saying that gene therapy only creates an effective method. There is a long way to go for human beings to conquer the carcinoma.

By People's Daily Online

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