CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No.18- July 18, 2001
TOPICS THIS ISSUE:
- 10th Five-Year Plan for China Drug Industry
- SDA's Infrastructure Improving to Keep the National Drug Industry in Check
- Statistics of the Import and Export of Medical Supplies in China
- Swiss Hoffman La Roche Builds Another Plant in East China
- New Anti-Cancer Medicine Developed in China
10th Five-Year Plan for China Drug Industry
The following are the highlights of the Tenth Five-Year Plan (2001-2005) for the development of the pharmaceutical industry released by the State Economic and Trade Commission recently.
China's medicine market consumption will rise at an annual rate of 12 percent in the next five years, higher than the world's current speed of eight percent.
OBJECTIVES
The annual gross industrial output value is scheduled to go up 12 percent; the industrial added value up 13 percent; the gross commercial sales volume up 9 percent; the import and export volume up 6 percent; and industrial profits will increase 13 percent.
Large enterprises should set up technical development centers. The input in R&D will account for over 5 percent of the sales; and investment in R&D by small and medium-sized enterprises should increase sharply.
There must be breakthroughs in the key technology of bio-engineered medicine. Drugs made from gene-transferred plants and animals will begin to be put into batch production. Production and technical standards of major crude chemical drugs will undoubtedly be improved. The comprehensive production rate of benzylpenicillin (PCG), the comprehensive recovery rate of vitamin C and the rate of acid production of major amino acid products will increase. A number of intermediates such as 6-A-PA, 7-ADCA and 7-ACA, isophytol and trimethyl hydrochinonum will be industrialized and their market competitiveness sharpened.
A dozen large pharmaceutical enterprises each with an annual sales of RMB five billion will be established on the basis of the present large enterprise groups and by way of IPO, merger, association and reorganization. The annual sales of these groups will account for at least 30 percent of the country's total sales, and their products are expected to compete with those made by multinational corporations.
To make full use of stock assets, strictly control the construction of new pharmaceutical products, and guide existing enterprises to focus on bio-engineered drugs.
To establish risk funds mechanisms, pharmaceutical industrial foundations, channel idle social funds into the area of modern biotechnology, and encourage the state sector to increase input in modern biotechnology.
To strengthen the exchange of information among the Chinese Academy of Sciences, the Academy of Military Medicine, the Chinese Academy of Medical Sciences and related biotechnology research institutions and key pharmaceutical enterprises so as to form an effective mechanism for technological innovations to translate research achievements into productivity.
To adopt policy in favor of projects to industrialize modern biotechnology and form a number of competitive high-tech enterprises.
To raise the standards of fermentation and reduce cost by way of using DNA technology and protoplast fusion to cultivate new bacterial spawn and transform bacterial spawn of antibiotics, vitamins, amino acids and other products; to develop new vaccines, diagnostic agents and biotech drugs for the control, diagnosis and treatment of malignant tumors, cardiovascular system diseases, nervous system diseases, digestive system diseases, AIDS and other immunization deficiency diseases; and to develop new preparations of biotechnology products.
The state will continue to expand input in medical science and technology; encourage and support pharmaceutical enterprises to concentrate on technical innovation; and further introduce risk investment mechanism.
(Source: Xinhua News Agency)
SDA's Infrastructure Improving to Keep the National Drug Industry in Check
The State Drug Administration of China (SDA) has made it known that, to boost the government's efforts to monitor the drug industry, it will publish bulletins announcing drugs with negative or adverse effects, once those effects are identified.
After the identification and re-assessment of drugs on the market, the SDA is capable of using legal measures to curb the sale of drugs that are determined to have serious negative reactions or have questionable results. The SDA can warn drug companies, withdraw licenses, force instructions to be modified, or even suspend production, sales and use of a drug.
China has recently entered into a participatory role in the WHO's international initiative on cooperation of drug monitoring. Also, the Ministry of Health and the SDA have worked together to cooperate on the monitoring of the drug industry and the possible harmful side effects from the use of drugs on the market. Lately, besides establishing a National Monitoring Center for Adverse Drug Reactions, many agencies whose responsibility is to monitor the drug trade are also being established at the provincial level across China.
(Source: China Pharma News)
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Statistics of the Import and Export of Medical Supplies in China
Item | Export Volume (Ton) | Y-o-y chg (%) | Total | 86,485 | 11.6 | Antibiotics (not including preparations) | 11,206 | 8.0 | TCM | 4,910 | -2.8 | Medical dressing | 23,400 | 4.4 | |
Item | Export Volume(USD) | Y-o-y chg (%) | Total | 812,186,000 | 12.5 | Antibiotics (not including preparations) | 219,160,000 | 9.1 | TCM | 35,402,000 | 6.7 | Medical dressing | 106,729,000 | 3.9 | |
Item | Import value (USD) | Y-o-y chg (%) | Medical instruments and meters | 488,293,000 | 42.5 | |
Export Item | Export value (USD) | Y-o-y chg (%) | Medical instruments and meters | 220,094,000 | 30.7 | |
Export Volume (ton) | Y-o-y chg (%) | Value(USD) | Y-o-y chg (%) | 56,512 | -18.6 | 79,599,000 | -6.8 | |
(Source: General Administration of Customs)
Swiss Hoffman La Roche Builds Another Plant in East China
The Swiss multinational company Hoffmann-La Roche has publicly announced the opening of a joint venture citric acid plant in Wuxi, located in Jiangsu province in East China.
The joint venture with Wuxi Zhongya Chemicals Ltd. will produce 40,000 tons of citric acid per year. A large part of this acid is destined for the foreign market.
Citric acid is globally used as a raw material in the foods, pharmaceutical and detergent industries. This particular joint venture is the largest Hoffmann-La Roche has yet invested in China. The company believes such a move reflects the confidence it has in the Chinese market.
The company has so far launched five joint ventures and two solely funded operations in China, with total investments exceeding US $275 million.
(Source: Asia Pulse)
New Anti-Cancer Medicine Developed in China
A unique anti-cancer medicine named "Kanlight" has been developed in China. Based on vegetable substances, it is the world's only anti-tumor injection with such a nature. Spokesman for the "Kanlight" Pharmaceutical Company of Zhejiang Province, Xiong Shaowen, stated that "this is the most effective and promising medicine against cancer, on which great hopes are now being pinned."
Clinical tests of the medicine were begun in the United States, but practical studies will continue in Russia in September. After the patent for the medicine is obtained, there are plans to set up a joint Sino-Russian enterprise to develop and produce "Kanlight". Shaowen noted that the delegation of Russian scientists, who visited China a short while ago, had demonstrated great interest in the new medicine.
"Kanlight" was developed after the study of many years carried out by Li Dapeng, a staff member of the Zhejiang Institute of Chinese Medicine. Li Dapeng is also a foreign member of the Russian Academy of Sciences. The medicine proved very effective when tested in China, especially in treating severe forms of malignant tumors, when surgical interventions are no longer possible. The company's spokesman believes "This is an important breakthrough in the fight against cancer." It is worth noting that the company "Kanlight" is a large pharmaceutical enterprise with nation-wide subsidiaries in China.
The medicine enjoys a dramatic history. When the laboratory where it was being developed caught fire several years ago, the author of the medicine rushed into the blazing building, risking his life to save the formulas and notes from the flames.
(Source: TASS)
Lehman Lee & Xu
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