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Shanghai bird flu drug nears production
Hu Yan
Shanghai_Delta
page01 2006-3-21
The generic version of Tamiflu, the only drug effective against bird flu, is expected to be produced in Shanghai by early May. Development of the drug has progressed smoothly and entered the final clinical trial stage, according to the manufacturer in Shanghai, Sunve Pharmaceutical Co Ltd.
Guided by the document, "Special Process for Drug Approval," the State Food and Drug Administration (SFDA) recently approved the bioequivalence studies of oseltamivir (generic of Tamiflu) on human beings, the Xinhua News Agency reported over the weekend.
The Xinhua News Agency said the approval indicated significant progress in the development of domestic drugs against flu virus.
The news was confirmed by the drug manufacturer yesterday.
"We have got the approval from the SFDA to conduct bioequivalence trials on human beings," said an official of the Shanghai Sunve, who declined to be named.
"Actually, we have started the clinical trial in Shanghai, which will take around one month."
Shanghai Sunve Pharmaceutical Co Ltd is a company under Shanghai Pharmaceutical Group (SPG), one of China's leading drug manufacturers.
SPG won the licence from Roche AG to produce and sell Tamiflu generics on the Chinese mainland last December after competing with more than 10 domestic pharmaceutical companies.
Besides SPG, Roche also granted a Tamiflu sub-licence to India's Hetero Drugs to make flu medicine for India and developing countries.
Generic medicines are chemically equivalent to original products the patent protection of which has expired or has not been sought. The results of bioequivalence studies serve as important data for SFDA to decide whether the generics should be approved.
Conducted on healthy volunteers, the studies aim to test if generics contain the same active ingredients as the original products and are equivalent (equal) to their original counterparts in quality, safety and efficacy.
"The bioequivalence studies are required to be tested on 18 to 24 volunteers in hospitals which are approved to conduct clinic trials," said Wang Linda, director of the Drug Registration Department of the Shanghai Food And Drug Administration Bureau.
Wang explained that the studies on generics are much easier and quicker than clinical trials of innovative drugs, as the safety and efficacy of patented drug has been proved in clinical practice.
"Usually, it takes two months," said Wang, adding that the drug approval process
is shorter than usual due to the global epidemic of bird flu.
Last month, Yin Qinxie, spokesman for SPG, told China Daily Shanghai & Delta edition that the equipment and manufacturing technologies are all ready for producing oseltamivir in SPG.
SPG plans to produce 200,000 doses monthly at a more affordable price than Tamiflu, all for government stockpiling.
Bird flu or avian influenza has spread to 17 countries in Africa, Asia, Europe and the Middle East.
Since 2003, the fatal strain of H5N1 has struck 177 people and killed 98, according
to statistics from the World Health Organization.
In China, 15 people have been confirmed as bird flu cases and 10 have died, Ministry of Health figures indicate. |
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