Testing times for new liver drug
15 July 2008
By Hepeng Jia/Shanghai, China
AstraZeneca (AZ) is set to start clinical trials of a liver cancer drug developed for Chinese patients. Zhang Xiaolin, head of the AZ Innovation Centre China, where the custom-made drug was developed, thinks that the treatment is the first of its kind to be developed by a multinational pharma firm in China.
AZ's new liver cancer drug was initially a result of its worldwide chemistry research. 'We find it fits better to Chinese people and the Chinese market,' says Zhang. There is a huge potential market for the drug - liver cancer is the second largest killer in China, after lung cancer, causing at least 120,000 deaths a year.
Zhang Xiaolin, head of AstraZeneca's Innovation Centre China
China's State Food and Drug Administration (SFDA) has yet to approve clinical trials for the drug. The agency only considers giving the go-ahead to Chinese drug trials by international pharma firms once the first stage of the trial has been completed abroad. Zhang says the Phase I trials of the liver drug are now set to start in the US and other Asian countries. But he adds that the SFDA's policy 'will delay innovation and patients' benefits'.
The AZ Innovation Centre is the company's only complete pre-clinical and clinical research facility in Asia. It opened in 2006 when AZ planned to spend US$100 million over three years to recruit scientists, buy equipment and build the infrastructure. But actual spending has already far surpassed the original budget because much of the lab equipment is highly sophisticated, says Zhang.
Zhang does not expect the facility to develop many new drugs in the short term. Rather, it will be used to study genetic and pathological differences between Western and Chinese patients with diseases such as gastric/oesophagal cancers and liver cancers.
AZ's strategy to focus on China is already paying off. According to US drug marketing and research firm IMS Health, AZ's prescription drug sales in China grew to US$423 million last year, ranking it top out of all the international pharma firms in the Chinese market.
Jin Kewen, general manager of the Shanghai branch of Charles River Laboratories, a pre-clinical contract research firm, applauds AstraZeneca's China strategy. 'Although currently drug sales in China are far lower than in the West, its fast growth could mean much larger returns when the drug hits the market in several years' time.' In addition, Japanese and South Korean people share genetic features with the Chinese and could become potential users of AZ's 'China drugs', says Jin.
This article has been changed since its initial publication. The original version incorrectly stated that the SFDA had already given the go-ahead for Chinese clinical trials. IN-fact, Phase I clinical trials are set to start only in the US and other Asian countries.
Also of interest
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Special registration rules to speed approval and encourage innovation
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