Traditional Chinese medicine firm struggles for approval

Hepeng Jia/Beijing, China

A traditional Chinese medicine (TCM) company has asked China’s drug regulator, the State Food and Drug Administration (SFDA), to reconsider its decision to reject its herbal product for HIV/Aids sufferers. HSR Biotechnology, based in Kunming, Yunnan Province, claims it has been treated unfairly and says it is not ruling out sabotage of its clinical trial by a competitor.

HSR has spent the past eight years developing Fufang Sanhuangsan (FFSHS), which contains compounds derived from several plants including skullcap, dandelion and bupleurum. Clinical trials of FFSHS on 198 HIV patients in six Beijing-based hospitals started in 2005, with financial support from the Ministry of Science and Technology and other government agencies. In late 2007, HSR claimed that FFSHS had satisfactorily improved patients’ CD4 counts, which indicate how well the immune system is working, and reduced their HIV viral loads, but their results have not been published. ’We have had measurable indicators to show that FFSHS can not only improve the immunity level, but also inhibit integrase and revertase [enzymes which are key to HIV replication],’ a company head at HSR told Chemistry World.

HSR submitted a new drug application for FFSHS to the SFDA in 2007, but it was rejected in October 2008. The SFDA was not happy that lamivadin, a widely used anti-retroviral drug, was identified in 37 patients on the clinical trial during random blood tests, making it unclear whether lamivadin or FFSHS played the anti-HIV role.

On 28 October, after a failed petition, HSR Biotechnology asked the SFDA to reconsider its decision. Chen Dagang, FFSHS project manager at HSR Biotechnology, assured a press conference in Beijing that FFSHS was the only anti-viral medicine used in the clinical trial, and that no lamivadin was found in blood samples from the other patients. He thinks the SFDA’s refusal stems from the fact that many experts still don’t believe that TCM can be used to treat HIV. Indeed, Lui Aiping, a senior researcher at the China Academy of Chinese Medical Sciences, says that while some TCMs might be able to inhibit HIV, the results are not repeatable enough. ’Perhaps it is wiser to use TCM to supplement anti-retroviruses,’ Lui says.

In a separate interview with the newspaper 21st Century Business Herald, Xiao Yulin, the company’s financial head, said that the competition to get approval for an anti-HIV TCM is fierce, and he could not rule out the possibility that a competitor could have run a dirty tricks campaign, possibly persuading patients to take lamivadin.

SFDA spokesperson Yan Jiangying responded to HSR’s call by saying that the basic principle of the agency is simply to ensure that drugs are safe, effective and controllable.

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