Recent Articles in Gov't & Regulatory

China researchers have treated 86 cancer patients with genetically modified versions of their own immune cells. Using Crispr-Cas9 tools, the scientists have removed a small section of the patients' T-cell DNA that prevents the immune cells from destroying cancer. There are no similar trials in the US because, according to a Wall Street Journal article (see story), the regulatory systems are so different in the two countries. Until a year ago, China treated cell and gene therapies, particularly autologous cell therapies, as natural substances. Now they are considered drugs and reviewed by the CFDA, which ChinaBio® believes will align China and US regulations more closely. More details....

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According to an article in BioCentury, the CFDA plans to double its drug application reviewers from 800 presently to 1,600 by 2020. In 2015, the CFDA employed just 170 reviewers, meaning the agency will increase its reviewing staff by almost 10-fold over a six-year period. The news was disclosed by Ruyi He, MD, Chief Scientist of the CFDA and the Center for Drug Evaluation, who was speaking at the WuXi Global Forum in San Francisco earlier this week. More details....

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Singapore's Aslan Pharma now expects China approval of varlitinib one year earlier than its previous schedule, due to the CFDA's speeding up of approvals for drugs that address an unmet need. Aslan has started a 68-patient China single-arm trial of its lead drug, varlitinib, in patients with advanced or metastatic biliary tract cancer. Following a discussion with the CFDA, Aslan now says it will file for approval of the drug if the primary endpoint of the trial, objective response rate, is met. Aslan expects to have the data by the end of 2018. More details....

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Over the weekend, China's State Council issued a broad directive aimed at speeding up China's drug/device approval process, including using foreign trial data for approvals. The directive is a big boost for foreign pharmas that want to bring their drugs to China. In May, the CFDA released Draft Circulars (Numbers 52-55) that outlined the same changes, which were opened to a 30-day comment period. Although this is not the first time these changes have been made public, the official State Council statement means the proposals have been accepted and will be implemented. More details....

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