New CFDA Regulations Already Showing Benefits for China’s Biotech Innovation

1 Mar

By James Huang, Research Analyst, LSN

james-wpWithin the last few months, China has been formally rolling out their new CFDA regulations that have given startups and new technology developers in China all sorts of benefits. These benefits include allowing the submission of data from clinical trial sites outside of China, allowing more Chinese hospitals to run trials, and allowing drug makers who are waiting for the green light on a safety study to go ahead if they haven’t heard back from the CFDA within 60 days.

All these regulation changes have seen a big boom to China’s biotech innovations. In fact, many Taiwanese companies have seen this regulatory shift as an opportunity to get into the Chinese market. Companies such as Taiwan Liposome (TLC) have started joint ventures with Chinese investors in order to run trials and commercialize their products in China. With the ability to submit their clinical trial data from Taiwan and start their new trials more quickly in China, many of these companies expect to see NDA filings for their assets by the end of the year.

Another highlight of this new regulatory system is that CRISPR human trials have already started within Chinese hospitals. CRISPR in the US, on the other hand, has yet to receive any approval or the go ahead for such trials. Some describe this discrepancy as being the result of China’s lack of regulations. However, that is not necessarily the case. China’s new regulations are geared towards pushing new innovative technologies into trials and out onto market as quickly as possible and has the benefit of being a newly reformed system. In contrast, the US FDA is a much older system using regulations that have been built upon for years, resulting in a much slower and more meticulous process.

Therefore, it might be an advantageous for startups to consider working with Chinese investors through joint ventures. The benefits of having an accelerated clinical trial process with reduced trial costs may be worth the pain of forming a joint venture with a qualified Chinese partner. Of course, while the process of finding a qualified Chinese partner and working with them may be tedious on its own, it definitely should not be immediately discounted. Given how the times are changing, a global outlook towards potential partners and opportunities is becoming more and more necessary in order to succeed.

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