It’s been a little more than a year since China’s FDA (CFDA) announced sweeping policy changes intended to streamline the review of innovative new drugs and rid their system of subpar applicants blocking the progress of true candidates for commercialization. The global pharmaceutical industry raised a collective eyebrow, not sure if the CFDA was truly committed to its new “Fast Track” approval pathway for new drugs.
The CFDA was true to its word. An article published last week (January 4) revealed that the CFDA will conduct clinical trial data inspections on 14 recently received drug registration filings that have completed clinical trials and applied for manufacturing or import. The majority of 14 applications are from multi-national corporations (MNCs), with filings relating to 13 products. The list was released as part of a self-audit process, meaning that applicants who detect data authenticity issues are permitted to withdraw their filing without penalty ahead of inspection.
MNC drug candidates represent have of those on the CFDA’s list:
- Perampanel: Japan-based Eisai‘s anti-epileptic drug Fycompa
- Tamsulosin: Japanese firm Astellas‘s Harnal
- Osimertinib: AstraZeneca’s third-generation epidermal growth factor receptor inhibitor for lung cancer, marketed as Tagrisso in other markets
- Pentavalent, a rotavirus vaccine from U.S.-based Merck, Sharp & Dohme;
- Asunaprevir and daclatasvir, two direct acting antivirals for hepatitis C virus from Bristol-Myers Squibb and AstraZeneca. Asunaprevir is marketed as Sunvepra in Japan and Russia; daclatasvir is marketed under the Daklinza brand globally.
- Ibrutinib, Pharmacyclics’ (part of AbbVie) BTK inhibitor, branded as Imbruvica in other markets.
- Apixaban, Bristol-Myers Squibb’s anticoagulant Eliquis (AstraZeneca is also included on the application).
There are several things worth noting. First, the CFDA is committed to fast-tracking innovative drugs that address diseases or conditions prevalent in China such as Hepatitis C, lung cancer and hypertension/stroke. The list reflects this prioritization.
Second, the CFDA wants China to bring more modern therapeutics to market faster while playing a greater role in clinical trials and eventually the manufacture of MNC drugs in China. It’s encouraging to see half of the fast-tracked drug candidates are from MNCs. With contract manufacturing resources like PaizaBio’s fill-and-finish operations in Hangzhou, in-country manufacture of MNC drugs is more likely.
Finally, the CFDA is serious about ridding their system of poor drug candidates. In 2016, 80 percent of domestic applicants voluntarily withdrew their applications as part of the self-audit program. This has been more effective than “Draino” for removing blockages that in the past prevented progress. Thankfully, viable drugs from MNCs and domestic companies are a major step closer to final market approval and availability to China’s 1.4 billion potential consumers.