China FDA prioritizes innovative drugs as 2015 approvals dipped

China FDA said it plans to get more innovative new drugs approved faster by identifying clear clinical need as a priority even as the number of approvals dipped last year.

The regulator has also drafted new guidelines for applying for clinical trials and manufacturing registration within days of releasing a report that it approved 241 drugs in 2015, well below the previous two years and with the clear majority generics.

The CFDA approved 470 drugs in 2014 and 374 in 2013. The breakdown for 2015 showed 24 biologic drugs approved of the 241 and 76 in traditional Chinese medicine.

Key approval among multinationals that met with the focus on innovative drugs in oncology, cardiovascular and diabetes among other chronic disease areas included renal cell cancer therapy Inlyta (axitinib) from Pfizer ($PFE) and Johnson & Johnson's ($JNJ) Zytiga (abiraterone) for prostate cancer.

In diabetes, the CFDA approved Galvus (vildagliptin) from Novartis ($NVS) and Boehringer Ingelheim's Tradjenta (linagliptin), along with cardio drug Xarelto (rivaroxaban) from Bayer HealthCare.

And a local partnership with Shanghai-based Desano Pharmaceuticals aided approval of GlaxoSmithKline ($GSK) unit ViiV Healthcare's Tivicay (dolutegravir).

But the drop in approvals also likely reflects tough standards for applications that saw a slew of new drug applications withdrawn in the face of expected denials.

The new clinical guidelines suggest that the process will continue in 2016 with a focus on therapies that require advanced manufacturing technology to make, leaving many smaller firms on the sidelines, Reuters said.

Reuters, citing IMS Health, estimated drug sales in China reaching $185 billion by 2018, though the country has also launched aggressive efforts to stem costs in reimbursement.

One potential therapy area to watch is the new class of hepatitis C drugs vying to be the first in China for an approval, which includes candidates from Bristol-Myers Squibb ($BMY), Gilead Sciences ($GILD) and Shanghai-based Ascletis Pharmaceuticals.

- here's a Reuters story from the Economic Times
- and a China FDA release on revised rules (Chinese language)
- and a China FDA release on drug approvals

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