China, New Products, Regulatory

Roche picks up a speedy nod in China as regulators follow through on plans for a fast 48 new drug OKs

Chinese regulatory authorities are following through with their plan to rush along a slate of new drug approvals. And Roche finds itself near the front of the line formed to benefit from that new trend.

Sandra Horning

Overnight Roche reported that the China National Drug Administration had followed up with a green light for Roche to start selling Alecensa as a frontline therapy for advanced cases of ALK-positive non-small cell lung cancer. Roche heralded an OK that arrived just 8 and 9 months after the EMA and FDA flagged the drug through for frontline use following new data underscoring its efficacy in treating patients compared to a standard of care.

China’s drug regulators have been hustling along their reviews, intent on getting a list of 48 priority drugs into the market as swiftly as possible — eliminating barriers that once took years to overcome in the booming market.

The approval today, noted Roche CMO Sandra Horning, marks a “significant regulatory shift, with the approval received under unprecedented timelines.”

Roche has been speeding up the rollout in frontline, ALK-positive NSCLC after a key late-stage study proved that it was significantly better than Pfizer’s leading effort with Xalkori. Alecensa also is pitted against Novartis’ Zykadia, though Pfizer has remained the one to beat in clinical trials. In the ALEX trial the Alecensa arm hit a median PFS of 25.7 months with Xalkori patients registering only 10.4 months.

Look for a slate of new drug approvals to hit in China as regulators continue to make short work out of a long list of priority meds. While far from perfect, China’s drug market has been bustling as drugmakers hunt down a market that will rival the US and Europe. Cancer drugs, which have been placed on regulatory fast tracks in the US and Europe, make up a fourth of the 48 meds that Chinese officials have highlighted for VIP treatment.

One of those meds is Keytruda, which was approved in China last month based on Phase Ib melanoma data. And more are coming.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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