Hey, Big Pharma stars: China wants you. Aiming to speed new drugs to market, China just came up with a target list of 48 treatments greenlighted abroad, including some of the industry's biggest names.
The idea? Persuade their makers to apply for Chinese approval based on foreign trial data.
Some key new drugs are on the list, including Roche and Chugai’s ALK cancer drug Alecensa, psoriasis therapies Taltz by Eli Lilly and Cosentyx from Novartis, and Takeda’s anti-inflammatory treatment Entyvio. Even a few drugs just approved in the U.S. last year were ID'd as targets, including GlaxoSmithKline’s shingles vaccine Shingrix, Spark Therapeutics’ eye therapy Luxturna and Ultragenyx’s Mepsevii.
The list of "clinically urgently needed new drugs" was developed by experts convened by China’s State Drug Administration. The group mainly considered medications already approved in the U.S., EU and Japan, but not yet marketed in China. According to the agency’s Center for Drug Evaluation, the country is in urgent need of these drugs to fight rare diseases or life-threatening conditions, because no effective treatment exists in China or becuase they've shown clear advantages in clinical studies.
Some of the drugs on the list are already on their way to the Chinese market. Merck’s PD-1 star Keytruda, for example, was just waved through a few days ago to treat advanced melanoma patients. AstraZeneca, for one, has filed its PARP inhibitor Lynparza for approval.
As for the others yet to make a bid for approval, the agency says drug developers can apply using foreign data and evidence that supports no racial or ethnic differences in efficacy or safety. Once accepted, their new drug applications will be put under priority review.
China has taken major steps to speed up its drug review process and reduce its backlog of applications. Lynparza, for example, was the first drug to be filed using data from multicenter trials that included China sites, without the usual application to waive a China-specific clinical trial. Keytruda was approved under an accelerated approval process.
The country’s drug regulator also started offering conditional marketing authorizations. Merck’s HPV vaccine Gardasil 9 was handed a conditional nod in May based on foreign clinical data. It took the agency only nine days to make the decision.
China’s CDE is taking public comments on the 48-drug list and the required documents to gain expedited approval until Aug. 18.