China’s Drug Evaluation Center posted a list of 48 drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China.
Last December, China’s State Drug Administration released guidance to implement a priority review pathway to accelerate the development and approval of new drugs with “significant clinical value”.
To speed up approval of these “urgently needed” drugs in China, the Drug Evaluation Center said sponsors can submit applications which should include a report comparing the safety and efficacy of the drug in Western and Asian populations. The State Drug Administration will evaluate the applications under the Priority Review and approval process.
The 48-drug list comprises nine drugs that received their first approval since the beginning of 2017 including HCV drug Vosevi sofosbuvir/velpatasvir/voxilaprevir from Gilead Sciences; retinal dystrophy drug Luxturna voretigene neparvovec-rzyl from Spark Therapeutics; psoriasis drug Tremfya guselkumab from Johnson & Johnson; and acute myelogenous leukemia (AML) drug Idhifa enasidenib from Agios Pharmaceuticals and Celgene.
Also included on the list are cancer drug Keytruda pembrolizumab from Merck & Co., which was recently approved in China for advanced melanoma; ovarian cancer drug Lynparza olaparib from AstraZeneca and Merck & Co; breast cancer drug Ibrance palbociclib from Pfizer; cardiovascular disease and hyperlipidemia drug Repatha evolocumab from Amgen; spinal muscular atrophy (SMA) therapy Spinraza nusinersen from Biogen Inc; and Vimizim elosulfase alfa, which is approved to treat Morquio syndrome and is marketed by BioMarin Pharmaceutical. Public comments on the list are due Aug. 18.
In June, the China State Council set new policies to speed drug approvals, which include setting a review timeline of three months for imported drugs approved overseas to treat rare diseases and six months for therapies to treat life-threatening diseases