China, Regulatory

China regulators offer VIP treatment for 48 overseas drugs they’re ready to hustle up with accelerated reviews

China wants novel drugs already approved overseas to be available in the country faster. And in case some drugmakers didn’t get the memo, it’s now come up with a direct appeal.

Eight months after the Chinese drug administration rolled out its new priority review pathway, its Center for Drug Evaluation has unveiled a list of 48 drugs (which you can see below) approved in the US, EU or Japan that are urgently needed in the clinical setting. As long as the companies can provide evidence that the drug works equally well across races, they can immediately apply for marketing approval with the data they have and will be eligible for priority review.

In a recent report, the CDE concluded that they took an average of 59 working days to process an NDA once it’s accepted for priority review. That’s lightning fast by EMA or FDA standards — even for their breakthrough drug programs.

Cancer drugs make up a quarter of the group, with Roche/Chugai’s ALK inhibitor alectinib hydrochloride (Alecensa) and Merck’s PD-1 star pembrolizumab (Keytruda) topping the list. Amgen’s denosumab, which was first OK’d in Europe as Prolia in 2010, is the oldest drug in this subset; whereas enasidenib mesylate (Idhifa), a new AML therapy developed by Celgene and Agios, got its greenlight only a year ago.

When putting the list together, regulators wrote, they gave special consideration to new treatments for rare conditions, as well as drugs that target serious, life threatening diseases with no effective therapies currently available.

Other “wanted” drugs include Spark’s $ONCE gene therapy Luxturna, Biogen’s $BIIB SMA drug Spinraza, and Alexion’s $ALXN Soliris — all considered groundbreaking at the time of their first approval. Notably, Soliris, which treats the rare disorder paroxysmal nocturnal hemoglobinuria, has been approved in the US for more than 10 years.

The list marks another move by an agency that’s pushed out reform after reform in the past few years, including a decision to accept overseas clinical data in NDAs — saving foreign drugmakers the headache of conducting trials in China.


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