China: China adds 30 drugs to fast track for products approved overseas

11-04-2019

China: China adds 30 drugs to fast track for products approved overseas

(Source: RAPS 2019-04-12)

China has opened up its fast track for urgent needs to another 30 medicines. The action builds on the decision to provide a streamlined path to market for 48 drugs already approved overseas last year.

Officials created the original list last summer to encourage drug developers to bring certain products that address major unmet needs to market in China. China subsequently approved drugs on the list, such as Alexion Pharmaceuticals’ rare disease blockbuster Soliris, and created guidance to help the targeted companies win approval on the strength of data on racial and ethnic differences.

The second batch of drugs destined to benefit from the fast track features fewer cancer drugs than the original list. While oncology drugs accounted for around 25% of the first list, the cancer section of the second batch features just Bristol-Myers Squibb’s Lysodren and Johnson & Johnson’s Erleada.

Rare disease drugs feature heavily on both lists. Some of the new orphan drug additions, such as Kyowa Kirin’s Crysvita, only won approval anywhere in the world shortly before China created its first list. That does not explain why other drugs were absent from the first list, though. Genzyme won approval for Fabrazyme in 2001, but China only added the drug to the fast track in the second batch.

Other products on the second list include Sanofi’s PCSK9 drug Praluent and atopic dermatitis treatment Dupixent.

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