Today, Derek Lowe points out that Shenzhen Chipscreen received CFDA approval for chid amide (Epidaza), the first drug to be completely discovered, developed and approved exclusively in China. Chidamide is indicated for the treatment of peripheral T-cell lymphoma.
The original press release is here, with the company’s product page available here.
We’re pleased to see companies in China (and elsewhere) discover, develop, approve, and commercialize NCEs. It means that more drugs will make it out of the lab and into the marketplace.
Even if this product never gets approved in the US/EU, there could be an emergence of medical tourists who travel to China and other markets to receive potentially life-extending drugs like chidamide.
Presumably there are already HDAC inhibitors available on the market in China. But having a local drug means that Epidada will not be burdened with import taxes and fees that affect the prices of drugs developed outside China and imported into China.
It will be worthwhile to monitor the BD efforts of Chipscreen moving forward. Will they out-license this to a “Western” company? What kinds of trials with that prospective partner need to perform in their local markets? Can chidamide even compete in ex-China markets?