(Yicai) Jan 10 -- The European Union’s medicines watchdog has granted orphan drug designation to Pimicotinib, an experimental drug to treat inoperable tenosynovial giant cell tumors developed by Chinese biotechnology firm Abbisko Therapeutics.

As a result, Pimicotinib will receive incentives, including protocol assistance, fee reductions, procedural advantages for market authorization, and market exclusivity within the EU, the Shanghai-based firm’s parent company Abbisko Cayman said in a stock exchange filing yesterday.  EU member states can also offer specific incentives, it added.

The European Medicines Agency granted Pimicotinib, a small-molecule inhibitor of the colony-stimulating factor 1 receptor, priority medicines designation last June, which expedites the review process for promising medicines in areas of unmet medical needs, the company noted.

In December, Abbisko inked a deal with Merck, granting it an exclusive license to commercialize Pimicotinib in China. The German drugmaker was also given an exclusive option for the drug’s global commercial rights.

In addition to treating TGCT, a benign tumor, Pimicotinib has also been approved by China’s National Medical Products Administration for Phase II clinical studies involving chronic graft-versus-host disease, according to Abbisko Cayman. No highly selective CSF-1R inhibitors have been approved in China, it pointed out.

Shares of Abbisko Cayman [HKG: 2256] closed 2.4 percent lower at HKD3.22 (41 US cents) apiece in Hong Kong today.

Editor: Martin Kadiev