Yuhui Pharmaceuticals' Pimicotinib Approved by Health Canada, Second Global Market After China

According to Yuhui Pharmaceuticals' announcement, pimicotinib, a selective CSF-1R inhibitor developed by the company, has been approved by Health Canada for treating tenosynovial giant cell tumor (TGCT) patients where surgical resection may worsen function or cause serious complications. The approval completed the New Drug Submission process via Priority Review, compressing the standard 300-day evaluation to 180 days.

This marks pimicotinib's second global regulatory approval, following its China launch in December 2025. On June 9, Yuhui announced receipt of $13.52 million in milestone payments from partner Merck, including first prescription triggers and Q1 2026 sales royalties, signaling entry into commercial value realization.