Abbisko Wins First Global Approval for TGCT Drug Pimicotinib in China

Abbisko Cayman Limited ( (HK:2256) ) has issued an update.

Abbisko Cayman Limited announced that its subsidiary Abbisko Therapeutics has received approval from China’s National Medical Products Administration for pimicotinib, a novel, oral, highly selective CSF-1R inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor where surgery would likely cause significant functional impairment or morbidity. The drug, the first domestically developed systemic therapy for TGCT and the first regulatory approval for pimicotinib worldwide, was approved on the strength of positive global Phase III MANEUVER trial data showing a markedly higher objective response rate than placebo and meaningful improvements in pain, stiffness, physical function and range of motion; the swift, zero-deficiency review and successful overseas site inspection underscore regulators’ confidence in Abbisko’s R&D standards and mark a key milestone toward the company’s first product commercialization in partnership with Merck, which is now working to secure timely patient access in China, although the company cautions that ultimate commercial success is not guaranteed.

The most recent analyst rating on (HK:2256) stock is a Hold with a HK$15.00 price target. To see the full list of analyst forecasts on Abbisko Cayman Limited stock, see the HK:2256 Stock Forecast page.

More about Abbisko Cayman Limited

Abbisko Cayman Limited, through its subsidiary Abbisko Therapeutics, is a China-based biopharmaceutical company focused on discovering and developing innovative small-molecule drugs, particularly in oncology. Its pipeline includes targeted therapies such as pimicotinib, a CSF-1R inhibitor aimed at addressing unmet medical needs in rare tumors like tenosynovial giant cell tumor (TGCT), with commercialization rights for this asset licensed globally to Merck KGaA, Darmstadt, Germany.

Average Trading Volume: 2,706,813

Technical Sentiment Signal: Buy

Current Market Cap: HK$9.17B

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