Domestic TYK2/JAK1 new drug achieves BD licensing authorization

Aug 29, 2025 17:31 CST Updated Sep 02, 15:33

Fosun Pharmaceutical

Healthcare Industry Group

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YaoRong CircleMonitoring: On August 29 today, Fosun Pharma (600196.SH; 02196.HK) and AccuraBio (AccuraBio) jointly announced that AccuraBio will exclusively grant to Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. ("Fosun Pharma Industry"), a subsidiary of Fosun Pharma, the rights to develop, manufacture, and commercialize AC-201, the company's self-developed highly selective TYK2/JAK1 inhibitor, in Greater China (including mainland China and Hong Kong and Macao regions). AccuraBio will retain the rights to develop, manufacture, and commercialize AC-201 globally (excluding mainland China and Hong Kong and Macao regions).

According to the agreement, Aicono will receive an upfront payment and near-term milestone payments totaling RMB 80 million (including an initial payment of RMB 60 million and a milestone payment of RMB 20 million upon completion of manufacturing technology transfer), as well as development milestone payments of up to RMB 76 million. Aicono will also receive sales milestone payments and tiered sales royalties of up to a double-digit percentage based on product sales within the licensed territory.

AC-201 is a novel, highly selective, and potent oral small-molecule TYK2/JAK1 inhibitor that effectively binds to the pseudokinase domain (JH2) of TYK2/JAK1 without affecting the JAK2 pathway. It is being developed for the treatment of various autoimmune diseases. A Phase II clinical trial of AC-201 has been completed in patients with moderate-to-severe plaque psoriasis. The results showed that after 12 weeks of treatment, all dosing groups in the AC-201 Phase II study achieved the primary endpoint of PASI-75 as well as key secondary endpoints. AC-201 demonstrated overall favorable safety and tolerability across all dose groups, with no adverse events (AEs) or serious adverse events (SAEs) leading to discontinuation.

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