Core Viewpoint - The report from CICC indicates that HeYu-B's CSF-1R inhibitor, Pimitinib (Beijiemai), has been approved for marketing in China for the treatment of inoperable giant cell tumors of the tendon sheath, marking the company's first self-developed innovative drug approval [1] Group 1: Approval Details - Pimitinib's approval speed exceeded expectations, taking just over six months from the acceptance of its application in June 2025 to approval [1] - The approval is based on the results of the global Phase III MANEUVER clinical trial, which showed a 25-week overall response rate (ORR) of 54% compared to 3.2% for the placebo, with significant improvements in joint mobility and pain indicators [1] Group 2: Future Outlook - The report suggests monitoring the progress of Pimitinib's U.S. market entry, the registration clinical progress of Ipagofitinib in the second-line setting, and the first-line clinical plans [1] - Potential data readout opportunities for ABSK061 and ABSK043, as well as the development progress of early molecules including ABSK131 and ABSK141, are also highlighted [1] - The firm maintains an "outperform" rating for the stock with a target price of HKD 20 [1]
研报掘金丨中金：维持和誉-B“跑赢行业”评级 匹米替尼获批速度超预期