小分子联合治疗方案
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申万宏源:维持和誉-B“买入”评级 首款自研新药获批上市
Zhi Tong Cai Jing· 2025-12-29 06:11
Core Viewpoint - The approval of the CSF-1R inhibitor, Pimitinib, marks the company's first self-developed drug to be commercialized, initiating a new phase in its business journey while maintaining a steady advancement in its pipeline, leading to a positive self-sustaining cycle [1][2]. Group 1: Product Development and Commercialization - Pimitinib (brand name: Beijiemai) is an orally administered, highly selective, and effective small molecule CSF-1R inhibitor, which has shown the best overall response rate (ORR) in its class during the global Phase III MANEUVER study [2]. - The long-term follow-up data presented at the 2025 ESMO showed that the ORR for patients treated with Pimitinib increased significantly from 54% at 25 weeks to 76.2% at a median follow-up of 14.3 months, with four cases achieving complete remission [2]. - The company has established an exclusive commercialization partnership with Merck, which will expedite the commercialization process of Pimitinib [2]. Group 2: Ongoing Research and Development - Preliminary data from the Phase II study of the oral small molecule PD-L1 inhibitor combined with Vomeletinib for EGFR-mutant and PD-L1 positive advanced non-small cell lung cancer showed good safety and tolerability, leading to approval for first-line treatment research by the Chinese regulatory authority [3]. - The company announced several advancements in its pipeline, including the IND approval for the oral small molecule KRAS G12D inhibitor, ABSK141, which demonstrated potential best-in-class oral bioavailability in preclinical studies [3]. - The FGFR2/3 inhibitor, ABSK061, has completed the first patient dosing in a Phase II clinical trial for treating children with achondroplasia, being the first selective FGFR2/3 inhibitor to enter clinical trials globally [3]. Group 3: Financial Forecast - The company maintains its previous profit forecast, expecting net profits attributable to the parent company to be 63 million, 151 million, and 133 million for the years 2025 to 2027, corresponding to price-to-earnings ratios of 131X, 55X, and 62X respectively [4].