Group 1 - The core point of the article is the approval of the CSF-1R inhibitor, Pimitinib, by the Chinese drug regulatory authority for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients, marking the company's first self-developed drug to be approved for commercialization [1] - Pimitinib, marketed as Beijiemai, is an oral, highly selective, and effective small molecule CSF-1R inhibitor, which demonstrated the best overall response rate (ORR) in the global Phase III MANEUVER study, with significant safety advantages [1] - Long-term follow-up data presented at the 2025 ESMO showed that the ORR for patients treated with Pimitinib increased from 54% at 25 weeks to 76.2% at a median follow-up of 14.3 months, with four cases achieving complete remission [1] Group 2 - The company has established a commercial partnership with Merck, which will drive the commercialization process of Pimitinib following its approval [1] - The company is also advancing multiple pipeline projects, including the approval of the IND application for the oral small molecule KRAS G12D inhibitor, ABSK141, and the completion of the first patient dosing in the Phase II trial of the FGFR2/3 inhibitor, ABSK061, which is the first selective FGFR2/3 inhibitor to enter clinical trials globally [2] - The company maintains a "buy" rating and forecasts net profits of 63 million, 151 million, and 133 million for the years 2025-2027, corresponding to PE ratios of 131X, 55X, and 62X, respectively, indicating a positive outlook on the commercial journey and pipeline progress [3]
和誉-B(02256.HK)点评：匹米替尼获批 开启商业化新征程