和誉-B(02256.HK)：匹米替尼获批上市 正式迈入商业化阶段

Group 1 - CSF-1R highly selective small molecule Pimitinib has been approved for the treatment of symptomatic adult patients with tenosynovial giant cell tumor (TGCT) that may lead to functional limitations or serious complications after surgical resection [1] - Pimitinib is the company's first self-developed innovative drug product, demonstrating good efficacy and safety [1] - The MANEUVER III phase study showed an overall response rate (ORR) of 54.0% at 25 weeks for patients treated with Pimitinib, increasing to 76.2% at a median follow-up of 14.3 months [1] Group 2 - Patients who switched to Pimitinib from the control group also experienced clinical benefits, with an ORR of 64.5% at a median follow-up of 8.5 months [2] - Pimitinib has a higher ORR compared to existing drugs like Pexidartinib and Vimseltinib, which have ORRs of 39% and 40% respectively, and Pimitinib does not carry the risk of cholestatic liver toxicity [2] - The global commercialization process for Pimitinib is accelerating, with approvals in China and recognition from the FDA and EMA for breakthrough therapy designation and priority medicine status [2] Group 3 - ABSK043 is designed for combination therapy and is currently undergoing three phase II clinical trials in conjunction with other treatments [3] - The most common driver gene mutation in non-small cell lung cancer (NSCLC) is the EGFR mutation, and third-generation EGFR-TKIs have become the standard first-line treatment [3] - Previous studies indicate that the efficacy of third-generation EGFR-TKIs is inferior in patients with high PD-L1 expression compared to those with low or negative expression [3] Group 4 - In a phase II clinical trial of ABSK043 combined with Vemurafenib, the disease control rate (DCR) reached 71% and the ORR was 25% among patients with EGFR mutations and positive PD-L1 [4] - The company has a robust pipeline with over 10 clinical-stage oncology products, including the Pan-KRAS inhibitor ABSK211 expected to enter clinical stages by 2026 [4] - Revenue forecasts for the company are projected at 630 million, 685 million, and 637 million yuan for 2025-2027, with net profits expected to be 45 million, 70 million, and 102 million yuan respectively [4]