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和黄医药(00013.HK):SAFFRON完成入组 ATTC即将进入临床
Ge Long Hui· 2025-11-07 19:50
Company Updates - The company announced the completion of patient enrollment for the global Phase III clinical trial SAFFRON for savolitinib on November 5 [1] - On October 31, the company participated in the 2025 R&D Day, where management shared progress on the next-generation antibody-drug conjugate (ATTC) platform [1] Clinical Trial Insights - SAFFRON is a pivotal trial for savolitinib's registration in the U.S., with top-line results expected in 1H26 [1] - Savolitinib, in combination with osimertinib, has already been approved in China for MET mutation EGFRm NSCLC patients based on the Phase III trial SACHI [1] - Successful results from SAFFRON could support U.S. approval for savolitinib, opening significant commercialization opportunities [1] ATTC Platform Development - The first candidate molecule HMPL-A251 was showcased at the R&D Day, demonstrating early potential [2] - HMPL-A251 is a high-efficiency PI3K/PIKK inhibitor combined with trastuzumab targeting HER2, showing strong efficacy in blocking PAM and PIKK signaling pathways [2] - The company plans to advance HMPL-A251 to Phase I clinical trials in 4Q25 for HER2+ PAM+/- or HER2 low-expressing PAM+ breast cancer [2] - Additional ATTC molecules A580 and A830 are expected to enter U.S.-China Phase I studies in 1H26 and 2H26, respectively [2] Financial Forecast and Valuation - The company maintains its net profit forecasts for 2025 and 2026 at $366 million and $35 million, respectively [2] - The company retains an outperform rating based on a DCF model, with a target price of HKD 30, indicating a 23.9% upside from the current stock price [2]