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华源证券:维持和黄医药“买入”评级 关注ATTC平台价值
Zhi Tong Cai Jing·2025-11-11 07:08

Core Viewpoint - Huadong Medicine (00013) has significant potential in its innovative pipeline, with a "Buy" rating maintained by Huayuan Securities, projecting total revenues of $567 million, $676 million, and $816 million for 2025-2027 [1] Group 1: Event Highlights - Huadong Medicine shared key R&D and business progress during an investor meeting on October 31, 2025, focusing on advancements in innovative cancer and immune disease treatments, including its next-generation Antibody-Drug Conjugate (ATTC) platform and late-stage pipeline candidates [1] Group 2: Breakthrough ATTC Platform and Pipeline Potential - The ATTC platform is a proprietary cancer precision therapy drug development platform that connects monoclonal antibodies with patented targeted small molecule payloads, aiming for superior anti-tumor activity and safety compared to traditional Antibody-Drug Conjugates (ADC) [2] - The first potential pipeline from this platform is HMPL-A251, a PAM-HER2ATTC that combines a highly selective and potent PI3K/PIKK inhibitor as the payload with a humanized anti-HER2 IgG1 antibody via a cleavable linker, showing promising anti-tumor efficacy and tolerability in preclinical studies [2] - Based on preclinical data, Huadong Medicine plans to advance HMPL-A251 into clinical development starting at the end of 2025 [2] Group 3: Ongoing Late-Stage Projects - The FRUSICA-2 study of fruquintinib combined with sintilimab for second-line treatment of renal cell carcinoma will present data at the 2025 ESMO conference, showing a median progression-free survival (mPFS) of 22.2 months and an overall response rate (ORR) of 60.5% [3] - The SANOVO China Phase III study for savolitinib in first-line treatment of EGFR-mutant non-small cell lung cancer with MET overexpression has completed patient recruitment, while the SAFFRON global Phase III study for second-line treatment is progressing well, expected to complete recruitment by the end of 2025 [3] - The study of surufatinib for pancreatic cancer, in combination with carrelizumab, albumin-bound paclitaxel, and gemcitabine, is progressing well, with Phase II results to be announced at an upcoming scientific meeting [3] - The Chinese registration Phase II study of HMPL-453 for advanced intrahepatic cholangiocarcinoma has completed recruitment, with plans to submit a new drug application in the first half of 2026 [3]