First - in - Class (FIC) innovation

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SHANGHAI HENLIUS BIOTECH INC.(02696.HK):TARGETING GLOBAL MARKET WITH INNOVATIVE PIPELINE HAVING FIC POTENTIAL
Ge Long Hui· 2025-07-10 07:42
Core Insights - Henlius is a leading Chinese biopharmaceutical company focused on R&D with six products approved for marketing in China and four products successfully entering international markets [1][4] - The company's pipeline emphasizes oncology and autoimmune diseases, featuring innovative candidates like HLX43 (PD-L1 ADC) and HLX22 (anti-HER2 monoclonal antibody) [1][2] Product Development - HLX43 is the first PD-L1 ADC globally to enter Phase II clinical trials, showing promising efficacy with an objective response rate (ORR) of 75% in thymic squamous cell carcinoma (TSCC) patients and 40% in squamous non-small cell lung cancer (sqNSCLC) patients [1] - HLX22, a novel anti-HER2 monoclonal antibody, is expected to redefine the standard of care for first-line HER2-positive gastric cancer, with ongoing Phase III trials in combination with trastuzumab and chemotherapy [2] Market Performance - Hansizhuang (Serplulimab) has achieved rapid domestic sales growth, reaching Rmb1.31 billion in 2024, and has been approved in multiple international markets [3] - The company has successfully entered global markets with four products, including Hanlikang and Hanquyou, and has established collaborations for the commercialization of various biosimilars [4] Financial Projections - Revenue forecasts indicate growth to Rmb5.96 billion in 2025, Rmb6.36 billion in 2026, and Rmb7.02 billion in 2027, with net profits projected at Rmb790 million, Rmb900 million, and Rmb1.14 billion respectively [5]