和美药业IPO：商业化前景难言乐观 核心管线临床数据显著弱于竞品

Company Overview - He Mei Pharmaceutical has submitted an application for listing on the Hong Kong Stock Exchange, with Guo Zheng International as the sole sponsor [1] - The company was established in 2002 and focuses on discovering and developing small molecule drugs for autoimmune diseases and tumors, with key treatment areas including psoriasis, Behçet's disease, and inflammatory bowel disease [1][2] - The company has completed six rounds of financing, raising approximately 951 million yuan, with a post-investment valuation of 3.9 billion yuan after the completion of the E round in Q4 2024 [1] Clinical Development - He Mei Pharmaceutical has developed seven small molecule drug candidates, with two drugs in Phase III clinical trials or NDA stages [2] - The key product Mufemilast for psoriasis has completed its Phase III trial and submitted an NDA in March 2024, with expected approval in the second half of 2025 [3][4] - The company plans to prioritize clinical development for ulcerative colitis, Behçet's disease, Crohn's disease, psoriatic arthritis, and chronic obstructive pulmonary disease, while the clinical data for Mufemilast and Hemay022 for breast cancer are considered weaker compared to competitors [4] Competitive Landscape - Mufemilast's clinical efficacy data for psoriasis is significantly lower than that of competitors, with PASI-75 and PASI-90 scores at 53.6% and 32.5% respectively at week 16 [5][6] - Competitors such as Innovent Biologics and Johnson & Johnson have reported higher efficacy rates, with PASI-90 scores reaching up to 80% [6][7] - Hemay022, targeting advanced HER2+ breast cancer, also faces stiff competition, with its objective response rate of 29.1% in earlier trials being lower than that of similar products [10] Financial Performance - He Mei Pharmaceutical currently has no approved commercial products and thus no revenue, with pre-tax losses of 156 million yuan and 123 million yuan for 2023 and 2024 respectively [11] - The company’s cash reserves are limited, with net cash used in operating activities of 141 million yuan and 91.3 million yuan for the respective years, indicating a tight financial situation [11]