时迈药业IPO：核心产品研发投入逐年走低 四年四换CFO估值已超行业水平

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted its prospectus to the Hong Kong Stock Exchange, aiming for an IPO under Rule 18A, with Huatai International as the sole sponsor. The company focuses on T-cell engagers (TCE) therapies and has attracted investments from notable firms like Betta Pharmaceuticals and Tigermed, achieving a post-Series C valuation of 2.23 billion yuan. However, it faces multiple risks, including reduced R&D investment, frequent changes in financial leadership, and safety concerns regarding core products [1][2]. Financial Performance - The company's revenue for 2023, 2024, and the first half of 2025 is projected to be 14.65 million yuan, 6.62 million yuan, and 2.28 million yuan, respectively, indicating minimal income. Concurrently, net losses are expected to be 74.94 million yuan, 59.89 million yuan, and 25.42 million yuan, leading to cumulative losses exceeding 160 million yuan over two and a half years. Historical cumulative losses since inception are nearing 500 million yuan [2][4]. - R&D expenses have significantly decreased, with figures of 76.11 million yuan, 53.38 million yuan, and 22.39 million yuan for the respective years, reflecting a downward trend. The R&D investment for core products DNV3 and SMET12 has also seen a notable decline [2][4]. Product Development - The company has four clinical-stage candidates, including core products DNV3 and SMET12, which are currently in critical Phase II trials. The reduction in R&D spending during this pivotal phase raises concerns about the company's financial health and ability to validate drug efficacy and safety [4][5]. - DNV3's Phase I trial involved 11 patients, with an adverse event rate of 81.8%, while SMET12's trial included 16 patients, with 93.8% experiencing adverse events. These results raise questions about the safety of the products [6]. Market Position and Valuation - The global TCE market is projected to be only $3 billion in 2024, with the domestic market at 700 million yuan, indicating that TCE therapies are still in the early stages of development compared to the larger oncology market [5]. - The post-Series C valuation of 2.23 billion yuan places the company above industry averages, with a market-to-research ratio of approximately 42 times based on 2024 R&D expenditures. This is significantly higher than the median of 23.21 times for similar unprofitable biotech firms listed under Rule 18A [7].