时迈药业急切港股上市“续命”，股权合规等四问待答

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for 19 companies, including Shimai Pharmaceutical, which must clarify the progress of state-owned shareholder management procedures and other matters related to its overseas listing application [1]. Group 1: Company Requirements - Shimai Pharmaceutical needs to provide details on the progress of state-owned shareholders fulfilling state-owned stock identification and management procedures [2]. - The company must explain the pricing basis and reasons for price differences in past capital increases and share transfers, and confirm the legality and compliance of its establishment and share changes [3]. - It is required to clarify whether the shares held by shareholders participating in the "full circulation" are subject to pledges, freezes, or other rights defects [4]. Group 2: Financial Performance - Shimai Pharmaceutical has not generated any drug sales revenue or milestone payments, with total other income of approximately 14.65 million yuan, 6.62 million yuan, and 2.28 million yuan for 2023, 2024, and the first half of 2025, respectively [4]. - The company reported losses of 74.94 million yuan, 59.90 million yuan, and 25.42 million yuan for the years 2023, 2024, and the first half of 2025, with cumulative losses exceeding 160 million yuan [5]. - The primary reason for ongoing losses is the lack of commercialized products, with income mainly from government subsidies and investment returns, which are insufficient to cover high R&D and operational costs [5]. Group 3: R&D Expenditure - R&D expenses for the company were 76.11 million yuan, 53.38 million yuan, and 22.39 million yuan for 2023, 2024, and the first half of 2025, respectively, indicating a significant decline in R&D investment [6]. - The R&D expenditure for the core product SMET12 decreased by 73.7% in the first half of 2025 compared to the same period in 2024, raising concerns about the development of core products [6]. Group 4: Cash Flow and Financing - As of June 30, 2025, the company's cash and cash equivalents were only 85.74 million yuan, while the average annual R&D expenditure was around 60 million yuan [7]. - By September 30, 2025, cash and cash equivalents sharply declined to 5.71 million yuan, indicating a rapid depletion of funds [8]. - The company has completed three rounds of financing, with a post-Series C valuation of 2.23 billion yuan, supported by investors such as Betta Pharmaceuticals and Tigermed [9]. Group 5: Market Potential - The global TCE market is projected to reach approximately $3 billion by 2024, with a compound annual growth rate (CAGR) of 40% expected to grow to $121.1 billion by 2035 [10]. - The Chinese TCE market is anticipated to reach 700 million yuan by 2024, with a CAGR of 63.8% expected to grow to 159.6 billion yuan by 2035 [10]. Group 6: Shareholder Structure and Future Plans - The company's actual controller, Xiao Zuoxiang, holds 53.2% of the shares, making him the controlling shareholder, while Betta Pharmaceuticals holds 4.75% through its subsidiary [11]. - The company plans to use the funds raised from its Hong Kong listing primarily for clinical development of core products, optimization of technology platforms, new product development, and operational funding [11].