超五规则(bRo5)高生物利用度口服药物
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麓鹏制药闯关港股IPO,证监会要求补充架构合规等,研发投入已“刹车”
Sou Hu Cai Jing· 2025-12-29 10:16
Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for 19 companies, including LUPENG Pharmaceutical, which is preparing for an IPO in Hong Kong. The CSRC has requested clarifications on the company's offshore structure compliance, shareholder transparency, and the arrangements of the actual controller's trust [1][2]. Group 1: Regulatory Requirements - The CSRC requires LUPENG Pharmaceutical to clarify the compliance of its offshore structure and reverse mergers, including details on foreign exchange management, offshore investment, and tax management [1]. - The company must provide a complete transparency report on its controlling shareholders and any shareholders holding more than 5%, including the rationale for recent share prices and any potential conflicts of interest [2]. - The company is also required to verify its stock option incentive plan in accordance with regulatory guidelines before its IPO [2]. Group 2: Company Overview - LUPENG Pharmaceutical is a biopharmaceutical company focused on developing high bioavailability oral drugs for cancer and autoimmune diseases, with a proprietary drug development platform [4]. - The company has established a product pipeline with six major candidates, three of which are in the new drug application and clinical stages [4]. - As of June 30, 2025, the company reported cash and cash equivalents of 66.7 million yuan, with no commercial revenue generated to date [4]. Group 3: Financial Performance - The company reported net losses of 1.59 billion yuan in 2023, 338.5 million yuan in 2024, and a projected profit of 35.9 million yuan in the first half of 2025 [5]. - Research and development expenses accounted for over 80% of total operating expenses, with a decreasing trend observed in 2024 and the first half of 2025 [5][6]. - The increase in fair value gains from preferred shares contributed to the company's profitability in 2024, despite overall losses in previous years [6]. Group 4: Shareholder Structure - The largest single shareholder group, including Dr. Tan, Ms. Li, and Dr. Chen, holds a combined 22.27% of the company, with other significant shareholders including Kaita Capital (16.15%) and Eli Lilly Asia (9.03%) [6]. - The company plans to use the funds raised from the IPO primarily for clinical development of core products, pipeline expansion, and operational funding [9].