麦济生物递表港交所 核心产品可能无法上市

Core Viewpoint - The probability of IPO failure for companies like Maijizhi Bio, which have not yet entered the hearing stage after submitting their applications to the Hong Kong Stock Exchange, is increasing, with the company expressing concerns about the successful development and commercialization of its core product MG-K10 [1][4]. Company Overview - Maijizhi Bio, established in 2016, focuses on clinical-stage biopharmaceuticals for allergic and autoimmune diseases, with a pipeline of eight innovative candidates, the most advanced being the long-acting anti-IL-4Rα antibody MG-K10 [2][4]. - The company has partnered with Kangzhe Pharmaceutical, granting them exclusive commercialization rights for MG-K10, which reflects Maijizhi Bio's challenges in independently navigating a competitive market [2]. Market Potential - The global market for atopic dermatitis drugs is projected to grow from $14.2 billion in 2023 to $29.1 billion by 2032, with the Chinese market expected to increase from 8.4 billion RMB to 46.4 billion RMB [3]. - The IL-4Rα space in China is highly competitive, with multiple companies, including Sanofi and Kangzhe, already having products on the market or in advanced clinical stages [3]. Intellectual Property Challenges - Maijizhi Bio faces significant intellectual property challenges, particularly from its former parent company, Sanofi, which has initiated legal actions regarding patents related to MG-K10 [5][6]. - The company has previously lost a patent dispute to Sanofi, which raises concerns about the stability of its core patents and the potential impact on MG-K10's commercialization [7]. Financial Situation - Since its inception, Maijizhi Bio has operated without product revenue, relying on financing to sustain operations, with reported revenues of 8.72 million RMB, 24,000 RMB, and 0 RMB for 2023 and the first quarter of 2025 [8][9]. - The company has incurred significant losses, with net losses of 253 million RMB, 178 million RMB, and 27 million RMB for the same periods, and a cumulative loss exceeding 808 million RMB as of March 2025 [9]. - Cash flow is a critical concern, with only 70.78 million RMB in cash and equivalents as of March 31, 2025, and estimated costs of 500 to 600 million RMB needed to complete clinical trials and registration for MG-K10 [9]. Financing and Investment - Maijizhi Bio has successfully raised over 700 million RMB through multiple financing rounds since its establishment, achieving a post-investment valuation of 2.64 billion RMB after the Pre-IPO round in 2025 [10]. - Some early investors have begun to exit, with significant share transfers occurring prior to the company's IPO application, indicating potential investor concerns about the company's future [10].