Sunshine Guojian Pharmaceutical(SH:688336) Shen Zhen Shang Bao·2025-10-05 12:46Core Viewpoint - Hunan Maijizhi Biotechnology Co., Ltd. (referred to as "Maijizhi") has received feedback from the China Securities Regulatory Commission (CSRC) regarding its overseas listing application, requiring additional explanations on equity changes, medical research and development activities, and patent ownership disputes [1][2]. Group 1: Company Overview - Maijizhi was established in 2016 and is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative biologics to address unmet medical needs related to allergic and autoimmune diseases, as well as other inflammatory and immune diseases [1]. - The company submitted its IPO application for the Hong Kong stock market in July 2025 [1]. Group 2: Financial Performance - During the reporting period (2023 to the first quarter of 2025), Maijizhi reported losses of approximately 253 million yuan, 178 million yuan, and 27 million yuan, totaling a cumulative loss of about 458 million yuan [2]. - The company's revenue and profitability largely depend on the successful development, regulatory approval, and commercialization of its candidate products, particularly core products MG K10 and key products MG-014 and MG-013 [2]. Group 3: Regulatory Requirements - The CSRC has requested Maijizhi to clarify whether it has actually conducted medical research and development activities, whether it has obtained the necessary qualifications and licenses, and whether its business scope involves any foreign investment restrictions [2]. - The CSRC also requires the company to provide a conclusive opinion on the legality and compliance of its past capital increases and equity transfers, including whether there are any unfulfilled capital contribution obligations [3]. Group 4: Legal Issues - Maijizhi has been involved in a legal dispute with Sangfor Biopharma (Shanghai Stock Exchange code: 688336), where Sangfor claimed ownership of a patent application related to a monoclonal antibody [3]. - The CSRC has asked Maijizhi to explain whether this patent dispute has had a significant adverse impact on its business operations and whether it constitutes a substantial obstacle to the company's current listing application [3].