Mei Ri Jing Ji Xin Wen·2025-12-23 09:49Core Viewpoint - The IPO application of Maijizhi Biotechnology has not yet entered the hearing stage, raising concerns about the company's ability to successfully list and develop its core product MG-K10, an IL-4Rα antibody, amidst intense competition and patent disputes [1][2][6]. Company Overview - Maijizhi Biotechnology, founded in 2016, focuses on clinical-stage biopharmaceuticals for allergic and autoimmune diseases, with a pipeline of eight innovative candidates, the most advanced being MG-K10 [2][3]. - MG-K10 targets multiple indications, including atopic dermatitis and asthma, and is positioned as a long-acting differentiated product [2][3]. Market Context - 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 antibody market is highly competitive, with several companies, including Sanofi and Regeneron, already having approved products [3][4]. Product Development and Challenges - MG-K10's application for market approval was accepted by the NMPA on October 30, 2023, but the company has expressed uncertainty about its ability to successfully develop and commercialize the product [5][6]. - The company faces significant competition from other IL-4Rα antibodies that are either already approved or in late-stage clinical trials [3][4]. Financial Situation - Since its inception, Maijizhi has operated at a loss, with cumulative losses exceeding 800 million RMB as of March 2025, and minimal revenue generated from research services [11][12]. - The company has a cash flow crisis, with only 70.8 million RMB in cash as of March 31, 2025, while the estimated cost to complete clinical trials for MG-K10 is between 500 million to 600 million RMB [12]. Patent Issues - Maijizhi is embroiled in patent disputes with its former parent company, Sangfor Biopharma, which has filed for the invalidation of a key patent related to MG-K10 [9][10]. - The stability of the core patent is crucial for the commercial value of MG-K10, and any adverse ruling could significantly impact its market prospects [10]. Investment and Financing - The company has raised over 700 million RMB through multiple financing rounds since its establishment, with a post-money valuation increasing nearly 45 times over eight years [13]. - However, the financial structure is concerning, with a debt-to-asset ratio exceeding 100% for several years, indicating a substantial risk of insolvency [13]. Shareholder Agreements - Investors have the right to require the company or its founders to repurchase shares at principal plus 12% interest if the company fails to go public by December 31, 2025, with the deadline extended to December 31, 2026, after the IPO application [14].