新股消息 | 和美药业递表港交所 核心产品Mufemilast已获准于中国商业化

Core Viewpoint - Ganzhou Hemei Pharmaceutical Co., Ltd. (Hemei Pharmaceutical) has submitted its application for listing on the Hong Kong Stock Exchange, with Guotou Securities International as its sole sponsor. The company has made significant efforts in identifying, developing, and commercializing biotechnology and other candidate drug products, validated by a strong track record in R&D, including the successful development of its core product Mufemilast, which has received NDA approval in China for the treatment of moderate to severe psoriasis [1][3]. Company Overview - Established in 2002, Hemei Pharmaceutical is a biopharmaceutical company focused on discovering and developing proprietary small molecule drugs for autoimmune diseases and tumors, with expertise in psoriasis (Ps), Behçet's disease (BD), and inflammatory bowel disease (IBD) [3]. - The company has developed a robust product pipeline consisting of seven small molecule candidates, including two core products, Mufemilast and Hemay022, targeting various unmet medical needs [3][4]. Product Details - Mufemilast is a proprietary small molecule PDE4B expression blocker and PDE4 inhibitor with broad therapeutic potential for autoimmune diseases. It has been approved for commercialization in China and is set to be launched for treating moderate to severe plaque psoriasis [3][4]. - Hemay022 is a class 1 small molecule inhibitor targeting both EGFR and HER2, currently undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer. The trial aims to evaluate the efficacy of Hemay022 in combination with aromatase inhibitors, with results expected to support an NDA submission to the Chinese National Medical Products Administration in 2027 [4][5]. Commercialization Strategy - Hemei Pharmaceutical plans to launch Mufemilast in China, with production facilities in Ganzhou. The commercialization strategy includes a dedicated team for marketing and sales, combining direct sales with partnerships with third-party contract sales organizations (CSOs) [6]. - The company aims to build a sales team of approximately 80-85 members within the first year of launch, focusing on 160-200 leading hospitals and key opinion leader institutions, with expansion goals set for 2026 and 2027 [6]. Financial Overview - For the fiscal year ending December 31, 2023, Hemei Pharmaceutical recorded other income of 4.05 million RMB, with projected other income of 5.298 million RMB for 2024 and 3.661 million RMB for the first half of 2025. This income primarily consists of government subsidies related to R&D activities [8]. - R&D expenditures are a core aspect of the company's operations, with expenses of 123.255 million RMB for 2023, 96.987 million RMB for 2024, and 52.597 million RMB for the first half of 2025. The company anticipates continued increases in R&D spending as it advances its clinical development [9]. - The company has not yet generated revenue from product sales, reporting net losses of 156.354 million RMB for 2023, 123.393 million RMB for 2024, and 72.641 million RMB for the first half of 2025, primarily due to R&D and administrative expenses [10]. Industry Overview - The global market for autoimmune disease drugs is projected to grow from $116.9 billion in 2019 to $143.1 billion by 2024, with a compound annual growth rate (CAGR) of 4.1%. It is expected to reach $179.5 billion by 2028 and $192.3 billion by 2032, with a CAGR of 5.8% from 2024 to 2028 [11]. - In China, the autoimmune disease drug market is expected to grow from $2.4 billion in 2019 to $4.6 billion by 2024, with a CAGR of 14.2%. Projections indicate it will reach $12.1 billion by 2028 and $26.3 billion by 2032, with a CAGR of 27.6% from 2024 to 2028 [11]. - The psoriasis drug market in China is anticipated to reach 18.2 billion RMB by 2024, with a CAGR of 30.5% from 2019 to 2024. It is estimated to grow to 48.3 billion RMB by 2028 and 87.1 billion RMB by 2032, with a CAGR of 27.6% from 2024 to 2028 [15].