NDA获批+FDA孤儿药资格！「和美药业-B」二次递表，创新药领跑自免赛道

Company Overview - Hemay Pharmaceutical Co., Ltd. (referred to as "Hemay") submitted its second prospectus to the Hong Kong Stock Exchange on December 1, 2025, aiming for a main board listing, with Guotai Junan Securities as the sole sponsor [1] - Established in 2002, Hemay focuses on the discovery and development of proprietary small molecule drugs for autoimmune diseases and tumors, maintaining a leading position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [1] Financial Performance - For the fiscal year ending December 31, 2024, Hemay reported other income of approximately RMB 0.05 billion and a net loss of RMB 1.23 billion, with a 20% year-on-year increase in net loss for the first half of 2025 [1][6] - In the first half of 2025, other income was RMB 0.04 billion, with a net loss of RMB 0.73 billion, reflecting a 26.93% year-on-year increase in net loss [7] - The company’s cash flow from operating activities was -RMB 0.52 billion as of June 30, 2025, with cash reserves of approximately RMB 0.73 billion at year-end [7] Product Pipeline - Hemay has developed seven small molecule drug candidates, including its core product Mufemilast, which has received NDA approval in China for the treatment of moderate to severe plaque psoriasis [2] - Hemay022, another candidate, is undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer [3] - Mufemilast is also being evaluated for Behçet's disease in a pivotal Phase III trial and has received orphan drug designation from the FDA [2] Market Potential - The psoriasis drug market in China is projected to reach RMB 18.2 billion by 2024, with a compound annual growth rate (CAGR) of 30.5% from 2019 to 2024, and is expected to grow to RMB 48.3 billion by 2028 [8] - The market for Behçet's disease drugs in China is anticipated to grow from RMB 490 million in 2019 to RMB 666.6 million by 2024, with a CAGR of 6.4% [12] Competitive Landscape - As of the latest data, there are 17 approved targeted therapies for psoriasis in China, including five small molecule drugs and twelve biologics, with some showing superior efficacy in head-to-head clinical trials [11] - Hemay's Mufemilast is positioned against established treatments like Apremilast, which has been recommended in clinical guidelines for Behçet's disease [15] Comparable Companies - Hemay's peer in the industry, Qianxin Biopharmaceutical-B (2509.HK), had an IPO on March 20, 2024, with a market capitalization of approximately HKD 4.397 billion [16]