迪哲医药同时还公布了另一消息，舒沃哲国际多中心注册临床研究"悟空1B"（WU-KONG1B）最新数 据入选了2025年世界肺癌大会（WCLC）口头报告，后者将于今年9月举行。该研究旨在评估舒沃哲二/ 后线治疗表皮生长因子受体（EGFR）20号外显子插入突变（Exon20ins）非小细胞肺癌的疗效和安全 性。 迪哲医药近日公告，公司肺癌靶向药舒沃哲（舒沃替尼片）被纳入美国国立综合癌症网络（NCCN）指 南，成为全球唯一纳入国际肺癌指南的EGFR Exon20ins非小细胞肺癌小分子靶向药。稍早前，该药获 得美国食品药品监督管理局（以下简称FDA）批准。 作为肺癌领域公认的难治靶点，EGFR exon20ins患者占非小细胞肺癌的比例为10%左右，照此估算其市 场规模不低于20亿美元。在武田制药旗下莫博赛替尼退市后，迪哲医药将与强生制药开展正面竞争。 舒沃哲入选国际肺癌指南 据迪哲医药公告，自主研发的新型肺癌靶向药舒沃哲已被纳入美国国立综合癌症网络（NCCN）指南， 该药也成为全球唯一纳入国际肺癌指南的EGFR Exon20ins非小细胞肺癌（NSCLC）小分子靶向药。 本月初，舒沃哲获FDA批准，用于既往经含铂 ...

Core Viewpoint - The recent approval of multiple innovative drugs in China and favorable policies have led to a surge in interest in the Hong Kong innovative drug sector, with several ETFs in the pharmaceutical space seeing gains of over 40% this year [1][2]. Company Overview - He Mei Pharmaceutical Co., Ltd. (referred to as "He Mei Pharmaceutical") has submitted an IPO application to the Hong Kong Stock Exchange, with a post-investment valuation of 3.9 billion RMB after completing six rounds of financing [1][2]. - The company, founded in 2002, focuses on developing small molecule drugs for autoimmune diseases and tumors, with a strong position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [1][2]. Financial Performance - As of the latest financial report, He Mei Pharmaceutical has not yet achieved profitability, with projected revenues of approximately 4.05 million RMB and 5.298 million RMB for 2023 and 2024, respectively, primarily from government subsidies [1][2]. - The company is expected to incur losses of approximately 156 million RMB and 123 million RMB for the same periods [1]. Product Pipeline - He Mei Pharmaceutical has developed seven small molecule drug candidates targeting unmet needs in autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages for 12 indications as of May 21, 2025 [2][3]. - The two core products include Mufemilast, a potential first-in-class treatment for psoriasis, and Hemay022, a dual-target EGFR/HER2 inhibitor for advanced breast cancer [4][8]. Mufemilast Details - Mufemilast is a novel PDE4B inhibitor with a favorable safety profile, showing potential for treating psoriasis patients with latent tuberculosis [4][5]. - The global psoriasis drug market is projected to reach 29.621 billion USD in 2024, with a compound annual growth rate of 9.19% from 2024 to 2029 [5][6]. Competitive Landscape - Despite Mufemilast's advantages, the psoriasis treatment market is highly competitive, with numerous new drugs entering the market, posing challenges for commercial success [8][11]. - Hemay022 is currently undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer, facing competition from existing EGFR/HER2 inhibitors [8][9]. Financial Pressure - The company anticipates significant financial pressure due to high R&D expenditures, with projected investments of 123 million RMB and 97 million RMB for 2023 and 2024, respectively [10]. - As of December 31, 2024, the company is expected to hold approximately 150 million RMB in cash and cash equivalents, indicating a tight financial situation [10]. Conclusion - Overall, while He Mei Pharmaceutical's core product for psoriasis shows rapid progress, the intense market competition and ongoing high R&D costs may hinder its ability to attract capital market interest [11].