招股书显示，这款瞄准银屑病、强直性脊柱炎等适应证的口服小分子药，凭借"中国首个双机制PDE4抑 制剂"已进入NDA（新药上市申请）优先审评，不过，这个赛道已是硝烟弥漫：前有同类竞品药进入集 采被砍价超过93%，后有37款临床竞品围追堵截，这也为该药品如愿获批上市后的商业化表现增添了不 确定性。 明星的病情能够引发公众对自身免疫疾病的关注，但身处其中的创新药企能否借资本破局，还得靠药效 说话。 核心产品面临激烈竞争 作为一家计划依据港股18A规则上市的生物医药企业，和美药业具有这类公司典型的高投入、高潜力特 征。 当李宇春轮椅出行的画面刺痛公众神经，当周杰伦近期佝偻行走的视频引爆热搜，"强直性脊柱炎"这个 医学名词在一夜之间"火"了。 公开资料显示，中国有约400万名强直性脊柱炎患者。实际上，在自身免疫疾病方面，中国有超过8000 万位患者面临无药根治的困境。 《每日经济新闻》记者注意到，近日，一家深耕该领域的药企赣州和美药业股份有限公司（以下简称和 美药业）正式向港交所递交上市申请，携核心药物Mufemilast冲刺18A生物科技IPO（首次公开募股）。 招股书显示，和美药业尚未获得收益，存在显著的"资金饥渴 ...

Core Viewpoint - The rising public awareness of autoimmune diseases, particularly ankylosing spondylitis, has led to increased interest in the pharmaceutical company Ganzhou Hemei Pharmaceutical Co., Ltd. as it seeks to go public with its core drug Mufemilast targeting psoriasis and ankylosing spondylitis [1][6]. Company Overview - Ganzhou Hemei Pharmaceutical is preparing for an IPO under the Hong Kong Stock Exchange's 18A biotechnology rules, focusing on high investment and potential returns typical of biopharmaceutical companies [2]. - The company has not yet generated revenue and relies heavily on government subsidies and continuous financing to sustain operations [2][11]. Product Pipeline - The company has seven clinical-stage small molecule candidates aimed at addressing unmet medical needs in autoimmune diseases and oncology [2]. - Mufemilast is a dual-action PDE4 inhibitor that has entered the NDA priority review process, targeting multiple indications including psoriasis and ankylosing spondylitis [2][3]. Market Potential - The market for psoriasis drugs in China has seen rapid growth, with a compound annual growth rate (CAGR) of 30.4% from 2019 to 2023, reaching a market size of 13.9 billion yuan in 2023, projected to soar to 89.4 billion yuan by 2032 [3]. - The autoimmune disease drug market in China has expanded from $2.5 billion in 2019 to $4 billion in 2023, with expectations to reach $26.3 billion by 2032, reflecting a CAGR of 23.3% [6]. Competitive Landscape - The competitive environment for Mufemilast is intense, with existing competitors having undergone significant price reductions due to national procurement policies, with price drops exceeding 93% for some products [5]. - There are currently five approved small molecule targeted therapies for psoriasis in China, with 37 more in clinical development, indicating a crowded market for Mufemilast [5][8]. Financial Status - The company reported significant losses of 156 million yuan in 2023 and 123 million yuan in 2024, with minimal other income [11]. - The company has undergone multiple rounds of financing since 2021, raising over 500 million yuan to support its operations, with a post-investment valuation of 3.9 billion yuan [11]. Leadership - The founder and chairman, Zhang Hesheng, has over 20 years of experience in biopharmaceuticals and holds a significant voting power in the company [12].

近日，港交所披露赣州和美药业股份有限公司（简称"和美药业"）已根据第18A章规则提交主板上市申 请，国证国际担任独家保荐人。这家成立于2002年的创新驱动型生物制药企业，专注于自身免疫性疾病 和肿瘤领域小分子药物研发，正试图通过资本市场为其持续亏损的研发管线寻求新的"输血"通道。 和美药业已构建由7个小分子候选药物组成的产品管线，其中4种处于II期、III期临床试验或NDA阶段， 适用于12种适应症。然而，财务数据显示，其在2023年和2024年分别亏损1.56亿元和1.23亿元，且截至 2024年底流动资产净值仅剩450万元，2025年3月更是出现2550万元流动负债。在已获近10亿元投资、估 值高达39亿元的背景下，和美药业能否成功突围？ 双核心产品赛道竞争激烈，差异化策略成效待考 和美药业的核心产品Mufemilast是一种新型小分子磷酸二酯酶4B（PDE4B）蛋白表达阻断剂和PDE4抑 制剂，具有双重作用机制，已于2024年3月向国家药监局提交针对银屑病的NDA并获优先审评资格，预 计2025年下半年获批上市。招股书显示，该产品是唯一可直接用于潜伏性结核感染银屑病患者的药物， 安全性获III期临床支持 ...

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].

Group 1: Company Overview - He Mei Pharmaceutical Co., Ltd. (和美药业) is an innovative biopharmaceutical company established in 2002, focusing on the discovery and development of small molecule drugs for autoimmune diseases and tumors [1][2] - The company has submitted an application for listing on the Hong Kong Stock Exchange, with Guo Zheng International as its exclusive sponsor [1] Group 2: Product Pipeline - He Mei Pharmaceutical has developed seven small molecule drug candidates targeting autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages [2][8] - The core product, Mufemilast, is a novel small molecule PDE4B inhibitor with potential applications in various autoimmune diseases, including psoriasis and inflammatory bowel disease [3][5] Group 3: Market Potential - The autoimmune disease drug market in China has grown from $2.5 billion in 2019 to $4 billion in 2023, with a compound annual growth rate (CAGR) of 12.5% [5] - The psoriasis drug market in China reached ¥13.9 billion in 2023, with a CAGR of 30.4% from 2019 to 2023, and is expected to grow to ¥89.4 billion by 2032, with a CAGR of 59.1% [5] Group 4: Clinical Development - Mufemilast is the only drug that can be directly used for psoriasis patients with latent tuberculosis infection, with its safety supported by Phase III clinical trials [3][5] - Hemay022, another core product, is a dual-target small molecule inhibitor for advanced breast cancer, currently undergoing a Phase III clinical trial [7] Group 5: Financial Overview - The company reported a pre-tax loss of ¥156.4 million in 2023 and ¥123.4 million in 2024, primarily due to R&D and administrative expenses [12][13] - As of the end of 2024, the company had cash and cash equivalents of ¥150 million, with a net cash outflow from operating activities of ¥141 million in 2023 [11][12]

文 | 医药研究社 港股18A再添一员？ 近日，港交所披露，赣州和美药业股份有限公司(以下简称"和美药业")已递交上市申请，根据上市规则第18A章寻求在联交所主板上市，国证国际为其独家 保荐人。 2023-2024年，和美药业实现其他收益分别约为405万元、529.8万元人民币；同期年内亏损分别约为1.56亿元、1.23亿元。其中，其他收益主要来自政府补 助，即地方政府就和美药业的研发活动及和美药业作为高增长科技公司授予的奖励和补贴。 | | 截至12月31日止年度 | | | --- | --- | --- | | | 2023年 | 2024年 | | | (人民幣千元) | | | 其他收益 | 4,050 | 5,298 | | 銷售和營銷開支 . | - | (818) | | 一般和行政開支 . | (27,936) | (33,304) | | 研發開支 | (123,255) | (96,987) | | 其他利得淨額 | 3,750 | 3,963 | | 經營虧損 | (143,391) | (121,848) | | 財務收益 | 1,387 | 263 | | 財務成本 ... | ( ...