美国斯克里普斯研究所团队开发出一种实现单细胞级别精准定位的新成像技术——vCATCH，其能在体 内"照亮"药物与单细胞结合的位点，有助发现药物的副作用。相关研究发表在《细胞》杂志上。 在验证实验中，他们绘制了抗癌药物伊布替尼和阿法替尼的结合图谱。结果显示，伊布替尼不仅与血细 胞中的目标结合，还会与肝脏、心脏组织和血管中的免疫细胞结合，这为其可能引起心律不齐和出血的 副作用提供了合理解释。 目前，团队正在利用vCATCH技术探索癌症药物是否能更具选择性地靶向肿瘤细胞，并研究抗抑郁药等 药物在大脑中的作用机制。 团队成员表示，这项技术有望成为测试候选药物的有力工具，帮助确保药物能强力结合靶标，同时避免 在其他器官产生不良结合，从而在新药开发早期降低潜在风险。 （文章来源：科技日报） 在药物进入体内后，人们并不清楚它们实际上是如何与靶标相互作用的，这一过程基本还是个黑匣子。 对于大多数药物，科学家只能作出推测。传统方法可显示药物大致的器官分布，以及药物在肝脏等器官 中的整体浓度，但无法精确定位药物与哪些细胞结合，更难以发现药物可能意外作用的部位。 vCATCH技术实现了单细胞级别的精准定位。该技术适用于共价药物，这 ...

| 突破性治疗申请公示详细信息 | | | | | --- | --- | --- | --- | | 受理号 CXHL2300625 | | 药品名称 | 甲磺酸伏美替尼片 | | 药品类型 化药 | | 注册分类 | 2.4 | | 申请日期 2025-11-18 | | 承か日期 | 2023-06-08 | | 公示日期 2025-12-25 | | 公示截止日期 | 2026-01-04 | | 是否为罕见病药 台 物 | | | | | 拟定适应症 (或 功能主治) 线治疗。 | | 本品适用于具有表皮生长因子受体 (EGFR) PACC突变的同部晚期或转移性非小细胞肺癌 (NSCLC)成人患者的一 | | | 理由及依据 | 三个文件的公告》(2020年第82号),同意纳入突破治疗药物程序。 | 经审核,本申请符合《药品注册管理办法》和《国家药监局关于发布《突破性治疗药物审评工作程序(试行) 〉等 | | 截图来源：CDE 官网 伏美替尼是第三代 EGFR-TKI，此前已在国内获批两项适应症，用于 EGFR 突变的局部晚期或转移性 NSCLC 成人患者的二线、 一线治疗。今年 7 月，伏美替尼的 ...

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].