近日，在2025年第30届欧洲血液学协会(EHA)年会上，复星国际(00656.HK)旗下复星医药自主研发的 MEK1/2抑制剂芦沃美替尼(FCN-159)治疗复发/难治性朗格汉斯细胞组织细胞增生症(LCH)儿童患者的关 键研究成果重磅发布，为其科学应用再添新证。 日前，芦沃美替尼片完成首批发货，已在上海、北京、广东、山东、江苏、湖南等多个省市医院开出首 批处方，正式投入临床使用。 目前，儿童LCH领域尚无药物获批。 芦沃美替尼是一种高选择性MEK1/2口服小分子抑制剂，通过阻断MAPK信号通路的异常激活，抑制肿 瘤细胞增殖并诱导其凋亡。目前芦沃美替尼已通过国家药品监督管理局优先审评审批程序，于5月29日 获批用于治疗朗格汉斯细胞组织细胞增生症(LCH)和组织细胞肿瘤成人患者；以及2岁及2岁以上伴有症 状、无法手术的丛状神经纤维瘤(PN)的I型神经纤维瘤病(NF1)儿童及青少年患者，是中国首个且目前唯 一拥有上述双适应症的药物。此外，芦沃美替尼用于儿童LCH的适应症也已被国家药监局药品审评中心 纳入突破性治疗药物程序。 本次EHA大会上，芦沃美替尼用于儿童LCH的II期研究成果以壁报形式发布，展示了其良好的疗 ...

Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has initiated a Phase III clinical trial for its self-developed drug, Rumaine (generic name: Luwomeitini tablets), aimed at treating pediatric low-grade glioma in mainland China [1][2]. Drug Information and Research Status - Rumaine is an innovative small molecule chemical drug that acts as a selective inhibitor of MEK1/2 [1]. - As of July 9, 2025, the drug is in Phase III clinical trials for treating pediatric low-grade glioma and is also in Phase II trials for treating extra-cranial arteriovenous malformations and pediatric Langerhans cell histiocytosis in mainland China [2]. - The drug has been included in the breakthrough therapy program by the National Medical Products Administration for two indications: inoperable or residual/recurrent NF1-related plexiform neurofibromas in adult patients and pediatric Langerhans cell histiocytosis [2]. - Cumulative R&D investment in the drug reached approximately RMB 607 million (unaudited) as of May 2025 [2]. - According to IQVIA MIDAS™, global sales of MEK1/2 selective inhibitors are projected to be approximately USD 2.068 billion in 2024 [2].

复星医药：控股子公司药品芦沃美替尼片中国境内启动Ⅲ期临床试验 智通财经7月9日电，复星医药(600196.SH)公告称，控股子公司上海复星医药产业发展有限公司就复迈 宁®（通用名：芦沃美替尼片）用于治疗儿童低级别脑胶质瘤于中国境内启动Ⅲ期临床试验。该药品为 集团自主研发的创新型小分子化学药物，为MEK1/2选择性抑制剂，已在中国境内上市并获批两项适应 症。截至2025年5月，集团针对该药品的累计研发投入约为人民币6.07亿元。根据IQVIA数据，2024 年，MEK1/2选择性抑制剂于全球范围的销售额约为20.68亿美元。药品研发存在一定风险，敬请广大投 资者注意投资风险。 ...

中新网北京新闻6月26日电 由复星医药自主研发的1类新药芦沃美替尼片（商品名：复迈宁®）在首都 医科大学附属北京天坛医院正式投入临床使用，标志着复迈宁®作为中国首个且目前唯一同时获批成人 朗格汉斯细胞组织细胞增生症（LCH）及组织细胞肿瘤、2岁及以上儿童青少年 I型神经纤维瘤病 （NF1）双适应症的靶向药物惠及当地患者，为相关领域肿瘤罕见病患者带来高品质的治疗新选择。 北京天坛医院投入临床使用，专家寄语新药价值 国产创新药芦沃美替尼片与5月29日正式获得国家药品监督管理局（NMPA）批准上市。获批不到一个 月在北京等多地投入临床使用，破除了罕见病从"无药可医"和"有药难及"的双重困境，切实提升了在罕 见病患者中的药物可及性，填补了国内相关领域的治疗空白，具有里程碑意义。 首都医科大学附属北京天坛医院肿瘤综合治疗中心主任李文斌表示，该药在北京投入临床使用，对于首 都的NF1相关丛状神经纤维瘤患者群体而言，是一个重要的好消息。这种疾病往往给患者，尤其是儿童 青少年，带来沉重的身心负担，手术干预存在局限。芦沃美替尼片作为国内首个获批用于此适应症的靶 向药物，其扎实的临床数据展现了良好的疗效和可控的安全性，为无法手术 ...

Core Insights - The rare disease drug market in China is rapidly growing, with 55 rare disease drugs approved for market entry and over 210 clinical trials in progress, indicating a significant shift from being a niche market to a major industry segment [1][3][4] - The market is driven by unmet clinical needs, favorable regulatory policies, and an improving medication security system, attracting both domestic and international pharmaceutical companies [1][4][6] Group 1: Market Dynamics - The global rare disease market is projected to reach $300 billion by 2028, accounting for 20% of the global prescription drug market, while China's rare disease drug market is expected to grow from $1.3 billion in 2020 to $25.9 billion by 2030, with a compound annual growth rate (CAGR) of 34.5% [4][6] - As of November 2022, 89 drugs for 45 rare diseases were approved in China, with a notable acceleration in approvals in 2023, including 45 drugs approved and 55 expected in 2024 [3][4] Group 2: Policy Support - The Chinese government has implemented reforms to expedite the approval process for rare disease drugs, including reducing clinical trial requirements and allowing for faster market access [5][6] - Over 90 rare disease drugs have been included in the National Medical Insurance Drug List, enhancing drug accessibility and affordability for patients [6][8] Group 3: Industry Participation - Major international pharmaceutical companies like Pfizer, Roche, Merck, and Novartis are actively entering the Chinese rare disease market, employing strategies that combine in-house development with external partnerships [4][7] - The presence of over 210 clinical trial pipelines for rare disease drugs in China indicates a robust interest from various companies, with nearly 38% in phase III trials [6][8] Group 4: Challenges and Considerations - Despite the promising market, the development of rare disease drugs remains challenging due to high research costs and limited patient pools, making commercial success highly dependent on expanding indications and market access [8][9] - The need for greater public awareness and clinical data on rare diseases poses additional hurdles for drug development and patient management [9][10]

Core Viewpoint - The article discusses the recent measures introduced by the National Healthcare Security Administration and the National Health Commission to support the high-quality development of innovative drugs in China, emphasizing the acceleration of innovative drugs from laboratories to hospitals and ensuring affordability for the public [1][2]. Group 1: Policy Measures - The new policy includes 16 measures aimed at invigorating the development of innovative drugs, marking a significant governmental push for the biopharmaceutical industry [1][2]. - The measures focus on encouraging "true innovation" in drug development and avoiding homogenization and insufficient clinical value in certain areas [2]. Group 2: Drug Approval and Market Dynamics - In 2024, the number of approved Class 1 innovative drugs reached 48, more than five times the number in 2018, indicating a significant increase in drug approvals [2]. - As of mid-2023, nearly 40 Class 1 innovative drugs were approved in the first half of the year alone, showcasing a clear "explosion effect" in the market [2]. Group 3: Affordability and Accessibility - The measures aim to enhance the multi-channel payment capabilities for innovative drugs, encouraging commercial health insurance and mutual medical assistance to include these drugs in their coverage [3][4]. - Since 2018, 149 innovative drugs have been included in the medical insurance directory, accounting for 17% of new drug approvals, with medical insurance fund expenditures reaching 4.1 trillion yuan, driving sales over 6 trillion yuan [3]. Group 4: Integration of Insurance Systems - The establishment of a commercial health insurance directory for innovative drugs is proposed to better align with basic medical insurance, enhancing overall coverage [4]. - The measures also suggest synchronizing settlements between basic medical insurance and commercial health insurance to streamline processes for patients [5]. Group 5: Drug Availability in Medical Institutions - The policy emphasizes the need to expedite the entry of innovative drugs into designated medical institutions and encourages timely meetings to address drug supply based on clinical needs [6]. - The ongoing reforms in medical insurance payment systems aim to support the reasonable use of innovative drugs, allowing medical institutions to apply for special cases when standard payment methods are not suitable [6]. Group 6: Global Market Expansion - The article highlights that Chinese pharmaceutical companies are increasingly engaging in overseas transactions, with over 90 deals completed in 2024, totaling more than 50 billion dollars [6]. - The measures propose to facilitate the global market development of innovative drugs by providing platforms and price support for companies looking to expand internationally [6].

沈阳一家药企研发人员在进行样品处理。新华社记者 杨青 摄 支持研发，鼓励医药企业"真创新"—— 近年来，我国创新药热潮涌现。2024年一类创新药获批数量达48种，是2018年的5倍以上。从治疗组织 细胞肿瘤的芦沃美替尼片，到国产减重药玛仕度肽注射液……今年仅上半年，一类创新药获批数量就已 接近40种。 但同时，一些领域创新药存在同质化、临床价值不够突出等问题。 对此，新措施亮出妙招：用医保数据为新药研发"导航"。依托全国统一的医保信息平台，进行疾病谱、 临床用药需求等数据归集和分析，探索为创新药研发提供医保数据服务。 一粒创新药，从实验室到病床前，正在加速跑—— 2018年以来，国家医保药品目录累计纳入149种创新药；2024年新纳入医保目录药品中，超30%为当年 获批新药；约80%创新药上市后两年内能纳入医保…… 7月1日，我国再次为创新药发展带来政策"及时雨"——国家医保局、国家卫生健康委联合印发《支持创 新药高质量发展的若干措施》，十六条举措将为创新药发展注入强劲活力。 此外，聚焦重大传染病、儿童用药、罕见病等重点领域，措施明确将组织实施创新药物研发国家科技重 大专项，让创新药研发有的放矢。 多元支付， ...

Core Viewpoint - The launch of Luwo Meitini tablets marks a significant advancement in the treatment of rare diseases in China, specifically targeting LCH and NF1, providing new therapeutic options for patients [1][2][3]. Group 1: Product Overview - Luwo Meitini tablets are the first and only targeted drug approved in China for both adult LCH and NF1 in children aged 2 and above [1]. - The drug is an innovative small molecule developed by Fosun Pharma, selectively inhibiting MEK1/2 protein activity to block the abnormal activation of the MAPK signaling pathway, thereby suppressing tumor cell proliferation and inducing apoptosis [2]. Group 2: Clinical Data and Efficacy - Clinical trial data shows a median follow-up time of 15.1 months, with a best objective response rate (ORR) of 60.5% and a median time to response (TTR) of 4.7 months, indicating effective and controllable safety [2]. - NF1 is a rare autosomal dominant genetic disorder, with a significant disease burden that can lead to pain, mobility issues, and disfigurement, necessitating the development of targeted therapies [2]. Group 3: Future Prospects - In addition to the current indications, Luwo Meitini is undergoing clinical trials for low-grade gliomas, extracranial arteriovenous malformations, and pediatric LCH, with the potential to expand its application to more disease areas [4].

Core Insights - The innovative drug sector is experiencing a significant uptrend driven by new drug launches, reduced losses in biotech, and major business development (BD) activities, with a positive outlook for continued growth in the industry [1] - Fosun International's health sector is gaining market attention due to its innovative transformation in the pharmaceutical industry, showcasing unique value in "innovation," "technology," and "globalization" [1] Group 1: Company Developments - Fosun Pharma and its subsidiary, Hualan Biological Engineering, are entering a critical phase of pipeline realization, with a focus on differentiated and internationalized R&D strategies [1][4] - The PD-1 monoclonal antibody, Hanshuo (Sru Li Single Antibody Injection), has become the first globally approved first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) [1] - Hualan's HLX43, a PD-L1 antibody-drug conjugate (ADC), is positioned to address unmet clinical needs in advanced/metastatic solid tumors, showing promising initial efficacy in non-small cell lung cancer (NSCLC) and thymic squamous cell carcinoma (TSCC) [2][3] Group 2: Market Expansion and Collaborations - Fosun is actively promoting its innovative products internationally, having established deep collaborations with over 20 leading biopharmaceutical companies to expand into global markets [5] - The approval of Sru Li Single Antibody in the EU and its coverage across over 30 countries demonstrates Fosun's capabilities in overseas registration and market access [5] - Ongoing clinical trials for innovative therapies targeting gastric cancer and breast cancer further indicate Fosun's commitment to expanding its global clinical capabilities [5] Group 3: Future Growth Potential - The combination of self-research, licensing, and globalization strategies positions Fosun for sustainable and high-value growth, with a strong pipeline and innovative technology platforms [6] - The recent approval of multiple new drugs by the National Medical Products Administration (NMPA) is expected to boost Fosun's performance, especially with the upcoming medical insurance negotiations [6] - The Chinese biotechnology sector has seen a significant revaluation, with a 72% increase year-to-date, indicating a robust outlook for the innovative drug market [6][7]

Core Viewpoint - Fosun Pharma has successfully completed the first batch shipment of its self-developed drug, Luwo Meitini Tablets (Fumainin®), marking its imminent clinical use and addressing patient medication needs [1][5]. Group 1: Product Launch and Approval - Fumainin® is the first and only targeted drug in China approved for dual indications: adult Langerhans cell histiocytosis (LCH) and tissue tumors, as well as type I neurofibromatosis for children aged 2 and above [1][6]. - The drug received approval from the National Medical Products Administration through a priority review and approval process by the end of May 2025 [5]. Group 2: Logistics and Distribution - The first batch of Fumainin® was successfully shipped from the production base of the entrusted manufacturer, Kelaiying Pharmaceutical Group, located in Tianjin [3]. - The logistics team completed a series of complex tasks within 10 working days after obtaining the approval, demonstrating efficient execution and a strong commitment to patient needs [5]. Group 3: Industry Impact and Responsibility - The rapid approval of Fumainin® fills a treatment gap in the rare disease oncology field in China, representing a significant breakthrough in domestic original innovation [6]. - The company emphasizes its responsibility to ensure that Fumainin® reaches patients in need as quickly as possible, reflecting a strong sense of social responsibility [6].