华夏时报（www.chinatimes.net.cn）记者 杨燕 北京报道 近日，港股三生制药股价单日暴涨超30%受到广泛关注，子公司三生国健在A股市场更是连续四个交易日斩 获"20CM"涨停。点燃这场资本狂欢导火索的，是一笔高达60.5亿美元的对外授权合作交易——辉瑞拿下其抗癌双 抗药物SSGJ-707海外权益，仅首付款就达到12.5亿美元。 这只是中国创新药板块火爆行情的一个缩影。截至发稿，德琪医药股价自年初以来飙升492%，和铂医药、加科 思、舒泰神涨幅均突破300%，荣昌生物、益方生物、科伦博泰等创新药概念股年初至今涨幅超100%。资本市场 的热情，正以前所未有的力度拥抱中国创新药。 "本轮行情是临床突破、BD大单和政策利好共同作用的结果。"CIC灼识咨询总监卢李康对《华夏时报》记者表 示，"过去一段时间，中国创新药资产在二级市场的估值与临床价值存在显著错配，近期不断的BD大单和临床数 据突破的好消息持续驱动了中国创新药资产的价值回归。" 本轮"吃药"行情与过往医药牛市存在显著差异：涨幅龙头集中于创新药企业，且港股表现尤为强劲。南下资金持 续涌入带来的估值抬升，使得重仓港股的医药主题QDII基金表现亮 ...

Core Insights - China Biologic Products (01177.HK) announced the latest results of a Phase III clinical study for Bemesumab injection combined with or without Anlotinib capsules for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) at the 2025 ASCO annual meeting [1][3] Group 1: Clinical Study Results - The study (R-ALPS) demonstrated that the combination of Bemesumab and Anlotinib significantly extended the median progression-free survival (PFS) to 15.1 months compared to 4.2 months in the placebo group, reducing the risk of disease progression or death by 51% [1][2] - A total of 553 patients were randomized in the study, with 209 in the treatment group receiving Bemesumab and Anlotinib, 212 receiving Bemesumab and placebo, and 132 in the control group receiving placebo, with a median follow-up of 19.4 months [1][2] Group 2: Safety Profile - The safety profile of the treatment was consistent with known risks, with no new safety signals reported; the incidence of grade 3 or higher treatment-related adverse events was 48.8%, 29.4%, and 19.7% for the three groups respectively [2] Group 3: Industry Context - Lung cancer has the highest incidence and mortality rates among all malignancies globally, with 2.48 million new cases reported in 2022, of which 1.061 million were in China; NSCLC accounts for approximately 80%-85% of all lung cancer cases [2] - The R-ALPS study is the first of its kind in the field of combined therapy following concurrent or sequential chemoradiotherapy for unresectable stage III NSCLC, potentially reshaping clinical practice guidelines and benefiting more NSCLC patients [3]

创新药ETF天弘(517380)是全市场唯一一只跟踪恒生沪深港创新药精选50指数的ETF产品，该指数覆盖 了沪、深、港三地创新药龙头，十大权重股包括百济神州、药明康德、恒瑞医药、泰格医药等细分领域 龙头，创新药"浓度"极高。同时，该ETF及联接基金（A类：014564，C类：014565）采用量化指标优 化。 6月5日，三大指数高开低走，创新药概念盘中回调。相关ETF中，创新药ETF天弘(517380)截至发稿跌 1.07%，成分股中和黄医药涨超5%，常山药业、浙江医药、先声药业等个股跟涨。 拉长时间来看，2025年年初以来，创新药ETF天弘（517380）年内（截至6月4日收盘）累计涨 25.96%。 消息面上，国产创新药又迎来新进展。据上海证券报，6月3日，港股龙头药企中国生物制药带着自研抗 癌创新药以及突破疗法亮相美国临床肿瘤学会年会。其中，"得福组合"即贝莫苏拜单抗注射液+盐酸安 罗替尼胶囊，在肺癌等领域多个突破性临床研究数据备受关注，特别是一线治疗PD-L1阳性晚期非小细 胞肺癌的III期临床研究数据以大会最高等级形式公布，该治疗方案中位进展生存期达到11个月，治疗效 果超过了全球"药王"帕博利珠单 ...

Group 1 - The Hong Kong stock market opened higher on June 5, with the Hang Seng Index rising by 0.63% and the Hang Seng Tech Index increasing by 0.65% [1] - The Hong Kong Innovative Drug ETF (159567) saw a rise of 1.26%, with a turnover rate of 16.38% and a trading volume exceeding 280 million yuan, indicating active trading [1] - Notable stocks within the ETF included Zai Lab, which rose over 7%, Hutchison China MediTech, which increased over 4%, and Luye Pharma, which gained over 3% [1] Group 2 - China National Pharmaceutical Group announced that its Bemarituzumab injection combined with Anlotinib capsules achieved a median progression-free survival (PFS) of 11 months in treating PD-L1 positive advanced non-small cell lung cancer, outperforming the global leader Pembrolizumab by 3.9 months [1] - According to Zhongtai Securities, the Chinese innovative drug industry is transitioning from a previous capital bubble to a phase of genuine results, suggesting a positive outlook for the pharmaceutical sector [1] - The report recommends actively investing in segments expected to recover, such as CRO&CDMO, upstream research, specialty raw materials, chain pharmacies, and branded OTC products [1] Group 3 - Guoyuan Securities stated that China's innovative drugs have gained recognition from large overseas pharmaceutical companies, demonstrating that the R&D capabilities are internationally competitive and a key driver for growth [2] - The innovative drug sector in China is entering a phase of realization of results, with numerous catalysts in R&D progress, which is expected to remain a main investment theme in the pharmaceutical sector through 2025 [2]

Core Insights - A new Chinese innovative drug combination, "Defu Combination," has outperformed the global leader, Pembrolizumab (K drug), in treating PD-L1 positive advanced non-small cell lung cancer (NSCLC) [2][3] - The results were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showcasing significant improvements in median progression-free survival (PFS) [2][4] Company Insights - China National Pharmaceutical Group (HK01177) reported that the "Defu Combination" achieved a median PFS of 11 months, surpassing K drug by 3.9 months, with a 30% reduction in the risk of disease progression or death [4] - The "Defu Combination" consists of two first-class innovative drugs: Anlotinib, a multi-targeted anti-angiogenic TKI approved in May 2018, and Bemarituzumab, a PD-L1 monoclonal antibody approved in May 2024 [3][4] Industry Insights - The CAMPASS study, a randomized controlled phase III trial, included 531 PD-L1 positive patients and demonstrated that the "Defu Combination" significantly benefits nearly all subgroups, especially those with high PD-L1 expression (TPS≥50%) [3][4] - The trend of increasing head-to-head clinical trials in China is notable, with domestic companies challenging established drugs like K drug, indicating a competitive landscape for innovative therapies [5][6] - The number of head-to-head trials initiated by domestic companies has risen from 2 in 2020 to 8 in 2023, reflecting a growing commitment to developing competitive treatments [6]

5月13日，第36届医药经济信息发布会在广州召开。国家药监局副局长徐景和表示，要全面贯彻落实党 的二十届三中全会精神，落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量 发展的意见》，全过程深化药品监管改革、全方位筑牢药品安全底线、全链条支持产业高质量发展，为 保护和促进公众健康作出更大贡献。 药械审批 泽璟制药：盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请获得受理 政策动向 国家药监局：全过程深化药品监管改革全方位筑牢药品安全底线 荣昌生物RC278获得临床试验申请受理通知书 5月12日，荣昌生物公告，注射用RC278的临床试验申请获CDE受理。RC278是公司自主研发的具有 First-in-Class/Best-in-Class潜质的ADC分子，能特异识别一个新型肿瘤靶点，在临床前研究中展现出广 5月13日，泽璟制药公告称，公司收到国家药品监督管理局核准签发的《受理通知书》，公司递交的盐 酸吉卡昔替尼片治疗重度斑秃的新药上市申请（NDA）获得受理。这是盐酸吉卡昔替尼片第二个申请 新药上市的适应症。盐酸吉卡昔替尼是一种新型的JAK抑制剂，对JAK激酶的四个亚型JAK1、JAK2、 JAK3 ...