本文约 2 5 0 0 字，推荐阅读时长 1 5 分钟，欢迎关注新财富公众号。 1 引言 4月14日，美国商务部宣布启动对进口药品的国家安全调查。这一调查覆盖了所有进口药品，包括成 品仿制药、原研药以及用于生产这些药品的关键药用成分。此举属于特朗普政府根据1962年《贸易扩 展法》第232条对多个行业进行的关税调查的一部分。虽然调查尚未结束，预计结果将在270天内公 布，但业内普遍认为，这将赋予特朗普政府对进口药品和原料药征收关税的权力。特别是对中国等主 要药品出口国的影响，可能会带来严重的供应链中断及成本上升。 事实上，美国每年从中国进口药品总额约60亿美元，其中大量为抗生素、抗病毒及心血管药物等基础 药物。一旦关税进一步扩大实施，这些进口药品的成本预计将明显上升，对美国本土药品生产商带来 直接冲击。为应对这种风险，特朗普政府提出多项措施推动产业本土化。 分析师预计，如果对来自中国的API征收10%的关税，仿制药企业的利润将下跌2%-3%，创新药利润 下跌可能更严重。 2 美国关税筑墙， 中概股 跌宕 自2025年特朗普重新执政以来，美国政府出台了一系列针对生物医药产业的重要政策，核心目标是强 化美国医药产 ...

Core Viewpoint - The recent incident involving the articles published by "Meisi Oncology New Frontier" highlights the intensifying competition in the PD-1 monoclonal antibody market, indicating a shift towards a saturated market where established players dominate future growth opportunities [4][5][8]. Market Dynamics - The PD-1 monoclonal antibody market has transitioned from a "golden track" to a "red ocean" due to increased product launches leading to homogenization of competition [5][8]. - Major players like Merck's "K drug" (pembrolizumab) and Bristol-Myers Squibb's "O drug" (nivolumab) continue to show strong sales, with projected global revenues of approximately $29.5 billion and $10.1 billion respectively for 2024 [5][6]. - In China, BeiGene's tislelizumab leads with sales of 4.467 billion yuan, a 17.4% increase year-on-year, while Innovent's sintilimab and Junshi Biosciences' toripalimab also report significant growth [6][7]. Competitive Landscape - The market is characterized by a clear division between leading companies with established products and newer entrants struggling to gain market share [8][9]. - Companies that fail to differentiate their products or adapt to the competitive landscape are increasingly exiting the PD-1 market, with at least six companies having withdrawn in the past four years [9][12]. Future Trends - The emergence of PD-1 bispecific antibodies is seen as a potential game-changer, with products like Ivosidenib showing superior efficacy in clinical trials compared to traditional PD-1 monoclonal antibodies [14][15]. - The potential for PD-1 bispecifics to address "hard-to-treat" patient populations and improve outcomes in various cancer types is being recognized as a significant opportunity for innovation [16]. Broader Applications - Beyond oncology, PD-1 inhibitors are being explored for autoimmune diseases, with ongoing clinical trials for conditions like rheumatoid arthritis [19][20]. - The distinction between PD-1 inhibitors and PD-1 agonists is crucial, as the latter has not yet seen any products approved for market, indicating a potential area for future development [20].

Investment Rating - The industry investment rating is maintained at "Outperform the Market" [3][41]. Core Insights - The pharmaceutical fund allocation structure remains balanced, with the overall allocation ratio at a historically low level. As of Q1 2025, the active pharmaceutical fund size reached 188.5 billion yuan, an increase of 12.6 billion yuan from Q4 2024. The passive pharmaceutical fund size reached a historical high of 140.4 billion yuan [4][10]. - The top three sectors for active pharmaceutical theme funds in Q1 2025 are innovative drugs (34%), traditional pharmaceuticals (26%), and CDMO (17%). Notable holdings include BeiGene, Zai Lab, Innovent Biologics, and others, which have seen significant increases in their positions [4][19]. - The pharmaceutical sector's heavy holdings in all funds account for 9.5% (+0.5 percentage points), while the heavy holdings excluding pharmaceutical funds stand at 4.6% (+0.5 percentage points), indicating an increase but still at a relatively low level [5]. Summary by Sections Fund Size and Share - As of Q1 2025, the active pharmaceutical fund size is 188.5 billion yuan, up 12.6 billion yuan from Q4 2024. The passive pharmaceutical fund size is 140.4 billion yuan, marking a historical peak [4][7]. - The active pharmaceutical fund share is 124.6 billion shares, down 15.2 billion shares from Q4 2024, primarily due to stock price increases. The passive pharmaceutical fund share is 266.2 billion shares, up 41.2 billion shares, also reaching a historical high [10][10]. Sector Allocation - As of Q1 2025, there is an over-allocation in innovative drugs, CDMO, traditional pharmaceuticals, and CRO, while sectors like commercial circulation and traditional Chinese medicine are under-allocated [16][18]. - The top holdings in the innovative drug sector include Zai Lab, BeiGene, and others, with significant increases in their market values from Q4 2024 to Q1 2025 [19]. Heavy Holdings - The pharmaceutical sector's heavy holdings in all funds account for 9.5%, with a slight increase, while the ratio excluding pharmaceutical funds is 4.6% [5][5]. - The report highlights the top ten pharmaceutical heavy holdings in both active and passive funds, indicating a trend towards innovative drug companies [21][24].

于 2025 年 4 月 24 日向美国证券交易委员会提交 编号：333 - 美国证券交易委员会 华盛顿特区 20549 F-6 表格 根据 1933 年证券法提交的 由美国存托凭证证明的美国存托股份 注册声明 百济神州有限公司 BEIGENE, LTD. （发行人章程中列明的存托证券发行人准确名称） 不适用 （发行人名称的英文） 开曼群岛 （发行人注册地或组织机构所在的司法管辖区） 花旗银行 CITIBANK, N.A. （存托银行章程中列明的存托银行准确名称） 388 Greenwich Street New York, New York 10013 (877) 248-4237 （存托银行主要办事处地址，包括邮政编码和电话号码，包括区号） Cogency Global Inc. 122 East 42nd Street, 18th Floor New York, New York 10168 (800) 221-0102 （送达代理人的地址，包括邮政编码和电话号码，包括区号） Mitchell S. Bloom 先生 Edwin M. O'Connor 先生 Marishka DeToy 先生 Good ...

Core Insights - The latest net value of Wanjiay Economic New Momentum Mixed C Fund (005312) is 1.6754 yuan, reflecting a decrease of 0.66% [1] - The fund has shown a return of 3.35% over the past month, ranking 200 out of 4491 in its category; a return of 32.05% over the past three months, ranking 29 out of 4444; and a year-to-date return of 33.98%, ranking 34 out of 4418 [1] Fund Holdings - The top ten stock holdings of Wanjiay Economic New Momentum Mixed C Fund account for a total of 75.95%, with the following allocations: - Ruixin Microelectronics (9.12%) - BeiGene-U (8.80%) - Deepin Technology (8.64%) - Innovent Biologics-U (7.88%) - Cambricon Technologies-U (7.65%) - iFlytek (7.51%) - Sierpo (7.46%) - Sanan Optoelectronics (6.89%) - BGI Genomics (6.18%) - Zhongwei Company (5.82%) [1] Fund Overview - Wanjiay Economic New Momentum Mixed C Fund was established on February 7, 2018, and as of March 31, 2025, it has a total scale of 1.223 billion yuan [1] - The fund manager is Huang Xingliang, who has extensive experience in the investment management industry [2]

Company Overview - BeiGene, Ltd. is a global, commercial-stage biotechnology company focused on the research, development, production, and commercialization of innovative drugs, with key products including Brukinsa (a BTK inhibitor), Tislelizumab (an anti-PD-1 monoclonal antibody), and Pamiparib [1]. Financial Performance - For the third quarter of 2024, the company reported a revenue of 19.136 billion yuan, representing a year-on-year increase of 48.63% [1]. - The net profit for the same period was -3.686694 million yuan, showing a year-on-year change of 4.94% [1]. - The gross profit margin was reported at 83.94% [1]. Market Position - As of the latest data, BeiGene's stock closed at 246.08 yuan, down 1.42%, with a price-to-earnings (P/E) ratio of -69.25 and a price-to-book (P/B) ratio of 14.26, leading to a total market capitalization of 344.732 billion yuan [2]. - The company is held by 218 institutions, with a total shareholding of 37.9473 million shares valued at 9.063 billion yuan [1]. Industry Comparison - The average P/E ratio for the industry is 54.59, while the median is 36.70, indicating that BeiGene's valuation metrics are significantly lower than the industry average [2]. - Other companies in the industry, such as RenDu Biotech and NuoSiLanDe, have P/E ratios of -196.33 and -104.41 respectively, suggesting a challenging environment for profitability across the sector [2].

Core Viewpoint - Kangfang Biopharma's dual antibody drug Ivosidenib has successfully challenged PD-1 monoclonal antibodies in head-to-head trials, indicating potential shifts in the PD-1 market for immunotherapy [1][6]. Company Summary - On April 23, Kangfang Biopharma's stock price reached a historic high of 100 HKD per share following the announcement of Ivosidenib's success in head-to-head trials against BeiGene's Tislelizumab [2]. - Ivosidenib (PD-1/VEGF dual antibody) demonstrated significant clinical benefits in a Phase III clinical trial for advanced squamous non-small cell lung cancer (sq-NSCLC), achieving the primary endpoint of progression-free survival (PFS) [3]. - The trial results showed that Ivosidenib combined with chemotherapy outperformed Tislelizumab combined with chemotherapy, with significant PFS benefits observed in both PD-L1 positive and negative populations [3]. Industry Summary - Ivosidenib is the world's first PD-1/VEGF dual-specific tumor immunotherapy drug, approved for use in China for specific lung cancer patients as of May 2024 [4]. - The drug is currently undergoing head-to-head clinical trials to expand its indications, with successful outcomes potentially leading to significant commercial value [4]. - The PD-1 market is highly competitive, with BeiGene's Tislelizumab holding a leading market share in China, generating revenue of 621 million USD in 2024 [4]. - Merck's Keytruda is the highest-selling PD-1 drug globally, with projected revenues of 29.482 billion USD in 2024 [5]. - Lung cancer remains the most prevalent and deadly malignancy worldwide, with PD-1 combined chemotherapy being the current standard first-line treatment for non-small cell lung cancer [6].

在此次头对头试验中，依沃西联合化疗把替雷利珠单抗联合化疗作为对照组。康方生物表示， HARMONi-6临床试验共入组532例受试者，中央型鳞癌占比约为63%，与真实世界患者分布一致。研究 数据表明，在意向治疗人群(ITT)中，依沃西联合化疗组的患者无进展生存期（PFS）相较对照组，获得 了决定性胜出的阳性结果。 在安全性方面，依沃西组总体表现良好，未发现新的安全性信号。与治疗相关的严重不良反应发生率以 及三级及以上出血事件发生率与对照组相似。 记者注意到，去年依沃西在单药头对头临床试验中战胜帕博利珠单抗（K药），此次也是依沃西第2个 头对头PD-1疗法取得阳性结果的III期临床研究，来自全国共66家临床研究中心参与了此项研究。 肺癌根据癌细胞的形态，可初步分为非小细胞肺癌（NSCLC）和小细胞肺癌(SCLC)。其中NSCLC占比 约85%，它又能进一步被分为三类，分别是腺癌、鳞癌和大细胞癌，肺鳞癌占所有肺癌病例的 25%~30%。 《每日经济新闻》记者了解到，大部分驱动基因突变发生在肺腺癌，肺鳞癌驱动基因突变较少，患者的 生存预后相对较差。随着免疫治疗药物的上市，sq-NSCLC患者的生存期得到明显改善。恒瑞 ...

医药板块持续走高 众生药业等多股涨停 智通财经4月22日电，午后医药板块持续走高，创新药方向继续领涨，众生药业、华森制药、富士莱涨 停，百利天恒、诺诚健华、新诺威、百济神州创历史新高，复旦张江、上海谊众、信立泰、热景生物等 涨幅靠前。消息面上，4月25日至4月30日，美国癌症研究协会（AACR）年会将在芝加哥召开。作为全 球规模最大的癌症研究会议之一，AACR年会一直是癌症领域最新研究成果的重要展示平台。 ...

港股创新药板块走强，歌礼制药(01672.HK)涨超20%，荣昌生物(09995.HK)、石药集团(01093.HK)涨超 6%，百济神州(06160.HK)、信达生物(01801.HK)跟涨。 ...