维立志博最初便决定重点解决PD-(L)1等现有疗法不能治疗的 疾病。目前维立志博共有14款候选创新药，其中4款在全球临 床进度前三，有望成为全球first-in-class（同类首创）药 物。 "又是免疫治疗得奖。"看到消息后，维立志博-B（09887.HK）创始人、董事长、CEO康小强并不感到意 外，因为肿瘤等很多疾病，都与免疫息息相关。维立志博是一家专注于肿瘤免疫治疗的创新药企，目前处 在临床阶段。 肿瘤免疫疗法自1980年代兴起，其原理是利用并增强人体自身的免疫系统，识别并摧毁癌细胞。2014 年，两款有划时代意义的PD-1免疫检查点抑制剂药物获批，即百时美施贵宝的"O药"与默沙东的"K药"。 PD-1药物证明了免疫治疗是在化疗、放疗和手术之外的可行治疗思路，展现出更好的疗效和安全性，也带 来巨大的经济回报。2024年"K药"的全球销售额约为320.56亿美元，在2023年—2024年，"K药"均蝉联 全球"药王"。 PD-(L)1靶点也成为近年肿瘤治疗领域中最"卷"的赛道之一。在国内，获批的PD-(L)1单抗已经有20款。 然而，在PD-(L)1获批之后，还没有下一款类似的重磅药物获批。同时，PD-( ...

来源：市场资讯 （来源：抗体圈） ：Genmab官网 Merus最早创立于2003年，总部位于荷兰，核心资产是一款EGFR/LGR5双抗——petosemtamab（MCLA- 158）。 2025年ASCO上，Merus公布了petosemtamab联合K药对比K药单药一线治疗局部晚期头颈部鳞状细胞癌 （HNSCC）的II期临床数据。具体来看，这项II期研究共纳入45名局部晚期HNSCC患者。最终43名可评 估患者数据显示，联合用药组经实体瘤反应评估标准的总体缓解率（ORR）达63%（27/43，95% CI： 49-75），中位无进展生存期（mPFS）为9个月（95%CI：5.2-12.9），12个月总生存率为79%。研究暂 未达到中位缓解持续时间和中位总生存期。 当地时间2025年9月29日清早，Genmab官宣将收购Merus N.V.（以下简称为"Merus"）。根据协议， Genmab将以每股97.00美元的现金收购Merus的全部股份，交易价值约80亿美元。这是Genmab自成立以 来最大的一笔收购（去年收购普方生物总价为18亿美元）。 显然，联合用药方案在各指标上明显优于K药单药治疗组。Mer ...

来源：市场资讯 （来源：动脉新医药） 编者按： 全球视野下的跨国药企深度洞察——创新、博弈与中国答卷 在全球医药产业发展的宏大叙事中，跨国药企始终扮演着关键角色——他们既是科学前沿的探索者，也 是大多市场规则的塑造者，更是各国医疗生态的重要参与者。从FDA到EMA再到NMPA ，从成熟市场 到新兴市场，跨国药企的战略抉择不仅关乎企业自身的兴衰，更深刻影响着全球患者的健康福祉。而在 这一版图中，中国市场也正从"可选项"到"必选项"再升级为"决胜场"，其独特的政策环境、临床需求和 创新潜力，为跨国药企提供了前所未有的机遇与挑战。 我们拟打造《跨国药企洞察》栏目，致力于以全球视野观察跨国药企的发展逻辑，既关注MNC巨头的 顶层战略——辉瑞如何平衡新冠红利后的增长焦虑，强生怎样通过拆分重塑竞争力；也聚焦区域市场的 关键战役——中国医保谈判中的定价艺术，ADC领域中日韩创新药企的竞合博弈；更试图揭示行业本 质问题：在细胞与基因治疗、GLP-1等颠覆性技术浪潮下，未来诸多面临"专利断崖"的跨国药企护城河 是正在加固还是被瓦解？ 与此同时，中国篇章亦无疑是这一洞察的核心维度。无论是将中国纳入全球早期研发体系，还是以"中 国 ...

Group 1 - The core point of the article highlights the remarkable market performance of Yaojie Ankang (02617.HK), which achieved a market capitalization exceeding HKD 100 billion shortly after its IPO, surpassing several established biotech companies [1][3] - As of September 15, 2025, Yaojie Ankang's stock price surged by 115.58%, reaching a market cap of HKD 164.71 billion, with significant price increases over the preceding trading days [1][3] - The company’s IPO price was HKD 13.15 per share, and by September 15, the closing price had risen to HKD 415, marking an approximate cumulative increase of 30.6 times [1][3] Group 2 - Yaojie Ankang is focused on developing innovative therapies for oncology, inflammation, and cardiovascular metabolic diseases, with its lead product, Tiengengtinib, targeting multiple key pathways [3][4] - Tiengengtinib is currently undergoing nine clinical trials globally, with the fastest progress in cholangiocarcinoma, expected to complete its Phase II registration trial in China by the second half of 2025 [3][4] - The global cholangiocarcinoma drug market is projected to reach USD 2 billion in 2024, with a compound annual growth rate (CAGR) of 16.2% from 2019 to 2024, and the Chinese market is expected to grow to CNY 3.2 billion [4] Group 3 - In the first half of 2025, Yaojie Ankang reported zero revenue and a loss attributable to shareholders of CNY 123 million, contrasting sharply with other biotech firms like Innovent Biologics and Kangfang Biotech, which have achieved profitability [5][6] - Innovent Biologics reported a net profit of CNY 834 million in the first half of 2025, with 16 products on the market, while Kangfang Biotech had seven approved products, indicating a significant difference in business fundamentals [5][6] - Some investors expressed confusion regarding the stock price surge of Yaojie Ankang, questioning the underlying reasons for such a dramatic increase in valuation [6][7]

Core Viewpoint - The recent market turbulence in the innovative drug sector is attributed to reports of a potential executive order from the Trump administration, which aims to impose stricter reviews on U.S. companies acquiring Chinese innovative drugs and increase FDA scrutiny on Chinese clinical trial data [1][5]. Group 1: Market Reaction - After an initial drop of over 4% in the innovative drug sector index and a 7% decline in the Hang Seng Biotech Index, market panic subsided quickly [2]. - Analysts believe the likelihood of the executive order being implemented is low, suggesting that the immediate impact on innovative drug business development (BD) will be limited and primarily emotional [3][7]. Group 2: Implications of the Executive Order - The proposed executive order includes stricter reviews by the Committee on Foreign Investment in the United States (CFIUS) for U.S. multinational pharmaceutical companies acquiring pipelines from Chinese firms [5]. - In the first half of this year, the total value of BD transactions for Chinese innovative drugs reached nearly $66 billion, with projections indicating that by 2040, 35% of new drugs approved by the FDA could originate from China [5][6]. Group 3: Competitive Landscape - The executive order reflects a conflict between U.S. biotech companies, which lobby for restrictions, and multinational corporations (MNCs) that benefit from acquiring overseas assets [6]. - By 2035, $115 billion worth of drug patents will expire in Europe and the U.S., necessitating MNCs to seek new pipelines, with Chinese assets being a favorable option due to their quality and cost [6]. Group 4: Clinical Trial Data Scrutiny - The FDA's stricter scrutiny of clinical trial data from Chinese patients is seen as unlikely to change the current landscape, as the FDA has already been tightening its review processes [8][10]. - The high costs associated with conducting clinical trials abroad compared to domestic trials lead many Chinese firms to retain domestic rights while transferring overseas rights to MNCs [9]. Group 5: Future Outlook - Despite the potential for political interference, analysts believe there remains a 5-10 year window of opportunity for BD transactions, driven by the high demand from large pharmaceutical companies [11][12]. - The recent surge in large BD deals indicates a shift in perception regarding the value of Chinese assets, moving away from the notion of "selling assets cheap" to recognizing their quality and efficiency [13][14].

9月11日上午，A股、港股开盘后创新药板块下跌，创新药板块指数在早盘阶段跌超4%，恒生生物指数 一度跌超7%。 市场震荡背后，源于有报道称，特朗普政府正研议一项行政命令，草案内容包括美企收购中国新药纳入 外国投资委员会(CFIUS)强制审查，并提高中国临床试验数据的FDA审核门槛，鼓励药品本土生产与采 购，以及加快审批美国本土药企的临床试验申请等。意在严格限制来自中国的实验性药物与临床数据， 以应对中国生物科技崛起对美国产业的威胁。 不过，市场的恐慌情绪很快缓和。 多位医药投资、分析人士对《健闻咨询》分析，上述消息的落地可能性较低，中短期内对创新药BD业 务影响有限，更多是一种情绪上的扰动，并无更进一步实质性影响。 特朗普政府一纸草案，实质影响有限，却也从"对手"的视角揭示了创新药BD出海的方向和困境。 行政令意图强化BD交易审查， 但落地可能性极低？ 数据可以解释这项政策背后的逻辑。今年上半年，我国创新药出海的BD交易总额已经接近660亿美元。 截至2024年，源自中国的药物占美国FDA新药批准量约4%，按照目前的BD出海势头发展，摩根士丹利 的报告预测称，到2040年，这一数字将攀升至35%。 数据反映出 ...

Group 1 - Novo Nordisk's new CEO has announced a global layoff plan, aiming to simplify organizational structure and refocus resources on growth opportunities in diabetes and obesity treatment [2][4] - The company plans to cut 9,000 jobs, which represents approximately 11% of its total workforce of 78,400, with over half of the layoffs occurring in Denmark [4][3] - The layoffs are expected to save 8 billion Danish kroner (approximately 1.2 billion USD) annually, which will be reinvested into growth areas, including commercial initiatives and R&D projects [2][4] Group 2 - Novo Nordisk's revenue for the first half of the year reached 154.944 billion Danish kroner (approximately 22.926 billion USD), reflecting an 18% year-on-year growth, although the growth rate has slowed compared to the previous year [6] - The company has lowered its full-year performance expectations for 2025 due to increased market competition and the impact of generic drugs [6] - The competitive landscape in the obesity treatment market is intensifying, with new entrants and alternative therapies gaining interest, particularly after the efficacy of semaglutide was questioned [6][5] Group 3 - The company has undergone significant leadership changes, including the replacement of the CEO and adjustments in other key positions, to better align with market demands [7] - Novo Nordisk's restructuring efforts are part of a broader trend in the pharmaceutical industry, where many companies are implementing layoffs and restructuring to enhance efficiency and reduce costs [9][10]

Core Viewpoint - Novo Nordisk is undergoing significant layoffs, with plans to cut approximately 9,000 jobs, representing about 11% of its global workforce, as part of a transformation strategy to streamline operations and focus on growth opportunities in diabetes and obesity treatment [2][3][4]. Group 1: Layoff Details - Novo Nordisk announced layoffs of around 9,000 employees, aiming to save 8 billion Danish kroner (approximately 8.94 billion RMB) annually by the end of 2026 [2]. - The layoffs are part of a broader transformation plan due to recent growth slowdowns, with the company adjusting its organizational structure to enhance decision-making speed [3][4]. - The company currently employs 78,400 people globally, with over half of the layoffs expected to come from its headquarters in Denmark [3]. Group 2: Financial Impact - Novo Nordisk has revised its 2025 operating profit growth forecast down to 4%-10%, from a previous estimate of 10%-16% [3]. - The transformation plan is expected to incur a one-time restructuring cost of 8 billion Danish kroner, which will negatively impact the operating profit growth forecast by approximately 6 percentage points [5]. Group 3: Market Context - The company has seen a slowdown in growth, particularly in key markets like the U.S. and China, where sales of its diabetes drug, semaglutide, have declined by about 11% in the first half of 2025 [4]. - Novo Nordisk's semaglutide generated $16.5 billion in revenue in the first half of 2025, surpassing the previous top-selling drug, K drug, which earned $15.2 billion [4].

Core Insights - The global pharmaceutical sales ranking for the top 50 drugs has been revealed, with Novo Nordisk's semaglutide surpassing Merck's Keytruda to become the new sales champion, achieving over $16.6 billion in sales [1][3] - Eli Lilly's tirzepatide shows significant growth potential with a sales increase of 121.3%, reaching nearly $15 billion [1][2] - The entry of domestic innovative drugs into the ranking marks a notable shift in the competitive landscape [1] Group 1: Top Selling Drugs - Semaglutide, including Ozempic, Rybelsus, and Wegovy, generated sales of $16.632 billion, with a year-on-year growth of 29.8% [3][4] - Tirzepatide achieved sales of $14.734 billion, with a remarkable growth rate of 121.3% [3][8] - Dulaglutide, another Eli Lilly product, saw a decline in sales, highlighting the competitive pressures in the market [3][4] Group 2: Vaccine Sales Decline - Three vaccine products in the top 50 experienced sales declines, despite a favorable competitive landscape [4][5] - Gardasil 9, a nine-valent HPV vaccine, saw a nearly 50% drop in revenue [5][6] - The decline in vaccine sales is attributed to reduced government subsidies and market saturation [6][7] Group 3: Emerging Drugs and Growth - Over 70% of drugs in the ranking maintained positive sales growth, with only seven drugs exceeding a 30% growth rate [8] - Enzalutamide, approved for 13 years, continues to show over 30% growth, with sales projected to reach $4.6 billion in 2022 [9][10] - The competitive landscape for enzalutamide is expected to intensify as its core patent expires in 2026 [10]

Group 1: Pharmaceutical Sales Overview - The Insight database released the TOP 50 pharmaceutical sales list for the first half of 2025, highlighting that chemical drugs and monoclonal antibodies dominate the list, with additional contributions from dual antibodies, preventive vaccines, ADCs, and fusion proteins [1] - A total of 44 drugs exceeded $2 billion in sales, with 10 surpassing $5 billion, and 3 drugs exceeding $10 billion in sales [1] - Semaglutide, with sales of $16.632 billion from its three versions (Ozempic, Rybelsus, and Wegovy), surpassed Keytruda, which maintained $15.161 billion in sales, to take the top position [1] Group 2: CDK4/6 Inhibitors Market Dynamics - The CDK4/6 inhibitor market is characterized by intense competition among major pharmaceutical companies, with Pfizer's Ibrance initially leading the market [2] - However, the market dynamics shifted as Eli Lilly's Verzenio gained significant traction, and in 2024, it surpassed Ibrance in sales for the first time [2] - In the first half of this year, Ribociclib experienced a remarkable growth rate of 58.7%, generating $2.133 billion, while Abemaciclib led the market with $2.648 billion, and Ibrance fell to $2.026 billion [2] Group 3: BTK Inhibitors Market Analysis - There are currently six approved BTK inhibitors globally, with Ibrutinib, Acalabrutinib, and Zanubrutinib holding over 97% of the market share [3] - Ibrutinib, despite its initial success with sales reaching $9.777 billion in 2021, has seen a decline, with sales dropping below $3 billion in the first half of 2025, a 9% year-over-year decrease [3] - In contrast, Zanubrutinib has shown impressive growth, achieving $2.644 billion in sales for 2024, a 103.4% increase, and breaking into the TOP 50 list with $1.742 billion in the first half of 2025, a 54.7% year-over-year growth [3]