Fam-trastuzumab deruxtecan-NXKI

作者：周予西 美工：何国红 罗真真 排版：马超 在全球生物制药的竞技场上，抗体药物偶联物（ADC）正以其精准靶向和强大疗效，成为肿瘤治疗领域增速最快的品类之一。随着中国药企研发实力不断提升，ADC领域正在成为我国医药出海的主力军。 01 百亿美元市场，加速迈向新纪元 根据各药企已披露的2025年销售数据和丁香园发布的《2024年医药交易报告》，ADC药物市场规模正呈现爆发式增长，市场的蓬勃发展吸引了大量资本关注。 ▶ 市场热度速览 全球交易规模：2021-2024年，ADC以1500亿美元的交易总额，在生物药物中遥遥领先。 中国交易规模：同期，中国ADC交易总额近550亿美元，成为交易总额和单笔平均金额最高的药物类型。 单笔价值：全球与中国ADC交易的单笔平均金额分别高达19亿美元和13亿美元，彰显其极高的资产价值。 ▲ 图1. 2021-2024年全球医药交易各药物类型金额 ▲ 图2. 2021-2024年中国医药交易各药物类型金额 市场的高热度直接体现在资本的重磅押注上。近年来，全球制药巨头通过数笔金额惊人且具有战略指向性的交易，激烈争夺ADC领域的核心资产与未来领导权。这些交易并非孤立事件，而是一系列环环相扣的产业里程碑，清晰地勾勒出行业从产品竞争、平台并购到前沿技术卡位的完整发展轨迹与战略方向。 其中，2023年的几笔标志性交易尤为关键，它们按时间顺序串联起了行业的进化之路： ● 2023年3月，辉瑞宣布并完成以430亿美元的天价整体收购ADC龙头企业Seagen，这是制药史上针对该领域规模最大的并购案。它并非只为单一产品，而是旨在掌控一个完整的ADC技术王国与管线生态，代表了传统巨头为转型而发起的“全面进军”。 ● 2023年10月，默沙东与第一三共就三款在研ADC达成总额高达220亿美元的合作，这标志着巨头开始以“超级合作”模式，大规模押注下一代技术平台，提前布局未来。 ● 2023年11月，艾伯维以约101亿美元收购ImmunoGen，核心目标是掌控其已上市的首款靶向FRα的ADC药物Elahere。这笔交易体现了巨头们对抢占全新靶点制高点的迫切性。 ● 2023年12月，中国创新药企百利天恒将其EGFR/HER3双抗ADC的海外权益授权给百时美施贵宝，交易总额达84亿美元，创下了当时全球ADC单药对外授权的金额纪录。这预示着中国顶尖创新力量开始进入全球交易的核心舞台，并重新定义资产价值。 这些交易层层递进，共同讲述了一个清晰的故事：ADC领域的竞争已从单一产品的引进，升级为对颠覆性技术平台、稀缺靶点资产乃至整个行业领军企业的战略性争夺。资本的流向精准地绘制了一张通往未来的产业地图。 在这些高光交易的前后，行业发展的脉络早已埋下伏笔。早在2020年，吉利德公司以210亿美元收购Immunomedics，获得首个TROP-2 ADC药物Trodelvy，就已为巨头重金押注非HER2靶点的战役拉开了序幕。而在2023年的交易浪潮之后，市场的探索并未停歇。2025年，石药集团将其靶向新兴靶点ROR1的ADC授权出海，其“低首付、高里程碑”的交易结构，凸显了资本对前沿靶点“高风险、高回报”的审慎博弈。同年，科伦博泰将靶向ITGB6的ADC授权，则进一步显示了交易热点从少数成熟靶点向更多差异化靶点的扩散。 这些交易共同表明，ADC领域的竞争已从对单一明星产品的争夺，深化为对下一代技术平台和未来靶点阵地的系统性卡位，同时印证了ADC已成为生物医药领域资本追逐的焦点。资本的强力注入，正持续推动ADC疗法的发展与可及性，引领整个产业迈向更广阔的未来。 02 明星药物领跑，销售业绩耀眼 全球重磅ADC药物的商业成功，不仅验证了赛道的无限潜力，也为中国药企的研发与出海价值提供了“黄金标杆”。 2024年上市的ADC药物累计共有21个，披露数据的14条ADC上市药物管线2024销售总额超过140亿美元。在众多ADC药物中，一些明星产品表现尤为出色。根据各药企年报销售数据，第一三共的Trastuzumab deruxtecan（德曲妥珠单抗，T-DXd，Enhertu）2024年销售额居于榜首，为38亿美元，已成为重磅产品。该药物于2024年4月获得美国FDA加速批准，用于治疗不可切除或转移性HER2阳性实体瘤成人患者，成为不限癌种适应症的HER2靶向ADC疗法。T-DXd具有高达8的药物抗体比（DAR）。其采用的是一种基于四肽的可裂解连接子，该设计能在血液中保持稳定，减少脱靶毒性；而一旦进入肿瘤细胞，则能被特异性切割，高效释放强效载荷DXd。更重要的是，DXd具有良好的细胞膜渗透性，能产生“旁观者效应”，使其对HER2低表达甚至异质性的肿瘤也同样有效。 ▲ 图3. Trastuzumab deruxtecan分子结构示意图 其次是罗氏的Trastuzumab Emtansine（恩美曲妥珠单抗，T-DM1，Kadcyla），2024年销售额为23亿美元。T-DM1由曲妥珠单抗、不可裂解连接子和强效微管抑制剂DM1构成。这种设计确保了细胞毒性药物主要在HER2阳性癌细胞内部释放，提升了安全性。其在HER2阳性乳腺癌的二线及辅助治疗中均显示出显著的生存获益。 ▲ 图4. Trastuzumab Emtansine作用机制示意图 排在第三位的为辉瑞的Enfortumab vedotin（维恩妥尤单抗，Padcev），其2024年销售额近16亿美元。与2023年的5200万美元相比，同比增长达到了惊人的2953.85%。该药物联合派姆单抗已被确立为一线局部晚期或转移性尿路上皮癌的标准治疗，在2025年第三季度营收达4.64亿美元，同比增长13%。 ▲ 图5. Enfortumab vedotin作用机制示意图 此外，吉利德制药的Sacituzumab govitecan、罗氏制药的Polatuzumab vedotin、安斯泰来制药的Enfortumab vedotin、辉瑞制药的Brentuximab Vedotin在2024年销售额均超过10亿美元。 03 中国力量崛起，创新成果备受瞩目 中国ADC正扮演越来越重要的角色，成为全球ADC领域不可忽视的力量。创新管线的对外授权自2020年以来持续活跃，ADC与双抗等前沿技术正是出海的核心。 科伦博泰的Trop2 ADC（芦康沙妥珠单抗）已获批上市，成为全球首款获批治疗肺癌的Trop2 ADC。乐普生物的EGFR ADC作为全球首创药物，也已获批上市。百利天恒的EGFR/HER3 ADC（BL-B01D1）已申报上市。映恩生物的HER2 ADC预计2026年在美国递交上市申请。 这些企业的成功，标志着中国ADC产业从跟随创新向源头创新的实质性转变。据摩根士丹利报告显示，全球至少有1400项ADC的临床试验正在进行中，而国内拥有较为丰富的ADC在研管线，进入研发后期的国产原研产品占全球55%以上。 04 出海势头强劲，交易纪录屡创新高 2021-2023年，中国ADC药物的出海交易呈现出爆发式增长态势。2021年可以看作是ADC出海的起步年，2022年交易额大幅增长，2023年ADC出海进入爆发期。国产ADC “license out” 总交易金额达364亿美元，展现了中国ADC资产的全球吸引力。 这一势头在后续年份进一步加强。2024年，我国创新药出海总数达98笔，披露总交易金额攀升至600亿美元；在Top10交易中，有2项为ADC管线。 ▼ 表1. 2024年中国TOP10交易 2025年，中国ADC领域的“出海”交易持续活跃，在合作规模、技术先进性和模式多样性上均有新的突破。如信达生物将靶向DLL3的IBI3009授权给罗氏；映恩生物将EGFR/HER3双抗ADC DB-1418授权给Avenzo Therapeutics等。 ▼ 表2. 2025年已有报道的中国ADC出海交易（部分） 05 展望千亿未来，潜力与挑战并存 2025年中国ADC出海交易结构趋于多元与务实。既有像信达与罗氏这样首付款比例较高的稳健型合作，也出现了“低首付、高里程碑”的激进型交易。后者以极低的前期现金换取潜在高额回报，但高度依赖合作方的后续研发能力和资金状况，这对中国药企的临床推进和跨国项目管理能力提出了更高要求。 当前，ADC技术平台价值日益凸显，合作内容从单一产品授权，扩展到对新一代技术平台的认可和利用。“中国研发”全球竞争力持续增强，中国药企提供的已不仅仅是成熟的晚期管线。像靶向DLL3、CDH6等新兴靶点的ADC药物，在临床早期就能获得国际合作，这证明中国在ADC源头创新和前沿靶点探索上的能力已获得全球产业界更深入的认可。 然而，中国ADC出海也面临挑战。随着全球ADC竞争加剧，如何持续保持创新优势、应对国际监管要求、管理全球临床试验，以及应对商业市场上的激烈竞争，都是中国企业需要解决的问题。 总体而言，ADC作为精准抗癌的“生物导弹”，正引领中国创新药驶入出海新航道。随着中国药企研发实力不断提升，未来有望在全球ADC市场占据更核心的位置，不仅“驶入出海新航道”，更将深度参与乃至引领全球ADC治疗的“游戏规则”制定，真正“撬动”并重塑这千亿美元赛道的新格局。 Sanyou 10th Anniversary: ADC Going Global: Chinese Pharma Companies Pioneering a Hundred-Billion-Dollar Global Frontier On the global biopharmaceutical stage, Antibody-Drug Conjugates (ADCs)—lauded for their precise targeting and potent efficacy—have emerged as one of the fastest-growing segments in oncology treatment. As the R&D capabilities of Chinese pharmaceutical companies continue to advance, the ADC space is rising as a core driver of China’s pharmaceutical out-licensing and global expansion. 01 A Multi-Billion-Dollar Market Accelerating into a New Era According to disclosed 2025 sales figures from pharmaceutical companies and the 2024 Pharmaceutical Transaction Report released by DXY.cn, the ADC market is experiencing explosive growth—momentum that has attracted substantial capital interest. ▶ Snapshot of Market Momentum Global Transaction Scale: From 2021 to 2024, ADCs topped the biopharmaceutical sector with a total transaction value of $150 billion. China Transaction Scale: Over the same period, total ADC transaction value in China reached nearly $55 billion, securing its position as the drug class with the highest total transaction value and average per-deal value. Per-Deal Value: The average global and Chinese ADC transaction values reached $1.9 billion and $1.3 billion, respectively, underscoring their exceptional asset value. ▲ Figure 1. 2021-2024 Transaction Value by Drug Class (Global) ▲ Figure 2. 2021-2024 Transaction Value by Drug Class (China)   The market’s vitality is directly reflected in heavy capital commitments. In recent years, global pharmaceutical giants have fiercely competed for core assets and future leadership in the ADC space through a series of landmark, strategically significant deals. These transactions are not isolated events but interconnected industry milestones, clearly mapping the sector’s evolution: from product-focused competition and platform mergers & acquisitions to preemptive positioning in cutting-edge technologies. Several pivotal 2023 deals epitomized this industry progression: ● March 2023: Pfizer announced and completed its landmark $43 billion acquisition of ADC leader Seagen—the largest M&A deal in pharmaceutical history targeting the ADC space. Beyond acquiring individual products, the move aimed to gain control of a complete ADC technology platform and pipeline ecosystem, representing a "full-scale push" by a traditional giant to transform its portfolio. ● October 2023: Merck & Co. (MSD) and Daiichi Sankyo struck a collaboration deal valued at up to $22 billion for three investigational ADCs. This marked a shift: giants began placing large-scale bets on next-generation technology platforms via "super collaborations," laying early groundwork for future competitiveness. ● November 2023: AbbVie acquired ImmunoGen for approximately $10.1 billion, with the core goal of securing Elahere—the first-in-class, marketed FRα-targeting ADC. The deal highlighted giants’ urgency to capture the commanding heights in novel targets. ● December 2023: Chinese innovator Biokin Pharma out-licensed the overseas rights to its EGFR/HER3 bispecific ADC to Bristol-Myers Squibb (BMS) in an $8.4 billion deal—setting a then-record for the global out-licensing value of a single ADC asset. This signaled that China’s top innovators had entered the core stage of global transactions and were redefining asset value standards. These layered, progressive deals tell a clear story: competition in the ADC space has evolved from acquiring individual products to strategically pursuing disruptive technology platforms, scarce target assets, and even industry-leading enterprises. Capital flows have accurately charted the sector’s path forward. Industry development trends were already taking shape before these high-profile deals. As early as 2020, Gilead’s $21 billion acquisition of Immunomedics—securing Trodelvy, the first TROP-2 ADC—kicked off the race for non-HER2 targets among giants. Following the 2023 deal wave, market exploration continued apace. CSPC Pharmaceutical Group out-licensed its ADC targeting the emerging ROR1 target. Its "low upfront payment, high milestone payments" structure reflected capital’s prudent gamble on the "high-risk, high-reward" nature of frontier targets. Kelun-Biotech’s out-licensing of its ITGB6-targeting ADC further demonstrated the diffusion of deal activity—from a handful of mature targets to more differentiated, niche ones. Collectively, these transactions confirm that ADC competition has deepened from chasing single star products to systematically positioning for next-generation technology platforms and future target battlegrounds. They also reaffirm ADCs as a focal point of capital interest in biopharma. Robust capital injection continues to drive the development and accessibility of ADC therapies, steering the entire industry toward broader horizons. 02 Star Drugs Lead the Way with Stellar Commercial Performance The commercial success of global blockbuster ADCs not only validates the track’s immense potential but also sets a "gold standard" for the R&D and global value of Chinese pharmaceutical innovations. By 2024, a total of 21 ADC drugs had been approved globally. The disclosed 2024 sales of 14 of these approved ADC products reached over $14 billion, with several star products delivering standout performance: Trastuzumab Deruxtecan (T-DXd, Enhertu): Developed by Daiichi Sankyo, it topped 2024 sales with $3.8 billion, solidifying its status as a blockbuster. Granted approval by the US FDA in April 2024 for adult patients with unresectable or metastatic HER2-positive solid tumors, it became the first HER2-targeted ADC therapy with a tumor-agnostic indication. T-DXd boasts a high Drug-to-Antibody Ratio (DAR) of 8 and uses a tetrapeptide-based cleavable linker—stable in the bloodstream to minimize off-target toxicity, yet specifically cleaved inside tumor cells to release the potent payload DXd. Critically, DXd’s favorable cell membrane permeability enables a "bystander effect," making it effective even against tumors with low HER2 expression or heterogeneity. ▲ Figure 3. Molecular Structure Schematic of Trastuzumab Deruxtecan Trastuzumab Emtansine (T-DM1, Kadcyla): Roche’s ADC ranked second with 2024 sales of $2.3 billion. Comprising trastuzumab, a non-cleavable linker, and the potent microtubule inhibitor DM1, its design ensures cytotoxic drug release primarily within HER2-positive cancer cells, improving safety profiles. It has demonstrated significant survival benefits in both second-line and adjuvant therapy for HER2-positive breast cancer. ▲ Figure 4. Mechanism of Action Schematic for Trastuzumab Emtansine The third ranked drug is Pfizer's Enfortumab vedotin, Padcev）， Its sales revenue in 2024 is nearly 1.6 billion US dollars. Compared to $52 million in 2023, the year-on-year growth has reached an astonishing 2953.85%. The combination of this drug and pembrolizumab has been established as the standard treatment for first-line locally advanced or metastatic urothelial carcinoma, with revenue reaching $464 million in the third quarter of 2025, a year-on-year increase of 13%.   ▲ Figure 5. Mechanism of Action Schematic for Enfortumab Vedotin In addition, Gilead's Sacituzumab govitecan, Roche's Polatuzumab vedotin, Astellas' Enfortumab vedotin, and Pfizer's Brentuximab Vedotin all had sales exceeding $1 billion in 2024. 03 The Rise of Chinese Power: Innovative Achievements Garner Global Acclaim Chinese ADCs are assuming an increasingly pivotal role, emerging as an indispensable force in the global ADC landscape. Since 2020, out-licensing of innovative pipelines has remained robust, with ADCs and bispecific antibodies (BsAbs) at the core of China’s pharmaceutical exports. ▶ Key milestones for Chinese ADC innovators: Kelun-Biotech’s Trop2 ADC (Lukangshatuozumab) has received marketing approval, becoming the world’s first Trop2 ADC approved for lung cancer treatment. Lepu Biopharma’s EGFR ADC—an innovative first-in-class drug—has also secured approval. Biokin’s EGFR/HER3 ADC (BL-B01D1, Iza-bren) has submitted a marketing application. DualityBio’s HER2 ADC is expected to file for US approval in 2026. These successes mark a substantive shift in China’s ADC industry—from follow-on innovation to originative innovation. According to a Morgan Stanley report, at least 1,400 ADC clinical trials are underway worldwide, and China boasts a robust ADC R&D pipeline: domestic innovator products in late-stage R&D (Phase III or under regulatory submission) account for over 55% of the global total. 04 Strong Global Expansion Momentum: Transaction Records Broken Repeatedly From 2021 to 2023, Chinese ADC out-licensing transactions saw explosive growth: 2021: The "starting point" of ADC global expansion. 2022: Significant growth in transaction value. 2023: The "boom period" for ADC out-licensing, with total domestic ADC out-licensing value reaching $36.4 billion—demonstrating the global appeal of Chinese ADC assets. This momentum intensified in subsequent years: 2024: The total number of out-licensing deals for Chinese innovative drugs reached 98, with the disclosed total transaction value surging to $60 billion. Two ADC pipelines ranked among the Top 10 deals. ▼ Table 1. China's TOP 10 Innovative Drug Out-Licensing Transactions in 2024 2025: Chinese ADC global expansion transactions remained active, securing new breakthroughs in deal size, technological advancement, and model diversification. Examples include Innovent’s out-licensing of its DLL3-targeting ADC (IBI3009) to Roche, and DualityBio’s out-licensing of its EGFR/HER3 bispecific ADC (DB-1418) to Avenzo Therapeutics. ▼ Table 2. Disclosed Chinese ADC Out-Licensing Transactions in 2025 (Partial) 05 Toward a Trillion-Dollar Future: Opportunities and Challenges Coexist In 2025, the structure of Chinese ADC out-licensing deals trended toward diversification and pragmatism: Steady collaborations: Such as the partnership between Innovent and Roche, featuring a relatively high upfront payment ratio. High-risk deals: "Low upfront payment, high milestone payments" structures—trading minimal initial cash for potential high returns, but heavily dependent on partners’ subsequent R&D capabilities and financial health. These deals place higher demands on Chinese pharma companies’ clinical development execution and cross-border project management skills. Currently, the value of ADC technology platforms is becoming increasingly prominent. Collaboration scope has expanded beyond single-product licensing to include recognition and utilization of next-generation technology platforms. The global competitiveness of "R&D in China" continues to strengthen: Chinese pharmaceutical companies now offer more than just mature late-stage pipelines. ADCs targeting emerging targets (e.g., DLL3, CDH6) are securing international collaborations even in early clinical stages—proving that China’s capabilities in ADC originative innovation and frontier target exploration have garnered deeper recognition from the global industry. However, Chinese ADC global expansion also faces challenges. Amid intensifying global ADC competition, Chinese companies must address critical questions: How to sustain innovation advantages, meet international regulatory standards, manage global clinical development, and navigate intense commercial market competition? In conclusion, as "biological missiles" for precision cancer treatment, ADCs are guiding China’s innovative drugs onto a new path of global expansion. With ongoing improvements in R&D strength, Chinese pharmaceutical companies are poised to secure a more central position in the global ADC market. They will not only "sail into new global frontiers" but also deeply participate in—even lead—the formulation of global ADC therapy "rules of the game," ultimately driving and reshaping the landscape of this hundred-billion-dollar sector. ▶ References 1. 2024 Pharmaceutical Transaction Report: Chinese Pharma Companies Usher in a New Era of Pharmaceutical Transactions 2. Insight Jointly with BCG Released Global Innovative Drug R&D Landscape Insight Series Report (Part 2: ADCs) 3. https://db.dxy.cn/v5/annualreportsalesdata 4. https://file1.dxycdn.com/p/s183/2025/0207/540/0276480377903187881.pdf 5. https://file1.dxycdn.com/p/s183/2024/0218/847/8290452184793309571.pdf 6. https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?scorecard=3 7. https://www.2minutemedicine.com/trastuzumab-emtansine-improves-outcomes-in-residual-her2-positive-breast-cancer/ 8. Pfizer 2025 Q3 Earnings Report 9. Halford Z, Anderson M K, Clark M D. Enfortumab vedotin-ejfv: a first-in-class anti–nectin-4 antibody-drug conjugate for the management of urothelial carcinoma[J]. Annals of Pharmacotherapy, 2021, 55(6): 772-782. 关于三优生物 三优生物是一家以“让天下没有难做的创新生物药”为使命，以超万亿分子库和智能科技驱动的生物医药高科技企业。 公司致力于打造全球顶尖的原创新药创新工场。公司以智能超万亿分子库（AI-STAL）为核心；以干湿结合、国际领先的创新生物药智能化及一体化研发平台为依托；以多样化的业务模式推动全球创新药物的研发及产业化。 公司总部位于中国上海，在亚洲、北美洲、欧洲等多地建立了业务中心，形成了全球化的业务网络，现有投产及布局的研发及GMP场地20000多平方米。 公司已与全球2000多家药企、生技公司等建立了良好的合作关系，已赋能1200多个新药研发项目；已完成50多个合作研发项目，其中10多个协同研发项目已推至IND及临床研发阶段。 公司已申请130多项发明专利，其中30多项发明专利已获得授权，并获得了国家级高新技术企业、上海市专精特新、ISO9001、ISO27001等10余项资质及体系认证。 推荐阅读 三优十周年｜平台篇-创新抗体产生平台 三优十周年｜眼科治疗前沿：用抗体药物精准点亮未来 三优十周年｜磁阵列全人源小鼠抗体发现平台 三优十周年｜新“药王”加冕：减重增肌 三优十周年｜抗体药物如何实现精准“狙击”炎症？ 三优十周年｜血液肿瘤治疗革命-精准分层治疗新时代 三优十周年｜抗体药免疫原性全方位解析 三优十周年｜肿瘤免疫2025及2018双诺奖解析 三优十周年｜TCE药物-重塑免疫治疗版图的新力量 三优十周年｜神经系统疾病治疗进展 三优十周年｜AI-STAL 智能超万亿分子库发展历程 三优十周年｜打造全球顶尖的原创新药创新工场 三优十周年｜抗体治疗50年风雨江湖 三优十周年｜针对宠物疾病的单克隆抗体药物 三优十周年｜CAR-T细胞治疗现状挑战与未来 三优十周年｜服务篇-体外药效筛选解决方案

2025 年 12 月 19 日，《亚洲医药快报》（Fierce Pharma Asia）发布年度最后一期行业周报，聚焦制药领域关键进展：第一三共（Daiichi Sankyo）两款抗体偶联药物（ADC）迎来一喜一忧，武田（Takeda）银屑病新药试验成功，同时行业并购、跨国合作及政策变动多点开花。以下是核心信息的通俗解读：1. 乳腺癌新药组合获批，十年首破治疗格局 阿斯利康与第一三共合作的 Enhertu，联合罗氏的 Perjeta，获美国 FDA 批准成为 HER2 阳性转移性乳腺癌的一线新疗法 —— 这是该领域十多年来首个新一线治疗方案。临床试验显示，该组合比传统 THP 疗法降低 44% 的疾病进展或死亡风险。2. 患者死亡引发 ADC 试验暂停，跨国合作遇挫 第一三共与默克合作的一款 ADC 药物（ifinatamab deruxtecan），因出现意外的间质性肺病死亡病例，其全球 III 期临床试验已暂停招募患者。此前双方本计划基于 II 期数据，为这款针对小细胞肺癌的药物申请加速获批。3. 武田银屑病新药试验告捷，2026 年冲刺 FDA 获批 武田制药的口服 TYK2 抑制剂 zasocitinib（一款有望对标百时美施贵宝 Sotyktu 的药物），在中重度斑块状银屑病的两项 III 期试验中表现优异。用药 16 周后，该药在医生整体评估达标率、银屑病面积严重程度改善 75% 以上两项关键指标上，均显著优于安慰剂。武田计划 2026 年向 FDA 提交获批申请。4. 美国《生物安全法》附随国防法案通过，中企出海再添门槛 美国参众两院均通过年度国防法案，其中包含修订后的《生物安全法》（Biosecure Act），预计特朗普总统将签署生效。该法案生效后，中国生命科学企业进入美国市场的准入门槛将进一步提高。5. 复星 2 亿美元收购绿谷过半股权，重启争议阿尔茨海默病药物 绿谷制药的阿尔茨海默病药物甘露特纳（GV-971）未获中国监管机构续展 conditional approval 后，复星医药拟斥资约 2 亿美元收购其 53% 股权，试图让这款争议药物重获生机。上海证券交易所已就该交易向复星发出监管函，提醒其注意潜在合规风险。6. Harbour BioMed 与百时美施贵宝达成 11 亿美元合作 中国生物药企 Harbour BioMed 与百时美施贵宝（BMS）签署多特异性抗体合作协议，总金额最高达 11 亿美元。根据协议，Harbour 先获 9000 万美元预付款，后续若达成研发、商业化里程碑，还可获得 10.35 亿美元额外款项。此前该公司已与大塚、阿斯利康有过合作。7. 赛诺菲一日两签生物科技合作，10 亿美元押注阿尔茨海默病新药 赛诺菲与韩国生物科技公司 Adel 签署授权协议，以最高 10.4 亿美元拿下阿尔茨海默病候选药物 ADEL-Y01 的相关权益。该药是一款靶向 tau 蛋白的抗体，不同于广谱靶向 tau 的药物，它专门针对赖氨酸 280 位点乙酰化的 tau 蛋白，目前处于临床阶段，赛诺菲先支付 8000 万美元预付款。 参考来源：https://www.fiercepharma.com/pharma/daiichi-adcs-first-line-nod-trial-deaths-takeda-tyk2-trial-win 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。