Patritumab Deruxtecan

May 19, 2025 7:00 am ET BASKING RIDGE, N.J. & RAHWAY, N.J., – The first patient has been dosed in the IDeate-Esophageal01 Phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint inhibitor. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed with Merck (NYSE: MRK), known as MSD outside of the United States and Canada. ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis for those diagnosed at an advanced stage of the disease. While the evolved landscape in the first-line metastatic setting of ESCC has helped to improve outcomes for patients, treatment options are limited for patients progressing after first-line therapy, reinforcing the need for new approaches. “Patients with metastatic esophageal squamous cell carcinoma continue to experience poor outcomes despite currently available treatments,” said Mark Rutstein, MD, head, therapeutic area oncology development, Daiichi Sankyo. “The encouraging clinical activity seen in our early-phase signal finding trial supports further evaluation of ifinatamab deruxtecan as a potential treatment strategy for these patients.” “Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The initiation of the pivotal Phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to further expand our clinical development program evaluating this potentially first-in-class ADC across multiple solid tumors where there are unmet needs for new treatment options.” The initiation of IDeate-Esophageal01 is based on results from the IDeate-PanTumor01 Phase 1/2 trial presented at both the 2022 and 2023 European Society of Medical Oncology (ESMO) where ifinatamab deruxtecan showed promising responses in heavily pretreated patients with ESCC. About the IDeate-Esophageal01 trial IDeate-Esophageal01 is a global, multicenter, open-label, randomized Phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg) versus treatment of physician’s choice of chemotherapy (paclitaxel, docetaxel or irinotecan hydrochloride) in patients with advanced or metastatic ESCC with disease progression following treatment with platinum-based chemotherapy therapy and an immune checkpoint inhibitor. Eligible patients must have received no more than one prior line of systemic therapy in the advanced or metastatic setting. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival and objective response rate as assessed by blinded independent central review, and safety. IDeate-Esophageal01 will enroll approximately 510 patients across Asia, Europe and North America. For more information, please visit ClinicalTrials.gov. About esophageal squamous cell carcinoma More than half a million esophageal cancer cases were diagnosed in 2022, with nearly half a million deaths globally.ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis for those diagnosed at an advanced stage of the disease. ESCC is most prevalent in Eastern Asia where mortality rates are also the highest. While the evolved landscape in the first-line metastatic setting of ESCC has helped to improve outcomes for patients, treatment options are limited for patients progressing after first-line therapy, reinforcing the need for new approaches. About B7-H3 B7-H3 is a transmembrane protein that belongs to the B7 family of proteins which bind to the CD28 family of receptors that includes PD-1. B7-H3 is overexpressed in a wide range of cancer types, including ESCC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. There are currently no B7-H3 directed medicines approved for the treatment of any cancer. About ifinatamab deruxtecan Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. In addition to IDeate-Esophageal01, ifinatamab deruxtecan is being evaluated in a global development program that includes IDeate-Lung01, a Phase 2 monotherapy trial in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC); IDeate-Lung02, a Phase 3 trial in patients with relapsed SCLC versus investigator’s choice of chemotherapy; IDeate-Lung03, a Phase 1b/2 trial in patients with ES-SCLC in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy; IDeate-PanTumor02, a Phase 2 monotherapy trial in patients with recurrent or metastatic solid tumors; and,IDeate-PanTumor01, a Phase 1/2 first-in-human monotherapy trial in patients with advanced solid malignant tumors in collaboration with Sarah Cannon Research Institute (SCRI) with study operational oversight and delivery provided through SCRI’s early phase oncology clinical research organization, SCRI Development Innovations in Nashville, TN. Ifinatamab deruxtecan has been granted orphan drug designation in the EU, Japan, Taiwan, and U.S. for the treatment of SCLC. About the Daiichi Sankyo and Merck collaboration Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for gocatamig. About the ADC portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU®, a HER2 directed ADC, and DATROWAY®, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www-merck-com.libproxy1.nus.edu.sg/research/oncology. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. 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The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). ### Media Contacts: Merck Julie Cunningham (617) 519-6264 julie.cunningham@merck.com Michael McArdle (908) 447-9453 michael.mcardle@merck.com Daiichi Sankyo Global/US Media Jennifer Brennan jennifer.brennan@daiichisankyo.com (908) 900-3183 Japan Media DS-PR@daiichisankyo.co.jp Investor Contacts: Merck Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Steven Graziano (732) 594-1583 steven.graziano@merck.com Daiichi Sankyo DaiichiSankyoIR_jp@daiichisankyo.com

关注并星标CPHI制药在线       在中国医药产业波澜壮阔的发展长卷中，近十年无疑是浓墨重彩的华章。这一时期，国内药企犹如破晓之曙光，冲破阴霾，从全球医药竞争的边缘奋勇突围，逐渐崛起为举足轻重的创新力量。这背后，是无数科研人员、企业决策者、政策推动者等各方的砥砺前行，更是一场关乎技术、市场、理念等全方位的深刻变革。       一、黄金十年：中国药企的逆袭与突围       曾经，中国药企在国际舞台上只能扮演“跟随者”的卑微角色，依附于跨国巨头的技术框架，艰难地在市场夹缝中求生存。然而，时代给予了勇于变革者无限可能，中国药企凭借坚韧不拔的毅力与敏锐的市场洞察，在创新浪潮中完成华丽转身，逐步成为规则制定者。       百济神州的泽布替尼，宛如一颗耀眼的星辰，在全球医药市场划出壮丽轨迹。这款 BTK 抑制剂，不仅成功叩开 70 多个国家和地区的市场大门，收获 26 亿美元的海外销售额，更在与伊布替尼的头对头试验中力挽狂澜，以卓越的疗效证明中国创新药的实力，打破国际权威产品的不可挑战神话，开启中国药企以创新成果引领全球治疗标准的先河。       恒瑞医药，国内药企的佼佼者，凭借 PD-1 卡瑞利珠单抗在国内年销 40 亿的佳绩，稳固其在国内市场的霸主地位。同时，其 HER2 ADC 药物 SHR-A1811 以 1.6 亿欧元首付款授权出海，彰显其在 ADC 领域深厚的技术底蕴与研发实力。恒瑞的“无招胜有招”战略，仿若令狐冲的独孤九剑，不拘泥于传统靶点、适应症的限制，以灵活多变的研发思路，在肿瘤免疫与靶向治疗的复杂武林中，精准击破市场空白，开拓出一片片新蓝海。       翰森制药的蜕变之路，恰似金庸笔下无名老僧的修行历程。从传统仿制药业务起家，历经漫长技术积累与转型阵痛，终在创新药领域修成正果，创新药收入占比高达 77.3%。其与 GSK、默沙东达成的 52 亿美元交易，是合成多肽与 siRNA 技术受到国际认可的有力证明，成为国内药企从仿制迈向创新的教科书式范例，启示着全行业转型的可行路径。       二、技术革命：AI 制药与细胞接合器的“魔法时代”       技术革新，如同清晨的号角，唤醒制药行业沉睡的潜力，宣告“魔法时代”的降临。AI 制药与细胞接合器等前沿技术，正以摧枯拉朽之势重塑研发逻辑，为患者带来更多生的希望。       AI 制药领域，华为云携手天士力打造的“神农大脑”，仅用 18 个月便完成传统模式下 5 年的靶点筛选工作。这一壮举，宛如《三体》中智子对宇宙规律的解构，AI 算法深入生命科学的微观世界，挖掘隐藏在海量数据背后的疾病机理与药物靶点关联，极大缩短研发周期，降低研发成本，为人类攻克疑难杂症提供全新的技术引擎。       英矽智能的 ISM001-055 针对特发性肺纤维化这一棘手病症，顺利推进至临床试验阶段。AI 技术精准的靶点选择与药物设计能力，在该项目中展现得淋漓尽致，为肺纤维化患者这一长期被忽视的群体带来曙光，也进一步验证 AI 在小分子药物研发领域的实用性与巨大潜力。       细胞接合器方面，强生的塔奎妥单抗与特立妥单抗聚焦 CD3 靶点，在多发性骨髓瘤治疗领域屡建奇功。它们如同《哈利波特》中的魔法子弹，精准识别并锁定肿瘤细胞，引导免疫系统发起致命一击，在血液肿瘤的复杂战场上开辟新战线，为患者提供除传统化疗、靶向治疗外的全新选择。       康诺亚 CM355 则是一款 CD20/CD3 双抗产品，凭借出色的临床数据，以 5.2 亿美元授权出海。其独特的双抗设计，既能同时结合肿瘤细胞表面的 CD20 分子与免疫 T 细胞表面的 CD3 分子，又能巧妙避免传统细胞因子风暴风险，展现出中国药企在细胞接合器研发领域高超的技术造诣与创新能力，也标志着国内在双抗药物这一细分赛道与国际先进水平的接轨。       ADC 药物研发竞争激烈，科伦博泰 A166 以 81%的疾病控制率在 HER2 乳腺癌治疗中脱颖而出。它精准的抗体-药物结合技术，确保药物像精确制导的导 弹一样，将高效细胞毒素精准递送至 HER2 阳性乳腺癌细胞，最大 程度减少对正常组织的损伤，在乳腺癌治疗领域树立新标杆。而第一三共 HER3-DXd 在肺癌脑转移治疗中创造 5 例完全缓解的医学奇迹，其独特的 HER3 靶向设计与高效载荷药物搭配，突破血脑屏障这一传统治疗难题，为肺癌脑转移患者这一预后极差的群体带来生的转机，成为 ADC 药物研发的又一座里程碑。       三、出海征途：从借船到造船的范式革命       中国药企的出海之路，恰似古代航海家探索未知海域的壮丽史诗，从早期的借船出海到如今自主造船远航，再到联合舰队模式的创新实践，每一步都镌刻着成长与蜕变。       华北制药维生素原料药出口，是中国药企出海的早期缩影。彼时，国内药企凭借成本优势，主要集中在附加值较低的原料药出口业务，在国际医药产业链底端艰难谋生。而传奇生物的 CAR-T 产品西达基奥仑赛犹如一颗震撼弹，在美国获批上市，以 98%的客观缓解率惊艳全球医药界。这标志着中国药企在生物药这一高附加值领域的创新突破，开启中国创新药以高端生物治疗产品叩开欧美主流市场大门的新纪元，为后续药企出海树立起全新的高度与标杆。       在出海模式的探索上，百济神州的借船出海模式独树一帜。其与诺华的深度合作，借助诺华遍布全球的销售网络、成熟的市场推广团队以及深厚的医学事务资源，迅速将产品推向欧美、亚太等主要市场。这种模式如同古代商贾借助巨商大贾的商船出海贸易，以较低的成本、较快的速度实现产品的国际化布局，为国内创新药企在产品获批初期快速打开国际市场提供了可借鉴的范本。       信达生物则选择自主造船远航的勇者之路。其自主开展全球多中心临床试验，在欧美、亚洲等多地建立完善的临床研究团队与质量控制体系，直接与国际顶尖研究机构合作，确保临床数据的全球认可度。同时，构建自己的国际销售渠道与品牌推广团队，以独立之姿闯荡国际市场。这恰似古代有实力的航海家族打造自己的舰队开辟新航路，虽面临资金、法规、市场竞争等重重挑战，但能最大 程度掌握产品商业化的话语权与利润分配权，塑造中国药企在国际市场的自主品牌形象。       康诺亚的 NewCo 模式则是联合舰队的新尝试。通过与国际合作伙伴共同成立新公司，整合双方在技术、资金、市场资源等方面的优势，共同推动药物研发与商业化进程。这种模式就像不同国家航海势力为攻克某个航海难题而组成的联合舰队，实现优势互补，降低单一企业出海风险，又充分发挥各方特长，成为近年来中国药企针对全球性研发项目、开拓新兴市场的一种创新合作模式，为行业出海战略增添新的维度与选择。       四、绿色觉醒：ESG 重构制药法则       可持续发展浪潮席卷全球，ESG 理念在制药行业生根发芽，成为衡量企业竞争力的关键标尺。中国药企在绿色生产的积极探索，不仅是对地球家园的温柔守护，更是面向未来的战略抉择。       药明生物的绿色 CRDMO 平台，宛如一座可持续发展的灯塔，为行业照亮前行方向。其通过优化生产工艺、引入节能设备、改进能源管理系统等措施，实现能耗降低 30%、废水回收率高达 95%的卓越成绩。在保证产品质量与生产效率的前提下，最大 程度减少对环境的负荷，同时降低运营成本，提升企业的长期竞争力，向全球证明绿色生产与商业成功并非矛盾体，而是可协同共进的双赢局面。       恒瑞医药的零碳工厂建设则是另一道亮丽风景线。厂房屋顶整齐排列的光伏板，如同绿色能源的守护者，将阳光转化为源源不断的清洁电力；车间内智能的 AI 温控系统，精准调控温度湿度，实现能源的精细化管理，降低碳足迹 40%。这不仅是企业对“双碳”目标的积极践行，更成为行业绿色转型的示范样板，激励更多药企加入到环保降碳的行列中，共同塑造制药行业绿色、低碳、可持续的未来生态。       五、未来蓝图：以创新为翼的星辰大海       展望未来，制药行业正如浩瀚宇宙，充满无限可能。三大趋势将引领行业继续高歌猛进，在星辰大海中开拓新天地。       AI 全流程渗透将重塑研发生态。从疾病靶点的发现，AI 算法挖掘基因数据、临床样本数据背后的隐藏关联，精准定位潜在药物靶点；到药物分子设计阶段，利用生成式 AI 创造全新的分子结构并预测其活性、成药性；再到临床试验设计，AI 模拟患者招募、试验流程优化，提高试验成功率；直至商业化阶段，大数据分析预测市场趋势、制定精准营销策略。AI 将深度融入制药的每一个神经末梢，成为企业不可或缺的智能伙伴，推动研发效率呈几何级数提升，使更多创新药以前所未有的速度到达患者手中。       细胞治疗 2.0 时代磅礴来袭，通用型 CAR-T 细胞产品打破传统 CAR-T 制备周期长、成本高昂的桎梏，实现细胞产品的批量化生产、即取即用，为血液肿瘤乃至实体肿瘤的大规模临床应用铺平道路；体内基因编辑技术则以病毒载体或纳米颗粒为“星际飞船”，将基因编辑工具精准递送至病变细胞内部，在细胞内部完成基因修复、替换，实现对遗传性疾病、罕见病的根治，为患者带来一次性治愈的新希望，让基因治疗从科幻走向现实。       全球研发网络的构建将打破地域界限，形成创新合力。以上海为亚洲研发枢纽，链接国内丰富的临床资源、科研人才；以波士顿对接美国顶尖的生物医药创新生态，汲取基础科研最新成果、风险投资活力；以都柏林辐射欧洲，融入欧洲严谨的医学传统与完善的法规体系。三地形成紧密互动的三角矩阵，科研人员跨国交流、项目合作实时开展，数据共享平台高速运转，实现 24 小时不间断的创新接力，加速药物从实验室到市场的进程，推动中国药企深度融入全球创新网络，提升在全球医药版图的话语权与引领力。       在这充满希望与挑战的新征程中，中国药企如同一群怀揣梦想的少年，以创新为翼，无畏前行。他们带着对医学的炽热初心、对人类健康的庄严承诺，在技术的海洋遨游、在市场的天空翱翔。从江湖新秀到武林盟主，从技术追赶到规则引领，每一步都踏出属于中国医药的时代强音。未来，他们将继续书写传奇，在星辰大海般的医药宇宙中，为全人类寻觅更多生命的曙光，开启一个又一个充满奇迹的新篇章，让中国医药之光闪耀全球。       参考文献       1. 中国创新药“黄金十年”启幕：百亿赛道背后的竞速与突围？_制药_全球_国际化，搜狐，2025-04-11       2. 聚焦自身优势 中国药企探路差异化创新与国际化发展，东方财富网，2025-04-10  3. AI制药兴起 生物医药行业迈上新台阶，新浪财经，2025-01-14       4. 又一款TCE在国内获批上市！《领航2025》新型抗体药物—免疫细胞接合器白皮书免费领，搜狐，2025-02-12       5. 药明生物连续五年获评晨星Sustainalytics ESG“行业最高评级”，药明生物官网，2025-02-10  6. 2025年值得关注的七大生物制药领域趋势：AI驱动、癌症疫苗突破与全球资本热潮，腾讯新闻，2025-01-27       7. 2025年创新药企盈利破冰，百济、信达、康方等头部企业商业化反哺研发，搜狐，2025-04-01 8. 1.66万亿美金市场下的中国药企出海之路！百济神州、传奇生物领航，雪球，2025-04-20       9. AI制药兴起 生物医药行业迈上新台阶，中国日报网，2025-01-14       10. 六大抗体偶联(ADC)药物2025年获批在即，全球肿瘤医生网，2024-12-24        作者简介：@南柯，由于父母都是医药行业工作者的原因，自小耳濡目染，对其抱有极大的兴趣。少年不知天高，带着对制药的痴迷，斗胆提笔记录这个创新迸发的时代——中国药企正用硬核科技改写世界医药史，而我想用文字为这场变革按下青春注脚。END领取CPHI & PMEC China 2025展会门票来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~