Datopotamab Deruxtecan

August 18, 2025 7:01 am ET Data from IDeate-Lung01 trial will be presented at upcoming IASLC 2025 World Conference on Lung Cancer First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 Phase 2 trial, with support from IDeate-PanTumor01 Phase 1/2 trial Fourteenth Breakthrough Therapy Designation granted by FDA across the oncology portfolio of Daiichi Sankyo BASKING RIDGE, NJ AND RAHWAY, NJ, – Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. 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 by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada. The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines. The FDA granted the BTD based on data from the IDeate-Lung01 Phase 2 trial, with support from the IDeate-PanTumor01 Phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). This is the first BTD for ifinatamab deruxtecan and represents the first BTD since the start of the Daiichi Sankyo and Merck collaboration. “This Breakthrough Therapy Designation granted by the FDA to ifinatamab deruxtecan highlights the urgent need for new treatment options for patients with pretreated extensive-stage small cell lung cancer,” said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. “We are committed to advancing this medicine with the goal of bringing the first B7-H3 directed antibody drug conjugate to patients in order to transform the outcomes of those facing this aggressive disease.” “Patients living with extensive-stage small cell lung cancer often have limited therapeutic options following disease progression after standard of care treatments,” said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “This Breakthrough Therapy Designation reinforces our confidence in the promise of ifinatamab deruxtecan to play an important role in the treatment of extensive-stage small cell lung cancer, and we are looking forward to sharing data at the upcoming IASLC 2025 World Conference on Lung Cancer that show the potential of this novel option.” About IDeate-Lung01 IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part Phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible. In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan 8 or 12 mg/kg intravenously Q3W. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan 12 mg/kg intravenously Q3W. The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response, progression-free survival, disease control rate, time to response, overall survival, pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis. IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov. About IDeate-PanTumor01 IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label Phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists. The Phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The Phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistance prostate cancer or esophageal squamous cell carcinoma. The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating overall response rate, duration of response, disease control rate, progression-free survival, overall survival and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints will also be assessed. IDeate-PanTumor01 enrolled approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov. About small cell lung cancer More than 2.48 million lung cancer cases were diagnosed globally in 2022. Small cell lung cancer (SCLC) is the second most common type of lung cancer, accounting for approximately 15% of cases. SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment 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 SCLC, 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 (I-DXd) 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. Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. About the ifinatamab deruxtecan clinical development program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other anticancer medicines across multiple cancers. About the Daiichi Sankyo and Merck collaboration Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) 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 & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA 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 & Co., Inc, Rahway, NJ, USA. 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 www.merck.com/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. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. 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

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1 CXSL2500690 仿制药申请 药品名称 企业 注册分类 受理号 盐酸卡替洛尔滴眼液 成都地奥九泓制药厂 3 CYHS2503016 洛索洛芬钠颗粒 辽宁海一制药有限公司 3 CYHS2503013 联苯苄唑溶液 中山万汉制药有限公司 3 CYHS2503009 盐酸多巴酚丁胺注射液 石家庄四药有限公司 3 CYHS2503006 联苯苄唑溶液 杭州上禾健康科技有限公司 3 CYHS2503005 盐酸西替利嗪口服溶液 海南万玮制药有限公司 3 CYHS2503004 布比卡因脂质体注射液 浙江博崤生物制药有限公司 3 CYHS2503003 布比卡因脂质体注射液 浙江博崤生物制药有限公司 3 CYHS2503002 氨磺必利口服溶液 河北义海医药科技有限公司 3 CYHS2503000 枸橼酸西地那非口溶膜 杭州和泽坤元药业有限公司 3 CYHS2502996 JP-1366片 丽珠医药集团股份有限公司 3 CYHS2502991 聚乙二醇4000散 西安安健药业有限公司 3 CYHS2502988 普瑞巴林口服溶液 江苏贝佳制药有限公司 3 CYHS2502986 普瑞巴林口服溶液 江苏贝佳制药有限公司 3 CYHS2502983 叶酸片 成都通德药业有限公司 3 CYHS2502973 枸橼酸苯海拉明布洛芬片 合肥恩瑞特药业有限公司 3 CYHS2502972 盐酸多西环素片 江苏润恒制药有限公司 3 CYHS2502969 盐酸多西环素片 江苏润恒制药有限公司 3 CYHS2502968 瑞舒伐他汀钙口崩片 广东万泰科创药业有限公司 3 CYHS2502966 瑞舒伐他汀钙口崩片 广东万泰科创药业有限公司 3 CYHS2502965 注射用硫酸多黏菌素B 国药集团国瑞药业有限公司 3 CYHS2502963 叶酸片 建昌帮药业有限公司 3 CYHS2502979 复方聚乙二醇(3350)电解质口服溶液 湖北午时药业股份有限公司 3 CYHS2502957 中性腹膜透析液(碳酸氢盐-G1.5%) 成都青山利康药业股份有限公司 3 CYHS2502955 中性腹膜透析液(碳酸氢盐-G1.5%) 成都青山利康药业股份有限公司 3 CYHS2502954 中性腹膜透析液(碳酸氢盐-G1.5%) 成都青山利康药业股份有限公司 3 CYHS2502953 中性腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502952 中性腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502951 中性腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502950 复方磷酸盐颗粒 江苏润恒制药有限公司 3 CYHS2502947 草酸艾司西酞普兰口服溶液 浙江领创优品药业有限公司 3 CYHS2502944 维生素B12注射液 江苏润恒制药有限公司 3 CYHS2502943 中性低钙腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502930 中性低钙腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502929 中性低钙腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502928 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) 宁波天益药业科技有限公司 3 CYHS2502922 帕拉米韦注射液 哈尔滨三联药业股份有限公司 3 CYHS2502916 色甘酸钠滴眼液 苏州乐珠制药有限公司 3 CYHS2502936 帕拉米韦氯化钠注射液 哈尔滨三联药业股份有限公司 4 CYHS2503015 帕拉米韦氯化钠注射液 哈尔滨三联药业股份有限公司 4 CYHS2503014 注射用磷酸特地唑胺 安徽省先锋制药有限公司 4 CYHS2503008 阿达帕林凝胶 东阳祥昇医药科技有限公司 4 CYHS2503007 盐酸曲唑酮缓释片 合肥力成药业有限公司 4 CYHS2503001 双氯芬酸钠盐酸利多卡因注射液 四川健林药业有限责任公司 4 CYHS2502999 阿法骨化醇滴剂 石家庄科仁医药科技有限公司 4 CYHS2502998 聚乙烯醇滴眼液 北京汇恩兰德制药有限公司 4 CYHS2502981 氧(液态) 准格尔旗鼎承气体有限责任公司 4 CYHS2502980 蒙脱石混悬液 浙江百代医药科技有限公司 4 CYHS2502997 左氧氟沙星氯化钠注射液 四川太平洋药业有限责任公司 4 CYHS2502995 洛索洛芬钠贴剂 苏州弘森药业股份有限公司 4 CYHS2502994 洛索洛芬钠贴剂 苏州弘森药业股份有限公司 4 CYHS2502993 骨化三醇软胶囊 江苏万高药业股份有限公司 4 CYHS2502992 聚乙二醇4000散 西安安健药业有限公司 4 CYHS2502990 瑞舒伐他汀依折麦布片(I) 山东新华制药股份有限公司 4 CYHS2502989 氟轻松玻璃体内植入剂 苏州欧康维视生物科技有限公司 4 CYHS2502987 乳果糖口服溶液 浙江震元制药有限公司 4 CYHS2502985 乳果糖口服溶液 浙江震元制药有限公司 4 CYHS2502984 乳果糖口服溶液 浙江震元制药有限公司 4 CYHS2502982 磷酸芦可替尼片 齐鲁制药有限公司 4 CYHS2503012 磷酸芦可替尼片 齐鲁制药有限公司 4 CYHS2503010 磷酸芦可替尼片 齐鲁制药有限公司 4 CYHS2503011 甲磺酸沙非胺片 扬子江药业集团有限公司 4 CYHS2502946 碘佛醇注射液 福安药业集团宁波天衡制药有限公司 4 CYHS2502971 灌注用盐酸氨酮戊酸己酯 江苏联环药业股份有限公司 4 CYHS2502970 伏立康唑干混悬剂 河北嵘霖制药有限公司 4 CYHS2502967 泊那替尼片 成都硕德药业有限公司 4 CYHS2502964 盐酸曲唑酮缓释片 中曦(福建)药业有限公司 4 CYHS2502978 盐酸曲唑酮缓释片 中曦(福建)药业有限公司 4 CYHS2502977 沙库巴曲缬沙坦钠片 江西施美药业股份有限公司 4 CYHS2502976 沙库巴曲缬沙坦钠片 江西施美药业股份有限公司 4 CYHS2502975 沙库巴曲缬沙坦钠片 江西施美药业股份有限公司 4 CYHS2502974 甲磺酸沙非胺片 扬子江药业集团有限公司 4 CYHS2502945 塞来昔布胶囊 吉林亚泰永安堂药业有限公司 4 CYHS2502959 塞来昔布胶囊 吉林亚泰永安堂药业有限公司 4 CYHS2502958 达格列净片 青岛百洋制药有限公司 4 CYHS2502956 美阿沙坦钾片 福建东瑞制药有限公司 4 CYHS2502949 美阿沙坦钾片 福建东瑞制药有限公司 4 CYHS2502948 卡铂注射液 南京泽恒医药技术开发有限公司 4 CYHS2502942 替普瑞酮胶囊 广东迈德珐医药科技有限公司 4 CYHS2502941 巴瑞替尼片 江苏万高药业股份有限公司 4 CYHS2502940 巴瑞替尼片 江苏万高药业股份有限公司 4 CYHS2502939 瑞维那新吸入溶液 复星医药(徐州)有限公司 4 CYHS2502938 瑞维那新吸入溶液 遂成药业股份有限公司 4 CYHS2502937 艾普拉唑肠溶片 广东君康药业有限公司 4 CYHS2502961 沙库巴曲缬沙坦钠片 国药集团致君(深圳)坪山制药有限公司 4 CYHS2502960 巴瑞替尼片 浙江华海药业股份有限公司 4 CYHS2502962 阿达帕林凝胶 河北三禾实创生物科技有限公司 4 CYHS2502934 甲钴胺片 天津柏海药业有限责任公司 4 CYHS2502933 盐酸伐昔洛韦片 浙江浙北药业有限公司 4 CYHS2502932 非奈利酮片 重庆莱美药业股份有限公司 4 CYHS2502931 苯磺酸左氨氯地平片 山西汾河制药有限公司 4 CYHS2502927 苯磺酸左氨氯地平片 山西汾河制药有限公司 4 CYHS2502926 非诺贝特片(III) 深圳格莱恩生物医药科技有限公司 4 CYHS2502925 乙酰半胱氨酸颗粒 武汉远大弘元股份有限公司 4 CYHS2502924 溴芬酸钠滴眼液 盈科瑞(珠海金湾)制药有限公司 4 CYHS2502923 注射用氨苄西林钠舒巴坦钠 山东安信制药有限公司 4 CYHS2502921 注射用氨苄西林钠舒巴坦钠 山东安信制药有限公司 4 CYHS2502920 注射用氨苄西林钠舒巴坦钠 山东安信制药有限公司 4 CYHS2502919 门冬氨酸钾镁注射液 裕松源药业有限公司 4 CYHS2502918 洛索洛芬钠凝胶贴膏 浙江恒研医药科技有限公司 4 CYHS2502917 蒙脱石散 重庆康刻尔制药股份有限公司 4 CYHS2502935 注射用硫酸艾沙康唑 石药集团欧意药业有限公司 4 CYHS2502915 沙库巴曲缬沙坦钠片 苏州第三制药厂有限责任公司 4 CYHS2502914 沙库巴曲缬沙坦钠片 苏州第三制药厂有限责任公司 4 CYHS2502913 奥利司他胶囊 湖南本草制药有限责任公司 4 CYHS2502912 奥利司他胶囊 湖南本草制药有限责任公司 4 CYHS2502911 乙酰半胱氨酸注射液 重庆康刻尔制药股份有限公司 4 CYHS2502910 达格列净二甲双胍缓释片(III) 重庆博腾药业有限公司 4 CYHS2502909 达格列净二甲双胍缓释片(II) 重庆博腾药业有限公司 4 CYHS2502908 达格列净二甲双胍缓释片(I) 重庆博腾药业有限公司 4 CYHS2502907 低钙腹膜透析液(乳酸盐-G4.25%) 辰欣药业股份有限公司 4 CYHS2502906 贝伐珠单抗眼内注射液 珠海亿胜生物制药有限公司 3.2 CXSS2500082 司美格鲁肽注射液 惠升生物制药股份有限公司 3.3 CXSS2500084 司美格鲁肽注射液 惠升生物制药股份有限公司 3.3 CXSS2500083 瑞卢戈利片 山东朗诺制药有限公司 3 CYHL2500147 异硫蓝注射液 康哲(湖南)制药有限公司 3 CYHL2500146 盐酸羟甲唑啉滴眼液 北京汇恩兰德制药有限公司 3 CYHL2500145 甲磺酸酚妥拉明滴眼液 浙江视方极医药科技有限公司 3 CYHL2500143 呫诺美林曲司氯铵胶囊 江苏恩华药业股份有限公司 3 CYHL2500142 呫诺美林曲司氯铵胶囊 江苏恩华药业股份有限公司 3 CYHL2500141 呫诺美林曲司氯铵胶囊 江苏恩华药业股份有限公司 3 CYHL2500140 茚达特罗格隆溴铵吸入粉雾剂 山东京卫制药有限公司 4 CYHL2500144 冻干人用狂犬病疫苗(人二倍体细胞) 成都康华生物制品股份有限公司 3.3 CXSL2500692 QL2302注射液 齐鲁制药有限公司 3.3 CXSL2500693 进口申请 药品名称 企业 注册分类 受理号 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500087 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500086 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500085 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500084 艾沙妥昔单抗注射液(皮下注射) Sanofi Winthrop Industrie 2.1 JXSS2500108 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500216 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500215 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500214 Icotrokinra片 Janssen Research & Development, LLC 1 JXHL2500213 Rilzabrutinib片 Sanofi-Aventis Recherche & Developpement 2.4 JXHL2500217 马立巴韦干混悬剂 Takeda Pharmaceuticals U.S.A., Inc. 2.4;2.2 JXHL2500212 马立巴韦干混悬剂 Takeda Pharmaceuticals U.S.A., Inc. 2.4;2.2 JXHL2500211 AZD0486 AstraZeneca AB 1 JXSL2500154 AZD0486 AstraZeneca AB 1 JXSL2500153 AZD0486 AstraZeneca AB 1 JXSL2500152 AZD0486 AstraZeneca AB 1 JXSL2500151 AZD0486 AstraZeneca AB 1 JXSL2500150 BCD-261注射液 SPH-BIOCAD (HK) LIMITED 1 JXSL2500149 MEDI5752 AstraZeneca AB 1 JXSL2500148 Lunsekimig注射液 Sanofi-Aventis Recherche & Developpement 1 JXSL2500146 Lunsekimig注射液 Sanofi-Aventis Recherche & Developpement 1 JXSL2500145 注射用SAR446523 Sanofi-Aventis Recherche & Developpement 1 JXSL2500144 注射用替奈普酶 Boehringer Ingelheim International GmbH 2.2 JXSL2500155 DS-1062a AstraZeneca AB 2.2 JXSL2500147 中药相关申请 药品名称 企业 注册分类 受理号 小儿胆青双解颗粒 海南葫芦娃药业集团股份有限公司 1.1 CXZL2500065 苏黄止咳胶囊 杨凌科森生物制药有限责任公司 4 CYZS2500009 注：绿色字体部分为潜在首仿品种； 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。