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Chinese President Xi Jinping's meeting with business leaders, Donald Trump's "Liberation Day" tariffs and BioNTech's bispecific data in small cell lung cancer made our news this week. Several pharma CEOs met with Chinese President Xi Jinping in Beijing. President Donald Trump's reciprocal tariffs have mostly spared pharmaceuticals. BioNTech's PD-L1xVEGF bispecific antibody, bought from China's Biotheus, showed promise in small cell lung cancer. And more. 1. AstraZeneca, Sanofi, Lilly, Pfizer CEOs meet with Xi Jinping amid US-China trade tensionsThe CEOs of AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GSK, Merck KGaA, Pfizer and Sanofi joined more than 40 international business leaders to meet with Chinese President Xi Jinping in Beijing a week ago. Sanofi’s Paul Hudson was among seven business officials from different countries who spoke at the meeting. In his speech, Xi highlighted the importance of maintaining a stable China-U.S. relationship.2. As Trump's 'Liberation Day' tariffs seem to spare pharmaceuticals, threat of industry-specific duties and loopholes persistsPharmaceuticals were excluded from President Donald Trump’s reciprocal tariffs on a slew of countries unveiled April 2. However, the omission from country-specific duties does not mean pharmaceutical-specific tariffs, which Trump has repeatedly threatened, are off the table. 3. BioNTech shows off lung cancer survival data behind phase 3 push for red-hot bispecificBioNTech has unveiled promising Chinese phase 2 data for its recently bought PD-L1xVEGF bispecific antibody BNT327 in extensive-stage small cell lung cancer. Among 48 patients who had completed at least one tumor evaluation, BNT327’s combination with chemotherapy led to a median overall survival of 16.8 months. The result appeared to be better than what Roche’s Tecentriq and AstraZeneca’s Imfinzi have shown in separate phase 3 trials that supported their approvals.4. Merck KGaA pays $85M to nab global rights for Abbisko's rare tumor drug after phase 3 winAfter bagging a positive phase 3 trial in tenosynovial giant cell tumors, Merck KGaA has expanded its licensing deal with Abbisko Therapeutics for the CSF-1R inhibitor pimicotinib to include the global market. The German company originally paid $70 million for the drug’s greater China commercialization rights. Now, it’s paying an $85 million option fee for rights in the rest of the world.5. Japan's Marubeni takes on Sumitomo's Asia pharma business to make new company in deal worth up to $480MJapanese conglomerate Marubeni is shelling out 45 billion Japanese yen ($300 million) for a 60% stake in a new company created based on Sumitomo Pharma’s operations in Asia, which generated about 45.8 billion Japanese yen ($305 million) in 2024 revenues. The firm will become Marubeni’s “pharmaceutical strategic platform.” After 2029, Marubeni can purchase the remaining shares for about $180 million.Other News of Note:6. Hanmi restructures, aims to be ‘master of new drug development’ (Korea Biomedical Review)7. Apollomics hands Asia rights to its lead c-MET inhibitor to Taiwan’s LaunXP in $60M deal8. Eisai offloads proton pump inhibitor Chinese rights for about $100M (release)9. Astellas partners with JFCR to drive oncology R&D (release)

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。PART 01周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。本文将深入分析2025年3月24日至2025年3月30日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。PART 02国内64款新药IND获批根据摩熵医药数据库统计，2025年3月24日至2025年3月30日期间，共有69个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号41个，进口药品受理号28个。本周共计64款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药33款，生物药30款，中药1款。本周获批临床创新药/改良型新药（部分）信息速览(不含补充申请)注：完整数据可识别“文末”二维码下载查看PART 03本周全球TOP10创新药研发进展在全球创新药研发领域，3月24日，云顶新耀的EVM14注射液在美国获批进入临床阶段，适应症涵盖非小细胞肺癌（NSCLC）及头颈癌等多种实体瘤。公开资料显示，EVM14是一款靶向Claudin 18.2的抗体偶联药物（ADC），通过精准识别肿瘤细胞表面抗原并释放化疗药物，实现高效杀伤癌细胞。3月25日，Alnylam Pharmaceuticals的RNAi疗法Amvuttra（vutrisiran）获FDA批准扩展适应症，用于治疗转甲状腺素蛋白淀粉样变心肌病（ATTR-CM）。ATTR-CM是一种由异常淀粉样蛋白沉积引发的心脏疾病，传统治疗仅能缓解症状。Amvuttra通过靶向肝脏中TTR mRNA，从源头抑制致病蛋白生成。本周全球 TOP10 创新药研发进展截图来源：摩熵咨询周报PART 04本周全球TOP10临床试验结果此外，本周全球TOP10临床结果中，3月26日，阿斯利康公布了第三代EGFR-TKI奥希替尼（泰瑞沙）在表皮生长因子受体（EGFR）突变非小细胞肺癌（NSCLC）患者中的3期临床试验结果。与安慰剂组相比，奥希替尼组中位总生存期（OS）达58.8个月（95% CI 54.1-NR）），而安慰剂组为54.1个月（95% CI 42.1-NR）。3月28日，BioNTech公布了其双特异性抗体BNT327联合化疗治疗广泛期小细胞肺癌（ES-SCLC）的2期试验数据。中位随访14.5个月时，联合治疗的疾病控制率（DCR）达97.9%，确认客观缓解率（ORR）为85.4%，远超传统化疗（ORR约60%-70%）。该疗法还表现出可控的安全性，未出现新的免疫相关不良反应。本周全球 TOP10 积极/失败临床结果截图来源：摩熵咨询周报PART 0512款品种过评，河北天成药业领跑根据摩熵医药数据库统计，2025.03.24-2025.03.30期间共有95项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号79项（包括化药3类，4类），新注册分类临床申请受理号9项（包括化药3类，4类），一致性评价申请7项。本周12个品种通过一致性评价（按受理号计21项），本周无视同通过一致性评价品种。本周无生物类似物注册申报动态。截图来源：摩熵咨询周报本周过评/视同过评品种主要为系统用抗感染药物，过评/视同过评产品剂型主要为注射剂；本周注射用头孢唑肟钠过评/视同过评受理号数量最多达6个，同时注射用头孢唑肟钠也是本周过评/视同过评企业最多的品种达2家；本周河北天成药业股份有限公司过评/视同过评品种数最多达2种，其余各企业过评/视同过评品种数紧随其后，本周过评/视同过评企业共包括海南通用三洋药业有限公司、河北天成药业股份有限公司和安徽茂康药业有限公司等12家企业。截图来源：摩熵咨询周报本周有茶苯海明片、氯化钙注射液2个品种首次过评/视网过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报摩熵咨询本期完整周报识别二维码领取下载往期周报回顾#73款新药IND获批！66个品种过评，科伦药业等2家药企领跑……#75款新药IND获批！10款重磅品种过评，涉及苏州二叶制药……#74款新药IND获批！158个品种过评，山东新时代药业领跑……#35款新药IND获批！79个品种过评，涉及康弘药业等药企……END本文为原创文章，转载请留言获取授权更多详细报告获取方式后台回复关键词“周报1”，获取2月26日-3月3日周报PDF。后台回复关键词“周报2”，获取3月4日-3月10日周报PDF。后台回复关键词“周报3”，获取3月11日-3月17日周报PDF。后台回复关键词“周报4”，获取3月18日-3月24日周报PDF。后台回复关键词“周报5”，获取3月25日-03月31日周报PDF。后台回复关键词“周报6”，获取4月1日-4月7日周报PDF版。后台回复关键词“周报7”，获取4月8日-4月14日周报PDF版。后台回复关键词“周报8”，获取4月15日-4月21日周报PDF版。近期最新周报识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！