Olympus Corp.

全球医疗行业每日重点资讯文 | 苏丁企业动态奥林巴斯公司（Olympus） 董事会一致决定任命美敦力前执行副总裁兼内外科产品组合总裁Bob White接替奥林巴斯董事、代表执行官、总裁兼首席执行官Yasuo Takeuchi，自2025年6月1日起生效。Bob还将在定于2025年6月举行的奥林巴斯股东大会上被提名为董事会候选人。在加入美敦力之前，Bob曾在GE医疗、Merge Healthcare和IBM医疗保健部门担任领导职务。德国医疗保健和材料集团默克(Merck KGaA)周一表示，已达成协议，将以39亿美元的股权价值收购美国生物技术公司SpringWorks Therapeutics，以加强其抗癌药物业务。SpringWorks总部位于美国康涅狄格州的斯坦福德，于2019年在纽约上市。该公司开发治疗癌症和罕见肿瘤的药物，目前在市场上有两种产品。诺和诺德(Novo Nordisk)取得了一场重大的法律胜利，这在很大程度上限制了配制药店营销或销售该制药商的畅销减肥药维格威(Wegovy)和糖尿病治疗药物奥泽美匹克(Ozempic)的更便宜且未经批准的仿制版本。得州联邦法官周四晚间作出关键裁决，驳回了复合药房行业协会的初步禁令申请，维持美国食品药品监督管理局(FDA)关于糖尿病药物Ozempic和减肥药Wegovy活性成分司美格鲁肽(semaglutide)“供应短缺状态已结束”的认定。安进（Amgen）正在加倍扩大其在美国的生产业务，并计划对其位于俄亥俄州中部的工厂进行重大升级。安进表示，该公司将投资9亿美元扩建其位于俄亥俄州新奥尔巴尼的生物制造工厂。该项目预计将使该州的安进的工作岗位总数达到750个，并将公司在俄亥俄州的总投资增加到14亿美元以上。艾伯维计划未来十年内在美国投资数十亿美元，目标是到2035年在美国投资100亿美元，以支持其当前的增长计划，并扩展到肥胖等新领域。这笔款项的一部分将专门用于建造四个新的美国生产设施，专门用于活性药物成分（API）、药品、肽和设备。赛默飞世尔科技（Thermo Fisher Scientific）表示，未来四年将在美国额外投资20亿美元。承诺的四分之三资金将支持赛默飞世尔的制造业务，而剩余的5亿美元将扩大其研发工作。赛默飞世尔已经拥有由64个美国工厂组成的广泛网络，覆盖37个州。该公司在其他43个国家也有业务。截至去年年底，该公司的全球员工人数约为125,000人，其中超过50,000人在美国工作。4月28日，恒瑞医药宣布，其发行H股计划正式获得中国证监会备案，拟发行不超过8.15亿股普通股赴港上市。这是继2000年A股上市后，恒瑞首次通过股权融资“补血”，也是其国际化战略的关键一步。依据此前披露的IPO计划，若成功登陆港股，恒瑞拟将募资20亿美元（约145亿元人民币）主要用于海外研发中心建设、全球多中心临床试验及国际化销售网络扩张。首药控股拟以自有及自筹资金不超过7.87亿元，在亦庄新城国际医药创新公园（BioPark）自主建设新的“首药控股新药研发与产业化基地”项目，并与北京经济技术开发区管委会签署《经济发展合作协议》。该合作协议生效后，公司将按照招拍挂供应程序取得项目宗地，建设包括研发中心、质控中心、临床试验中心、销售中心及生产基地在内的公司新总部，建设期3年。科源制药公告，拟收购山东宏济堂制药集团股份有限公司99.42%股权，交易作价约35.81亿元。同时拟定增募资不超7亿元。宏济堂是国内知名的阿胶产品生产企业。宏济堂与科源制药均为“力诺系”旗下公司，二者实控人均为高元坤。科源制药2023年4月登陆创业板上市，主要从事化学原料药及其制剂产品的研发、生产和销售。康弘药业公告，公司全资子公司北京康弘生物医药有限公司拟吸收合并北京弘健医疗器械有限公司、四川康弘中药材种植有限公司拟吸收合并成都康弘医药贸易有限公司、四川济生堂药业有限公司拟吸收合并四川济生堂兴尚生物科技有限责任公司。吸收合并后，北京康弘生物、康弘种植、济生堂存续经营，公司名称、股权结构保持不变。产业动态美敦力（Medtronic）宣布与Dragonfly Endoscopy达成战略合作，正式将后者研发的Dragonfly胰胆内窥镜系统引入美国市场。这一协议标志着胰胆疾病诊疗领域数十年来首次迎来重大技术升级。根据协议，美敦力将于2024年内率先在美国20家顶尖学术医疗中心及综合性医院启动Dragonfly系统的临床应用，未来三年逐步覆盖全美。美敦力宣布，其自主研发的全球最小直径无腔除颤导线OmniaSecure正式获得美国食品药品监督管理局（FDA）批准，用于右心室植入治疗危及生命的心律失常疾病。波士顿科学宣布，针对FARAPULSE脉冲电场消融（PFA）系统和辅助使用FARAPOINT PFA导管治疗持续性心房颤动（AF）患者的ADVANTAGE AF临床试验第二阶段达成12个月的主要安全性和有效性终点。该研究的主要结果已在圣地亚哥举行的第二届PFA现场手术峰会上公布，并同时在《Circulation》杂志上发表。益普生与上药控股有限公司达成战略合作协议。双方将围绕达菲林展开合作，通过加强资源整合和渠道覆盖，进一步推动达菲林产品在中国市场的深度覆盖。达菲林作为常用的促性腺激素释放激素类药物（GnRHa），在前列腺癌、中枢性性早熟、子宫内膜异位症、女性不孕症、子宫肌瘤的术前治疗等多种疾病中被广泛应用。复星医药控股子公司复宏汉霖与Alvogen Korea签订《许可协议》，复宏汉霖授予Alvogen Korea于许可区域（即韩国）及领域（即广泛期小细胞肺癌（ES-SCLC）、非鳞状非小细胞肺癌（nsNSCLC）、转移性结直肠癌（mCRC）、胃癌（GC）和食管鳞状细胞癌（ESCC）适应症）独家商业化斯鲁利单抗注射液的权利。Alvogen Korea应就许可产品向复宏汉霖支付至多1450万美元。基于许可产品于许可区域的年度净销售额达成情况，Alvogen Korea应依约向复宏汉霖支付至多9750万美元的商业销售里程碑款项。易瑞生物公告，公司与Chr. Hansen A/S（科汉森）签署合同，约定的2025-2029年度销售目标合计为7305.77万欧元，折合约6.01亿元人民币。合作内容包括公司在指定区域内授权科汉森独家销售、分销及推广公司产品，主要产品为乳中抗生素残留筛查测试、黄曲霉毒素M1筛查及定量测试、三聚氰胺及乳清掺假测试等。合同自2025年6月16日起生效，持续有效期为5年。以岭药业公告，公司全资孙公司万洋衡水制药有限公司提交的“来曲唑”化学原料药上市申请已获国家药品监督管理局批准。来曲唑是一种高效、选择性非甾体类芳香化酶抑制剂，用于乳腺癌治疗。君实生物宣布，由公司自主研发的抗PD-1单抗药物特瑞普利单抗注射液（拓益®）用于不可切除或转移性黑色素瘤的一线治疗的新适应症上市申请于近日获得国家药品监督管理局（NMPA）批准。这是特瑞普利单抗在中国内地获批的第12项适应症。信达生物宣布，第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）靶向药物奥壹新（利厄替尼片）的新药上市申请获得国家药品监督管理局批准，用于具有表皮生长因子受体（EGFR）外显子19缺失（19DEL）或外显子21置换突变（L858R）的局部晚期或复发转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。奥壹新（利厄替尼片）是目前唯一获批上市的，以萘胺结构为基础的第三代EGFR-TKI药物。清华人工智能医院正式揭牌成立，建设将分阶段进行，初期将在清华AI全面布局和多学科医工交叉的基础上，建设AI医院系统，依托北京清华长庚医院及北京清华长庚互联网医院试运行，以全科医学科和眼科、放射诊断科、呼吸科等专科为试点。未来，将构建“AI+医疗+教育+科研”生态闭环，促进优质医疗资源的高效扩容与均衡布局。联系美通社+86-10-5953 9500info@prnasia.com

CHENGDU, China, April 25, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") today announced CM518D1, a CDH17-targeted antibody-drug conjugate (ADC) developed by Keymed, received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is currently undergoing Phase I/II clinical trials in China for the treatment of solid tumors. This milestone marks another breakthrough in Keymed's ADC drug development, further strengthening its innovative therapeutic pipeline in oncology. CM518D1: a novel ADC drug targeting CDH17 CDH17 (Cadherin-17), a member of the cadherin superfamily, is an emerging therapeutic target in gastrointestinal cancers. Studies indicate that CDH17 is highly expressed in multiple gastrointestinal cancers including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, and plays a critical role in tumor invasion and metastasis. CM518D1 delivers cytotoxic payloads precisely to tumor cells by a CDH17-specific monoclonal antibody, which combines the specificity of antibodies and the potent cytotoxicity of chemotherapeutics. Preclinical studies demonstrated that CM518D1 exhibits strong direct cytotoxic activity, potent bystander killing effect and excellent plasma stability. CM518D1 exhibits remarkable anti-tumor efficacy in multiple solid tumor xenograft models and a favorable safety profile and wide therapeutic window in toxicological evaluations. Clinical development: providing a potential treatment regimen for gastrointestinal cancers Keymed is currently conducting Phase I/II clinical trials in China to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. Future studies aim to provide a more precise, effective, and safe therapeutic option for patients worldwide with gastrointestinal cancers. Keymed's ADC platform: a next-generation of proprietary ADC program for innovative drug development Keymed's proprietary ADC platform has capabilities for developing next-generation ADCs with novel payloads (e.g., diverse mechanisms of action), hydrophilic linkers (optimized for stability and drug release) and engineered antibodies (enhanced binding and pharmacokinetics). To meet the demands of next-generation ADC development and clinical research, Keymed has established GMP-compliant facilities for linker-payload and ADC drug substance production. This infrastructure positions Keymed at the forefront of ADC therapeutic development, helping to address unmet medical needs for patients worldwide. About Keymed Biosciences Keymed Biosciences Inc. (HKEX: 02162) is a biotech company focused on the urgent unmet clinical needs, and committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. SOURCE Keymed Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China, April 24, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") recently announced CM518D1, a CDH17-targeted antibody-drug conjugate (ADC) developed by Keymed, received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is currently undergoing Phase I/II clinical trials in China for the treatment of solid tumors. This milestone marks another breakthrough in Keymed's ADC drug development, further strengthening its innovative therapeutic pipeline in oncology. CM518D1: a novel ADC drug targeting CDH17 CDH17 (Cadherin-17), a member of the cadherin superfamily, is an emerging therapeutic target in gastrointestinal cancers. Studies indicate that CDH17 is highly expressed in multiple gastrointestinal cancers including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, and plays a critical role in tumor invasion and metastasis. CM518D1 delivers cytotoxic payloads precisely to tumor cells by a CDH17-specific monoclonal antibody, which combines the specificity of antibodies and the potent cytotoxicity of chemotherapeutics. Preclinical studies demonstrated that CM518D1 exhibits strong direct cytotoxic activity, potent bystander killing effect and excellent plasma stability. CM518D1 exhibits remarkable anti-tumor efficacy in multiple solid tumor xenograft models and a favorable safety profile and wide therapeutic window in toxicological evaluations. Clinical development: providing a potential treatment regimen for gastrointestinal cancers Keymed is currently conducting Phase I/II clinical trials in China to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. Future studies aim to provide a more precise, effective, and safe therapeutic option for patients worldwide with gastrointestinal cancers. Keymed's ADC platform: a next-generation of proprietary ADC program for innovative drug development Keymed's proprietary ADC platform has capabilities for developing next-generation ADCs with novel payloads (e.g., diverse mechanisms of action), hydrophilic linkers (optimized for stability and drug release) and engineered antibodies (enhanced binding and pharmacokinetics). To meet the demands of next-generation ADC development and clinical research, Keymed has established GMP-compliant facilities for linker-payload and ADC drug substance production. This infrastructure positions Keymed at the forefront of ADC therapeutic development, helping to address unmet medical needs for patients worldwide. About Keymed Biosciences Keymed Biosciences Inc. (HKEX: 02162) is a biotech company focused on the urgent unmet clinical needs, and committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. SOURCE Keymed Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED