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复星医药(600196.SH):HLX22联合注射用HLX87获临床试验批准
智通财经网· 2025-12-09 12:18
智通财经APP讯,复星医药(600196.SH)发布公告,近日,公司控股子公司上海复宏汉霖生物技术股份 有限公司及其控股子公司(以下合称"复宏汉霖")收到国家药品监督管理局关于同意HLX22(即重组人源化 抗HER2单克隆抗体注射液)联合注射用HLX87(即靶向HER2抗体偶联药物)于中国境内开展如下临床试 验的批准:(1)用于HER2阳性乳腺癌(BC)一线治疗的Ⅱ/Ⅲ期临床试验;(2)用于HER2阳性乳腺癌新辅助治 疗(BC neo)的Ⅱ/Ⅲ期临床试验。复宏汉霖拟于条件具备后于中国境内开展上述相关临床研究。 ...
复星医药:HLX22联合注射用HLX87获临床试验批准
智通财经网· 2025-12-09 12:17
智通财经APP讯,复星医药(600196.SH)发布公告,近日,公司控股子公司上海复宏汉霖生物技术股份 有限公司及其控股子公司(以下合称"复宏汉霖")收到国家药品监督管理局关于同意HLX22(即重组人源化 抗HER2单克隆抗体注射液)联合注射用HLX87(即靶向HER2抗体偶联药物)于中国境内开展如下临床试 验的批准:(1)用于HER2阳性乳腺癌(BC)一线治疗的Ⅱ/Ⅲ期临床试验;(2)用于HER2阳性乳腺癌新辅助治 疗(BC neo)的Ⅱ/Ⅲ期临床试验。复宏汉霖拟于条件具备后于中国境内开展上述相关临床研究。 ...
复星医药(600196.SH)控股子公司与辉瑞签订许可协议
智通财经网· 2025-12-09 12:12
智通财经APP讯,复星医药(600196.SH)发布公告,2025年12月9日,公司控股子公司药友制药、复星医 药产业与辉瑞共同签订《许可协议》,(其中主要包括)由药友制药就口服小分子胰高血糖素样肽-1受体 (GLP-1R)激动剂(包括YP05002)及含有该活性成分的产品授予辉瑞于许可区域(即全球范围)及领域(人 类、动物所有适应症的治疗、诊断及预防)独家开发、使用、生产及商业化权利;就本次许可,药友制药 将有权依约获得(其中包括)不可退还的首付款1.5亿美元及基于许可产品临床、商业化进展获得开发里程 碑付款至多3.5亿美元。此外,基于许可产品的年度净销售额达成情况,由辉瑞向药友制药依约支付至 多15.85亿美元的销售里程碑款项。 YP05002为集团自主研发并拥有自主知识产权的口服小分子胰高血糖素样肽-1受体(GLP-1R)激动剂;其主 要通过激活人的GLP-1R,促进胰腺的胰岛素分泌和降低胰高血糖素分泌,在胃肠道抑制胃排空和肠道 的蠕动,并通过影响中枢抑制食欲减少能量的摄入等机制,用于治疗2型糖尿病、肥胖症及其相关疾病。 YP05002拟用于代谢领域相关疾病的治疗,潜在适应症包括但不限于长期体重管理、2 ...
复星医药子公司药友制药与辉瑞签订许可协议
Bei Jing Shang Bao· 2025-12-09 12:04
北京商报讯(记者 王寅浩 宋雨盈)12月9日,复星医药发布公告称,公司控股子公司药友制药就口服小 分子胰高血糖素样肽-1受体(GLP-1R)激动剂(包括YP05002)及含有该活性成分的产品授予辉瑞于全 球范围及领域(即人类、动物所有适应症的治疗、诊断及预防)独家开发、使用、生产及商业化权利。 就本次许可,药友制药将有权依约获得(其中包括)不可退还的首付款 1.5亿美元及基于许可产品临 床、商业化进展获得开发里程碑付款至多3.5亿美元。此外,基于许可产品的年度净销售额达成情况, 由辉瑞向药友制药依约支付至多15.85亿美元的销售里程碑款项。 ...
复星医药子公司药品临床试验获批
Bei Jing Shang Bao· 2025-12-09 12:04
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 in combination with HLX87 for HER2-positive breast cancer treatment in mainland China [1] Group 1 - The approved clinical trials will focus on the use of HLX22 as a novel targeted monoclonal antibody for first-line treatment and neoadjuvant therapy in HER2-positive breast cancer [1] - HLX87 is an innovative antibody-drug conjugate (ADC) that links a topoisomerase I inhibitor with an anti-HER2 monoclonal antibody through a stable cleavable linker [1]
Fosun Pharma's Subsidiary Yao Pharma and Pfizer Enter into Exclusive Collaboration and License Agreement
Prnewswire· 2025-12-09 11:55
Core Insights - Fosun Pharma's subsidiary Yao Pharma has entered into an exclusive collaboration and license agreement with Pfizer for the development and commercialization of oral small-molecule GLP-1R agonists, including YP05002 [1][2] - Yao Pharma will receive an upfront payment of $150 million and potential milestone payments up to $1.935 billion, along with tiered royalties on sales if approved [1] - The partnership is seen as a significant milestone in Fosun Pharma's strategy of innovation and internationalization, aiming to address unmet clinical needs in metabolic diseases [3] Company Overview - Yao Pharma has developed small-molecule GLP-1R agonists with proprietary intellectual property rights, targeting metabolic diseases such as chronic weight management, type 2 diabetes, and non-alcoholic steatohepatitis (NASH) [2] - YP05002 is currently in Phase 1 clinical development in Australia, indicating progress in the drug's development pipeline [2] Strategic Implications - The collaboration with Pfizer is viewed as a recognition of Yao Pharma's R&D capabilities and aims to leverage Pfizer's global development experience to expedite the commercialization of YP05002 [3] - Fosun Pharma's leadership emphasizes the importance of collaboration in maximizing the value of innovation and addressing global health challenges related to obesity and metabolic diseases [3]
复星医药:子公司与辉瑞达成GLP-1药物YP05002独家合作与许可协议,里程碑付款最高可达19.35亿美元
Xin Lang Cai Jing· 2025-12-09 11:49
根据协议条款,药友制药将完成YP05002于澳大利亚的I期临床试验,并授予辉瑞在全球范围内进一步 开发、生产和商业化的独家许可。药友制药将获得1.5亿美元的首付款,并有资格获得与特定开发、注 册和商业里程碑相关的最高达19.35亿美元的里程碑付款,以及产品获批销售后的分层特许权使用费。 12月9日,复星医药宣布,控股子公司重庆药友制药有限责任公司("药友制药")、上海复星医药产业 发展有限公司("复星医药产业")与Pfizer Inc. (辉瑞,NYSE: PFE)共同签订《许可协议》,由药友 制药就口服小分子胰高血糖素样肽-1受体(GLP-1R)激动剂(包括YP05002)及含有该活性成分的产品 授予辉瑞于全球范围独家开发、使用、生产及商业化的权利,许可领域包括人类、动物所有适应症的治 疗、诊断及预防。 ...
复星医药(02196):子公司药友制药、复星医药产业与辉瑞共同签订《许可协议》
智通财经网· 2025-12-09 11:49
Core Insights - Fosun Pharma (02196) announced a licensing agreement with Pfizer on December 9, 2025, involving the oral small molecule GLP-1 receptor agonist (including YP05002) for exclusive global development, use, production, and commercialization rights [1][2] - The agreement includes an upfront payment of $150 million and potential milestone payments of up to $350 million based on clinical and commercialization progress [1] Group 1 - YP05002 is an independently developed oral small molecule GLP-1 receptor agonist with proprietary intellectual property, aimed at treating type 2 diabetes, obesity, and related diseases [2] - The mechanism of YP05002 includes promoting insulin secretion, reducing glucagon secretion, inhibiting gastric emptying, and suppressing appetite, which are beneficial for metabolic disorders [2] - As of December 9, 2025, YP05002 is in Phase I clinical trials in Australia [2] Group 2 - The licensing agreement reflects recognition of the company's innovative research and development capabilities by its partners [2] - This collaboration is expected to accelerate the clinical development and commercialization of the licensed product globally, potentially benefiting more patients worldwide [2]
复星医药:子公司药友制药、复星医药产业与辉瑞共同签订《许可协议》
Zhi Tong Cai Jing· 2025-12-09 11:47
Core Insights - Fosun Pharma has signed a licensing agreement with Pfizer for the exclusive development, use, production, and commercialization rights of the oral small molecule GLP-1 receptor agonist YP05002 and related products globally [1][2] - The agreement includes an upfront payment of $150 million and potential milestone payments of up to $350 million based on clinical and commercialization progress [1] Group 1 - YP05002 is an innovative GLP-1 receptor agonist developed by the company, aimed at treating type 2 diabetes, obesity, and related metabolic disorders [2] - The drug works by activating GLP-1 receptors to enhance insulin secretion, reduce glucagon secretion, slow gastric emptying, and suppress appetite, thereby aiding in weight management and metabolic health [2] - As of December 9, 2025, YP05002 is in Phase I clinical trials in Australia, indicating ongoing development in the metabolic disease treatment space [2] Group 2 - The licensing agreement reflects recognition of the company's innovative research and development capabilities by its partners [2] - This collaboration is expected to accelerate the clinical development and commercialization of the licensed product globally, potentially benefiting a larger patient population [2]
复星医药:控股子公司许可口服小分子GLP-1R激动剂全球独家权利给辉瑞
Hua Er Jie Jian Wen· 2025-12-09 11:47
Core Transaction Details - The company has licensed the global exclusive rights for the oral small molecule GLP-1R agonist (including YP05002) for development, production, and commercialization to Pfizer [1] - The licensing scope covers all therapeutic, diagnostic, and preventive areas for humans and animals globally [1] Key Financial Terms - Upfront payment of $150 million (non-refundable) [1] - Development milestones up to $350 million based on clinical and commercialization progress [1] - Sales milestones up to $1.585 billion based on annual net sales achievements [1] - Royalties to be paid as a double-digit percentage of annual net sales [1] Product Overview - YP05002 is an oral small molecule GLP-1R agonist developed by the company [1] - Indications include type 2 diabetes, obesity, and metabolic dysfunction-related fatty liver disease [1] - Currently in Phase I clinical trials in Australia [1] Major Risks - Drug development carries inherent uncertainties, and milestone payments are subject to triggering risks [1] - Pfizer has the right to terminate the agreement with written notice [1]