摘要：今天，乐普生物科技股份有限公司（HK：02157）宣布，与ArriVent BioPharma, Inc.（纳斯达克：AVBP）就针对消化道癌的潜在同类最佳抗体偶联药物MRG007达成全球独家许可协议。
今天，乐普生物科技股份有限公司（HK：02157）宣布，与ArriVent BioPharma, Inc.（纳斯达克：AVBP）就针对消化道癌的潜在同类最佳抗体偶联药物MRG007达成全球独家许可协议。
根据协议，乐普生物授予ArriVent在大中华区（包括中国大陆、中国香港、中国澳门和中国台湾）以外地区开发、制造和商业化MRG007的全球独家许可。乐普生物将获得总计4700万美元的一次性首付款和近期里程碑付款，和最高达11.6亿美元的开发、注册和销售等里程碑付款，以及基于大中华区以外地区净销售额的分级特许权使用费。
MRG007在消化道癌的临床前模型中表现出强大的抗肿瘤活性，在IND支持性研究中显示出较高的治疗指数。首个IND申请计划于2025年上半年提交，初步临床开发重点是结直肠癌、胰腺癌及其他消化道恶性肿瘤。
乐普生物执行董事兼CEO隋滋野博士表示：
“我们很高兴能与ArriVent达成合作。乐普生物一直致力于推动国内ADC技术的进步，此次合作是对公司自主研发能力的认可。我们认为，MRG007是公司处于临床前阶段的潜在同类最佳ADC药物之一，我们期待通过与ArriVent的合作来推进MRG007在全球范围内的开发，努力将这一有潜力的治疗方法带给全球更多的患者。”
ArriVent董事长兼CEO Bing Yao表示：
“基于临床前和IND支持性研究，我们认为MRG007是一款针对消化道癌的潜在同类最佳ADC。将MRG007纳入我们的研发管线将拓宽公司的产品线布局，推进我们为全球未被满足临床需求的癌症开发新药的使命，这一即将进入临床阶段的分子也将进一步加速公司ADC产品管线的开发进度。我们期待着与乐普生物合作，在全球范围内推进这一项目。”
关于乐普生物
乐普生物是一家立足中国、面向全球的聚焦于靶向治疗和肿瘤免疫治疗的创新型生物制药企业。公司持续建设自身商业化能力，不断实现从核心技术到成药的强大转化和产业化。目前，乐普生物的产品管线覆盖三大领域，分别为免疫治疗、ADC靶向治疗和溶瘤病毒药物，包含1款商业化上市药物，7款临床阶段候选药物（其中6款为ADC产品）及3款临床阶段候选药物的联合疗法。公司的ADC候选药物管线在中国处于领先地位。
关于ArriVent
ArriVent是一家处于临床阶段的生物制药公司，致力于发现、开发和商业化差异化管线，以满足癌症患者未被满足的临床需求。ArriVent旨在利用团队深厚的药物开发经验，最大限度地开发重点潜力候选药物firmonertinib，并推动一系列新型治疗药物（如新一代ADC药物）获批和实现商业化。
Lepu Biopharma has granted ArriVent Exclusive License for MRG007, a Potential Best-in-Class ADC for the treatment of Gastrointestinal Cancers
Today, Lepu Biopharma Co., Ltd (Stock Code: 02157.HK) announced that it has entered into an exclusive licensing agreement with ArriVent BioPharma, Inc.(Nasdaq: AVBP) for MRG007, a Potential Best-in-Class antibody- drug conjugate (“ADC”) for the treatment of Gastrointestinal (“GI”) Cancers.
Under the terms of the agreement, Lepu Biopharma has granted ArriVent exclusive rights to develop, manufacture and commercialize MRG007 outside of Greater China. Lepu Biopharma will receive a one-time upfront and near-term milestone payments totaling $47 million in cash and is eligible to receive up to $1.16 billion in development, regulatory and sales milestones and tiered royalties on net sales outside of Greater China.
MRG007 has shown robust antitumor activity in preclinical models of GI cancers and a favorable therapeutic index based on IND enabling studies. The first IND submission is planned for the first half of 2025 with an initial clinical development focus in colorectal, pancreatic and other GI cancers.
Sui Ziye Ph.D., Executive Director and Chief Executive Officer of Lepu Biopharma said：
“We are very pleased to be working with ArriVent. Lepu Biopharma has been dedicated to promoting the technological advancement of innovative ADCs in China. We believe MRG007 is one of our potential best-in-class ADC molecules in pre-clinical stage. The agreement is a recognition of our self-dependent R&D capabilities. We look forward to collaborating with ArriVent to advance the development of MRG007 globally and help bring this potential promising therapy to more patients around the world.”
Bing Yao, Chairman and Chief Executive Officer of ArriVent said：
" We believe MRG007 is a potential best-in-class ADC for the treatment of GI malignancies based on preclinical and IND enabling studies. Expanding our pipeline with MRG007 furthers our mission to develop novel medicines for cancers with high unmet needs worldwide and accelerates our ADC portfolio by adding a program which plans to enter the clinic in the near-term. We look forward to collaborating with Lepu Biopharma in advancing this program globally.”
About Lepu Biopharma Co., Ltd.
Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is an innovation-driven company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. The company is dedicated to developing innovative ADCs through its advanced ADC technology platform. Lepu Biopharma highly values the continuing build-out of its own commercialization capabilities and is determined to pursue the goal towards strong transformation from core technology to drugs and industrialization. At present, the product pipeline of Lepu Biopharma covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including one clinical/commercialization- stage drug candidate, seven clinical-stage drug candidates (six of which are ADC drug candidates) and three clinical-stage combination therapies of the key candidates in its pipeline. The company houses the leading ADC drug candidate pipeline in China.
About ArriVent
ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.
Media Contacts
Lepu Biopharma Co., Ltd.
Tel：021-6768 0899
来源：动态宝