新码生物和Ambrx达成第二项合作——开发和商业化Ambrx的抗体偶联药物

美通社（PR Newswire ）/圣地亚哥和上海，2019年10月22日- Ambrx和浙江医药股份有限公司的控股子公司浙江新码生物医药有限公司（简称“新码生物”）今天通告，他们已达成第二项合作，开发和商业化Ambrx自主开发的定点修饰的抗体偶联药物（ADCs）。 根据协议，Ambrx和新码生物将联合继续开发ARX305，即一种由Ambrx开发的用于治疗CD70阳性肿瘤的ADC。
SAN DIEGO and SHANGHAI, October 22, 2019 /PR Newswire/ -- Ambrx and  NovoCodex Biopharmaceuticals Ltd., (NovoCodex), a majority owned company of Zhejiang Medicine Co Ltd., today announced that they have formed a second collaboration to develop and commercialize Ambrx's internally developed site-specific antibody drug conjugates (ADCs).  Under the agreement, Ambrx and NovoCodex will join forces to continue the development of ARX305, an Ambrx enabled ADC for the treatment of CD70 positive cancers.

新码生物将负责ARX305在中国的开发和商业化，而Ambrx保留ARX305在中国境外的商业权利。新码生物将为I期临床试验结束之前的全球开发活动提供资金，并向Ambrx支付数额非公开的预付款、研发里程碑费用和该产品中国销售收益的两位数百分比的专利费。新码生物也有权按照非公开比例获取ARX305产品的中国境外销售收益。
Under the terms of the agreement, NovoCodex is responsible for developing and commercializing ARX305 in China while Ambrx is responsible for developing and commercializing ARX305 outside of China. NovoCodex will fund global development activities to the end of Phase 1 clinical trials and pay Ambrx an undisclosed upfront payment, development milestones, and a double-digit royalty on product sales in China. NovoCodex is also eligible to share in undisclosed portion of ARX305 product sales outside of China.

“继ARX788的成功合作之后，我们很高兴与新码生物展开第二次合作。目前，ARX788正在进行HER2阳性乳腺癌和胃癌的I期临床试验。ARX305是我们合作的自然延伸，包含另一种Ambrx开发的ADC，该ADC旨在治疗CD70阳性肿瘤，如肾细胞癌和多发性骨髓瘤。此外，我们继续与中国的制药公司保持合作。” Ambrx首席执行官田丰博士说。“ARX305有望在2021年初启动I期临床试验，它将使Ambrx的ADC管线扩展到多种肿瘤类型，同时通过与新码生物的合作进入中国市场。”
"We are excited to initiate our second collaboration with NovoCodex following our successful collaboration with ARX788, which is currently in Phase 1 clinical trials for HER2 positive breast and gastric cancers. ARX305 is a natural extension to the first collaboration with the inclusion of another Ambrx enabled ADC that is intended to treat CD70 positive cancers such as Renal Cell Carcinoma and Multiple Myeloma. Further, we continue to align ourselves with China's leading pharmaceutical companies" said Feng Tian, Ph.D., Chief Executive Officer of Ambrx. "ARX305, which is expected to start Phase 1 clinical trials in early 2021, allows Ambrx to expand its ADC pipeline into multiple cancer types while gaining access to the China market through our partnership with NovoCodex."

浙江医药股份有限公司董事长李春波表示说：“ZMC-Ambrx合作的ADC项目ARX788的顺利进行，证明了Ambrx的技术是制备ADC药物的较佳方法之一。与Ambrx在ARX305上达成新合作将巩固我们在ADC研究方面的领先地位，并有望为相关的肿瘤患者带来新的治疗方法。”
Chunbo Li, Chairman of Zhejiang Medicine, commented, "The smooth progress of our first ZMC-Ambrx collaborated ADC project, ARX788, proves that Ambrx’ technology is one of the best methods to make an ADC drug.  The new alliance with Ambrx on ARX305 will strengthen our leading position on ADC research, and hopefully will bring new treatment to related cancer patients.”
ARX305简介
CD70在多种实体瘤和液体瘤中高度表达，如肾细胞癌、多发性骨髓瘤、非霍奇金淋巴瘤、AML等。ARX305采用Ambrx自主知识产权的抗体和经临床验证的毒素，是一个经过精密设计的较佳抗CD70 ADC， 在多种肿瘤细胞和模型中已证明强大的体外和体内功效，有望直接杀死过表达CD70的肿瘤，并改善肿瘤微环境中的免疫抑制作用。
About ARX305
CD70 is highly expressed in multiple solid and liquid tumors such as Renal Cell Carcinoma, Multiple Myeloma, Non-Hodgkin’s Lymphoma, AML, and etc. ARX305 is a best-in-class anti-CD70 ADC that was precision-engineered using Ambrx proprietary antibody and clinically validated drug payload. Strong in vitro and in vivo efficacy have been demonstrated in multiple tumor cells and models.  It is expected to deliver a direct killing to CD70-overexpressing tumor and improvement of the immune suppression in the tumor microenvironment.

新码生物简介
新码生物是浙江医药（股票代码SH.600216）的控股子公司，主要致力于生物制品的研发生产。公司实验室具备从基因工程构建、细胞培养、毒素合成、偶联、制剂灌装、临床前研究和临床研究方面的经验和能力。ARX788项目目前在中国已顺利推进至I期临床研究后期。有关更多信息，请访问http://www.novocodex.cn/
About NovoCodex
NovoCodex is a majority owned company of Zhejiang Medicine Co., Ltd. (stock code: SH.600216), mainly committed to the research and development of biological products. The company's laboratory has experience and capabilities in genetic engineering, cell culture, toxin synthesis, conjugation, formulation & filling, preclinical study and clinical study. ARX788 project has been successfully advanced to the later stage of Phase 1 clinical trial in China. For additional information, visit http://www.novocodex.cn/