美通社（PR Newswire ）/圣地亞哥和上海，2019年10月22日- Ambrx和浙江醫藥股份有限公司的控股子公司浙江新碼生物醫藥有限公司（簡稱“新碼生物”）今天通告，他們已達成第二項合作，開發和商業化Ambrx自主開發的定點修飾的抗體偶聯藥物（ADCs）。 根據協議，Ambrx和新碼生物將聯合繼續開發ARX305，即一種由Ambrx開發的用于治療CD70陽性腫瘤的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.

新碼生物將負責ARX305在中國的開發和商業化，而Ambrx保留ARX305在中國境外的商業權利。新碼生物將為I期臨床試驗結束之前的全球開發活動提供資金，并向Ambrx支付數額非公開的預付款、研發里程碑費用和該產品中國銷售收益的兩位數百分比的專利費。新碼生物也有權按照非公開比例獲取ARX305產品的中國境外銷售收益。
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.

“繼ARX788的成功合作之后，我們很高興與新碼生物展開第二次合作。目前，ARX788正在進行HER2陽性乳腺癌和胃癌的I期臨床試驗。ARX305是我們合作的自然延伸，包含另一種Ambrx開發的ADC，該ADC旨在治療CD70陽性腫瘤，如腎細胞癌和多發性骨髓瘤。此外，我們繼續與中國的制藥公司保持合作。” Ambrx首席執行官田豐博士說。“ARX305有望在2021年初啟動I期臨床試驗，它將使Ambrx的ADC管線擴展到多種腫瘤類型，同時通過與新碼生物的合作進入中國市場。”
"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."

浙江醫藥股份有限公司董事長李春波表示說：“ZMC-Ambrx合作的ADC項目ARX788的順利進行，證明了Ambrx的技術是制備ADC藥物的較佳方法之一。與Ambrx在ARX305上達成新合作將鞏固我們在ADC研究方面的領先地位，并有望為相關的腫瘤患者帶來新的治療方法。”
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簡介
CD70在多種實體瘤和液體瘤中高度表達，如腎細胞癌、多發性骨髓瘤、非霍奇金淋巴瘤、AML等。ARX305采用Ambrx自主知識產權的抗體和經臨床驗證的毒素，是一個經過精密設計的較佳抗CD70 ADC， 在多種腫瘤細胞和模型中已證明強大的體外和體內功效，有望直接殺死過表達CD70的腫瘤，并改善腫瘤微環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.

新碼生物簡介
新碼生物是浙江醫藥（股票代碼SH.600216）的控股子公司，主要致力于生物制品的研發生產。公司實驗室具備從基因工程構建、細胞培養、毒素合成、偶聯、制劑灌裝、臨床前研究和臨床研究方面的經驗和能力。ARX788項目目前在中國已順利推進至I期臨床研究后期。有關更多信息，請訪問http://www.fhm88.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.fhm88.cn/