药明生物和日本Toregem BioPharma公司针对抗USAG-1抗体研发签署合作备忘录

中国上海，

2022年10月12日

全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）和日本京都大学孵化的初创生物技术公司Toregem BioPharma（以下简称Toregem）今日宣布，双方针对治疗先天性牙齿缺失的靶向USAG-1单克隆抗体TRG035的研发签署合作备忘录（MOU）。

根据合作备忘录，Toregem公司将通过药明生物在细胞系开发、细胞株建库及分析方法开发、细胞培养工艺开发、原液和制剂生产以及生物活性方法开发等的端到端服务推进TRG035研发。药明生物将为该项目的新药临床试验申请（IND）提供支持，助力Toregem公司加快研发进程。

Toregem公司首席执行官Honoka Kiso博士表示，“我们很高兴与药明生物建立合作，他们在赋能高校前沿科研成果转化为具有治疗前景的产品方面具有丰富的经验，是公司加速将产品推向临床试验及实现最终商业化目标的最佳合作伙伴。借助药明生物的一体化IND赋能能力和全球GMP生产产能，Toregem BioPharma能够专注于实现TRG035的最大治疗潜力。我们期待这款牙齿再生药物顺利上市，惠及全球患者。”

药明生物首席执行官陈智胜博士表示，“我们很高兴成为Toregem公司的合作伙伴，通过端到端服务和专业洞见加速TRG035研发进程，这也是药明生物在日本市场赋能的首批从早期科研成果推进至临床阶段的综合项目。我们非常自豪能够为跨国药企、生物技术公司、科研院校等各种类型的全球合作伙伴赋能，助力解决未满足的临床需求，造福广大病患。”

关于Toregem BioPharma

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Toregem BioPharma是一家由京都大学孵化的初创企业，2020年5月成立，以京都大学齿科口腔外科 Katsu Takahashi博士的研究成果（Takahashi K., Inflamm Regen, 40, 21, 2020, Murashima-Suginami A., Sci Adv, 7,eabf, 2021）为基础，专注于研发让牙齿再生的抗体药物。

单个牙齿的形态发生取决于多种分子的相互作用，包括骨形态发生蛋白（BMP）和Wnt信号等。USAG-1是一种双功能蛋白，可拮抗BMP和Wnt这两种牙齿发育所必需的信号分子。因此Takahashi博士对靶向USGA-1的单克隆抗体的疗效进行了研究。实验表明，BMP/Wnt信号通路对于确定小鼠牙齿数量至关重要，而且单次给药就足以长出一颗完整的牙齿。

尽管正常成年人一般有32颗牙齿，但大约1%的人先天牙齿数量过多或者过少。科学家们研究了牙齿过多的遗传原因，用以帮助研究成年人牙齿再生的方法。该研究首次展示了单克隆抗体对牙齿再生的疗效，为目前只能通过植牙和其他人工方法解决的临床问题提供了新的治疗思路。

Takahashi博士表示， “传统的组织工程技术不适用于牙齿再生。我们的研究表明，无细胞分子疗法对先天性牙缺失具有广泛的疗效。” TRG035的I期临床研究计划于2024年初开始。

关于药明生物

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药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。

药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过10000名员工。凭借这些员工组成的专业服务团队，以及卓越的技术和洞见，公司为客户提供高效经济的生物药解决方案。截至2022年6月底，药明生物帮助客户研发和生产的综合项目高达534个，其中包括14个商业化生产项目。

药明生物将环境、社会和治理（ESG）视为业务发展和企业精神的重要组成部分，并致力于成为全球生物药CRDMO领域的ESG领导者，例如应用更绿色环保的新一代生物制药技术和能源等引领行业发展。公司成立了由首席执行官领导的ESG委员会，全面落实ESG战略并践行可持续性发展承诺。

更多信息，请访问：www.wuxibiologics.com。

WuXi Biologics and Toregem BioPharma Sign MOU for Development of Anti-USAG-1 Antibody

SHANGHAI,

Oct. 12, 2022

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and Toregem BioPharma, a biotech startup company from Kyoto University, today announced that they have signed a Memorandum of Understanding (MOU) to form a strategic partnership in the development of TRG035, a monoclonal antibody targeting USAG-1 for the treatment of congenital adentia.

Within the partnership, Toregem BioPharma will have access to WuXi Biologics' integrated CMC services in cell line development, cell banking and testing services, cell culture development, biologics GMP manufacturing, bioassay development, and related services. WuXi Biologics will support Toregem BioPharma on the TRG035 project for its Investigational New Drug (IND) application.

"We are glad to be collaborating with WuXi Biologics as they are experienced in enabling universities to turn advanced technologies into promising products," said Dr. Honoka Kiso, CEO of Toregem BioPharma. "By utilizing WuXi Biologics' comprehensive IND-enabling capabilities and large global footprint with extensive GMP production capacities, Toregem BioPharma will be able to focus on realizing and maximizing the therapeutic potential of TRG035. WuXi Biologics is the best partner for us as we step forward to conduct the clinical trial and realize the eventual commercialization of our unique product. We look forward to bringing this tooth regeneration drug to the global market, treating patients across the world."

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are very pleased to partner with Toregem BioPharma, and this is one of the first integrated CMC projects in Japan that we have supported – with our integrated services and experience – from early academic research phase all the way to clinical phase. WuXi Biologics is proud to support all kinds of global partners in bringing new biologics solutions to life for patients in multiple markets worldwide."

About Toregem BioPharma

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Toregem Bio Pharma Co., Ltd. is a startup venture from Kyoto University that was founded in May, 2020, for the purpose of research and development and launch of a tooth regeneration antibody drug based on the research results of Dr. Katsu Takahashi, Oral and Maxillofacial Surgery, Kyoto University. (Takahashi K., Inflamm Regen, 40, 21, 2020, Murashima-Suginami A., Sci Adv, 7,eabf, 2021.)

The morphogenesis of individual teeth depends on the interactions of several molecules, including BMP and Wnt, which are two signaling molecules essential for tooth development. Recognizing that USAG-1 is a bifunctional protein that antagonizes BMP and Wnt, Dr. Takahashi investigated the effects of a monoclonal antibody for USGA-1. His experiments with this antibody revealed that BMP/Wnt signaling was indeed critical for determining the number of teeth in mice, and moreover, a single administration of the antibody was enough to generate a whole tooth.

Although the normal adult mouth has 32 teeth, about 1% of the population has more or fewer due to congenital conditions. Scientists have explored the genetic causes for cases of having too many teeth as clues for regenerating teeth in adults. The study was the first to show the benefits of monoclonal antibodies on tooth regeneration and provides a new therapeutic framework for a clinical problem that currently can be resolved only with implants and other artificial measures.

"Conventional tissue engineering is not suitable for tooth regeneration. Our study shows that cell-free molecular therapy is effective for a wide range of congenital tooth agenesis," said Dr. Takahashi.

The Phase I clinical study of TRG035 is planned to start in early 2024.

About WuXi Biologics

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WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 10,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2022, WuXi Biologics is supporting 534 integrated client projects, including 14 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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注：本信息不构成药明生物的信息披露或投资建议