北大生物与HiRO达成战略合作协议, 携手更快, 更成功的为患者提供药物

2022年 1 月 17 日, 北大未名 （合肥）生物制药有限公司（以下简称 “北大生物”）和上海贺维斯特医药科技有限公司（Harvest Integrated Research Organization） （以下简称 “HiRO”）宣布签订《战略合作协议》（以下简称“协议”)。

根据协议，双方将主要就药品委托技术开发、生产、检测及临床委托开发订单等方面进行紧密合作。北大生物将在药品CMO/CDMO服务过程中的合作伙伴有在中国（含港澳台）、澳洲、新西兰、美国、日本进行药品临床开发、IND申报等相关合作机会推荐给HiRO。同时，HiRO也向有药品CMO/CDMO开发生产需求的合作伙伴介绍北大生物。双方都希望通过建立长期、全面的战略合作伙伴关系，实现优势互补及资源共享，以更好地促进双方业务发展。

北大生物首席执行官陈晋宇先生（右）与上海贺维斯特医药科技有限公司的创始人兼首席执行官Karen Chu博士（左）共同出席了2022年1月17日的合同签署仪式。

北大生物首席执行官陈晋宇先生对于本次合作表示：

“北大生物与 HiRO 建立长期、全面的战略伙伴关系，有利于实现优势互补、资源共享、共同发展。HiRO 作为一家具有国际运营与整合能力的临床试验专业 CRO公司，能够在广泛的治疗领域提供符合GCP的全方位临床、数据统计和管控等服务。传统一期临床试验需要12至18个月时间，但通过北大生物在新西兰和澳洲执行，只需6至9个月即可完成，也可显著降低投入成本。同时澳洲、新西兰出具的一期临床报告专业可靠，国际认可度高。北大生物与HiRO的核心团队引导项目及提供一站式的CDMO生物制药服务，为初创项目从药物开发、验证、CMC 准备、IND申报、临床样品生产、临床研究及一期到三期临床试验，节约时间和成本的同时也为客户的项目提高价值，达到国际标准及项目国际化。”

上海贺维斯特医药科技有限公司的创始人兼首席执行官Karen Chu博士对于本次合作表示:

“这个协议为我们不断扩大的服务平台增添了变革性优势，也是 HiRO 与北大生物共同推动下一波药物创新的一部分。我们相信这是一个潜在的协同合作伙伴关系，因为它建立在我们目前的能力之上，并将继续帮助我们为我们的客户重新构想更具成本效益的临床试验服务。HiRO 和北大生物将携手合作，并利用双方拥有最强的特定国家的运营资源和专业知识，在全球范围内提供高质量的临床试验解决方案。HiRO 致力于与合作伙伴合作，在更好的临床试验管理方面取得进步，增加我们对市场需求的了解，并探索创新的解决方案，更快, 更成功的为患者提供药物。我相信是次的伙伴关系将把双方最好的一面融合在一起，以综合方式支持生物制药行业，实现价值最大化。”

北大生物是一家一站式的生物制药CDMO专业机构，拥有多年的生物制药规模化、优化和技术转移经验，专注于生物药物从基因开发到CMC准备、IND申报、临床样品生产、BLA到商业化销售等。是安徽省领先取得《药品生产许可证》专业大分子CDMO公司，荣获2021年“安徽质量信用AAA级示范企业”，同时被合肥市“一带一路”科技产业创新战略联盟授予“日本合作交流基地“称号。拥有40万平方米的CDMO生产基地，在香港和厦门设有研发生产中心，以支持中国制药进入国际市场。我们的管理团队在药物开发、GMP生产和监管方面积累了多年的经验（NMPA、FDA、EMA、PMDA、TGA及MedSafe等），以帮助药物开发公司满足监管要求。

同时，我们与新西兰和澳洲的CRO公司为初创项目从药物开发、验证、CMC 准备、IND申报、临床样品生产到新西兰与澳洲执行一期临床试验，以低成本和短时间内为客户的项目提高价值，达到国际标准（GMP规格）及项目国际化。

北大生物为您的项目提高成本效益，是您在国际生物制药市场的 “生物大使“！

上海贺维斯特医药科技有限公司 Harvest Integrated Research Organization（HiRO），是一家立足中国，面向世界的创新临床研究组织（CRO），总部设立在上海。HiRO拥有全球化的运营和整合能力，始终致力于为全球客户提供全流程服务及解决方案。

HiRO的目标是成为一个市场领先的、综合的全球临床研究组织，与蒸蒸日上的生物技术和生物制药公司一同不断引领医药产品从实验室走向市场，为全球患者提供更具效益的解决方案。作为医药企业的亲密合作伙伴，我们以有效利用真实世界数据为基础，加之”管家“服务精神，提供全方位的定制化服务。

HiRO于2021年收购PharmaSols, 充分利用新西兰与澳大利亚更多的患者资源, 专业医疗知识和卓越的营运服务,提供给客户更专业的服务。

若有其他询问，请发送至以下电子邮箱：

info@harvestiro.com

HiRO 官网：www.harvestiro.com

Shanghai, January 17, 2022 - Peking University V-Ming (Hefei) Biologics Co., Limited (hereinafter known as ‘Peking University Biologics’) and Harvest Integrated Research Organization (hereinafter known as ‘HiRO’) announced today that both parties have entered into a Strategic Cooperation Agreement (‘Agreement’) for expanding research and development capabilities.

According to the Agreement, the two parties will mainly cooperate closely on drug technology development, manufacturing, testing, and clinical development orders. Peking University Biologics will introduce to HiRO its partners in the process of drug CMO/CDMO services, located in China (Hong Kong, Macau, and Taiwan), Australia, New Zealand, the United States, and Japan for clinical drug development, IND application and other related opportunities. In the meantime, HiRO will also introduce Peking University Biologics to its partners who have drug development and manufacturing needs of CMO/CDMO. Both parties wish that through this established long-term, comprehensive, and strategic partnership; both parties will achieve complementary advantages and leverage resources to better promote mutual business development.

Mr. Wayne Tan, CEO of Peking University Biologics (right) and Dr. Karen Chu (left), CEO and Founder of HiRO, attended the Cooperation Signing Ceremony on January 17, 2022.

Message from Mr. Wayne Tan, CEO of Peking University Biologics

“The establishment of a long-term and comprehensive strategic partnership between Peking University Biologics and HiRO is conducive to achieving complementary advantages, resource sharing, and common business development. As a professional clinical trial CRO company with international operations and integration capabilities, HiRO can provide a full range of GCP-compliant clinical, data statistics, and management services in a wide range of therapeutic areas. The traditional phase I clinical trial takes 12 to 18 months; however, it only takes 6 to 9 months to complete the project through Peking University Biologics in New Zealand and Australia, and the cost can also be significantly reduced. In the meantime, the phase I clinical trial reports issued by New Zealand and Australia agencies are professional and reliable with a high degree of international recognition. The core team of Peking University Biologics and HiRO guides the project and provides one-stop CDMO biopharmaceutical services for start-up projects from drug development, validation, CMC preparation, IND application, production of clinical samples, clinical research, and to conduct phase I to phase III clinical trials. While saving time and cost, it also increases the value of customers’ projects, reaching international standards and project internationalization.”

Message from Dr. Karen Chu, CEO and founder of HiRO

“This agreement adds transformative advantages to our expanding services platform and is part of the HiRO’s effort to drive the next wave of drug innovation with Peking University Biologics. We believe this is a potentially synergistic partnership, as it builds on top of our current capabilities and will continue to help us reimagine more cost-efficient clinical trials operations for our customers. Together, HiRO and Peking University Biologics will collaborate and leverage operational resources and expertise in specific countries where they both have the strongest and solid presence to deliver high-quality clinical trials solutions worldwide. HiRO is committed to working with its partners to pursue advances in better clinical trials management, increasing our understanding of the market needs, and exploring innovative solutions to bring medicine, faster and successfully to patients. I believe this partnership will bring the best of both parties together in supporting the biopharma industry in an integrated way, achieving maximized value.”

Peking University Biologics is a one-stop biopharmaceutical CDMO professional organization with many years of biopharmaceutical scale-up, optimization, and technology transfer experience focusing on biologic drugs from gene development to CMC preparation, IND application, commercial manufacturing, BLA to commercialization.

In 2021, we were the first leading biologics CDMO company to obtain the “Drug Manufacturing License” in Anhui Province, awarded the “Anhui Quality Credit AAA Demonstration Enterprise” and awarded the title of Hefei City’s “Japan Cooperation and Exchange Base” of the “One Belt, One Road” Alliance for Technology Industry Innovation. As one of the largest biologics CDMO manufacturing sites in China (over 400,000 ㎡ of the production facility and infrastructure), we also have R&D technical centers in Hong Kong and Xiamen to support China-based biotech and biopharmaceutical companies to enter the international market. Our management team has accumulated years of experience in drug development, GMP production, and regulatory experience (NMPA, FDA, EMA, PMDA, TGA, MedSafe, etc.) to help drug development companies fulfill regulatory requirements.

At the same time, we work with CRO companies in New Zealand and Australia for start-up projects from drug development, validation, CMC preparation, IND application, production of clinical samples to conducting Phase I clinical trials in New Zealand and Australia so as to increase the value for customers’ projects at low cost and within a short period to achieve international standards (GMP specification) and project internationalization.

To increase the cost-effectiveness for customers’ projects, Peking University Biologics is your “Biologics Ambassador” to the international biopharmaceutical market!

Harvest Integrated Research Organization (HiRO) is a China-based globally oriented innovative clinical research organization (CRO) with its headquarters in Shanghai, China. With global operations and integration capabilities, the company is dedicated to providing its clients with a full range of solutions and services. HiRO strives to become a market-leading, integrated global CRO that works together with biotech companies and pharmaceutical companies to bring new products from laboratory to the market, providing more effective solutions for patients worldwide.

HiRO acquired PharmaSols in 2021, making full use of more patient resources, professional medical knowledge and excellent operational services in New Zealand and Australia to provide customers with more professional services.

Additionally, email inquiries can be sent to following address:

info@harvestiro.com

HiRO websie: www.harvestiro.com