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 conductive 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 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.

Contact

Additionally, email inquiries can be sent to following address:

info@harvestiro.com

HiRO websie: www.harvestiro.com