HONG KONG, CHINA – Media OutReach – 3 June 2019 – Great Bay Bio, a leading biotechnology company dedicated to innovative drug CMC (Chemistry Manufacturing and Controls) and pre-clinical development of big data service platform, announced its formal establishment in Hong Kong today and the Chairman, Mr. Kingsley Leung is pleased to appoint Mr. Michael Chan as CEO and co-founder of the company on behalf of the board. Dr. Michael Chan has officially assumed his duties on May 20. He will formulate a sustainable development strategy for Great Bay Bio and be responsible for the overall operation and management of the enterprise. The Headquarter will be based in Hong Kong and expand its business domestically and internationally. The company currently focuses on two major business lines-CMC platform technology services and product development, including 2 subsidiaries as Dongguan Taili Biotech Co., Ltd. and Guangdong Taili Biomedical Technology Co., Ltd. Before its establishment, Great Bay Bio has won the favor of many financial investment institutions and strategic investment institutions.

Development Target and Unique Development Model of Great Bay Bio

1) Focusing on the Fusion and Development of Greater Bay Area to Help Pharmaceutical Innovation

In 2018, the Greater Bay Area of Guangdong, Hong Kong and Macao became a national strategy to encourage all kinds of scientific and technological innovation resources in this Area to cooperate and complement each other, and enterprises to develop together. After carefully studying the innovative thinking of the development strategy of this Area, Great Bay Bio began to gather the leading wisdom of experts and scholars in the field of life science and biotechnology and elites from all walks of life sciences, expecting to help China’s biotechnology R&D capability upgrade faster and better, and to support the development of biomedical industry in the region towards scale, agglomeration and internationalization.

Based on the principle of mutual benefit and win-win, Great Bay Bio closely adheres to the existing superior resources and development goals, providing high-quality CMC one-stop service for domestic and foreign pharmaceutical partners. The company has a full set of leading biomedical development equipment and facilities, and has successful experience in developing E. coli, yeast, CHO cells and other products. It can provide CMC services and complete all the work from project screening, clinical sample production and product testing, such as drug discovery, sequence screening, plasmid construction, cell strain (bacterial strain) construction, cell culture (fermentation), purification process development, preparation process development and quality research. Open service mode the company has been exploring is called “equity-for-service model”, which can provide new modes such as financial support plus technology equity and service support plus share or intellectual property equity, providing a variety of cooperation possibilities, insisting on the balanced development of specialization and diversity.

2) Constructing the talent echelon and exploring the new service package of CMC/CDMO

The importance of CMC research in the stage of new drug discovery and preclinical research is self-evident. Driven by the overall situation of the pharmaceutical industry and national policies, the domestic market of customized development and production of biopharmaceuticals (CDMO) is also rising rapidly. From 2016 to 2020, the CDMO market of biological drugs in China will grow from 2 billion yuan to 10 billion yuan, and the compound growth rate will reach 35%. The CMC/CDMO customized service market in the Greater Bay Area of Guangdong, Hong Kong and Macau has considerable potential, and international talents are gathered here. These advantages are the best business starting point for us.

Great Bay Bio’s Service Platform of CMC/CDMO Technology and Pre-clinical Research and Big Data Development has a technical team of over 40 scientists and investigators led by PhDs/senior engineers. The team will offer an integrated service package with variability and customization.

Among the subdivisions of the Service Platform in the field of biopharmaceutical innovation technology, the most noteworthy is the establishment of Fc Platform. The goal of this platform is to use Fc fragments of IgG to connect with unstable or short half-life polypeptides, cytokines, hormones or enzymes to form fusion proteins, prolong their half-life in vivo and reduce the frequency of administration. The company uses Fc fragments of IgG2 subtype (wild type) or IgG4 subtype (S228P mutation) to fuse with different polypeptides, and has incubated one project using this technology, rhEPO-Fc which is now in phase I clinical research. The company is also looking to begin development of additional first-in-class and best-in-class products with prospective technology partners. The most important feature of this platform is to use CMC technology to carry out rapid pre-clinical research, such as molecular structure stability study, in vitro biological activity study, animal pharmacodynamics sample preparation, process feasibility study, etc., which can quickly judge the possibility of drug formation in the research projects.

3) Deepening the Service System and Constructing One-stop New Drug Service

Dr. Michael Chan, CEO, said: Based on the international perspective, the Science and Technology Innovation Park in Greater Bay Area of Guangdong, Hong Kong and Macao has made a long-term layout for the R&D and innovation capabilities of the New Economic Zone. Since the development and Preparatory Period of Great Bay Bio and its formation of the business concept in 2018, we have clearly realized that innovation in this Area is no longer confined to providing basic facilities and sites for new drug research and development, and that greater value is to enable more industries. Internal experts, institutions and cross-border integrators jointly promote the development of pharmaceutical enterprises, which has entered a new stage of development, and the orientation and implementation of industrial integration will continue to deepen. The mission of Great Bay Bio is to speed up the development and production of biological drugs, which is in line with our business operation now and in the future. The meaning lies in that faster development of products will significantly reduce R&D cost for our partners, which will ultimately benefit patients with cheaper innovative drugs. Great Bay Bio Biological’s business model can provide precise and comprehensive customized one-stop new drug service, which will occupy an important position in the biopharmaceutical industry chain. At the same time, it will further expand the service space and capacity of biopharmaceutical and strive to become the best partner in the pharmaceutical industry.

Kingsley Leung (R) and Michael Chan (L)

Introduction of CEO and Co-Founder

Dr. Michael Chan graduated from the Doctor of Biochemistry, University of Georgia, USA. He has more than 30 years of rich experience in biomedical research and development, team building and operation management, In particular, Michael has ever been a distinguished leader for 5 projects of Biosimilar and innovative macromolecule’s IND Application during the same period within 3 three years. He has successively held senior management positions, chief operating officer and President Positions in many famous pharmaceutical companies in the United States and Shanghai Hengrui. Dr. Chan has published more than 18 articles and patents in international SCI journals.

Introduction of Chairman of the Board and Co-Founder

Mr. Kingsley Leung holds a BSc in Biochemistry from Imperial College London and an MSc in Pharmacology from the University of Oxford. In addition, he is currently a Chartered Financial Analyst and a member of The Hong Kong Society of Financial Analysts and holds a Professional Diploma in Corporate Governance & Directorship from the Hong Kong Institute of Directors. In 2018, Mr. Leung successfully completed the Insead EMBA project held by Tsinghua University. Prior to the founding of the Great Bay Bio, Mr. Leung is the chairman of Uni-Bio Science Group, a listed Biopharmaceutical company?HK0690?in HKEx main board and has broad experience in sourcing, evaluating and executing new growth opportunities, supporting the execution and alliance management of multiple deals, including the in-licensing of next generation oncology, inflammation and respiratory drugs from MNCs. Mr. Leung also has extensive experience in the finance industry where he worked in a number of budge bracket investment banks and a family office.

Great Bay Bio

About Great Bay Bio

Headquartered in Hong Kong, the CMC/CDMO platform of Great Bay Bio was originally established in 2002. Dongguan Taili Biotech Co., Ltd. and Guangdong Taili Biomedical Technology Co., Ltd. were founded successively. The R&D equipment invested more than 54 million yuan and the total R&D cost exceeded 300 million yuan. The CMC/CDMO platform has independent and integrated technology platform for drug R&D and large-scale preparation. The company has a strong existing track record of developing CMC packages for products entering NDA stage, some of which are national class I projects of innovative biological New drugs.

The platform has been recognized and certificated as “Patent Fostering Enterprise”, “Patent Pilot Enterprise”, “National High-tech Enterprise”, “Dongguan New R&D Institution”, “Guangdong Top Ten Foreign-funded R&D Center” and “Guangdong Genetically Pharmaceutical Engineering Research Center”. Since 2006, it has undertaken a number of government projects and obtained crucial breakthroughs in key areas of Guangdong and Hong Kong. Several provincial and national projects, such as “National Major New Drug Innovation”, have been funded by government support of more than 20 million yuan.

The platform has over 3100 square meters of research and Development Experimental sites, and has a whole set of advanced biopharmaceutical research and development hardware and facilities. The key equipments are labeled by Sartorius, Bio-Rad, GE Healthcare, Waters and other world-class brands. The pilot workshop is designed strictly in accordance with GMP requirements. The overall purification level of the plant is C-level and partial A-level.

For more information, you can visit Great Bay Bio’s official website: www.greatbay-bio.com

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