In recent years, with the continuous optimization of the review and approval process and resource allocation by the Chinese drug evaluation institutions, the innovation mode of pharmaceutical enterprises has changed significantly. Joining ICH to be in line with the international market makes it imperative for innovative drugs to go overseas. It also drives a large number of innovative R&D service institutions with deep cultivation in China, high professional degree, strong comprehensive ability and high quality resources to provide more comprehensive and high-end full life cycle R&D services for innovative enterprises, enabling the internationalization of enterprises.

In this context, on the afternoon of September 26, 2021, the “R&D Service Company Roadshow” (hereinafter referred to as the “Roadshow”) of the 2021 China BioMed Innovation and Investment Conference (CBIIC) was successfully held. Moderated by Chang Jianqing, Vice President of Regulatory Policy of Hangzhou Tigermed Consulting Co., Ltd., the

Roadshow brought professional insights and sharing to the audience through keynote speeches and high-quality roadshow projects from the innovation R&D service agencies.

Moderator and Speaker: Chang Jianqing, Vice President of Regulatory Policy of Hangzhou Tigermed Consulting Co., Ltd.

Keynote Speech: Latest Progress of the Clinical Value Oriented IND and NDA Review, Opportunities and Challenges to CRO

At the beginning of the Roadshow, Chang Jianqing delivered a speech entitled “Latest Progress of the Clinical Value Oriented IND and NDA Review, Opportunities and Challenges to CRO”. Through examples and other forms, Ms.Chang introduced the realistic connotation and significance of clinical value and analyzed the status quo of clinical value-oriented review and approval. Finally, some thoughts about the opportunities and challenges of clinical CRO were put forward. Ms.Chang noted that the progress of the review and approval system had brought greater development space for clinical CRO, as well as higher requirements and challenges for comprehensive talents, innovative technologies, policy understanding, communication and other aspects. While looking forward to more progress made by regulators and other institutions, it’s hoped that clinical CRO would continue to strive towards a more professional direction.

Prohects from New Drug Development Service Providers

The Roadshow covered 9 roadshow projects, including translational medicine, personalized diagnosis and treatment services, CRO and CDMO, bringing together all-round, professional and international services.

Projects on Translational Medicine and Personalized Diagnosis and Treatment Services

Project 1: Shanghai LIDE Biotech. Co., Ltd. is a precision cancer medical service company focusing on “functional testing”, providing CRO services of pharmacological efficacy for pharmaceutical companies and carrying out personalized precision medicine in clinical practice. The technical product “MiniPDX” represents a novel platform of fast turnaround (7 days) in vivo drug sensitivity test, suitable for testing targeted drugs, chemotherapy drugs, anti-angiogenesis and other drugs that affect the tumor microenvironment.

Project 2: Amoy Diagnostics Co., Ltd. is founded by Professor Zheng Limou back in 2008. It integrates the R&D, production, sales and service of precision oncology diagnosis products, and has the production/operation qualification of three types of in vitro diagnosis products and independent clinical medical examination qualification.

Projects on CRO Companies

Project 3: dMed Biopharmaceutical Co., Ltd. is a clinical Contract Research Organization (CRO) based in China and facing the world. Many of the employees are industry elites of multinational pharmaceutical companies and authoritative experts from Chinese and American pharmaceutical regulatory agencies. With years of rich experience in drug development, the company is able to provide customers with more valuable suggestions and more reliable operation management from scheme design to declaration strategy, and from operation execution to quality assurance.

Project 4: GX Pharma Technology (Beijing) Co., Ltd., founded in 2008, is a pharmaceutical research and CRO company that focuses on providing the overall clinical research services and registration applications solutions for drugs, biological products and medical devices, covering innovative traditional Chinese medicine, biological medicine, small drug molecules and cells treatment services, and is committed to creating a “Transformation Platform for Innovative Life Science Service ”.

Project 5: Shanghai Medicilon Inc. (Stock Code: 688202) is a drug R&D CRO that has established a comprehensive technical service platform in Shanghai that meets international standards, integrating compound synthesis, compound activity screening, structural biology, pharmacodynamics evaluation, pharmacokinetic evaluation, toxicology evaluation, preparation research and new drug registration.

Project 6: Rundo International Pharmaceutical Research & Development Co., Ltd., founded in 2004, is a CRO company specializing in providing one-stop clinical research outsourcing services. It is one of the leading clinical CRO companies in China, and is also exploring innovative models and digital technologies to transform into an innovative and integrated CRO. Its main services include providing customers with one-stop clinical research services in accordance with ICH-GCP and NMPA regulations and professional specifications.

Project 7: Redbud Medicine Co., Ltd., with its root in the world’s two most important drug R&D markets of China and the United States, has a strong network of doctors and specialists. The company has established a unique and comprehensive information retrieval system of health resources data, which can achieve rapid clinical trial execution and expert review, and provide customized international clinical CRO services.

Projects on CDMO Companies

Project 8: Located in Suzhou, Porton Biologics Ltd. (Portonbio) was established in December 2018. As a wholly-owned subsidiary of Porton Pharma Solutions Ltd. (Stock Code: 300363), Portonbio has established a CDMO platform integrating plasmid, viral vector and cell therapy products, providing services from early stage, investigator-initiated clinical trials, IND filling, registered clinical trial samples and commercial production to accelerate the transformation process of drug research.

Project 9: Peking University Biologics, a wholly-owned subsidiary of the listed company--Sinobioway Medicine (Stock Code: 002581), is a leading professional institution of biopharmaceutical CDMO with rich experience in the R&D and production of antibody drugs, recombinant proteins and other macromolecular drugs  in China. It aims to help start-up bio-companies by providing R&D to commercial production as well as the approval service of United States, Europe, and Japan.

R&D Service Company Roadshow