On the morning of September 28, 2020, the Forum “Leverage the Global Value of Pharmaceutical Innovations from China” (hereinafter referred to as "Forum") was successfully held in Suzhou Jinji Lake International Conference Center on the 2020 China BioMed Innovation and Investment Conference (2020 CBIIC).The Forum was organized by the newly-established International Regulatory Science Specialty Committee (hereinafter referred to as "Committee") of China Pharmaceutical Innovation and Research Development Association (PhIRDA), aiming at improving the competitiveness of Chinese pharmaceutical enterprises internationally and leading China’s high-quality innovative drugs towards the international layout strategically.

Specially invited by the Forum, Dr. He Ruyi, the initiator and Chairman of the first session of the Committee, CMO of RemeGen, CMO of SDIC and Former Chief Scientist of Center for Drug Evaluation, CFDA, took the moderator in the session. Firstly. Dr. He introduced the Committee: The Committee was newly established on September 27, 2020, composed of more than 30 senior experts who have rich experience in FDA works and regulatory laws of drugs and medical devices in China and the United States. In the future, a major work focus of the Committee will be to benchmark China's innovative drugs against international standards.

Moderator: Dr. He Ruyi

Dr. John Gong, Chairman & CEO of 3D Medicines, delivered the keynote on "Global Clinical Development Strategy of Oncology New Drugs". In recent years, China's pharmaceutical market has stepped into a fast track as the world's second largest market just following the United States. Oncology drugs account for a large proportion in the global market, with promising profit margin in foreign countries, that is why the global market layout is preferred. In terms of clinical needs, drug manufacturing is to solve clinical problems, and there are tremendous unmet clinical needs both in the United States and China. Dr. John Gong proposed that we should jointly work together to promote China's high-quality innovative oncology drugs internationally and to benefit patients all over the world!

Keynote Speaker: Dr. John Gong

Dr. Ben Zhao, Founder of Zhejiang Haichang Biotech, delivered the keynote speech on "Technical Challenges and Investment Opportunities of Nucleic Acid Drugs - Brighter Future Close at Hand" for participants. Small nucleic acid drugs can specifically mute the expression of disease genes in high specificity, high efficiency and long-term effect, etc. In this field, its transformation has been fully researched, with advantages of abundant targets and short R&D period. Now, nucleic acid drugs have recovered rapidly after experiencing a depression. In the past three years, the toxic and side effects caused by off-target have been fully solved with the help of different sequences selecting, chemical modification and carrier technology.

Keynote Speaker: Dr. Ben Zhao

Dr. Wen Hong, CSO of YuanBio Venture Capital, delivered a keynote speech entitled "Opportunities, Risks and the Role of Capital for Innovative Drugs". Facing increasing elderly population in China, health industry is embracing a golden age full of opportunities. "Healthy Longevity" is emerging as an urgent concern, thus bring new windows for innovative drugs. Dr. Wen mentioned that China's health sector is currently the most active one in the world. Given the huge number of patients, a lot of innovation led by laboratories, NMPA’s rapid and drastic reform and growing investment into pharmaceutical innovation, Chinese pharmaceutical enterprises will harvest further innovation.

Keynote Speaker: Dr. Wen Hong

Dr. Audrey Jia, Managing Director of Data Revive LLP, delivered a keynote speech on "Regulatory Challenge from R&D to Marketing for Biological Drugs". Innovative drugs in China are making rapid and huge progress in recent years, especially the biological drugs. Increasing number of products are stepping into China under a series of incentive policies such as the acceleration of review and approval for New Drugs, encouraging the listing of pre-revenue biotech companies in Hong Kong and SSE STAR Market, etc. At the same time, Chinese pharmaceutical enterprises also are preparing for involving international market. In such case, the strategy will play a particularly important role.

Keynote Speaker: Dr. Audrey Jia

Mr. Chen Shaoyu, Managing Partner of Arnold & Porter LLP Shanghai Rep. Office, delivered a keynote speech on "How to Meet the Business and Legal Challenges in US for Chinese Pharmaceutical Companies", and focused on data protection, patent linkage and other issues that Chinese pharmaceutical companies may encounter in the United States.

Keynote Speaker: Mr. CHEN Shaoyu

The last keynote speech, presented by Dr. He Ruyi, Former Chief Scientist of Center for Drug Evaluation, CFDA, illustrated "Key Considerations for New Drug Clinical Study Design" in details by taking Avimopan and Redesivir as examples.

Keynote Speaker: Dr. He Ruyi

The panel “Global Regulatory Strategy for New Drug Development” was moderated by Dr. Tom Du, Chief Advisor & CEO of Humphries Pharmaceutical Consulting, and joined by Dr. Li Ning, CEO of Shanghai Junshi Biosciences, Dr. Ben Zhao, Dr. Chen Shaoyu and Dr. John Gong. The panelists all agreed that innovation would be the only path for a company to survive and develop, besides that, internationalization is a must for innovation. Based on the perspective of registration, regulation, evaluation and clinical experience, an innovative drug in international track means that it is also on a fast track. The innovative pharmaceutical enterprises have been equipped with top R&D experts, complete system, as well as “innovation genes”, eventually, those enterprises will be the real star enterprises in China.

Panel Discussion

Thanks to a series of reforms that encourage pharmaceutical innovation and improve drug quality, such as deepening reform of China's drug regulatory system and accelerating the review and approval for New Drugs, globalization has become a key development strategy for innovation-oriented pharmaceutical enterprises. The Forum is a new-established parallel session on 2020 CBIIC. With the careful design and active participation of the core members of the Committee, the forum successfully presented a distinct theme, covering a wide range of the pharmaceutical industry, which meets the needs of the current pharmaceutical industry. The forum has attracted great attention and received high comments from participants. In the future, the Committee will further provide theoretical and intellectual support for the enterprises’ international development, so as to promote the overall transformation, upgrading and innovative development of China's pharmaceutical industry, and better benefit the health of Chinese people!

Plenary Meeting