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International Regulatory for New Drugs Forum Successfully Held
News & Events CBIIC 2023.09.29 264

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In recent years, with the profound revolution of domestic pharmaceutical market and  industrial development, a growing number of innovative pharmaceutical enterprises embark on a new journey towards “going global”. With the ever-changing industrial environment, how to plan the pathway and make strategies of “going global” is a common issue for all innovative pharmaceutical enterprises. During the 8th China BioMed Innovation and Investment Conference (CBIIC), the parallel session organized by the International Regulatory Science Specialty Committee of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) was successfully held on the September 26. He Ruyi, chairman of International Regulatory Science Specialty Committee, CMO of RemeGen, CMO of SDIC, former chief scientist of CDE was invited to chair the forum.

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He Ruyi

Zhao Xiaobin, founder & president of Haichang Biotech, addressed a keynote speech entitled “QTsome-based Nucleic Acid Drug Development and Clinical Translation”.

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Zhao Xiaobin

Hu Yunfu, CMO of Genetron Health, made a keynote speech entitled “Marketing Companion Diagnostics Overseas - Opportunities and Challenges”, sharing insights into why and how do in vitro diagnostic (IVDs) products go global, and challenges.

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Hu Yunfu

Cao Xianhua, co-founder & president of D2V Clinical addressed a keynote speech entitled “Strategies and Considerations to Conduct Simultaneous MRCT in U.S. and China for Chinese Innovative Drugs”.

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Cao Xianhua

Xiao Shen, CMO of 3D Medicines, addressed a keynote speech entitled “Discussion of Major Factors and Pathways for Domestic Biotech Going Overseas”.

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Xiao Shen

Sun Zhigang, senior vice president, Luye Pharma Group, addressed a keynote speech entitled “Case Sharing of Innovative Drug Rykindo® Approved in the U.S.”.

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Sun Zhigang

Panel discussion was moderated by Chen Shaoyu, managing partner of Arnold & Porter. Du Tao, chairman of Evergreen Therapeutics, Li Ning, CEO of Junshi Biosciences, Hu Yunfu, CMO of Genetron Health, Xiao Shen, CMO of 3D Medicines and Hu Yuzhi, former senior consultant of FDA participated the panel. Participants reached a consensus that the most critical issue is the differentiation of products for the innovative drugs to go global. Only by meeting the actual clinical needs can medical products go global smoothly.

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Panel Discussion

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Forum