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Chinese-Language Podcast: 聊聊肿瘤治疗疫苗和二十大的政策看点

Key Policies And Clinical Guidance To Watch

Executive Summary

China's once-in-five-years Communist Party National Congress and new leadership, as well as new guidelines on therapeutic cancer vaccines, are the main topics for this new China Biotech Hot Topic podcast. Brian Yang and Dexter Yan discuss key points to watch and the implications for major players and the wider pharma sector.

China’s Center for Drug Evaluation (CDE), the country’s top drug regulatory body, has revealed its considerations on how sponsors should design clinical trials for therapeutic vaccines for use in oncology, as biotechs in the country increasingly pursue innovation in this and other sectors.

On 9 October, the CDE published a draft version of the proposed new Technical Guidelines for Clinical Trials of Therapeutic Cancer Vaccines, on which it will collect public comments until 9 November.

The podcast discussion looks at the key differences between the planned Chinese guidance and that of the US Food and Drug Administration issued in 2011, along with other key points to watch and the major domestic players in the development of therapeutic cancer vaccines.

In the second part of the podcast, we take a look at the Communist Party's just concluded, once-in-five-years National Congress, which elected a new senior leadership group and which gave President Xi Jinping an unprecedented third term. Major themes including the ideas of "common prosperity" and "dual circulation" and the implications for the pharma and health sector are discussed.

欢迎来到下一期的中国生物制药热门话题播客。

本期节目中,两位主播首先讨论了新药审评中心CDE最新发布的《人乳头瘤病毒疫苗临床试验技术指定原则(征求意见稿)》,这个指导原则和美国食品药品监督管理局2011年的指导原则相比,有哪些相似和不同?特色之处何在?国内创新药企布局这个领域的主要有哪些?

节目的后半部分,最近召开的中共二十大,尤其是”共同富裕“,”双循环“对于健康行业有哪些可能的影响?市场和投资人对于今后的政策反应如何?会后有哪些政策亮点?

如果你有意见和建议,请电邮我们。

感谢收听,下期再会。

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