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China Biotech Podcast: 数据出境新规解读，EHA和ADA的中国数据发布

 
• By Brian Yang and Dexter Jie Yan

In this Chinese-language podcast episode, "Angus" Shipo Xie, a lawyer at Han Kun Law, joins Brian Yang to discuss the implications of China's updated Data Overseas Transfer rules issued in late March. Dexter Yan explains clinical data released by Hutchmed, Jiangsu Hengrui and Innovent Bio at the recent EHA and ADA annual conferences.

Chinese biotech podcast
• Source: Citeline/Shutterstock

在最近召开的国际学术大会，比如6月13到16日在西班牙马德里举行的欧洲血液学会EHA年会，和6月21到24日美国芝加哥举行的糖尿病学会ADA年会上，中国生物药企和黄医药(Hutchmed)、恒瑞医药以及信达生物分别有重磅新药数据发布。其中，和黄医药的syk抑制剂索乐匹尼布sovleplenib用于原发免疫性血小板减少症（ITP）有什么亮点？

恒瑞医药和信达生物分别在ADA年会上发布了减肥药GLP-1受体/GIP 受体双重激动剂，和减肥药GLP-1受体/GCG受体双重激动剂的临床试验结果。在诺和诺德获得GLP-1治疗肥胖在中国批准之后，这两家中国生物药企如何差异化竞争？

作为三个目前有较为明确规定的数据出境的行业，医药行业的数据出海将会如何？

3月22日正式公布实施的《促进和规范数据跨境流动规定》，在中国药企和海外公司交易不断热情高涨的当下，相比去年的草案，这个新规对于药企出海有哪些新的变化，对于药企数据出境有哪些影响？药企如何准备？

Special guest, "Angus" Shipo Xie from Han Kun Law, joins Brian Yang and Dexter Yan to discuss recent trending topics in the China biotech sector. Dexter also talks about the recent clinical data readouts presented at the recent European Hematology Association and American Diabetes Association meetings by Chinese firms HUTCHMED (China) Limited on sovleplenib, Jiangsu Hengrui Medicine Co., Ltd. on its GLP-1/GIP receptor agonist and Innovent Biologics, Inc. on a GLP-1/GCG receptor agonist. 

In the second part of the podcast, Angus explains notable changes to China's new rules on Promoting and Regulating Overseas Data Transfers, issued on 22 March by the national Cybersecurity Administration. What do the new changes mean for drug makers, what are the notable points worth paying close attention and what should companies do to be compliant?

Stories mentioned in this episode:

(Also see "China Phase III Results Boost Global Prospects For HUTCHMED ITP Drug" - Scrip, 18 June, 2024.)

(Also see "China Implements Data Transfer Regulation, With Some Waivers" - Pink Sheet, 4 April, 2024.)

Citeline · China Biotech Podcast - 26 June 2024 (Chinese language)

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