New Chinese-Language Podcast: 聊聊生物制药热门话题
Hot Topic Chat
Executive Summary
Join our China-based content team for this inaugural Chinese-language podcast discussing selected recent hot topics impacting the biopharma industry in China, including bispecific antibodies, antibody-drug conjugates and new regulatory policies designed to speed product approvals.
Brian Yang and Dexter Yan discuss recent hot topics in China's biopharma industry in this new podcast chat series (Chinese-language description below).
On 29 June, China officially approved its first bispecific anti-PD-1/CTLA4 antibody for cervical cancer. The move also marked the new addition of another immuno-oncology contender to an already highly competitive market.
Also in June, the National Medical Products Administration issued a policy to accelerate the approval of new drugs from overseas and with large clinical need, drugs to treat orphan and pediatric conditions, and products for major infectious diseases. Related measures included improving communications with foreign pharma firms, in China’s latest bid to attract and retain foreign investment in the country, amid Beijing’s draconian "COVID Zero" policy and months-long lockdowns in Shanghai and other parts of the country.
The latest developments in antibody-drug conjugates are also discussed in this episode, designed to help you understand what’s hot in China’s biopharma development sphere.
If you have any suggestions, ideas or comments, please contact the authors via the addresses in the byline box above.
欢迎来中国生物制药热点博客做客！
分析热点，政策解读和行业热门追踪是我们的宗旨。
在首期的节目中，中国主编杨宏新Brian和资深记者严洁Dexter首先讨论了康方生物最新获得药监局批准，世界首个PD-1/CTLA-4靶点双特异性抗体卡度尼利单抗Cadonilimab，用于二线治疗宫颈癌。 (Also see "China Approves World’s First Bispecific IO Drug Amid PD-1/L1 Glut" - Scrip, 1 Jul, 2022.)
这个获批也是中国第一个批准治疗宫颈癌的肿瘤免疫疗法。和默克的K药比较，这个获批有什么意义？对于中国国内其他在研的含PD-1靶点的双特异性抗体来说有什么影响？
接下来的话题是最近国家药监局公布《关于进一步加强外资企业服务工作的通知》，其中特别提出要加快临床急需境外新药，罕见病，儿童用药和重大传染病新药的审评审批。 (Also see "Invitation Extended: New Chinese Policies Aim To Lure Foreign Pharma Firms" - Pink Sheet, 1 Jul, 2022.)
除了加速新药审评审批，这个政策的亮点还包括：专栏链接制度，畅通企业诉求沟通渠道。作为“稳外资稳外贸”的一环，这些新政策将带来新药获批的加速和监管交流沟通的进一步加强。
这期博客还讨论了抗体偶联药物（ADC）的竞争格局，以及中国生物制药（Sino Biopharmaceutical）计划通过旗下InvoX以1.61亿美元收购纳斯达克上市的英国抗体药企F-star Therapeutics。 (Also see "Asia Deal Watch: invoX Builds Novel Pipeline Through $161m F-star Acquisition" - Scrip, 24 Jun, 2022.)
这也是2022年至今中国药企的首个数亿美元级别的大手笔收购。此次收购对于中国药企来说，无疑是一剂强心剂。
如果你有任何建议，意见和希望听到我们讨论的话题，欢迎留言！我们还将不定期邀请特邀嘉宾一起来到博客间，和我们一起深度“潜水”，聊聊影响中国生物制药领域的各种有意思的热点和政策话题。
感谢收听，让我们下一期节目见！
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