China Biotech Podcast: Going Global, IPO Status, Shanghai New Stimulus Policy
Executive Summary
RNK Pharma founder and CEO Yaning Wang joins Brian Yang to discuss the latest biopharma stimulus policies offered by Shanghai and the globalization of China biotech. Dexter Yan also talks about China biotech initial public offering trends in the first half of this year.
In this new episode of the China Biotech Podcast, Brian Yang and guest speaker Yaning Wang discuss the globalization prospects for China biotechs following the setback for Innovent Biologics, Inc.'s anti-PD-1 drug Tyvyt (sintilimab) in the US.
Yaning Wang has 18 years of experience working for the US Food and Drug Administration and then joined Chinese company CreateRNA as the CEO. He recently started up another firm, RNK Pharma, which advises Chinese biotechs on their go-global strategies.
During the discussion, the executive also shed light on the Shanghai government's latest financial stimulus policies to encourage local biotechs and innovative drug companies to develop and seek approval of their products and launch them in overseas markets.
Drawing upon his broad experience, Wang also takes a look at what's lacking for Chinese biotechs as they increasingly sit around the negotiating table with multinational drug makers, and what strategies they should be adopting to maximize valuations of their innovative assets.
Meanwhile, Shanghai-based Dexter Yan discusses his recent coverage of biotech sector initial public offering trends in mainland China and Hong Kong. While the mainland remained in deep freeze, Hong Kong has seen three IPOs so far this year .
大家好,欢迎收听本期也是Brian Yang主持的最后一期的中国生物热点话题讨论。他将于8月初离职。
在本期节目中,我们特意请到了王亚宁博士,他有长达18年在美国食品药品监督管理局FDA工作,他曾担任生物药研发审评中心CBER的生物信息学主任,回国后他加入朗来科技任首席执行官。
最近,他创立了瑞康宁生物医药,专业为公司出海境外注册提供咨询服务。王博士将为我们分享他在三年国内药企工作与大药企谈判的第一手感谢和体会,结合他在FDA的长期经验得出的出海的短板和补齐的对策。
首先,Dexter将分析截止到7月底,创新药企在国内的IPO融资情况有什么新的发展?除了在中国内地上市,在香港上市的情况有何不同?
随后,王博士对于上海最新公布的全链条支持生物制药的政策,尤其对其中的鼓励出海的部分,比如1000万人民币鼓励去国外获批上市创新药和器械,谈了自己的看法。
他认为,在目前资本严冬下,对于小企业来说,这笔钱仍然非常可贵,尤其是对于处于临床I期和临床II期的药企来说。这笔扶持资金对于政府可能不是小数,显示了上海市对于生物药出海的大力支持。
在出海之路上的一个坎是获得境外监管部门的批准,尤其是FDA的批准。信达PD-1信迪利单抗美国FDA被拒,是生物药企出海的一个setback。这样的事例对于中国生物药企有哪些启示?
生物安全(BIOSECURE Act)法案和地缘政治下,是否进军美国市场更加困难?是否应该转向欧洲,东南亚市场?
即使不是拿到美国获批为目的,大部分中国生物药企也在美国有临床试验,获得临床数据,在大的国际学术会议发表,这样可以增大与大药企合作的计划,这样的路径存在哪些挑战?
出海人才方面有哪些短板?海归CEO是否就意味着优势?在文化方面如何让海外的交易更容易达成?
海外药企出海有哪些可以供中国生物药企汲取的教训和经验?比如:日本药企等等。
Stories mentioned in this podcast:
(Also see "China Biotech IPOs Remain In Deep Freeze, Hong Kong Fares Better" - Scrip, 28 Jul, 2024.)
(Also see "Will US Clinical Study Diversity Guidance Cloud Chinese Firms’ Prospects For Going Global?" - Pink Sheet, 11 Jul, 2024.)
(Also see "EU Firms' China Sentiment Plummets, China Go-Global Push Hits Reality Check" - Scrip, 4 Jul, 2024.)