Chinese Language Podcast: BIOSECURE Act, US PD-1 Approval, ADC Updates
Executive Summary
Guest speaker and lawyer Kevin Duan joins Brian Yang and Dexter Yan to discuss the planned US BIOSECURE Act, the US approval of BeiGene's anti-PD-1 drug and the latest antibody-drug conjugates in development at Chinese pharma firms.
The proposed BIOSECURE Act is advancing through the US Congress after the Senate voted in favor of passing the associated bill, creating worry among industry insiders in China about the planned legislation's unintended consequences. (Also see "China Biotechs, CDMOs Embrace Uncertain Future, New Options Amid WuXi Woes" - Scrip, 19 Mar, 2024.)
In this latest Chinese-language podcast, editors Brian Yang and Dexter Yan, along with guest, lawyer Kevin Duan, discuss the significance, potential scope and impact of the law, how potentially affected companies should prepare and likely next steps.
Also in the US, the Food and Drug Administration recently approved BeiGene, Ltd.'s anti-PD-1 antibody Tevimbra (tislelizumab) after a long 20-month wait. (Also see "US Tevimbra Approval Validates BeiGene’s Asia-Heavy Global Trial Approach" - Scrip, 17 Mar, 2024.)
As the approval was largely based on a Phase III trial that had the majority of its participants from Asia, what are some of the lessons to be learned about clinical study design for other biopharma companies eyeing US product approvals? Also discussed is the competitive landscape for the drug's approved indication and the prospects for tislelizumab to move into the first-line setting.
China's originators of antibody-drug conjugates (ADCs) have continued venturing into more therapeutic targets, including EGFR x HER3. (Also see "Chinese ADC Developers Unveil More Target Combos In Bispecific Drive" - Scrip, 13 Mar, 2024.) What are the latest developments at Biokine Therapeutics Ltd. and partner Bristol Myers Squibb Company and what are other ADC developers doing to catch up across various targets?
百济神州的替雷利珠单抗最新在美国获批二线治疗食管鳞癌。替雷利珠此次成功在美获批，有什么可以让中国药企借鉴的经验，特别在开展临床试验方面？替雷利珠将来在美国面临的与同类药物的竞争格局是怎么样的？包括二线食管鳞癌治疗，以及未来可能获批的新适应症方面，如一线食管鳞癌治疗，一线胃或胃食管结合部腺癌？
中国双特异性抗体偶联药物最新的研发进展。从去年12月百利天恒和BMS关于EGFR x HER3双抗ADC的合作后，双方有什么新的进展？其他国内药企在双抗ADC研发是否也在跟进？
美国国会最近的BIOSECURE法案进展如何，这个法案，和拜登政府上个月公布的限制受关注的国家和公司使用美国个人数据的行政命令（EO）一起，对于生物临床试验机构和研发生产外包企业有哪些潜在影响？影响的范围怎样？生物药企如何应对？下一步会是怎样？特邀嘉宾，汉坤律师事务所数据合规负责的段志超（Kevin）从法律角度对这些关系的问题做了专业的分析。