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China Approval For Akeso’s Bispecific But ASCO Data Unnerve Investors

 
• By Dexter Jie Yan

Ivonescimab in combination with chemotherapy reduced the risk of disease progression or death by 54% versus placebo in EGFR-mutated, non-squamous NSCLC after failed EGFR inhibitor treatment. However, the progression-free survival data did little to satisfy investors’ demand for clear benefits versus competitors. 

China pharma US trial
Akeso's ivonescimab faces twisty road to efficacy superiority over rivals • Source: Shutterstock

Akeso Inc. has snagged a world-first approval, in China, for ivonescimab, its first-in-class PD-1/VEGF-targeting bispecific antibody.

But the glitter of the breakthrough was dimmed by investors’ alleged concerns over efficacy data from the Phase III trial with the agent, the same data on which the regulatory green light was based and which will be presented

Key Takeaways

  • Akeso's ivonescimab, a PD-1/VEGF-targeting bispecific antibody, was approved in China on 24 May in combination with chemotherapy for EGFR-mutated NSCLC after progression on EGFR inhibitor treatment.

  • But the same day, investors sold off Akeso shares amid concerns over efficacy data to be presented in an oral report at ASCO

More from China

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

 
• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By Xu Hu

CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.

Akeso Explains Ivonescimab Prelim OS Data After Investors’ Negative Reactions

 
• By Dexter Jie Yan

Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.

More from Focus On Asia

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By Xu Hu

CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Akeso Explains Ivonescimab Prelim OS Data After Investors’ Negative Reactions

 
• By Dexter Jie Yan

Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.