In separate DLL3 antibody-drug conjugate (ADC) deals, Roche licensed from Innovent Biologics and Ideaya reached for Hengrui. Experts weighed in on the potential implications and lessons from two investigations into AstraZeneca's practices in China. A Viatris plant in India was issued an FDA warning letter. And more.
1. Roche returns to Innovent Biologics with new $1B biobucks ADC drug deal
The DLL3 space continues to gain traction. Roche has joined the race by paying Innovent Biologics $80 million upfront for IBI3009, a DLL3-targeted antibody-drug conjugate. Potential milestones could reach $1 billion. The deal comes shortly after Zai Lab reported impressive response data for its DLL3 ADC, ZL-1310, in small cell lung cancer.
2. 2025 forecast: What can AstraZeneca's China probes teach other biopharma companies?
Experts expect that operations at AstraZeneca China will slow down at least in the short term thanks to two investigations into its sales practices. But in a sign that the company might be let off the hook largely unscathed, CEO Pascal Soriot recently had a virtual meeting with Beijing Mayor Yong Yin. Analysts suggested that the company and other biopharma companies operating in China will remain vigilant about compliance and be realistic about sales goals.
3. Viatris says India plant hit with FDA warning letter, import ban on 11 products
Viatris’ manufacturing facility in Indore, India, was hit with an FDA warning letter banning 11 products from entering the U.S. But the company also said the agency could make an exception for four—and possibly more—of the products due to shortage concerns. The exact nature of the problems was unknown, while Viatris said it has implemented a remediation plan.
4. BeiGene, Brii and Ideaya ring in 2025 with deal news, betting billions in biobucks on prospects
In another DLL3 ADC deal potentially worth more than $1 billion, Ideaya Biosciences is paying Jiangsu Hengrui Pharmaceuticals $75 million upfront for rights to SHR-4849 outside of China. Separately, in two follow-up deals, BeiGene has taken up its option to license Duality Biologics’ B7H4-directed ADC, and Brii Biosciences has fully acquired its hepatitis B candidate from VBI Vaccines.
5. With $608M divestment, Hutchmed continues to focus on ADC development
Hutchmed is divesting its 45% interest in Shanghai Hutchinson Pharmaceuticals Limited to its joint venture partner Shanghai Pharma and private equity firm GP Health Service Capital for $608 million. The unit is focused on traditional Chinese medicines. Hutchmed plans to use the proceedings to invest in ADCs.
6. Sanofi scoops up China rights to Cytokinetics' heart disease med ahead of approval decision
In a peculiar deal, Sanofi bought China rights to Cytokinetics’ aficamten, a hypertrophic cardiomyopathy candidate, from Shanghai-based Corxel Pharmaceuticals. This is the second China-specific purchase by Sanofi in the last few months. In September, the French pharma acquired China rights to the CD73 antibody uliledlimab from I-Mab spinout TJ Biopharma.
Other News of Note:
7. Sanofi pays SK bioscience €50M as children's pneumococcal vaccine enters phase 3
8. Lonza to boost gelatin capsule capacity in India, China as it looks to shed the division
9. CARsgen touts phase 2 stomach cancer win for cell therapy, revs up for China submission