Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.

Higher-dose mazdutide showed superiority over placebo after 24 weeks of treatment in a Phase II trial in Chinese adults with obesity. The potential best-in-class efficacy profile of the Lilly-originated GLP-1 receptor agonist is expected to help it gain the upper hand in the race for the leadership of the country's obesity market, estimated at $5.5bn in 2030.

The partners’ dual GLP-1/GCGR agonist has achieved up to 14.9% weight loss in obese and overweight adults in a mid-stage trial but rival products Wegovy and Mounjaro will likely dominate the space according to analysts.

Cross-border deals are down and investment has dried up, while geopolitical tensions have started hitting the Chinese biotech sector in unprecedented ways. Biopharma firms are expecting more rainy days ahead and are embracing new fundraising and deal-making approaches to survive and thrive.