The U.S. FDA issued warning letters to a pair of non-clinical testing labs located in China for violations of good laboratory practices, but the fall-out may reach existing marketing authorizations.

Qure.ai Technologies Private Ltd.’s Qxr artificial intelligence-powered chest X-ray interpretation system identified high-risk pulmonary nodules an average of 32 months before physicians diagnosed lung cancer, a study presented September 8 at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer in San Diego found.

Two leading glucagon-like peptide-1 (GLP-1) receptor agonists for obesity and type 2 diabetes – Novo Nordisk A/S’s semaglutide (Wegovy/Ozempic) and Eli Lilly and Co.’s tirzepatide (Mounjaro/Zepbound) – are advancing in China after taking the U.S. market by storm. China represents the world’s largest population of diabetes and obesity patients. Its GLP-1 market, valued at about $1.7 billion in 2023 according to Clarivate, is expected to grow as the number of obesity patients is projected to exceed 500 million by 2033.

The Stock Exchange of Hong Kong is “all ears” to foster local biotech IPOs, speakers said at the Bio Hong Kong 2024 conference Sept. 11, and more than 60 companies have jumped on board since the introduction of the Chapter 18A listing regime in 2018.

From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the ChinaBio Partnering Forum in Shanghai Sept. 10-11.

With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.

More than three months ago, investors first learned that ivonescimab, a PD-1/VEGF-targeting bispecific antibody from Summit Therapeutics and Akeso Pharmaceuticals Inc., bested Keytruda (pembrolizumab) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, Summit rolled out detailed data from the phase III Harmoni-2 trial, which included a nearly doubling of progression-free survival for ivonescimab compared to Merck & Co. Inc.’s established blockbuster drug.

Technological breakthroughs are changing the biopharmaceutical landscape and forcing regulators to think on their feet and facilitate (not impede) innovation, experts said at the Global Bio Conference (GBC) 2024. “Regulatory speed and agility are necessary amid emergencies to cater to unmet medical needs,” Choong May Ling, CEO of Singapore’s Health Sciences Authority, told audience members in Seoul, South Korea.

Asia Pacific is the fastest growing region for health care spending, and by 2030 APAC will account for more than 20% of global health care spending, Tom Lawry, managing director of Second Century Tech told the APACMed Forum 2024 conference held in Singapore, Sept 5-6.