Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
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.
Chinese pharmaceutical and biotech companies are leading development of glucagon-like peptide-1 receptor agonists as Novo Nordisk A/S and Eli Lilly and Co. edge closer to launching blockbuster therapies in China. At the heart of the GLP-1 boom is a nationwide obesity problem driven by a confluence of factors, including the rise of a modern, sedentary lifestyle, according to Clarivate. Despite the rising prevalence of obesity and type 2 diabetes, the gap in obesity therapeutics is “substantial and leaves a solid market opportunity for weight loss drugs,” Karan Verma, principal analyst of healthcare research & data analytics at Clarivate, said.
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.
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.
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
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.
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