Safiglipron

In the two weeks before and after Independence Day in the U.S., AstraZeneca signed potential billion-dollar licensing deals with CSPC Pharmaceutical and Sino Biopharmaceutical, Hengrui Pharma's Kaleira Therapeutics-partnered oral GLP-1 candidate reported obesity and diabetes phase 3 data from China, and biotech insiders decried certain U.S. lawmakers' scrutiny over Chinese clinical trials as a distraction. And more. 1. AstraZeneca pens $2.1B Sino deal for challenger to Merck’s COPD drug Ohtuvayre AstraZeneca pens $1.7B kidney drug discovery pact with go-to Chinese partner CSPC AstraZeneca has continued to strike deals with Chinese partners. The British pharma is paying CSPC Pharmaceutical $30 million upfront, with $1.74 billion in potential development and sales milestones, to jointly discover and develop two kidney disease candidates based on the latter company's siRNA platform. Separately, AZ agreed to pay Sino Biopharmaceutical $200 million upfront and up to $1.9 million in milestones for ex-China rights to a PDE3/4 inhibitor as a potential challenger to Merck & Co.’s chronic obstructive pulmonary disease drug Ohtuvayre. 2. Kailera’s oral GLP-1 asset sees 11% weight loss, hits goals in Chinese phase 3 obesity and diabetes trials Hengrui Pharma’s once-daily oral GLP-1 prospect, HRS-7535, led to a mean weight loss of up to 10.9% at week 44 in a China phase 3 obesity study after excluding premature treatment discontinuations and the use of other weight-loss drugs. The efficacy results are in the same ballpark as data on existing oral GLP-1 drugs by Eli Lilly and Novo Nordisk. However, the rates of adverse events around nausea and vomiting were notably higher for the Kailera Therapeutics-partnered drug by cross-trial comparisons. 3. As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ Rep. John Moolenaar, R-MI., chair of the U.S. House Select Committee on China, recently sent letters to four large pharmas with allegations of human rights violations and military involvement in their clinical trials in China. A spokesperson from a biotech industry group said the political scrutiny creates shifting goal posts that are “wasting time and money.” 4. China approved the world’s first solid tumor CAR-T therapy. When will the US follow? The world’s first solid tumor CAR-T therapy, Claudin18.2-targeted satricabtagene autoleucel (satri-cel) from China’s CARsgen Therapeutics, is not coming to the U.S. anytime soon. After resolving a clinical hold installed by the FDA for manufacturing reasons, the company’s CEO said it will take time to re-establish its efforts with the agency. 5. Fosun Pharma plots global push beyond oncology, fueled by multi-asset Alzheimer’s strategy Fosun Pharma co-president and CEO of innovative medicines division, Xingli Wang, M.D., Ph.D., explained to Fierce Pharma how the company’s recent acquisition of Green Valley Pharmaceuticals and a licensing deal with AriBio could quickly build up its portfolio in Alzheimer’s disease. While PD-1 inhibitor serplulimab is on the cusp of an FDA filing to become Fosun’s first innovative medicine in the U.S., the company is looking to neuroscience to diversify. 6. Insilico keeps partnership sprint apace in $600M biobucks collab with Takeda Takeda is the latest company to partner with Insilico Medicine. The Japanese pharma is offering $60 million upfront to tap into the artificial intelligence specialist’s Pharma.AI platform to discover new drug candidates in Takeda’s therapeutic areas of interest. The deal could be worth $600 million eventually. 7. Genentech lays off 103 alongside gRED rethink, pens $490M breast cancer collab Roche’s Genentech agreed to pay $25 million to Otsuka subsidiary Astex Pharmaceuticals to get an exclusive license to compounds from the U.K. firm’s existing early-stage program for breast cancer. The two will work together on lead optimization to finalize the preclinical candidates. Astex is in line to receive up to $490 million in milestones. 8. Deerfield’s Boulevard Bio pens $1.6B deal for trispecific TCE from China’s Metis TechBio 9. FDA selects Lilly, Regeneron, Fujifilm, 4 others for PreCheck Pilot Program 10. Foreign drugmaker caught faking doctors’ petition to evade China’s price cut scheme 11. Whitehawk swoops in for five ADCs via development deal with China's Biocytogen 12. On heels of Bain buyout, Tanabe inks deal to sell manufacturing unit and 17 drugs to Towa 13. FDA slaps Dr. Reddy's Hyderabad biologics plant with seven observations in new Form 483 14. Fosun pays $32M to join Lilly and Novartis in fiercely competitive psoriasis market 15. Sino Biopharm, GSK expand China alliance to over 2 respiratory drugs (release, PDF) 16. Nobel-winning chemist leaves US to direct AI materials lab in China (Nature)