AZD-4747

AstraZeneca's licensing of a KRAS G12D candidate, BeiGene's purchase of a CDK2 candidate and Coherus' 20% discount for Loqtorzi made our news. Because of the recent Thanksgiving holiday in the U.S., we're highlighting two weeks' worth of biopharma news related to Asia. AstraZeneca in-licensed a KRAS G12D inhibitor from China's Usynova. BeiGene bought global rights to a CDK2 inhibitor in a bid to overcome resistance to existing cancer drugs. Coherus BioSciences has priced the first China-made PD-1 inhibitor to enter the U.S. market at a 20% discount to Merck's Keytruda. Plus more. 1. AstraZeneca pays $24M to join race for next big KRAS opportunity, bagging Chinese rival to Mirati asset AstraZeneca paid $24 million upfront and committed up to $395 million in milestones to license a KRAS G12D inhibitor from China’s Usynova. The preclinical candidate will join AZ’s own KRAS G12C candidate AZD4747 in the company's pipeline. Elsewhere, Mirati Therapeutics, which is being acquired by Bristol Myers Squibb, has a KRAS G12D asset in phase 1/2 development. 2. BeiGene stakes out space in hot cancer niche, offering up $1.3B in biobucks for preclinical prospect BeiGene has signed a heavily backloaded deal potentially worth $1.3 billion to purchase Ensem Therapeutics’ CDK2 inhibitor ETX-197. The preclinical candidate complements BeiGene’s internally discovered CDK4 inhibitor, BeiGene’s R&D head, Lai Wang, Ph.D., said. The companies believe that the CDK2 pathway could help cancer patients who have acquired resistance to standard CDK4/6 inhibitors. 3. Coherus prices China-made PD-1 drug Loqtorzi at 20% discount to Merck's Keytruda As the first China-made PD-1 to gain an FDA approval, Coherus Biosciences’ Loqtorzi is being priced at a wholesale acquisition cost of $8892.03 per vial. The price is 20% lower than what Merck is charging for Keytruda. Coherus CEO Denny Lanfear described 20% as a “modest” discount and a “very reasonable” entry point. Coherus doesn’t plan to significantly change the price as the drug reaches new indications, he said. 4. We won't get fooled again: Fierce Biotech Bureau of Investigations seeks Takeda ACR poster burglar A poster of Takeda’s late-breaking data for TAK-279 in active psoriatic arthritis mysteriously went missing at the American College of Rheumatology Convergence 2023. The phase 2 data showed that TAK-279, at either 15 mg or 30 mg, helped more than half of patients achieve at least 20% improvement known as an American College of Rheumatology 20 response. 5. Novartis drops subpoena request in trade-secret spat with Takeda Novartis has withdrawn a request in court to access Takeda’s documents. The request was originally filed in October as Novartis tried to find out whether a former employee in Egypt took sensitive information to his new job at Takeda. Now, the matter between the two companies “has been resolved,” Novartis said. 6. FDA signs off on new uses for Astellas and Pfizer's Xtandi, Merck's Keytruda The FDA has approved Astellas and Pfizer’s Xtandi as the first androgen receptor inhibitor to treat nonmetastatic castration-sensitive prostate cancer with recurrence at high risk for metastasis. The drug can be used either alone or alongside a GnRH analog such as leuprolide. The approval was based on phase 3 data from the EMBRAK trial showing Xtandi could lower the risk of metastasis over leuprolide alone. 7. Fosun, Treehill launch joint investment business to fund drugs angling for US market Fosun Pharma’s U.S. unit and consulting firm Treehill Partners have formed a “jointly operating vehicle” to invest in mid- to late-stage clinical programs that aim to enter the U.S. market. The two will initially focus on cancer drugs, with the first tranche of investments expected in 2024. Although Big Pharmas also have venture arms, Fosun Pharma’s U.S. chief, Rong Yang, still sees plenty of opportunities. 8. AstraZeneca plans to exit 'beating heart' of Indian operations in Bangalore AstraZeneca plans to exit its production plant in Bangalore, India, as part of the review of the company’s global manufacturing and supply network. AZ plans to auction off the site “in a fully operational manner” to a buyer who can continue to help produce drugs currently made at the plant, AZ’s Indian subsidiary said in a securities filing. The site currently supports 51 global AZ brands. Other News of Note: 9. Troubled Cipla plant slammed with FDA warning letter for ongoing problems 10. Intas on import alert as FDA flags data manipulation, management failures in warning letter 11. Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing 12. Sumitomo anoints actor as first ‘Gemtesa Go-Getter’ in extended overactive bladder campaign 13. Ascendis sells Japanese rights to Skytrofa and two other hormone drugs for $70M upfront 14. Simcere links up with Connect, pays $21M cash for rights to eczema asset in China 15. Daiichi Sankyo signs pact to supply 1.4M mRNA COVID vaccine doses in Japan