Fierce Pharma Asia—BMS’ $8.4B ADC bet; China’s reimbursement update; FDA’s CAR-T roadblock
15 Dec 2023
Clinical ResultPhase 3Phase 2ADCAccelerated Approval
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Source: FiercePharma
Bristol Myers' ADC deal with SystImmune, China's drug-reimbursement update and the FDA's clinical hold on three CAR-Ts made our news this week.
Bristol Myers Squibb inked an antibody-drug conjugate (ADC) licensing deal worth up to $8.4 billion. AstraZeneca and Gilead's ADCs passed on China's national insurance scheme. The FDA put three CAR-T candidates from CARsgen Therapeutics on a clinical hold. And more.
1. BMS pays $800M upfront for antibody-drug conjugate, opening new front in Merck rivalry
In another Big Pharma deal for an antibody-drug conjugate coming out of China, Bristol Myers Squibb is shelling out $800 million upfront for a phase 2 bispecific candidate targeting EGFRxHER3. On the other end of the deal is SystImmune, a Washington-based subsidiary of China’s Sichuan Biokin Pharmaceutical. The deal’s total value could reach up to $8.4 billion if all milestones are met.
2. Drugmakers cut prices by 62% to add 126 meds to China’s national insurance scheme (Yicai)
China has wrapped up another round of additions to its National Reimbursement Drug List. This time, 126 new drugs were added, an average discount of 61.7% to be covered by national health insurance. Fifteen rare disease meds made it in, including two generalized myasthenia gravis therapies by argenx/Zai Lab and AstraZeneca. However, several antibody-drug conjugates, including AZ and Daiichi Sankyo’s Enhertu and Gilead Sciences’ Trodelvy, were left out.
3. FDA puts up CAR-T roadblock, slapping holds on 3 CARsgen cell therapies after inspecting facility
The FDA has put three CAR-T candidates from CARsgen Therapeutics on a clinical hold following an inspection of the Chinese company’s North Carolina facility. One of the programs, a Claudin18.2 candidate coded CT041, is part of a collaboration with Moderna. The other two candidates target BCMA and GPRC5D; all three are popular targets among drug developers.
4. Merck and Eisai's Keytruda-Lenvima combo comes up short yet again, this time in endometrial cancer
Merck and Eisai’s Keytruda-Lenvima combo has failed as a first-line treatment in a phase 3 study in patients with advanced or recurrent endometrial cancer whose disease is mismatch repair proficient. The combo couldn’t beat chemotherapy on overall survival or progression-free survival. PD-1 inhibitors like Keytruda works well in mismatch repair deficient tumors, but not so much in MMR proficient ones.
5. ASH: With high tumor response, AstraZeneca spinout Dizal explores FDA path and US partner for PTCL drug
AstraZeneca spinout Dizal Pharmaceutical reported a 44.3% overall response rate and 23.9% complete response rate from a pivotal phase 2 trial for its peripheral T cell lymphoma candidate golidocitinib. The company plans to file for an FDA accelerated approval but will first need to iron out a phase 3 confirmatory trial plan.
Other News of Note:
6. FDA hits Torrent Pharma with a Form 483, citing 5 observations
7. AstraZeneca to pull Forxiga from Korea amid generics onslaught (Korea Biomedical Review)
8. Cipla unit recalls one lot of anti-seizure drug because of faulty packaging
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