AstraZeneca and Daiichi Sankyo shared the pooled analysis behind the refiling of their TROP2 antibody-drug conjugate (ADC) with the FDA. The BIOSECURE Act missed a key opportunity to become U.S. law. Three top executives at Amgen China reportedly left the company. And more.
1. AstraZeneca, Daiichi share data behind Dato-DXd do-over amid 2nd bid for lung cancer approval
Data supporting AstraZeneca and Daiichi Sankyo’s FDA refiling of datopotamab deruxtecan showed that the antibody-drug conjugate induced an overall response rate of 42.7%, a median progression-free survival length of 5.8 months and median overall survival of 15.6 months in patients with previously treated EGFR-mutated non-small cell lung cancer. The results came from a pooled analysis of two trials presented at the ESMO Asia Congress 2024.
2. Daiichi Sankyo builds $152M ADC plant in China as Enhertu wins national coverage
Meanwhile, Daiichi Sankyo said it will invest 1.1 billion Chinese yuan ($152 million) to build its first ADC manufacturing facility in China. Located in Shanghai, the plant is expected to be operational in 2030. Daiichi’s announcement came on the heels of AZ-partnered Enhertu’s inclusion in China’s national insurance program effective next year.
3. Biosecure Act MIA from US defense bill in key win for China biopharma service providers
The BIOSECURE Act was left out of the text of the 2025 National Defense Authorization Act, which was seen as the easiest path forward for the bill. There remains a slim chance that the bill could hitch a ride with a continuing resolution scheduled for Dec. 20. If BIOSECURE doesn’t make the legislative cut this year, its path to law will become even more uncertain.
4. Earthquake at Amgen China as general manager, 2 business unit heads depart (Jiemian, Chinese)
Amgen China’s general manager, Irene Hsu, along with the leaders of the branch’s cardiovascular and bone business units, Harry Wu and Eddie Fan, have abruptly left the company, multiple local media outlets report. Some reports cited an internal communication from Amgen’s Asia-Pacific chief My Linh Kha, who is reportedly stepping into the China GM role on an interim basis amid a search for replacements. Amgen declined to comment.
5. BioNTech's overall survival data show promise of potential Keytruda killer in breast cancer
BioNTech’s PD-L1/VEGF bispecific BNT327 reported an 18-month overall survival rate of 69.7% among 42 triple-negative breast cancer patients enrolled in a phase 1b/2 trial. The number looked favorable compared with the 47.8% that Merck’s Keytruda-chemo regimen posted in the KEYNOTE-355 trial. BioNTech gained the drug from China’s Biotheus, which it’s buying for $800 million upfront.
6. Chasing Merck, BioNTech and DualityBio post first clinical data on ADC
As for another BioNTech-partnered asset, Duality Biologics reported a 32.4% response rate from the first 277 patients enrolled in a phase 1/2 study of the B7-H3 ADC candidate BNT324. The trial encompasses several tumor types, including small cell lung cancer, non-small cell lung cancer and castration-resistant prostate cancer. Several other companies, including GSK/Hansoh and Merck/Daiichi, are also working on B7-H3 drugs.
Other News of Note:
7. Teva, Takeda sell generics joint venture in Japan to focus on innovative drugs
8. Vertex, Saudi Arabia ink memorandum of understanding to boost local gene therapy manufacturing