Fierce Pharma Asia—Merck and BioNTech's I-O bispecific buys; AZ CEO's China defense

Merck and BioNTech are buying Chinese biotechs to gain PD-(L)1/VEGF bispecifics. AstraZeneca's CEO argued that the company did not lose compliance oversight in China amid local authorities' investigations into the drugmaker's senior executives. AZ and Daiichi Sankyo have refiled their TROP2 antibody-drug conjugate with the FDA. And more.

1. Merck pays $588M for bispecific to defend Keytruda’s kingdom from emerging threat

After trying to poke holes in Akeso and Summit Therapeutics’ PD-1xVEGF bispecific win against Keytruda, Merck & Co. has hopped on the same bandwagon. The New Jersey pharma is paying $588 million upfront, plus up to $2.7 billion in milestones, to bag a PD-1xVEGF bispecific from China’s LaNova Medicine. The asset, LM-299, is entering phase 1 testing in China.

2. BioNTech pays $800M to take control of potential Keytruda killer

BioNTech is paying $800 million upfront, plus up to $150 million in milestones, to buy its Chinese partner Biotheus, gaining full control over the PD-L1xVEGF bispecific antibody BNT327. About a year ago, BioNTech paid $55 million upfront and committed more than $1 billion in milestones to license the drug.

3. AstraZeneca CEO defends corporate oversight, $80B revenue target amid China probes

AstraZeneca has increased its internal compliance safeguards in China, CEO Pascal Soriot told reporters. Despite recent investigations into AZ’s top executives in China, Soriot argued that the company did not lose oversight. While the CEO admitted that “it’s reasonable to assume that there will be some impact” from the ongoing probes on AZ’s large China business, he stood by the company’s $80 billion revenue goal by 2030.

4. AstraZeneca, Daiichi withdraw lung cancer approval application for Enhertu follow-up and try again

After conversing with the FDA, AstraZeneca and partner Daiichi Sankyo have withdrawn their previous application for the TROP2 antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) in nonsquamous non-small cell lung cancer (NSCLC) and refiled in EGFR-mutated NSCLC. The new submission uses data from three trials and is seeking an accelerated approval.

5. Daiichi Sankyo links up with Korea's Alteogen on subcutaneous Enhertu in $300M licensing deal

Daiichi Sankyo is paying Korea’s Alteogen $20 million upfront to develop a subcutaneous version of its AstraZeneca-partnered HER2 ADC Enhertu. Commercial and development milestones could add up to $280 million. Alteogen's human hyaluronidase platform, dubbed Hybrozyme, has also been tapped by Merck & Co. in a separate collaboration.

6. Merck KGaA's phase 3 rare tumor trial hits goal, teeing up rivalry with Daiichi and Ono

Merck KGaA’s CSF-1R inhibitor pimicotinib has succeeded in a phase 3 tenosynovial giant cell tumor trial. The German company last year paid Chinese biotech Abbisko Therapeutics $70 million upfront for pimicotinib rights in greater China, plus an option in the rest of the world. The drug could be a competitor to Daiichi’s Turalio. Japan’s Ono, through its recent acquisition of Deciphera Pharmaceuticals, has also filed its CSF-1R candidate vimseltinib in the U.S.

Other News of Note

7. With China ties under US scrutiny, GenScript goes Down Under with new facility

8. Otsuka, ICU Medical form joint venture to boost IV solution supply in North America

9. Insilico's AI-designed med tied to respiratory health improvements in midstage lung disease trial

10. Ideaya pushes ahead with Biocytogen bispecific ADC bet