In the past two weeks, CARsgen Therapeutics won the world's first regulatory approval for a solid tumor CAR-T, a behind-the-scenes look at Pfizer and Innovent Biologics' $10.5 billion cancer deal revealed a less-than-five-month sprint, Daiichi Sankyo's new R&D chief discussed how he plans to keep the antibody-drug conjugate leader ahead in the game, and a flurry of China licensing deals with various structures have emerged.
1. CARsgen makes history as China approves world's first CAR-T therapy for solid tumors
In three world-first approvals, Chinese authorities cleared CARsgen Therapeutics’ satricabtagene autoleucel as the first CAR-T therapy for a solid tumor; Sichuan Biokin Pharmaceutical’s Bristol Myers Squibb-partnered izalontamab brengitecan, the first bispecific antibody-drug conjugate; and a novel bispecific antibody made by Genrix Bio for post-exposure prophylaxis against rabies.
2. A 5-month sprint: Behind Pfizer’s $10B deal and Innovent’s global pharma ambition
Pfizer’s potential $10.5 billion cancer deal with Innovent Biologics was reached in less than five months, Innovent CEO Michael Yu, Ph.D., told Fierce. Pfizer initially resisted a co-development, co-commercialization structure for four of the assets, but Innovent pushed for it, leveraging interest from other companies, as the Chinese company aims to become a global pharma giant.
3. ‘We think about it every day’: How Daiichi Sankyo’s R&D chief plans to stay ahead in the ADC game
Daiichi Sankyo’s newly minted R&D chief, John Tsai, M.D., is adjusting to a different view at the Japanese company after spending more than 20 years at Western pharmas. To outrun the antibody-drug conjugate gold rush that Daiichi helped ignite, Tsai is now thinking about getting to unique targets first and designing new platform technologies with novel payloads and antibody engineering.
4. Eli Lilly reunites with Abbisko in $1.9B, multiple target R&D pact
After partnering with Abbisko Therapeutics on a cardiometabolic small molecule, Eli Lilly has returned to the Chinese biotech with a potential $1.9 billion deal. Abbisko will apply its drug discovery and early development capabilities to multiple targets selected by Lilly.
5. Serapha Bio takes flight from Boundless merger with $230M and gene-editing prospect from China
Serapha Bio has launched with $230 million in funding commitments from an investor group led by RA Capital Management and RTW Investments. The focus of the company is an in vivo base editing program licensed from China’s YolTech Therapeutics as a potential treatment for alpha-1-antitrypsin deficiency (AATD), a direct competitor to Beam Therapeutics’ BEAM-302.
6. Insilico lands heavily backloaded $2.5B AI drug discovery deal with SK Biopharm
Insilico Medicine and SK Biopharmaceuticals have teamed up in a potential $2.5 billion deal. Using Insilico’s AI drug discovery platform and SK’s neuroscience know-how, the two firms will discover and develop drugs for neuroimmune disorders. SK already sells epilepsy drug Xcopri, and the deal marks Insilico’s third in central nervous system diseases this year.
7. Nature retracts provocative PD-1 study that tied lung cancer survival to treatment timing
After a four-month investigation, Nature Medicine has decided to retract a viral paper that linked earlier PD-1 treatment in the day to improved survival in first-line non-small cell lung cancer patients. The findings came from a single-center, randomized study conducted in China. Since its publication in February, concerns were raised over major revisions to trial design and inconsistent trial protocol, plus unusual efficacy and safety data patterns.
As genomic medicine developer Sangamo enters the bankruptcy process, Astellas has become a stalking horse bidder for the biotech’s Fabry disease candidate, isaralgagene civaparvovec. As of last June, Sangamo touted data from a phase 1/2 trial that it said would support an accelerated approval bid.
Other News of Note:
9. Big obesity bets and China's rise fuel potential $2T in 2032 drug sales: Evaluate
10. Ollin hauls in $330M to enlist Vabysmo challenger in phase 3 eye disease gauntlet
11. cAMPfield harvests $180M series A to advance oral IBD drug licensed from Newsoara
12. Helmed by Sanofi vet, Bionyra emerges with $165M and three licensed I&I assets
13. F2G, Shionogi prep regulatory push after novel antifungal passes ph. 3 test
14. Otsuka posts phase 3b ADHD trial win ahead of looming FDA approval decision
15. Nuvectis licenses complement inhibitor, BRAF candidate from Haisco in $1.46B deal (release)
16. FTC orders Aurobindo to divest 4 drugs to complete $250M Lannett acquisition
17. Eisai snares government manufacturing grant as it brings Leqembi packaging to UK with $65M expansion
18. Amgen loses in Harbour antibody patent case, ordered to pay $20M+
19. Japan, South Korea challenge the West’s place in research rankings: report
20. Novo Nordisk opens Czech plant and unveils $29M upgrade to China facility
21. Jubilant HollisterStier gets FDA warning letter for quality control problems
22. Oblenio Bio, Memento raise money to advance Asia-licensed multi-specifics (fundraising tracker)