GSK has tapped Chongqing Zhifei to distribute Shingrix in China. BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. Manufacturing shortfalls have derailed Biocon's FDA application for a proposed biosimilar to Novo Nordisk's NovoLog. And more.
1. GSK strikes $3B Shingrix partnership with China powerhouse Zhifei. Is a deal for an RSV shot next?
GSK has signed on Chongqing Zhifei Biological Products to distribute its shingles vaccine, Shingrix, in China. Zhifei will buy around $3 billion worth of the vaccine to sell in China from 2024 through 2026, and the partnership could be extended. The two companies could expand the deal to include GSK’s RSV shot in the future. Zhifei made a name for itself by propelling the growth of Merck’s Gardasil franchise in China.
2. BioNTech takes another leaf out of Daiichi playbook, paying $70M for HER3-directed ADC
BioNTech has inked another partnership with a Chinese biotech. This time, the German company has paid $70 million upfront to MediLink Therapeutics for an HER3-directed antibody-drug conjugate, a potential competitor to Daiichi Sankyo’s patritumab deruxtecan. The deal value could grow to more than $1 billion if all milestones are met. BioNTech has recently teamed with several Chinese companies, including Duality Biologics and Biotheus.
3. FDA hits Biocon's insulin copycat with a CRL as plant awaits pre-approval inspection
The FDA has rejected Biocon’s biosimilar version of Novo Nordisk’s NovoLog, or insulin aspart, again. Back in early 2022, the FDA issued a complete response letter for the drug’s application. This time, the rejection is related to observations from an August 2022 inspection that resulted in a Form 483 for Biocon’s Malaysia facility. The FDA didn’t perform a reinspection in time before the regulatory decision date.
4. Sanofi pays $10M upfront in hope 'biological map of proteins' leads to drug discovery treasure
In a deal potentially worth more than $1 billion, Sanofi has tapped Sino-American company BioMap’s artificial-intelligence-based protein map. The technology aims to guide how protein therapies may be applied in different disease areas. Sanofi has recently laid out a plan to become “the first pharma company powered by artificial intelligence at scale.”
5. Fujifilm Irvine Scientific, Formulated Solutions each lay off 50-plus staffers, filings show
Fujifilm Irvine Scientific recently laid off 57 workers in California. The company offers cell culture solutions and medical devices for researchers in cell therapy and regenerative medicine. It opened a new manufacturing facility in the Netherlands in late 2021 alongside its campuses in California and Tokyo.
Other News of Note:
6. Astellas starts Veozah TV push, pitching menopause drug as how to go from hot flashes to not flashes
7. Korean CDMO Lotte Biologics buys land, sets out to build 3 new plants by 2030