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Fierce Pharma Asia—GSK, Zhifei's vaccine pact; BioNTech's latest China deal; Biocon's biosimilar rejection
疫苗上市批准
GSK's partnership with Zhifei, BioNTech's HER3 ADC deal and the FDA's rejection of Biocon's insulin aspart biosimilar made our news this week.
GSKGSK strikes Chongqing Zhifeitnership with CShingrixerhouse ZhiBioNTecha deal for an RHER3hot next?MediLink TherapeuticsBioconFDANovo Nordisk
GSKGSKs signed on Chongqing Zhifei Biological Products to distZhifei 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.
GSKBioNTech takes Chongqing Zhifei Biological Products, paying $70M for Hshingles vaccineShingrixZhifeiGSKZhifeiMerck
BioBioNTechs inked another partnershipDaiichi Chinese biotech. This timeHER3-directedcADCany 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.
BioNTechits Biocon's insulin copycat with a CRL as plant awaits pre-approval inspectionMediLink TherapeuticsHER3-directedDaiichi SankyopatritumabderuxtecanBioNTechDuality BiologicsBiotheus
TheFDAA has Bioconed 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. SFDAfi pays $10M uBiocon in hope 'biological map Novo Nordisk leads to drug insulin aspartsureFDABioconFDA
In Sanofi 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.”
FujFujifilmvIrvine ScientificceFormulated Solutionskers 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.
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
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