Recent developments
Collaborative discovery
Japan advanced open-innovation models: FRONTEO and UBE will pair AI target identification with small‑molecule design, and Toray and Aichi Medical University launched an iPSC-based efficacy platform for ALS. In autoimmunity, Boehringer expanded via a global licensing agreement to develop CDR111 and a pre-clinical program from Kyowa Kirin, while Merck secured a funding agreement with Blackstone Life Sciences for a TROP2 ADC.
Bioprocessing and excipients
Virus filtration and separation assets progressed: Asahi Kasei’s Planova FG1 filter adds high‑permeability PES membranes with validated pause robustness. Suppliers scaled localized support—Nouryon opened a new innovation center in Shanghai featuring Kromasil chromatography media, and Clariant completed an expansion of its Daya Bay site for excipients and specialty surfactants.
Capacity and supply chain
Scale-up continued with Lilly’s new manufacturing facility in Katwijk targeting oral GLP‑1 production, while Novo Nordisk prepared U.S. production for oral semaglutide 25 mg pending approval. These moves complement Asahi Kasei’s Nobeoka assembly expansion noted in the Planova update.
Pipeline readouts
Late-stage data could shift demand for biologics inputs: DARZALEX FASPRO gained the first HR‑SMM approval. Roche’s fenebrutinib met key endpoints in RMS and PPMS studies. Takeda’s mezagitamab sustained kidney function and reduced proteinuria in IgAN. The FDA granted a priority voucher to Boehringer Ingelheim’s zongertinib for HER2‑mutant NSCLC.
Metabolic disease focus
Cardiometabolic programs advanced: Wegovy’s STEP UP trial supported higher‑dose efficacy and risk‑factor improvements, while oral semaglutide analyses reinforced oral options. Roche accelerated FGF21 development for MASH through its acquisition of 89bio, aligning with broader investment in metabolic and liver disease pipelines.
Access and pricing
U.S. market access evolved: Novo Nordisk reached an agreement with the U.S. Administration to lower GLP‑1 prices and pilot Medicare Part D obesity coverage; Lilly’s parallel agreement with the U.S. government caps out‑of‑pocket costs and expands self‑pay discounts, alongside major domestic manufacturing investments.