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Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal
Shots: Kali Therapeutics has entered into a license agreement with Sanofi for KT501 to treat a broad range of B cell-mediated autoimmune diseases As per the deal, Sanofi will obtain exclusive worldwide rights to KT501, while Kali will receive upfront & near-term payments totaling $180M and up to $1.05B in development & commercial milestones, with tiered royalties…
March 23, 2026
Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)
Shots: The Chinese NMPA has granted IND approval to HLX18, a biosimilar version of Opdivo (nivolumab) for the treatment of certain resected solid tumors following the US FDA IND clearance Additionally, HLX17 (biosimilar, Keytruda) & HLX13 (biosimilar, Yervoy) are under P-I trials with first patient dosing completed, while the IND for HLX15-SC (biosimilar, Darzalex), was…
March 23, 2026
Bio-Thera Expands Collaboration with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) in India 
Shots:  Bio-Thera Solutions expanded its partnership with Intas Pharmaceuticals for BAT2506, a proposed biosimilar of Simponi (golimumab), through an exclusive commercialization and licensing agreement for India  BAT2506 is a proposed golimumab biosimilar by Bio-Thera. Golimumab, a human IgG1 monoclonal antibody, targets TNF-α to reduce key inflammatory markers such as CRP, IL-6, ICAM-1, MMP-3, and VEGF. The reference drug is approved…
March 23, 2026
Cytiva and Yoshindo Collaborate to Strengthen Domestic Biosimilar Manufacturing through their FlexFactory Contract in Japan 
Shots:  Cytiva and Yoshindo sign a FlexFactory contract to support the establishment of domestic biosimilar drug substance manufacturing in Japan. The investment is partly supported by Japan’s MHLW  Yoshindo plans to supply biosimilars from its Toyama plant starting in 2028, supporting a stable and affordable biologics supply in Japan  Cytiva’s FlexFactory platform uses modular bioprocessing technologies to support faster transition from facility design to GMP…
March 23, 2026
Mochida Pharmaceutical and AYUMI Pharmaceutical Receives Manufacturing & Marketing Approval for Tocilizumab BS MA (Biosimilar, Actemra) in Japan  
Shots:  The company has received manufacturing and marketing approval in Japan for tocilizumab BS MA, a biosimilar version of Actemra (tocilizumab)   Tocilizumab BS MA, a biosimilar jointly developed by Mochida Pharmaceutical and Gedeon Richter. Under their agreement with AYUMI Pharmaceutical, Mochida will supply the product, while AYUMI will handle its sales in Japan   Mochida Pharmaceutical…
March 23, 2026
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