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CompanyDrug

Keymed Biosciences Initiates CMG901 Phase III – AstraZeneca Triggers $45 Million Milestone for Claudin 18.2 ADC

SicaGene's SG12 ASO Wins NMPA Approval – Antisense Oligonucleotide Targets Hepatitis B Functional Cure
CompanyDrug

SicaGene’s SG12 ASO Wins NMPA Approval – Antisense Oligonucleotide Targets Hepatitis B Functional Cure

CompanyDrug

Kelun-Biotech’s SKB575/HBM7575 Wins NMPA Approval – Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential

CompanyDrug

Henlius Biotech’s HLX3901 Wins NMPA Approval – First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors

CompanyDrug

Qyuns Therapeutics’ QX002N NDA Accepted by NMPA – IL-17A Antibody Targets Ankylosing Spondylitis Market

CompanyDeals

GSK Licenses Linerixibat to Alfasigma for $300 Million Upfront – IBAT Inhibitor Targets PBC Pruritus with $690 Million Total Deal Value

Policy / Regulatory

FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market

Everest Medicines Launches Etrasimod in China – Next-Gen S1P Modulator Hits Market for Ulcerative Colitis
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Everest Medicines Launches Etrasimod in China – Next-Gen S1P Modulator Hits Market for Ulcerative Colitis

Policy / Regulatory

FDA Advances Section 804 Drug Importation Program – States Meet Agency on Canadian Prescription Import Pathway

Novo Nordisk Settles with Hims & Hers – Ozempic Wegovy Distribution Deal Ends Patent Litigation, Eliminates Compounded GLP-1 Advertising
CompanyDeals

Novo Nordisk Settles with Hims & Hers – Ozempic Wegovy Distribution Deal Ends Patent Litigation, Eliminates Compounded GLP-1 Advertising

Policy / Regulatory

NMPA Removes OCALIVA from GQCE Reference List – Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile

HutchMed Withdraws TAZVERIK from China – Safety Concerns Drive Global Recall of Epizyme/Ipsen EZH2 Inhibitor
CompanyDrug

HutchMed Withdraws TAZVERIK from China – Safety Concerns Drive Global Recall of Epizyme/Ipsen EZH2 Inhibitor