Avistone Biotechnology’s Andatinib Receives China Conditional Approval for EGFR Ex20ins NSCLC
Beijing Avistone Biotechnology Co., Ltd. announced that its self-developed EGFR exon 20 insertion (ex20ins) inhibitor,...
Drug
BeOne Medicines’ Tislelizumab-Zanidatamab Combo Receives FDA Priority Review for HER2-Positive Gastric Cancer
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), formerly BeiGene, announced that the U.S....
Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives China BTD for Advanced Prostate Cancer
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that its investigational antibody-drug conjugate (ADC) HS-20093...
Lianhuan Pharmaceutical’s SGLT-2 Inhibitor LH-1801 Meets Primary Endpoint in Phase III Type 2 Diabetes Trial
Jiangsu Lianhuan Pharmaceutical Co., Ltd. (SHA: 600513) announced that its Phase III clinical study for...
Allist Pharmaceuticals Secures NMPA Approval for Pivotal Trial of Furmonertinib Against Standard EGFR TKIs in Rare NSCLC Mutations
Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that China’s National Medical Products Administration (NMPA) has...
Allist Pharmaceuticals Secures China BTD for KRAS G12C NSCLC Combination Therapy with 71% Response Rate
Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that China’s regulatory authorities have granted Breakthrough Therapy...
Gilead’s Investigational HIV Regimen BIC/LEN Receives FDA Acceptance for Review with Decision Expected August 2026
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has...
HutchMed’s Sovleplenib Granted NMPA Priority Review for Warm Antibody Autoimmune Hemolytic Anemia
HutchMed (China) Limited (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Changchun High & New Tech’s GenSci161 Bispecific Antibody Receives NMPA Approval for Non-Infectious Uveitis Trial
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its GenSci161 has...
Insilico Medicine Secures Chinese Clinical Clearance for AI-Discovered Rentosertib Inhalation in Pulmonary Fibrosis
Insilico Medicine (HKG: 3696), a generative artificial intelligence (AI)-driven biotechnology company, announced it has received...
Immunotech Biopharm’s EAL Cellular Therapy Rejected by NMPA; Confirmatory Trials Required
Immunotech Biopharm Ltd. (HKG: 6978), a chimeric antigen receptor T-cell (CAR-T) specialist based in China,...
GluBio Pharmaceutical Advances GLB-002 Molecular Glue Degrader to Phase II for Relapsed Follicular Lymphoma
GluBio Pharmaceutical Co., Ltd., a molecular glue targeted protein degradation (TPD) specialist based in Zhejiang,...
Henlius Biotech Secures European Commission Approval for Poherdy Biosimilar to Roche’s Perjeta
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received marketing authorization from the European...
AbbVie Submits FDA Application for RINVOQ in Severe Alopecia Areata – Expanding JAK Inhibitor Franchise
AbbVie Inc. (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to...
Pfizer Extends VYNDAMAX Patent Protection to 2031 Through Generic Settlements
Pfizer Inc. (NYSE: PFE) announced settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals,...
Santo Therapeutics Secures Dual FDA Designations for ST002 Gene Therapy in NF2-Related Schwannomatosis – Advancing In Vivo Lentiviral Platform
Santo Therapeutics, a Hangzhou-based in vivo gene therapy developer, announced it has received both Orphan...
Johnson & Johnson’s Imaavy (nipocalimab) Receives FDA Priority Review for Warm Autoimmune Hemolytic Anemia – Expanding FcRn Blocker Franchise
Johnson & Johnson (J&J, NYSE: JNJ) announced that its supplemental Biologics License Application (sBLA) for...
AbbVie Submits FDA Filing for Skyrizi Subcutaneous Induction Therapy in Crohn’s Disease – Expanding IL-23 Inhibitor Franchise
AbbVie (NYSE: ABBV) announced it has submitted a marketing approval filing to the U.S. Food...
GSK’s Efimosfermin Receives Dual Regulatory Designations for MASH Treatment – Breakthrough Therapy and PRIME Status Support Phase III Development
GlaxoSmithKline plc (GSK, NYSE: GSK) announced on April 27, 2026, that efimosfermin, a once-monthly investigational...
Prothena’s Coramitug Receives FDA Fast Track Designation for ATTR-CM – Advancing Novo Nordisk’s $1.2B Amyloidosis Pipeline
Prothena Corporation plc (NASDAQ: PRTA) announced that the U.S. Food and Drug Administration (FDA) has...