BMS Secures NMPA Approval for Sotyktu in Psoriatic Arthritis – First Selective TYK2 Inhibitor Expands China Indications
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that China’s National Medical Products Administration (NMPA) has granted...
TKIs (EGFR VEGF BTK etc.)
Novartis Secures Fourth China Approval for Tafinlar-Mekinist Combo in BRAF V600E-Mutated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Novartis AG (NYSE: NVS) announced that China’s National Medical Products Administration (NMPA) has granted approval...
Everest Medicines Secures $1.14 Billion Deal with Travere Therapeutics for Next-Gen BTK Inhibitor Civorebrutinib in Global Kidney Disease Market
Everest Medicines (HKG: 1952) announced a strategic licensing agreement with Travere Therapeutics, Inc. (NASDAQ: TVTX),...
InnoCare Pharma’s BTK Inhibitor Orelabrutinib Gains NMPA Review Acceptance for Primary Immune Thrombocytopenia Indication
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced that the Center for Drug Evaluation (CDE)...
Dizal Pharmaceutical’s Zegfrovy Receives Priority Review for First-Line EGFR Exon20ins NSCLC – Phase III WU-KONG28 Data Shows Significant PFS Benefit Over Chemotherapy
Dizal Pharmaceutical Co., Ltd. (SHA: 688192) announced that China’s Center for Drug Evaluation (CDE) has...
InnoCare Pharma Secures Australian TGA Approval for Hibruka in Relapsed/Refractory Mantle Cell Lymphoma – Highly Selective BTK Inhibitor Expands International Footprint
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced that Australia’s Therapeutic Goods Administration (TGA) has...
TransThera Sciences and Allist Pharmaceuticals Launch Phase II Combination Study of TT-00973 and Furmonertinib in EGFR-Mutant NSCLC
TransThera Sciences (Nanjing), Inc. (HKG: 2617) and Allist Pharmaceuticals Co., Ltd. (SHA: 688578) have announced...
Lupeng Pharma Enrolls First Patient in Global Phase 3 ROCKET-CLL Trial of Fourth-Gen BTK Inhibitor Rocbrutinib vs. Pirtobrutinib
Lupeng Pharmaceutical Ltd. announced the enrollment of the first patient in its global Phase 3...
Hansoh Pharma’s HS-10504 Receives NMPA Breakthrough Therapy Designation for Fourth-Generation EGFR Inhibitor in Resistant NSCLC
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s Center for Drug Evaluation (CDE)...
Henlius Biotech Secures Exclusive China Rights to CTFH’s Third-Generation EGFR TKI FHND9041 for NSCLC
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced a strategic partnership with fellow Chinese biopharmaceutical company...
CStone Pharmaceuticals Launches First Commercial Batch of Gavreto in China Following NRDL Inclusion
CStone Pharmaceuticals (HKG: 2616) announced the first batch manufacturing and release of its Gavreto (pralsetinib...
European Commission Approves Bristol Myers Squibb’s Sotyktu for Psoriatic Arthritis Following FDA Clearance
The European Commission (EC) granted marketing authorization this week for Bristol-Myers Squibb‘s (BMS, NYSE: BMY)...
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,...
Roche’s Fenebrutinib Slashes MS Relapse Rates by Over 50% in Phase III Trials
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that its investigational non-covalent Bruton’s tyrosine kinase (BTK)...
Eli Lilly’s Jaypirca Combination Therapy Demonstrates Significant PFS Benefit in Phase III CLL/SLL Trial – Non-Covalent BTK Inhibitor Shows Promise Regardless of Prior Treatment History
Eli Lilly and Company (NYSE: LLY) announced positive topline results from the Phase III BRUIN...
Dizal Reports Positive WU‑KONG28 Results – ZEGFROVY First‑Line Win Positions as First Chemo‑Free EGFR exon20ins NSCLC Therapy
Dizal Pharmaceutical Co., Ltd. (SHA: 688192) announced that its multinational Phase 3 WU‑KONG28 study evaluating...
TransThera Sciences Doses First Patient in Phase II Tinengotinib Combination Study – Multi-Kinase Inhibitor Plus Fulvestrant Targets HR+/HER2- Breast Cancer
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced first patient dosing in a Phase II clinical...
Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis
Bristol-Myers Squibb (BMS, NYSE: BMY) announced FDA approval for a label extension of Sotyktu (deucravacitinib),...
Novartis’ Remibrutinib Wins CHMP Positive Opinion – Oral BTK Inhibitor Nears EU Approval for Chronic Urticaria
Novartis (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the...
FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track
The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...