-
Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
-
AffaMed Therapeutics’ Luminate Receives Clinical Trial Approval for Dry AMD in China
•
AffaMed Therapeutics, a China-based biotech firm, has announced the receipt of its first clinical trial approval in China for its pipeline candidate, Luminate (risuteganib; AM011). This development marks a significant milestone for the company, which acquired the Greater China manufacturing, development, and commercial rights to risuteganib from Hanmi Pharmaceutical, a…
-
Hansoh Pharmaceutical Gets NMPA Approval for HS-20105 Clinical Study in Solid Tumors
•
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study of its Category 1 drug candidate, HS-20105, for the treatment of advanced solid tumors. This development marks a…
-
Shanghai Junshi’s Tuoyi Meets Primary Efficacy Endpoint in Phase III Melanoma Study
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that the Phase III MELATORCH study (NCT03430297) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has successfully reached the progression-free survival (PFS) primary efficacy endpoint. This study evaluates Tuoyi as a first-line…
-
Abbisko Therapeutics Gets NMPA Approval for Irpagratinib Combination Study in HCC
•
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
-
CDE Introduces New Guidelines for Generic Drug Quality and Efficacy Consistency Evaluation
•
The Center for Drug Evaluation (CDE) has released a new set of Guidelines for “the Acceptance and Review of Quality and Efficacy Consistency Evaluation of Generic Drugs.” Although described as a draft proposal with a one-month feedback period from the date of issuance, the guidelines are set to take immediate…
-
Hepagene Therapeutics’ HPG7233 Receives US FDA IND Approval for NASH Treatment
•
Hong Kong-based biopharmaceutical company Hepagene Therapeutics Inc. has announced that the US Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) approval for its drug candidate, HPG7233. This small-molecule thyroid hormone receptor beta (THR-β) agonist is poised for development as a treatment for non-alcoholic steatohepatitis (NASH) and…
-
Abbisko Therapeutics’ Irpagratinib Receives FDA Clearance for Phase I Study in HCC
•
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth…
