-
Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
•
Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line…
-
Ji Xing Pharmaceuticals Gets CDE Green Light for Phase III Aficamten Study in nHCM
•
Ji Xing Pharmaceuticals, a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct the Phase III ACACIA-HCM study for its drug aficamten (CK-3773274) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development…
-
InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
•
InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has received approval for an Investigational New Drug (IND) clinical trial filing in China. The company is set to initiate a clinical trial for its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with its Bruton’s…
-
Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
•
Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3. This molecule is intended for the treatment of recurrent or…
-
Fosun Pharmaceutical Gets NMPA Green Light for Phase I Study of Fibrosis Drug HLX6018
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its drug candidate HLX6018. This investigational compound is a GARP/TGF-β1 compound…
-
NMPA Releases 78th Batch of Reference Drugs for Generic Quality Consistency Evaluation
•
The National Medical Products Administration (NMPA) has released the 78th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs. This batch includes 28 new specifications and 28 specifications with modifications, with 7 of these being…
-
China’s NHC Outlines Cross-departmental Law Enforcement to Strengthen Medical Supervision
•
The National Health Commission (NHC) has issued a set of “Opinions on Strengthening Cross-departmental Law Enforcement in Medical Supervision,” addressing local health commissions, market supervision, healthcare security, traditional Chinese medicine, medical product administration, and other relevant bureaus. The document emphasizes the daily supervision of medical practice, handling of reports and…
-
Kexing Pharmaceutical Secures Rights for Chia Tai Tianqing’s Generic Ibrance in 11 Countries
•
Kexing Pharmaceutical (SHA: 688136), based in China, has entered into an international collaboration agreement with fellow Chinese firm Chia Tai Tianqing, securing commercialization rights for Chia Tai’s generic version of Pfizer’s Ibrance (palbociclib). This agreement encompasses an initial batch of 11 countries. Palbociclib, recognized as the world’s first CDK4/6 inhibitor,…
