-
NMPA Expands Generic Drug Catalog with 74th and 75th Batches for Quality Consistency Evaluation
•
The National Medical Products Administration (NMPA) has released the 74th and 75th batches of reference drugs for generic quality consistency evaluation (GQCE) work, further expanding the catalog to enhance the standardization of generic drugs in the market. The 74th batch encompasses 32 newly added specifications along with 28 modified specifications,…
-
China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and…
-
China Anti-Cancer Association Forms Consortium for Standardizing Cancer Research Ethics Reviews
•
The medical ethics professional committee of the China Anti-Cancer Association (CACA) has announced the formation of the China Cancer Clinical Research Medical Ethics Review Mutual Recognition Consortium. This consortium aims to streamline and standardize the ethical review process for clinical research in cancer treatment across China. The founding members of…
-
Boan Biotech Secures FDA Orphan Drug Designations for Two Claudin18.2 Targeting Candidates
•
Boan Biotech (HKG: 6955), a Chinese biotechnology company, has announced that it has received orphan drug designation (ODD) awards from the US Food and Drug Administration (FDA) for two of its pipeline candidates. The ODDs were granted to the antibody BA1105 and the antibody-drug conjugate (ADC) BA1301, both of which…
-
Alphamab and 3D Medicines License Envafolimab Rights to Glenmark for Multiple Regions
•
Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244), two Chinese pharmaceutical companies, have announced a licensing agreement with Glenmark Pharmaceuticals Ltd (NSE: GLENMARK). The agreement grants the Indian company exclusive development and commercialization rights to the co-developed drug envafolimab (KN035) in India, Asia Pacific (excluding Singapore, Thailand, Malaysia), Middle…
-
Lingyi Biotechnology’s Gene Therapy Candidate LY-M001 Gets FDA Green Light for Gaucher’s Disease
•
Lingyi Biotechnology Co., Ltd, a China-based gene therapy developer, has secured clinical trial approval from the US Food and Drug Administration (FDA) for its proprietary AAV gene therapy candidate, LY-M001, which is being developed to treat type I or III Gaucher’s disease. LY-M001 utilizes a recombinant adeno-associated virus (rAAV) as…
-
WuXi Biologics Launches WuXiaADCC PLUS Platform for Non-Fucosylated Antibody Development
•
WuXi Biologics (HKG: 2269), a Contract Research, Development, and Manufacturing Organization (CRDMO) based in China, has announced the launch of a new mammalian cell line construction technology platform named WuXiaADCC PLUS. This platform is designed to be an efficient, high-yield, and high Antibody Dependent Cell Mediated Cytotoxicity (ADCC) activity platform…
-
Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
•
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP)…
