Clinical & Regulatory
China Pharma’s Candesartan Hypertension Product Passes the Quality and Efficacy Consistency Evaluation of Generic Drugs
China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), a specialty pharmaceutical company, today announced that its wholly-owned subsidiary Hainan Helpson Medical & Biotechnology Co., Ltd. (hereinafter referred to as "Helpson") has received the "Drug Supplementary Application Approval Notice" for its candesartan tablets by National Medical Products Administration of China (hereinafter referred to as NMPA"), indicating that the Company's candesartan tablets have passed the quality and efficacy consistency evaluation of generic drugs.
BioCity announces FDA clearance of Investigational New Drug application for its first-in-class CD3/EGFR bispecific antibody
BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC3448 (CD3/EGFR Bispecific antibody, BsAb).
VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally
Venus Medtech (Hangzhou) Inc. ("Venus Medtech"), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced the Investigational Device Exemption (IDE) full approval for its in-house developed VenusP-Valve from the U.S. Food and Drug Administration (FDA).
Oricell OriCAR-017 CAR-T Therapy Clears IND Hurdle, Paving the Way for Global Impact
August 10, 2023, in a groundbreaking development, Oricell Therapeutics Co., Ltd. ("Oricell") has received the green light for its Investigational New Drug (IND) application of OriCAR-017, a cutting-edge CAR-T cell therapy targeting GPRC5D to combat relapsed or refractory multiple myeloma (R/R MM).
Ascentage Pharma Received Clearance from U.S. FDA to Proceed with Global Registrational Phase III Clinical Trial for Lisaftoclax (APG-2575) in Previously Treated Patients with CLL/SLL
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that lisaftoclax (APG-2575), a novel Bcl-2 inhibitor and one of the company's core assets, has been cleared by the US Food and Drug Administration (FDA) to enter a global registrational Phase III study.
AffaMed Therapeutics Announces Partner Vistagen Reports Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder
AffaMed Therapeutics ("AffaMed") announced today that its partner Vistagen Therapeutics ('Vistagen' -NASDAQ: VTGN), a clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, reported positive top-line results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol (PH94B) nasal spray in adults diagnosed with social anxiety disorder (SAD).
Asieris Announces Positive Phase III Bridging Trial of Hexvix®, a Diagnostic Drug for Bladder Cancer
Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the Phase III bridging clinical trial of Hexvix® for bladder cancer diagnosis met the primary endpoint.
HUIDAGENE THERAPEUTICS RECEIVES FDA RARE PEDIATRIC DISEASE DESIGNATION FOR HG004 TO TREAT INHERITED BLINDNESS
HuidaGene Therapeutics (辉大基因，"HuidaGene"), a clinical-stage biotechnology company focused on developing CRISPR-based programmable genomic medicines, today announced the U.S. Food and Drug Administration (FDA) had granted Rare Pediatric Disease Designation (RPDD) to HG004 for the treatment of inherited retinal disease caused by RPE65 mutations (RPE65-IRDs).
Jacobio Pharma Announces Breakthrough Therapy Designation from China CDE for KRAS G12C Inhibitor Glecirasib for the Treatment of Pancreatic Cancer
Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, today announced that Jacobio's in-house KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment.
Baird Medical Submits Disposable Microwave Ablation Needle and MWA System Application to U.S. FDA for Treatment of Soft Tissue Microwave Ablation
Baird Medical Investment Holdings Limited ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced the 510(k) premarket notification submission of the Company's Disposable Microwave Ablation ("MWA") Needle and the Company's MWA System to the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue microwave ablation.
