-
Jiangsu Recbio’s Shingles Vaccine REC610 Accepted for Review by China’s NMPA
•
Jiangsu Recbio Technology Co., Ltd, a China-based company, has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for REC610, a novel adjuvanted recombinant shingles vaccine, for review. Phase I Clinical Trial Design and ObjectivesThe Phase I clinical trial is a randomized, double-blind, and GSK…
-
Mirxes Holding Company Secures USD 50 Million in Series D Financing for RNA Technology
•
Mirxes Holding Company Ltd, a Singapore-headquartered RNA technology company specializing in blood-based miRNA test kit products, has successfully closed a Series D financing round, raising USD 50 million. The funding round was supported by a consortium of existing and new investors, including Beijing Fupu, in which the Zhejiang Anji Economic…
-
Shanghai Henlius Completes Phase I/II Study for Anti-VEGF mAb HLX04-O in Wet AMD
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary, Shanghai Henlius Biotech, Inc. (HKG: 2696), has announced the completion of a Phase I/II study for its anti-VEGF monoclonal antibody (mAb) HLX04-O in the treatment of wet age-related macular degeneration (wAMD). The drug has reportedly demonstrated a good safety…
-
Innovent Biologics’ Altruist Biologics Partners with Longbio Pharma in RMB 500 Million Deal
•
Altruist Biologics, the Contract Development and Manufacturing Organization (CDMO) unit of China-based Innovent Biologics, Inc. (HKG: 1801), has entered into a partnership with compatriot firm Longbio Pharma. The RMB 500 million (USD 70 million) deal will leverage Altruist’s NDA filing experience, world-class quality system, and continuous stable commercial manufacturing capacities to…
-
SSY Group Ltd Receives NMPA Approval for Stiripentol Dry Suspension for Dravet Syndrome
•
China-based SSY Group Ltd (HKG: 2005) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its stiripentol dry suspension, a drug used to treat Dravet syndrome. SSY’s product is confirmed to have passed the generic quality consistency evaluation (GQCE) process, marking a significant…
-
Novo Nordisk’s Turoctocog Alfa Pegol for Hemophilia A Accepted for Review by China’s CDE
•
The Center for Drug Evaluation (CDE) in China has indicated on its website that the market filing for turoctocog alfa pegol, developed by Denmark-based Novo Nordisk (NYSE: NVO), has been accepted for review. The drug is intended for the treatment of hemophilia A, a genetic bleeding disorder. Turoctocog Alfa Pegol:…
-
Sisram Medical’s Alma Veil Launches in the US for Vascular Lesion Treatment
•
Alma Lasers, a subsidiary of Sisram Medical (HKG: 1696), has announced the commercial availability of Alma Veil in the US. This marks a significant step for the medical aesthetic solutions unit as it introduces an advanced dual wavelength vascular laser equipment platform designed to optimize and enhance therapeutic effects. Advanced…
-
AstraZeneca’s Eplontersen Gains Tacit Approval from CDE for ATTR-CM Clinical Study
•
The Center for Drug Evaluation (CDE) website indicates that UK pharmaceutical major AstraZeneca’s (AZ, NASDAQ: AZN) injectable eplontersen has been tacitly approved for clinical study in hereditary and wild-type transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), aiming to reduce cardiovascular mortality and cardiovascular-related hospitalizations. Eplontersen: An Antisense Oligonucleotide Therapy for ATTR-CMEplontersen, an antisense…
