Clinical & Regulatory
Neurophth Secures Australian Approval for Ophthalmic Gene Therapy
Neurophth Therapeutics (hereinafter referred to as "Neurophth"), a leader in in-vivo gene therapy for ophthalmic diseases in China, announced the Australian Therapeutic Goods Administration (TGA) has registered and approved its candidate drug, NFS-05, for clinical trials targeting Autosomal Dominant Optic Atrophy (ADOA).
AnHeart Therapeutics Announces Initiation of Global Phase 2 Trial Evaluating Safusidenib for IDH1-Mutant Glioma
AnHeart Therapeutics (“AnHeart”), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced the first patient has been dosed in a Phase 2 clinical trial, G203, evaluating safusidenibin patients with Grades 2 or 3 recurrent or progressive mutant isocitrate dehydrogenase 1 (mIDH1) glioma, one of the most common types of adult primary brain cancer.
Brii Biosciences Announces Topline Interim Results of Phase 2 Study Evaluating BRII-179 (VBI-2601) in Combination with PEG-IFNα for the Treatment of Chronic Hepatitis B
Brii Biosciences Limited ("Brii Bio," "we," or the "Company," stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced topline cohort-level unblinded Week 24 and Week 36 data from interim analysis of a randomized, placebo-controlled and double-blinded Phase 2 study of BRII-179, a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in patients with chronic hepatitis B (CHB) compared with PEG-IFNα only treatment.
First Patient with NyokAssist™ Interventional Ventricular Assist Device: Dr. Junbo Ge’s team successfully completed the first high-risk PCI treatment supported by the new generation of interventional VAD
Recently, NyokAssist™ was first-in-man (FIM) use, supporting High-risk PCI completed by Dr. Junbo Ge's team from Zhongshan Hospital in Shanghai.
Baird Medical’s Single-Use Sterile Biopsy Needle Receives Approval from Jiangsu Medical Products Administration in China
Baird Medical Investment Holdings Limited ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Nanjing Changcheng Medical Equipment Co., Ltd., has received approval of its Single-Use Sterile Biopsy Needle ("SSBN") from Jiangsu Medical Products Administration, the drug regulatory body for Jiangsu Province in China.
Gloria Biosciences Announces Zimberelimab Approved in China for the Treatment of Recurrent or Metastatic Cervical Cancer
Guangzhou Gloria Biosciences ("GloriaBio"), a commercial stage biopharmaceutical company focusing on the discovery, development and commercialization of biologics in immuno-oncology, today announced that its fully human anti-PD-1 monoclonal antibody, Zimberelimab injection (YuTuo®, GLS-010) has received marketing approval from the China National Medical Products Administration (NMPA)
ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers
ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors.
Foresee Pharmaceuticals Announces FDA Orange Book Listing of New U.S. Patent for CAMCEVI®, Extending Patent Protection to 2039
Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces that a new U.S. patent which covers CAMCEVI® (leuprolide mesylate) and its labeled indication is now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as "the Orange Book".
Asieris Obtained IND Approval from NMPA for APL-1401, a Drug for the Treatment of Moderately-to-Severely Active Ulcerative Colitis
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 National Medical Products Administration （NMPA） has approved the Investigational Drug (IND) application for its oral drug APL-1401 for the treatment of moderately-to-severely active ulcerative colitis (UC).
InxMed Receives Approval to Initiate Phase I Clinical Trial in China for OMTX705, a First-in-Class FAP-Targeting ADC
InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies targeting drug resistance for hard-to-treat solid tumors，announced today the first-in-class ADC OMTX705 has obtained the IND (Investigational New Drug) approval from China National Medical Products Administration (NMPA) recently.
