Clinical & Regulatory
Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review
OSAKA, Japan & CAMBRIDGE, Mass. & HONG KONG & SHANGHAI & FLORHAM PARK, N.J.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (HUTCHMED) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).
BioRay Filed IND Application for BRY812, a Novel Antibody Drug Conjugate Targeting LIV-1
SHANGHAI, May 24, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as BioRay) announced that the Investigational New Drug (IND) application for the clinical trial of its proprietary BRY812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors, has been accepted by the China National Medical Products Administration (NMPA) (Acceptance No. CXSL2300366).
Allgenesis Announces Encouraging Preliminary Safety and Efficacy Data from the AG-73305 Phase 2a Trial for the Treatment of Diabetic Macular Edema
TAIPEI, May 23, 2023 /PRNewswire/ -- Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, announces exciting preliminary data from the two initial cohorts of the on-going AG-77305 FIH Phase 2a clinical trial for the treatment of Diabetic Macular Edema (DME) in the US.
Minghui Pharmaceutical Inc. Announces First-in-Human Dose of MHB018A, a Subcutaneous Single-Domain IGF-1R Antibody in Phase 1a Healthy Volunteer Study
SHANGHAI and HANGZHOU, China and WILMINGTON, Del., May 23, 2023 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a clinical-stage biopharmaceutical company focusing on oncology and autoimmune diseases, today announced that the phase 1a trial of MHB018A has commenced with the dosing of its first subject. The phase 1a, randomized, double-blinded, vehicle-controlled first-in-human study aims to evaluate the safety, tolerability and pharmacokinetics of MHB018A in healthy volunteers.
Antengene Announces Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers
SHANGHAI and HONG KONG, May 23, 2023 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that ATG-022, a Claudin 18.2 antibody drug conjugate (ADC) in-house discovered and developed by Antengene, has been granted two Orphan Drug Designations (ODD) consecutively by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.
Junshi Biosciences Announces Acceptance of the Supplemental NDA for Toripalimab in Combination with Chemotherapy for Advanced Triple-negative Breast Cancer
SHANGHAI, China, May 23, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (“NMPA”) has accepted the supplemental new drug application ("sNDA”) for the company’s anti-PD-1 monoclonal antibody, toripalimab, used in combination with albumin-bound paclitaxel for the treatment of PD-L1 positive (CPS ≥ 1) untreated metastatic or recurrent metastatic triple-negative breast cancer (“TNBC”).
Oramed Announces that its Chinese Partner, HTIT, has Successfully Completed a Phase 3 Oral Insulin Clinical Trial and Submitted a Marketing Authorization Application in China
NEW YORK, May 15, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com) announced today that Hefei Tianhui Biotechnology Co. Ltd. (HTIT), a strategic partner of Oramed, has successfully completed its Phase 3 trials of oral insulin in type 2 diabetes in China under a differentiated study protocol. HTIT is now moving toward regulatory approval and has submitted the data to the National Medical Products Administration (NMPA, formerly the CFDA).
HuidaGene Therapeutics’ Novel DNA Gene-Editing System Cas12i Patent Granted by USPTO
SHANGHAI and CLINTON, N.J., May 16, 2023 /PRNewswire/ -- HuidaGene Therapeutics (辉大基因; HuidaGene), a clinical-stage company focusing on developing gene editing tools and gene therapies, today announced that the United States Patent and Trademark Office (USPTO) has granted to the Company patent US11,649,444B1 with respect to its independently-developed DNA editing system, CRISPR-Cas12i (Cas12Max®), in just 9 months post-filing with the assistance of a reputable US law firm.
Antengene Announces Clearance of U.S. IND for the Phase I Trial of First-in-Class Anti-CD24 Monoclonal Antibody ATG-031
HONG KONG, May 17, 2023 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the Investigational New Drug (IND) for a Phase I study of the first-in-class anti-CD24 monoclonal antibody ATG-031 has received clearance from the U.S. Food and Drug Administration (FDA).
HiST Pharma Announces U.S. FDA Approval to Initiate Phase III Clinical Study With TC Cream – World’s First Botanical Small
HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG) announces today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based multicenter Phase III clinical study to treat patients with psoriasis vulgaris, following a previously completed Phase II^b trial (NCT03372811).
