Clinical & Regulatory
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)
Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. In addition, we are in the process of EU and FDA regulatory interaction.
InnoCare Announces First Psoriasis Patient Dosed in Clinical Trial of TYK2 Allosteric Inhibitor ICP-488 in China
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the first psoriasis patient has been dosed in clinical trial of the Company’s TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor ICP-488 in China.
Hexvix®, A Diagnostic Drug for Bladder Cancer of Asieris has Completed the Phase III bridging trial Enrollment
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 the completion of patient enrollment for its Phase III bridging clinical trial of Hexvix®, a drug used for the diagnosis of bladder cancer.
FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease (AD).
Innovent and IASO Bio Announce the NMPA Approval of FUCASO®, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma
Innovent Biologics and IASO Biotechnology announce that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO® (Equecabtagene Autoleucel, co-developed and co-commercialized by Innovent and IASO Bio.
Pfizer to end development of experimental obesity pill due to elevated liver enzymes
Pfizer on Monday said it would stop developing its experimental obesity and diabetes pill, lotiglipron, due to elevated liver enzymes in patients who took the drug once a day in midstage clinical studies.
FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.
LianBio Announces Marketing Approval of CAMZYOS® (mavacamten) in Singapore
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other Asian markets, today announced that CAMZYOS® (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Singapore Health Sciences Authority.
CANbridge Reports Positive Preliminary Data in the Omoprubart (CAN106) Phase 1b Trial in Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
BEIJING & BURLINGTON, Mass.--(BUSINESS WIRE)--CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced positive preliminary results from the ongoing Phase 1b study of omoprubart (CAN106), a novel, long-acting, anti-C5 complement recombinant humanized monoclonal antibody, in paroxysmal nocturnal hemoglobinuria (PNH) in China.
Junshi Biosciences Announces Initiation of Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer
Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180) announced that the U.S. Food and Drug Administration (“FDA”) has recently agreed a randomized, double-blind, placebo-controlled, multi-regional phase 3 clinical study of tifcemalimab (product code: TAB004/JS004), an anti-BTLA monoclonal antibody used in combination with toripalimab, an anti-PD-1 monoclonal antibody, as consolidation therapy for patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy may proceed.
