China
CANbridge to Continue CAN008 Phase 2 Trial in Glioblastoma Multiforme (GBM) in China Based on Interim Analysis of Independent Data Monitoring Committee
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 that, based on the interim analysis recommendation of the independent data monitoring committee, it plans to continue the ongoing Phase 2 study of CAN008 in patients with newly diagnosed glioblastoma multiforme (GBM) in China to completion.
Registrational Pivotal Phase III Study of Olverembatinib for the First-Line Treatment of Patients with Ph+ ALL Approved by the CDE in China
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 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved a registrational pivotal Phase III study of olverembatinib, Ascentage Pharma's lead drug candidate, in combination with chemotherapy (investigational arm) comparing imatinib in combination with chemotherapy (control arm) for treatment of patients with naïve Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
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.
Sirnaomics Establishes a Strategic Partnership with EDIRNA Inc., an RNA-Editing Therapeutic Company
Sirnaomics has established a strategic partnership with EDIRNA Inc. ("EDIRNA"), an early-stage biotech company focused on RNA-Editing therapeutic company, for advancing its proprietary "Edit-to-Cure Therapeutics™" platform, targeting diseases with high unmet clinical need.
Brii Biosciences Broadens its Leadership in Hepatitis B with a Portfolio Now Addressing Disease’s Burdens from Prevention to Cure
Brii Biosciences announced that it has entered into license agreements with VBI Vaccines, Inc. ("VBI", NASDAQ: VBIV), expanding the companies' collaboration in the hepatitis B virus (HBV) field.
Biocytogen Pharmaceuticals Enters Into License Agreement With Pheon Therapeutics
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotech company focusing on the discovery of novel antibody therapeutics, today announces an antibody license agreement with Pheon Therapeutics (Pheon), a leading Antibody-Drug Conjugate (ADC) specialist developing next generation ADCs for a wide range of hard-to-treat cancers.
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.
