Clinical & Regulatory
Baird Medical Obtains NMPA Approval of Class III Registered Microwave Ablation Needle for Thyroid Nodules
Baird Medical Investment Holdings Limited ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, announced today that the Company's independently developed and produced disposable MWA needle for the treatment of benign thyroid nodules received approval from China's National Medical Products Administration (the "NMPA") on July 13, 2023.
BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235),a global biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) in combination with obinutuzumabfor the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy.
Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab
Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180) announced that the supplemental new drug application for toripalimab in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma has been accepted by the National Medical Products Administration.
BRONCUS COMPLETES THE FIRST CASE OF REGISTERED CLINICAL TRIALS OF ITS TARGETED LUNG DENERVATION RADIOFREQUENCY ABLATION SYSTEM
Broncus Holding Corporation (HKG:2216) has completed the first case of registered clinical trials of its targeted lung denervation (''TLD'') radiofrequency ablation system.
Shineco Subsidiary Receives Marketing Approval from China’s Regulatory Body for its Cardiac 5-Minute Test
Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI), a producer of technologically advanced healthcare products and services, announced today that on June 21, 2023, Changzhou Biowin Pharmaceutical Co., Ltd., a majority-owned subsidiary of the Company ("Biowin"), received marketing and distribution approval for its Cardiac 5-Minute Test from the Jiangsu Bureau of the National Medical Products Administration (“NMPA"), which is China’s regulatory equivalent of the U.S. Food and Drug Administration (FDA).
280 Bio receives IND approval from the FDA for YL-17231
280Bio, Inc. a clinical stage biotechnology company focused on the development of precision oncology medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for the investigational drug YL-17231, a small molecule inhibitor of RAS signaling.
Skyline Therapeutics Receives FDA Clearance of IND for SKG0106, a Novel Intravitreally Delivered AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration
Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Phase I/IIa clinical trial of SKG0106, a one-time intravitreally delivered AAV gene therapy for the treatment of neovascular age-related macular degeneration (nAMD).
Jacobio Receives CDE Approval for Glecirasib’s Pancreatic Cancer Pivotal Study in China
Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its novel KRAS G12C inhibitor glecirasib's pivotal study for pancreatic cancer has been approved from CDE (Center for Drug Evaluation), which became the first global pancreatic cancer registrational clinical study for KRAS G12C.
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).
