Clinical & Regulatory
Transcenta Anti-sclerostin Monoclonal Antibody TST002 (Blosozumab) Received Approval from China CDE to Initiate Phase II Clinical Trial in Patients with Reduced Bone Mineral Density
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 approval from China Center for Drug Evaluation (CDE) to initiate Phase II clinical trial of TST002(Blosozumab).
Cullgen Announces First-In-Human Dose in Phase I/II Trial of CG001419, a First-in-Class TRK Protein Degrader for Treatment of Cancer Patients
Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE™ platform of targeted protein degradation technology, today announced that it has initiated dosing with its orally bioavailable pan-TRK degrader, CG001419, in a Phase I/II clinical trial for patients with solid tumors.
Acceptance Of Clinical Trial Application For The Recbio’s Novel Adjuvanted Recombinant Shingles Vaccine REC610 In China And Overseas Clinical Trial Progress
Jiangsu Recbio Technology Co., Ltd. (the"Board") is pleased to announce that the Group has recently received the notice of acceptance (acceptance number: CXSL2300518) issued by National Medical Products Administration ("NMPA"), pursuant to which the clinical trial application for its self-developed novel adjuvanted recombinant shingles vaccine REC610 has been accepted.
Everest Medicines Announces Commercial Launch and First Prescription for XERAVA® in China
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University.
LianBio Partner Tarsus Pharmaceuticals Announces U.S. FDA Approval of XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the Treatment of Demodex Blepharitis
Tarsus Pharmaceuticals (Tarsus) announced yesterday that the U.S. Food and Drug Administration (FDA) approved XDEMVY™ (lotlilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis.
InnoCare Announces Approval of Clinical Trial of pan-TRK Inhibitor Zurletrectinib for the Treatment of Pediatric Patients in China
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the Company has received approval to conduct clinical trial of its second generation pan-TRK inhibitor zurletrectinib (ICP-723) to treat pediatric patients (2 to 12 years old) in China.
HighField Biopharmaceuticals Announces First Patient Dosed in Phase 1b/2 Trial of HF1K16 for Recurrent and Refractory Glioma
HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today the first patient has been dosed in a Phase 1b/2 trial of HF1K16 for recurrent and refractory glioma.
Antengene Announces First Patient Dosed in the Nivolumab Combination Portion of the Clinical Study Evaluating the ERK1/2 Inhibitor ATG-017 in Patients with Advanced Solid Tumors in the United States
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 the first patient has been dosed in the United States in the combination portion of the Phase I ERASER trial to evaluate ATG-017 plus nivolumab.
Mabwell Announces the NMPA Approval of Novel Trop-2 ADC (9MW2921) for IND
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of 9MW2921 for advanced solid tumor was approved by the National Medical Products Administration (NMPA).
Kintor Pharma Announces Completion of First Patient Enrollment in Long-term Safety Phase III Trial of KX-826 for Treatment of AGA
Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the company has initiated the long-term safety trial (the "Long-term Safety Trial") of KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA) developed in-house, in China and has completed the first patient enrollment today.
