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SciClone’s Danyelza Approved for Marketing in China by NMPA
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The National Medical Products Administration (NMPA) website indicates that SciClone Pharmaceuticals Inc’s (Nasdaq: SCLN) Danyelza (naxitamab) has been approved for marketing in China. Danyelza is a GD2-targeted monoclonal antibody originated by Y-mAbs Therapeutics Inc., and was fast-tracked for marketing approval in November 2020. SciClone struck a licensing deal with Y-mAbs…
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Enhertu Confirmed as New Standard of Care for Breast Cancer in Phase III Study
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AstraZeneca PLC (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) released the latest data supporting the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) as a new standard of care for breast cancer. An update from the DESTINY-Breast03 Phase III study assessing Enhertu head-to-head against Roche’s Kadcyla (trastuzumab emtansine, TDM-1) in patients with…
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MicuRx Pharmaceuticals Gains Clinical Trial Approvals for MRX-4 in Europe
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Sino-US firm MicuRx Pharmaceuticals Inc. announced receiving clinical trial approvals in France, Greece, Hungary, Italy, Latvia, Lithuania, Portugal, Spain, and Estonia for its novel anti-microbial agent MRX-4 combined with contezolid (MRX-I) as a sequential treatment for diabetic foot infection. Drug Overview and DevelopmentBoth drugs are in-house developed new-generation oxazolidinone antibiotics.…
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Beijing Wantai’s Nasal Spray COVID-19 Vaccine Approved for Emergency Use in China
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China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) announced the inclusion of its nasal spray influenza virus vector SARS-CoV-2 vaccine co-developed by Xiamen University and Hong Kong University, in the emergency use program in China. Vaccine Development and MechanismThe vaccine, produced by inoculating Madin-Darby Canine Kidney (MDCK) cells…
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Junshi Biosciences Files for EMA Approval of Tuoyi for Nasopharyngeal and Esophageal Cancers
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that a market approval filing has been made for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) with the European Medicines Agency (EMA). The biotech is seeking approval for the checkpoint inhibitor in combination with chemotherapy as a first-line treatment for locally recurrent…
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WestVac Biopharma’s Recombinant COVID-19 Vaccine Approved for Emergency Use in China
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Chengdu-based WestVac Biopharma Co., Ltd announced the inclusion of its recombinant COVID-19 vaccine (Sf9 cells) in the emergency use program in China. It is the first recombinant protein novel coronavirus vaccine produced by the insect cell technology platform approved for emergency use in China. Vaccine Efficacy and TechnologyThe data shows…
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Qilu Pharmaceutical’s QL1604 Plus Chemotherapy Shows Promise in Phase II Study
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China-based Qilu Pharmaceutical announced that the results of the Phase II study assessing its QL1604 plus chemotherapy as a first-line treatment for patients with recurrent or metastatic (R/M) cervical cancer were released on December 4, 2022, in an oral presentation (Proffered Paper, 179O) at the European Society for Medical Oncology…
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Hybio Receives Ethical Approval for HY3000 COVID-19 Nasal Spray Phase II Study
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced receiving ethical approval for a Phase II clinical study protocol for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. The clinical filing for the product was accepted for review by the National Medical Products Administration (NMPA) in August 2022. Study…
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Clover Biopharmaceuticals’ COVID-19 Vaccine SCB-2019 Included in China’s Emergency Use Program
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China-based vaccine specialist Clover Biopharmaceuticals, Ltd (HKG: 2197) announced the inclusion of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in the emergency use program in China. The protein vaccine was developed using Clover’s proprietary Trimer-Tag (protein trimerization) technology, a drug development platform which allows the production of novel, covalently-trimerized fusion proteins.…
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Henlius Biotech Doses First Patient in Phase I Study for HLX60 in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing of a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. Study Design and ObjectivesThe open, dose escalation, first-in-human Phase I study is designed to assess the safety and tolerability of the drug…
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Fudan Team Presents Ribociclib Phase II Bridging Study Results at ESMO Asia
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A Fudan University Shanghai Cancer Center team led by Shao Zhimin made an oral presentation of results from a Phase II bridging study for ribociclib at the European Society for Medical Oncology (ESMO) Asia Congress 2022. Ribociclib (trade name: Kisqali) is a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor developed by Swiss…
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Hansoh’s EGFR Inhibitor Ameile Filed for EMA Review by Partner EQRx
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a market filing for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been filed for review with the European Medicines Agency (EMA) by US-based partner EQRx Inc. Hansoh/EQRx’s targeted indication is as a first-line treatment of locally advanced…
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Sinocelltech’s SCTV01C Vaccine Included in China’s Emergency Use Program
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China-based Sinocelltech Group Ltd (SHA: 688520) announced the inclusion of its recombinant novel coronavirus alpha+beta mutant S-trimer protein vaccine SCTV01C in the emergency use program in China. SCTV01C is a next-generation bivalent mutant recombinant protein vaccine being developed to prevent diseases caused by COVID-19. The active ingredient of SCTV01C contains…
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Lynk Pharmaceuticals Doses First Patient in Phase II Study for LNK01003
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China-based Lynk Pharmaceuticals (Hangzhou) Co., Ltd announced first patient dosing in a Phase II clinical study assessing the efficacy and safety of its Category 1 innovative drug candidate LNK01003 in active ulcerative colitis (UC). Ulcerative Colitis and LNK01003Ulcerative colitis is one of the two main forms of inflammatory bowel disease…
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Innovent Biologics Doses First Volunteer in Orismilast Phase I Study
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China-based Innovent Biologics Inc., (HKG: 1801) and Denmark-based partner Union Therapeutics A/S revealed that a first healthy volunteer has been dosed in a Phase I study in China for orismilast (IBI353), a potential best-in-class PDE4 inhibitor. The study (CTR 20222393) is a dose-escalation Phase I designed to assess the pharmacokinetic…
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Daiichi Sankyo Doses First Patient in Global Phase III TROPION-Lung08 Study
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced the first patient dosed in the global multi-center Phase III TROPION-Lung08 study in China. The trial is assessing the efficacy and safety of Dato-DXd combined with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) with high expression of PD-L1 without…
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NMPA Approves Henlius’ HLX04 Biosimilar for Lung and Colorectal Cancer
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The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696) HLX04, a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab), has been approved for use in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (CRC). Henlius’s drug becomes the eighth…
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Pyxis Oncology Receives FDA Approval for Biosion’s PYX-106 Clinical Trials
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China-based Biosion, Inc’s US partner Pyxis Oncology, Inc. (NASDAQ: PYXS) announced receiving clinical trial approval from the US FDA for its PYX-106 (BSI-060T). The anti-Siglec-15 monoclonal antibody (mAb) can now be assessed in clinics in bladder cancer, bile duct cancer, colorectal cancer, kidney cancer, and more. Preclinical Data and Drug…
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Kintor’s KX-826 Reaches Primary Endpoint in Phase II Study for Female AGA
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced that the Phase II clinical study for its AR antagonist KX-826 (pyrilutamide) in female patients with androgenetic alopecia (AGA) in China has reached the primary endpoint. Study Design and ResultsThe randomized, double-blind, placebo-controlled, multicenter study, with 160 patients enrolled, is designed to assess…
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Simcere’s Edaravone, Borneol Sublingual Tablets Reach Phase III Efficacy Endpoint
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) announced that a Phase III clinical study for its edaravone, borneol sublingual tablets in acute ischemic stroke (AIS) has reached the pre-set efficacy endpoint. Preliminary analysis showed that, compared with a placebo, edaravone, borneol sublingual tablets could significantly improve the neurological recovery and…
