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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…
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ImmuneOnco Initiates Phase II Clinical Study for CD47 Antibody IMM01
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the initiation of a Phase II clinical study for its investigational drug IMM01, an antibody targeting the cluster of differentiation 47 protein (CD47), in combination with a programmed-death 1 (PD-1) inhibitor for the treatment of solid tumors and lymphomas. This marks a significant…
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Luye Pharma’s Biosimilar to Amgen’s Xgeva Launched in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first prescription of its biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), known as LY06006/BA6101, in Shandong, Jiangsu, Hunan, Tianjin, Shaanxi, and Jilin provinces. The drug was launched just 21 days after receiving marketing approval, marking a rapid entry into the…
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Double-Crane Pharma Gains NMPA Approval for COVID-19 Drug CX2101A Clinical Trials
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its COVID-19 treatment candidate, CX2101A. This marks a significant step forward in the development of new therapeutic options for COVID-19 in China. CX2101A Technology and DevelopmentCX2101A is a…
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CSL Vifor and Fresenius Kabi Win China Approval for Ferinject
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Swiss firm CSL Vifor and Germany’s Fresenius Kabi have announced the first regulatory approval in China for Ferinject (ferric carboxymaltose), an iron deficiency treatment used to manage anemia in patients with chronic kidney disease and those undergoing surgery. The drug is indicated for adults with iron deficiency for whom oral…
