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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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Peijia Medical Enrolls First Patient in GeminiOne TEER System Study
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China’s Peijia Medical Ltd (HKG: 9996) announced first patient enrollment in a multi-center clinical study for its transcatheter edge-to-edge repair (TEER) system GeminiOne in China. The first operation went smoothly, with the whole device being manipulated for a mere 30 minutes. The prospective regulatory, multi-center, target value study is designed…
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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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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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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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Youcare’s YKYYO17 Aerosol Inhalation Agent Approved for COVID-19 Clinical Study
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China-based Youcare Pharmaceutical Group’s YKYYO17 aerosol inhalation agent, a broad-spectrum coronavirus membrane fusion inhibitor polypeptide drug, has been approved in China for a clinical study in COVID-19 infection. Drug Mechanism and DevelopmentThe Category 1 drug candidate, co-developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences, can play…
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Ascletis Pharma Completes Enrollment for ASC40 Phase II Acne Study
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the completion of enrollment of 180 patients in a Phase II clinical study for ASC40 (denifanstat). The molecule is set to be assessed in treating moderate to severe acne. The study is currently still blinded. Study Design and ObjectivesThe randomized, double-blind, placebo-controlled, multicenter…
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Luye Pharma Initiates Phase II Study for LY 03014 in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug candidate, LY 03014. The multi-center, randomized, double-blind, placebo-controlled, and positive drug parallel control study aims to assess the preliminary efficacy and safety of the drug in treating…
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Henlius Completes First Dosing in Head-to-Head Study of PD-1 Inhibitor HanSiZhuang
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a head-to-head bridging study for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The study is evaluating serplulimab as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) against Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), the…
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Hope Medicine Gains Global Approval for Phase II Trial of HMI-115
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China-based Hope Medicine Inc. has announced receiving approval to conduct a global multi-center Phase II clinical study for its monoclonal antibody (mAb) HMI-115, targeting the prolactin receptor (PRL R). The drug is being evaluated as a treatment for endometriosis, a condition that affects many women worldwide. This potential first-in-class (FIC)…
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Jiangsu Hengrui Gets NMPA Approval for HR20031 Clinical Study in Type 2 Diabetes
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its HR20031 in patients with type 2 diabetes. This marks a significant step forward in the development of a novel treatment option for patients with poorly controlled…
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Fosun Pharma’s Henlius Completes Clinical Trial Filing for HLX301 in Australia
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its subsidiary, Shanghai Henlius Biotech (HKG: 2696), has completed a clinical trial filing for HLX301 in Australia. Henlius will conduct a Phase I clinical study in the country for the bispecific antibody (BsAb) targeting programmed-death-ligand 1 (PD-L1)…
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Peijia Medical Announces First Patient Implant in MonarQ TTVR System Clinical Study
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China’s Peijia Medical Limited (HKG: 9996) has announced the first patient implant in a global first-in-man (FIM) clinical study of its MonarQ transcatheter tricuspid valve replacement (TTVR) system. This marks a significant milestone in the development of innovative treatments for tricuspid regurgitation. MonarQ TTVR System ProfileThe MonarQ TTVR system is…
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Immorna’s JCXH-221 mRNA Vaccine Cleared by FDA for Phase I/II Study
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Immorna (Hangzhou) Biotechnology Co., Ltd has announced that the US FDA has cleared its investigational new drug (IND) application to conduct a Phase I/II multi-center study assessing the safety and immunogenicity of JCXH-221, a lipid nanoparticle (LNP) complex broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases, in healthy adult…
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Kanghong Pharma Receives FDA Approval for KH631 Gene Therapy Trial
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approval from the US FDA for its Category 1 innovative gene therapy eye injection KH631. The targeted indication is neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. KH631 ProfileKH631…
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Kexing Pharma Receives Ethical Approval for Phase II Study of SHEN26 COVID-19 Drug
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China-based Kexing Pharmaceutical (SHA: 688136) has announced receiving ethical approval to conduct a Phase II clinical study for its SHEN26, an oral small-molecule COVID-19 drug co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. The study aims to assess the efficacy and safety of SHEN26 in mild and common COVID-19 cases. Study…
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China’s First Gene Therapy for Deafness, RRG-003, Begins Clinical Study
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RRG-003, an adeno-associated virus (AAV) gene therapy co-developed by China’s Shanghai Dingxin Gene Technology Co., Ltd and the Eye & ENT Hospital of Fudan University, has initiated a clinical study targeting hearing loss in the country. This marks the first gene therapy trial for deafness, with the first patient expected…
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Legend Biotech Receives IND Approval for LB2102 CAR-T Therapy
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced receiving Investigational New Drug (IND) approval for its LB2102, an autologous chimeric antigen receptor-T (CAR-T) therapy designed to treat adult patients with small cell lung cancer (SCLC) by targeting DLL3, a cell surface protein highly expressed in SCLC. Clinical Study DesignThe open-label…
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Sun-Novo Pharma Gains NMPA Approval for STC007 Clinical Study in CKD-aP
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007. The study will focus on moderate to severe chronic kidney disease-associated pruritus (CKD-aP) in adults receiving hemodialysis (HD).…
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Mabwell Receives Approval for Clinical Study of 9MW3011 in Polycythemia Vera
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving approval to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 in polycythemia vera. The drug’s clinical trial filing was accepted for review in China last month, marking a significant step forward in its development. Drug Profile9MW3011…
