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Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
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SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its antibody drug conjugate (ADC), GQ1005, targeting HER2 in patients with non-surgical/metastatic breast cancer. Preclinical studies have shown that…
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Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
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SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to proceed with a clinical study for its in-house developed anti-angiogenic biologic drug, SCT520FF, for the treatment of neovascular age-related macular degeneration (nAMD). The drug SCT520FF is…
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AccurEdit Therapeutics’ Gene-Editing Drug ART001 Clears FDA Hurdle for US Clinical Trials
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SUZHOU—AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading Chinese specialist in gene editing therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) for its investigational drug ART001, which targets transthyretin amyloidosis. This milestone marks ART001 as the first in vivo gene-edited drug based on…
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Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
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GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical studies for BAT2406, a biosimilar version of Sanofi’s Dupixent (dupilumab). This monoclonal antibody, which targets interleukin-4 (IL-4) and interleukin-13 (IL-13), is now set to be…
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Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a Chinese pharmaceutical firm, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its innovative bispecific antibody-drug conjugate (ADC), DM005. This development marks a significant milestone for the company as it advances its pipeline towards…
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Jiyuan Biotechnology’s Stem Cell Therapy for Type 2 Diabetes Gains NMPA Tacit Approval for Clinical Trials
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BEIJING—Jiyuan Biotechnology, a leading Chinese biopharmaceutical company, has secured tacit clinical trial approval from the National Medical Products Administration (NMPA) for its cutting-edge therapy targeting type 2 diabetes. This marks the first clinical trial approval in China for domestically developed gene-modified mesenchymal stem cells. The therapy in question involves the…
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Jiangsu Simcere and AnDiConBio’s Anti-Influenza Drug ADC189 Doses First Patient in Phase III Study
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JIANGSU—In a significant development for the pharmaceutical industry, Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in collaboration with AnDiConBio, has initiated a Phase III clinical study for their anti-influenza drug, ADC189. This study marks a crucial step in the advancement of pediatric treatment options, with the first patient dosed in…
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Shanghai-Based ANEXT Commences Clinical Trials for Exosome Product ANEXT FIT CELL in Respiratory Conditions
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ANEXT, a Shanghai-based exosome specialist, has launched two clinical studies for their product ANEXT FIT CELL, which is derived from mesenchymal stem cells exosomes. One study aims to evaluate the product’s efficacy in treating cough symptoms following infection, while the other is focused on safety and preliminary efficacy in the…
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Hinova Pharmaceuticals’ HP515 Receives NMPA Approval for NASH Clinical Study
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Hinova Pharmaceuticals Inc., a biotech firm headquartered in Chengdu and listed on the Shanghai Stock Exchange (SHA: 688302), has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug candidate, HP515. The molecule is intended for the treatment of nonalcoholic…
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Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
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Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in Phase III Trial for TROP2 ADC FDA018 in TNBC
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 1349) and the Shanghai Stock Exchange (SHA: 688505), has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate FDA018. This TROP2 antibody-drug conjugate (ADC) is…
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China’s Guilin Sanjin Pharmaceutical Advances BC011 with NMPA Approval for Phase I Clinical Trial
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Guilin Sanjin Pharmaceutical Co. Ltd, a Chinese pharmaceutical company listed on the Shenzhen Stock Exchange (SHE: 002275), has announced that its subsidiary, Dragon Boat Pharmaceutical (Shanghai) Co., Ltd, has obtained approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its drug candidate BC011,…
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Changchun High & New Technology Industries Receives FDA Approval for GenSci098 Clinical Trial in Thyroid Eye Disease
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Changchun High & New Technology Industries (Group) Inc., a Chinese corporation listed on the Shenzhen Stock Exchange (SHE: 000661), has received tacit approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its Category 1 biologic product, GenSci098. This humanized anti-TSHR antagonistic monoclonal antibody (mAb)…
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China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
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The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude Therapeutics Inc.’s proprietary injectable drug candidate, AMT-676, as indicated on the CDE website. The drug is intended for the treatment of solid tumors. AMT-676 is an antibody-drug conjugate (ADC) that targets CDH17, a gene situated…
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Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
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Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
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Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
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Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
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Gene Cradle Initiates First Regulatory Gene Therapy Study in China for Late-Onset Pompe Disease
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Gene Cradle, a Beijing-based gene therapy specialist, has achieved a milestone by administering its GC301 to the first patient with late-onset Pompe disease (LOPD) in a regulatory study in China. This marks the nation’s first patient dosing of an adeno-associated virus (AAV) gene therapy for LOPD. GC301 is an innovative…
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Phase I Success for Shandong Xinhua’s OAB-14, Advancing to Phase IIa in Alzheimer’s Therapy
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Shandong Xinhua Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Shenzhen (SHE: 000756), has declared the successful completion of a Phase I clinical trial for its OAB-14 drug candidate in a dry suspension formulation. Following the positive outcome, the company is now gearing up to initiate a Phase IIa…
