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HKG:2637

6 stories mentioning HKG:2637Updated just now

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Asia

Fujian Haixi Pharmaceuticals Files Phase IIa Trial Application for Eye Drug

Fujian Haixi Pharmaceuticals (HKG:2637) submitted an application in China to begin a Phase IIa clinical trial of HX9428 for diabetic macular edema, according to a Wednesday company filing.The application was submitted to China's drug regulator on Aug. 31, making diabetic macular edema the second indication being developed for the oral drug candidate.HX9428 is also being studied in Phase II trials in China and the U.S. for neovascular age-related macular degeneration. The drug has received Fast Track Designation from the U.S. Food and Drug Administration.

HKG:2637
Asia

Fujian Haixi Pharma Granted Fast Track Designation for Eye Disease Drug by US FDA

Fujian Haixi Pharmaceuticals' (HKG:2637) HX9428 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA).The FTD was for the development of a treatment for neovascular age-related macular degeneration (nAMD), according to a Monday Hong Kong bourse filing.The grant of the FTD will allow closer communication between the company and the regulator on the drug's clinical development.

HKG:2637
Asia

Fujian Haixi Pharma Receives FDA Clearance for Eye Disease Drug Trial

Fujian Haixi Pharmaceuticals (HKG:2637) said the U.S. Food and Drug Administration approved its investigational new drug application for HX9428, an experimental treatment for neovascular age-related macular degeneration (nAMD), allowing a Phase II clinical trial to proceed in the U.S.The company also started a second Phase II trial in China to evaluate the treatment against Aflibercept, a standard therapy for the eye disease.The study is expected to enroll 60 patients.

HKG:2637
Asia

Fujian Haixi Pharmaceuticals Gets China Nod for Glioblastoma Drug Trial

Fujian Haixi Pharmaceuticals (HKG:2637) obtained approval for an investigational new drug application for a clinical trial of HXP089.The drug has been developed by the company to treat glioblastoma, according to a Tuesday Hong Kong bourse filing.

HKG:2637
Asia

Fujian Haixi Pharma Begins Phase III Trial of Osteosarcoma Drug

Fujian Haixi Pharmaceuticals (HKG:2637) officially began a phase III clinical trial of the C019199 tablets, according to a Friday Hong Kong bourse filing.The trial aims to evaluate the efficacy and safety of the drug for the treatment of osteosarcoma after the failure of at least two prior lines of therapy.

HKG:2637
Asia

Fujian Haixi Pharmaceuticals Starts Phase III Trial for Osteosarcoma Drug

Fujian Haixi Pharmaceuticals (HKG:2637) has initiated a Phase III clinical trial of its C019199 tablets for the treatment of osteosarcoma in patients whose disease has progressed after at least two prior lines of therapy.The study, expected to enroll about 120 patients across multiple clinical centers in China, will compare C019199 with gemcitabine plus docetaxel, according to a Thursday Hong Kong bourse filing. The primary endpoint is progression-free survival, with overall survival, objective response rate, disease control rate and safety among the secondary endpoints.

HKG:2637

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