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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has been approved for marketing in Macau. This approval expands the availability of the treatment to patients in the region. Previous NMPA ApprovalThe product previously received conditional approval from the…
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has received conditional marketing approval in China. GST-HG171 is a 3CL protease (3CLpro) inhibitor, characterized as having broad-spectrum anti-COVID-19 activity. 3CL protease is an essential protease for…
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for the Category 1 product GST-HG171/ritonavir, an oral therapy for COVID-19, has been accepted for review by China’s National Medical Products Administration (NMPA). Therapeutic Profile of GST-HG171/RitonavirGST-HG171 is identified as a…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the pivotal Phase II/III regulatory clinical study for its Category 1 product, GST-HG171/ritonavir, in mild/moderate COVID-19 patients has been unblinded and has successfully reached its primary endpoint. Design and Results of the StudyThe multi-center, randomized, double-blind, placebo-controlled study aimed…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the completion of 1,200 patient enrollment in a Phase II/III clinical study for its Category 1 product, GST-HG171/ritonavir. This multi-center, randomized, double-blind, controlled trial is designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients.…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced positive results from an investigator-initiated trial (ITT) for its Category 1 product GST-HG171/ritonavir in COVID-19 patients. The randomized, controlled trial was designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients and included a test…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) announced the completion of the enrollment of all subjects and their clinical observation, alongside the clinical study summary report of a Phase I clinical study for its Category 1 GST-HG171. The results showed that GST-HG171 had good safety, tolerability, and pharmacokinetics, which…
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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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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced plans to enter into a technology transfer agreement with compatriot firm Fujian Ruitailai Pharmaceutical Technology Co., Ltd. Under the agreement, Cosunter will obtain all technologies, materials, and rights to Ruitailai’s ursodeoxycholic acid capsules (250mg) for RMB 13.5 million (USD 1.9…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has been dosed in a Phase I clinical study for its Category 1 drug candidate GST-HG171. The randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy Chinese…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug candidate, GST-HG171, in adult patients with mild/common COVID-19. This marks a significant step forward in the development of…