更新于：2024-11-04
Fujian Akeylink Biotechnology Co., Ltd
福建广生中霖生物科技有限公司|
私营公司 | 子公司|
2021|
中国福建省
更新于：2024-11-04
概览
标签
感染
呼吸系统疾病
心血管疾病
小分子化药
疾病领域得分
一眼洞穿机构专注的疾病领域
技术平台
公司药物应用最多的技术
靶点
公司最常开发的靶点
关联
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole With GST-HG171/Ritonavir in Healthy Adult Chinese Participants
Food Effects Study of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants
100 项与 福建广生中霖生物科技有限公司 相关的临床结果
登录后查看更多信息
登录后查看更多信息
2024-05-01EClinicalMedicine
Efficacy and safety of GST-HG171 in adult patients with mild to moderate COVID-19: a randomised, double-blind, placebo-controlled phase 2/3 trial
Article
作者: Mao, John ; Li, Hongming ; Chen, Xiaochun ; Zhong, Nanshan ; Fu, Haijun ; Zhang, Kaiyu ; Lin, Feng ; Wang, Fu-Sheng ; Lu, Hongzhou ; Yang, Zifeng ; Lin, Yihua ; Li, Guoping ; Liang, Zhenyu ; Zhang, George ; Chen, Xinwen ; Tan, Hongshan ; Yan, Wenhao ; Lin, Yuanlong ; Huo, Liya ; Huang, Fuhu ; Zhan, Yangqing ; Yuan, Wenfang ; Chen, Xia ; Hu, Peng ; Lin, Zhuhua ; Mu, Lisa ; Tang, Yanan ; Zhang, Tianxiang ; Lin, Ling ; Tu, Xinyu ; Hu, Zhiqiang ; Sun, Ruilin ; Yan, Xiuping ; Wei, Zhaohui ; Zhu, Feiyue ; Zhuang, Xibin ; Zeng, Yiming
Background:
GST-HG171 is a potent, broad-spectrum, orally bioavailable small-molecule 3C like protease inhibitor that has demonstrated greater potency and efficacy compared to Nirmatrelvir in pre-clinical studies. We aimed to evaluate the efficacy and safety of orally administered GST-HG171 plus Ritonavir in patients with coronavirus disease 2019 (COVID-19) infected with emerging XBB and non-XBB variants.
Methods:
This randomised, double-blind, placebo-controlled phase 2/3 trial was conducted in 47 sites in China among adult patients with mild-to-moderate COVID-19 with symptoms onset ≤72 h. Eligible patients were randomised 1:1 to receive GST-HG171 (150 mg) plus Ritonavir (100 mg) or corresponding placebo tablets twice daily for 5 days, with stratification factors including the risk level of disease progression and vaccination status. The primary efficacy endpoint was time to sustained recovery of clinical symptoms within 28 days, defined as a score of 0 for 11 COVID-19-related target symptoms for 2 consecutive days, assessed in the modified intention-to-treat (mITT) population. This trial was registered at ClinicalTrials.gov (NCT05656443) and Chinese Clinical Trial Registry (ChiCTR2200067088).
Findings:
Between Dec 19, 2022, and May 4, 2023, 1525 patients were screened. Among 1246 patients who underwent randomisation, most completed basic (21.2%) or booster (74.9%) COVID-19 immunization, and most had a low risk of disease progression at baseline. 610 of 617 who received GST-HG171 plus Ritonavir and 603 of 610 who received placebo were included in the mITT population. Patients who received GST-HG171 plus Ritonavir showed shortened median time to sustained recovery of clinical symptoms compared to the placebo group (13.0 days [95.45% confidence interval 12.0-15.0] vs. 15.0 days [14.0-15.0], P = 0.031). Consistent results were observed in both SARS-CoV-2 XBB (45.7%, 481/1053 of mITT population) and non-XBB variants (54.3%, 572/1053 of mITT population) subgroups. Incidence of adverse events was similar in the GST-HG171 plus Ritonavir (320/617, 51.9%) and placebo group (298/610, 48.9%). The most common adverse events in both placebo and treatment groups were hypertriglyceridaemia (10.0% vs. 14.7%). No deaths occurred.
Interpretation:
Treatment with GST-HG171 plus Ritonavir has demonstrated benefits in symptom recovery and viral clearance among low-risk vaccinated adult patients with COVID-19, without apparent safety concerns. As most patients were treated within 2 days after symptom onset in our study, confirming the potential benefits of symptom recovery for patients with a longer duration between symptom onset and treatment initiation will require real-world studies.
Funding:
Fujian Akeylink Biotechnology Co., Ltd.
100 项与 福建广生中霖生物科技有限公司 相关的药物交易
登录后查看更多信息
100 项与 福建广生中霖生物科技有限公司 相关的转化医学
登录后查看更多信息
组织架构
使用我们的机构树数据加速您的研究。
登录
或
管线布局
2024年11月05日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
临床2期
1
1
临床3期
批准上市
1
登录后查看更多信息
当前项目
登录后查看更多信息
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
营收
使用 Synapse 探索超过 36 万个组织的财务状况。
登录
或
科研基金(NIH)
访问超过 200 万项资助和基金信息，以提升您的研究之旅。
登录
或
投资
深入了解从初创企业到成熟企业的最新公司投资动态。
登录
或
融资
发掘融资趋势以验证和推进您的投资机会。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用