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賽生藥業：自願公告 - Vaborem在中國的III期臨床試驗完成全部受試者入組

SCICLONE PHARMA: VOLUNTARY ANNOUNCEMENT - SciClone Announces Phase III Clinical Trial of Vaborem Completed Subject Enrollment in China

香港交易所 ·  Jan 31 17:10
Summary by Moomoo AI
賽生藥業控股有限公司（「賽生藥業」）宣布，其新型抗菌藥物Vaborem®在中國的III期臨床試驗已成功完成全部受試者入組。該試驗旨在評估Vaborem®對複雜性尿路感染（cUTI）患者的有效性和安全性，並由復旦大學附屬華山醫院和上海交通大學醫學院附屬仁濟醫院的教授主導，在全國27家研究中心共入組了108例受試者。研究結果將支持Vaborem®在中國的上市申請。Vaborem®是一種新型苯硼酸β-內醯胺酶抑制劑，專門開發用於抑制碳青黴烯類耐藥腸桿菌科細菌。賽生藥業於2022年8月與美納裡尼集團達成許可及合作協議，在中國獨家開發和商業化Vaborem®。賽生藥業表示，III期臨床試驗的完成是開發進程的重要裡程碑，並感謝所有參與試驗的研究者、患者和合作伙伴。然而，公司提醒股東及潛在投資者，Vaborem®臨床試驗的最終成功仍無法保證。
賽生藥業控股有限公司（「賽生藥業」）宣布，其新型抗菌藥物Vaborem®在中國的III期臨床試驗已成功完成全部受試者入組。該試驗旨在評估Vaborem®對複雜性尿路感染（cUTI）患者的有效性和安全性，並由復旦大學附屬華山醫院和上海交通大學醫學院附屬仁濟醫院的教授主導，在全國27家研究中心共入組了108例受試者。研究結果將支持Vaborem®在中國的上市申請。Vaborem®是一種新型苯硼酸β-內醯胺酶抑制劑，專門開發用於抑制碳青黴烯類耐藥腸桿菌科細菌。賽生藥業於2022年8月與美納裡尼集團達成許可及合作協議，在中國獨家開發和商業化Vaborem®。賽生藥業表示，III期臨床試驗的完成是開發進程的重要裡程碑，並感謝所有參與試驗的研究者、患者和合作伙伴。然而，公司提醒股東及潛在投資者，Vaborem®臨床試驗的最終成功仍無法保證。
Saisheng Pharmaceutical Holdings Limited (“Saisang Pharmaceuticals”) announced that the Phase III clinical trial of its novel antibacterial drug Vaborem® in China has successfully completed the enrollment of all subjects. The trial was designed to evaluate the efficacy and safety of Vaborem® in patients with complex urinary tract infections (cUTi) and was led by professors from Huashan Hospital of Fudan University and Yan Chai Hospital, affiliated with Shanghai Jiaotong University School of Medicine, and enrolled 108 subjects at 27 research centers nationwide. The study results will support Vaborem®'s listing application in China. Vaborem® is a novel phenoboric acid β-enamidase inhibitor developed specifically for the suppression of carbon-phenylphenol-resistant enterobacteria. Caiseng Pharmaceuticals reached a licensing and cooperation agreement with the Minarini Group...Show More
Saisheng Pharmaceutical Holdings Limited (“Saisang Pharmaceuticals”) announced that the Phase III clinical trial of its novel antibacterial drug Vaborem® in China has successfully completed the enrollment of all subjects. The trial was designed to evaluate the efficacy and safety of Vaborem® in patients with complex urinary tract infections (cUTi) and was led by professors from Huashan Hospital of Fudan University and Yan Chai Hospital, affiliated with Shanghai Jiaotong University School of Medicine, and enrolled 108 subjects at 27 research centers nationwide. The study results will support Vaborem®'s listing application in China. Vaborem® is a novel phenoboric acid β-enamidase inhibitor developed specifically for the suppression of carbon-phenylphenol-resistant enterobacteria. Caiseng Pharmaceuticals reached a licensing and cooperation agreement with the Minarini Group in August 2022 to exclusively develop and commercialize Vaborem® in China. The completion of the Phase III clinical trial is an important milestone in the development process, and thanked all researchers, patients and partners who participated in the trial. However, the company reminds shareholders and potential investors that the final success of the Vaborem® clinical trial is still not guaranteed.

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