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Internet Drug Information Service Certificate Number: (Lu)-non-commercial-2018-0066
Phase I clinical trial kick-off meeting of Kexing Biopharm's COVID-19 oral drug SHEN26 Capsule held successfully
Release date:2022 - 07 - 22
On July 20, 2022, the phase I clinical trial kick-off meeting of SHEN26 Capsule, a small-molecule oral drug against COVID-19 jointly developed by Shenzhen Kexing Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Kexing Biopharm (688136.SH), and Shenzhen Antiv Pharma Co., Ltd., was successfully held in the Second Affiliated Hospital of Anhui Medical University, indicating the official start of the clinical study for the project.
The honorable guests included Zhou Dian (Secretary of the Party Committee of the hospital), Zhao Hui (Vice President of the hospital), Hu Wei (Principal Investigator (PI) of this clinical trial and Director of the clinical trial site), Zhang Jing (Director of the Ethics Committee Office), Zhang Qian (Office Director of the clinical trial site), and representatives of all partners.
At the kick-off meeting, Secretary Zhou Dian extended his greetings to all the guests on site and online. Zhou mentioned that it is urgent to provide effective COVID-19 drugs in front-line treatment due to the current pandemic, and he was pleased to see the drugs independently developed by Chinese enterprises enter clinical trial.
The Second Affiliated Hospital of Anhui Medical University is a large Grade III-A general hospital. As a teaching hospital thereof, the hospital has complete facilities and medical disciplines, as well as high level of comprehensive diagnosis and treatment. It is one of the 13th "115" Industrial Innovation Teams in Anhui Province, and an approved Clinical Medical Research Center for Critical Respiratory Diseases in Anhui Province, and it has a Key Laboratory of Anhui Province (Anesthesia). In the past three years, medical workers of the hospital have been assisting Wuhan, Xiaogan, Fuyang, Bengbu and other places and have spared no effort to fight against COVID-19 pandemic.
Yang Mingming, Clinical Trial Director of Kexing Biopharm, introduced the Company in details to the participants. Ma Hongjie, Deputy General Manager of Kexing Biopharm, shared the current R&D status and preclinical achievements of the SHEN26 project, and expressed her thanks to the management of the hospital for their support; she said that Kexing Biopharm will, adhering to the purpose of "lean production, lean medication, and health protection", do its best in the clinical development of drugs, and strive to provide safe, economical and effective drugs to front-line medical workers and patients as soon as possible.
Li Shuo, General Manager of Shenzhen Antiv, expressed his pleasure for the quick entry of SHEN26 into clinical trial from the laboratory, his thanks to the whole project team (including Southern University of Science and Technology, Sun Yat-sen University, Medi-x Pingshan Institute of Southern University of Science and Technology, Shenzhen Kexing and Shenzhen Antiv), and his expectation for fruitful achievements and accomplishment of the goals in the clinical trial by Shenzhen Kexing and the Hospital.
This clinical trial will be carried out in strict accordance with the national GCP requirements, with full compliance in the procedures for informed consent from subjects. Its main objective is to investigate the tolerability and safety of SHEN26 capsules in healthy subjects, and provide a supporting basis for the dosages administrated to COVID-19 patients in subsequent Phase II/III trials.
Strive to improve more even though with great achievements already! Under the background of regular prevention and control of the epidemic, Kexing Biopharm will, as always, go all out to make contributions to the fight against COVID-19!
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