Information for medical professionals only.
Internet Drug Information Service Certificate Number: (Lu)-non-commercial-2018-0066
Kexing Biopharm's clinical trial application approved for small-molecule oral drug SHEN26 Capsule against COVID-19
Release date:2022 - 07 - 17
IND application approved for SHEN26 Capsule
On the evening of July 17, 2022, Kexing Biopharm Co., Ltd. (hereinafter referred to as "the Company" or "Kexing Biopharm") announced that it had received the Notice of Approval for Drug Clinical Trial issued by the National Medical Products Administration, indicating that the clinical trial of small-molecule oral drug SHEN26 Capsule against COVID-19 jointly developed by Shenzhen Kexing and Shenzhen Antiv was approved.
Main Contents of Notice of Approval for Drug Clinical Trial
Drug Name: SHEN26 Capsule
Acceptance No.: CXHL2200414, CXHL2200415
Review conclusion: According to the Drug Administration Law of the People's Republic of China and relevant regulations, SHEN26 Capsule meets the relevant requirements for drug registration, so it is agreed to carry out the clinical trial for the treatment of patients with COVID-19 as per the submitted protocol.
About SHEN26
SHEN26 is a broad-spectrum and potent inhibitor against RNA-dependent RNA polymerase (RdRp) of SARS-CoV-2. It exerts antiviral effect by inhibiting the synthesis of viral nucleic acid, showing in vitro inhibitory activity against multiple SARS-CoV-2 variants (wild-type, Alpha, Beta, Delta, and Omicron).
The in-vitro antiviral test data showed that the EC50 of SHEN26 against Omicron variant was 13 nM, with 103X inhibitory activity compared to Remdesivir; in -vivo PD studies showed that SHEN26 at 50 mg/kg was equivalent to Molnupiravir at 200 mg/kg against SARS-CoV-2, and SHEN26 significantly reduced the viral titer in lung tissues and improved the lesions in the K18-hACE2 mouse model infected with SARS-CoV-2, indicating significant improvement of tissues damaged by SARS-CoV-2.
The safety analysis demonstrated that SHEN26 had a low risk of off-target side effects, with negative results in teratogenicity and mutagenicity, showing a high therapeutic index and good safety.
This project is among the key projects for risk prevention and control and emergency technology and equipment for public safety supported by the Ministry of Science and Technology of the People's Republic of China, one of the 2021 Special Emergency Projects on Prevention and Control of SARS-CoV-2 Infection granted by Guangdong Province, and also amid "Three Majors" (major projects, major enterprises and major regions in the biomedical industry) Innovation Projects designated by Guangdong Medical Products Administration.
Share to:
Scan Code Consultation