Sirius Therapeutics' Long-Acting Anticoagulant siRNA Drug SRSD107 Granted Clinical Trial Approval in China
Sirius Therapeutics
Oligonucleotide Drug Developer
▎WuXi AppTec Content Team Report
Today (March 5),The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that,Sirius TherapeuticsSRSD107 Injection, filed by Sirius Therapeutics, has received clinical trial implied permission.Intended for the prevention or treatment of arteriovenous thrombosis。Public information shows,SRSD107 is a novel siRNA therapy and belongs to the new generation of anticoagulant drugs., currently conducting Phase 1 in AustraliaLinBedTest.
Screenshot source:CDE Official Website
Sirius Therapeutics was founded in 2021.Focus on the Development of Next-Generation Nucleic Acid Innovative Therapies in the Field of Cardiovascular Diseases.The companyChief Executive Officer (CEO)Dr. Jiqunsheng.In October 2023, Sirius Therapeutics announced the completion of a $60 million Series B round.Financing。
Using the core technology platform for small nucleic acid drug development, Sirius Therapeutics has developed multiple differentiated product pipelines with "first-in-class" or "best-in-class" potential. Previously, the company developedsiRNA Drug SRSD101 InjectionApproved for clinical use in China, intended for development as a treatmentPrimary Hypercholesterolemia.
The SRSD107 injection approved for clinical use this time is aDouble-stranded small interfering RNA (siRNA) drugs，YesSirius TherapeuticsOne of the important product pipelines in the cardiovascular disease field. The drugIntended to be developed for the prevention or treatment of arteriovenous thrombosis.Thrombosis refers to blood clots within blood vessels that restrict blood flow, which can occur in either arterial or venous circulation and serves as the common pathological basis for most myocardial infarctions, ischemic strokes, and venous thromboembolism (VTE).
According toAccording to publicly available information from Sirius Therapeutics,SRSD107 canBy specifically targeting the liver with coagulation factor XI (FXI) mRNA, inhibiting the protein expression of FXI, and blocking the activation of the intrinsic coagulation pathway, an anticoagulant/antithrombotic effect is achieved.Preclinical study data shows,A single subcutaneous injection of SRSD107 can achieve nearly 100% knockdown of FXI expression.，And lasted for half a year without any sign of bleeding.Therefore, SRSD107 combines potent and long-lasting effects with good safety, and has the potential to become a new generation of safer anticoagulant drugs.
Dr. Qunsheng Ji, CEO of Sirius Therapeutics, stated: "We are very pleased that SRSD107 has received tacit approval from the CDE, which will further accelerate the global development process of this product."
[1]Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Mar 5, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[3]Sirius Therapeutics' New Generation Long-Acting Anticoagulant siRNA Drug Clinical Trial Receives Approval from China's Regulatory Authority.Retrieved Mar 05， 2024. From https://mp.weixin.qq.com/s/J01LeFSleq7MLv1b9yZhww
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