SanegeneBio's C3-Targeting RNAi Therapy SGB-9768 Granted Clinical Trial Approval in China for Complement-Mediated Kidney Diseases

Jun 25, 2024 08:20 CST Updated 08:20

SANEGENEBIO

Small Nucleic Acid Drug Developer

▎WuXi AppTec Content Team Report

June 24,China National Medical Products Administration Center for Drug Evaluation (CDE) Official Website Announcement: SANEGENEBIO's Class 1 New DrugSGB-9768 Injection Receives Clinical Trial Implied Permission, Intended for Development in TreatmentComplement-Mediated Kidney Disease, including adult patients with IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. According to the public data from SANEGENEBIO, this is aRNAi Drug Targeting Complement C3 Protein, which has previously been approved for Phase 1 clinical research in New Zealand.

Screenshot source: CDE official website

Complement plays an important role in immune and physiological functions in the human body. However, abnormal complement regulation or excessive activation can induce inflammation and damage self-tissues, closely related to the occurrence and development of diseases in fields such as hematology, ophthalmology, and nephrology, for example, age-related macular degeneration.Myasthenia GravisForce、Paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, C3 glomerulopathy, IgA nephropathy, thrombotic microangiopathy, etc.

The complement system comprises more than 30 soluble proteins, membrane-bound proteins, and complement receptor components. Among them,The high content of complement C3, as a common component in all complement activation pathways, has become a promising therapeutic target for diseases.

According toSANEGENEBIOAccording to the press release,SGB-9768 is an siRNA-GalNAc conjugate targeting complement C3, delivered to liver cells using the company's innovative technology.Inhibition of Hepatic C3 Synthesis via RNAi。Preclinical study data show that the product can effectively and continuously reduce C3 synthesis.。The safety, efficacy, and stability of GalNAc-delivered siRNA drugs have been validated by a large amount of data. In addition,SGB-9768 can be administered once every 3 or 6 months, offering the advantages of a lower treatment frequency, better patient compliance, and long-lasting efficacy.。

SANEGENEBIOPreviously, the press release stated,SGB-9768 is the first candidate drug approved to enter the clinical stage in the field of immune-related diseases by SANEGENEBIO, and it is also the company's second siRNA drug to enter the clinical research stage.SGB-3403, an siRNA Therapy Targeting Hepatocyte PCSK9Previously entered clinical trial stages in China and Australia. In addition, in May this year,SANEGENEBIO and Innovent Biologics jointly developedSGB-3908 Injection, an siRNA drug for the treatment of hypertension, has also been submitted for clinical trials in China.。

References:

[1]Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved June 24，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] SANEGENEBIO's siRNA Drug Targeting Complement C3 Protein Approved for Phase I Clinical Trial in New Zealand. Retrieved Feb 26, 2024, from https://mp.weixin.qq.com/s/hgHioHWyz_VtPV882tjo6A

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