Today (March 7),SANEGENEBIO(SANEGENEBIO) announced that the company's self-developedSmall nucleic acid (siRNA) drugs targeting complement C3SGB-9768 Injection Initiated Phase 2 Clinical Trial in China.This launch is an evaluation of SGB-9768 inPatients with primary IgA nephropathy, C3 glomerulopathy, andImmune ComplexPatients with Membranoproliferative GlomerulonephritisA multicenter, open-label phase 2 study on the efficacy and safety in China.

SGB-9768 is an investigational siRNA drug targeting complement C3. It utilizes SANEGENEBIO's uniquely innovative next-generation GalNAc liver delivery platform to deliver to liver cells, reducing the protein expression of complement factor C3 to treat various complement-mediated diseases, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), and dry...Age-related Macular Degeneration(dry AMD), paroxysmal nocturnal hemoglobinuria (PNH), and other renal and hematological diseases.

Preclinical trial data shows that SGB-9768Can achieve a dosing frequency of once every 3 months or 6 months, and effectively and continuously reduce C3 synthesis., with the advantages of a lower treatment frequency, good patient compliance, and long-lasting efficacy.

In December 2024, SANEGENEBIO announced positive results from the preclinical and partial Phase 1 clinical trials of SGB-9768 at the 8th Global Complement Drug Development Summit held in Boston, USA. The trial data showed,After a single subcutaneous injection, SGB-9768 demonstrated good safety and tolerability, while a dose-dependent, significant, and sustained reduction in C3 protein levels and complement pathway activity was observed.Compared with other siRNA products targeting the same target, SGB-9768 can achieve higher target protein knockdown at the same dose and maintain the knockdown level for a longer duration. The positive results of SGB-9768 in Phase 1 clinical trials support its further advancement into Phase 2 clinical trials.

Dr. Wang Weimin, Founder and CEO of SANEGENEBIO, stated: "The clinical data obtained from the Phase 1 clinical trial of SGB-9768 has been very encouraging. We believe that SGB-9768 demonstrates highly effective therapeutic potential while maintaining good safety and tolerability. With the initiation of the Phase 2 clinical trial in China, we will continue to rapidly advance the various studies for this candidate drug, striving to bring more effective treatment options to patients with immune-related diseases as soon as possible. Additionally, the experience accumulated in the clinical development of SGB-9768 will lay a solid foundation for the company to develop more siRNA drugs targeting immune-related diseases."

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