SanegeneBio Announces NMPA Approval of SGB-9768 for Clinical Trials in Complement-Mediated Hematologic Disorders

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AboutSGB-9768

SGB-9768 is a C3-targeting siRNA candidate drug currently undergoing Phase II clinical trials for complement-mediated kidney diseases.

Previously obtained clinical trial approval for complement-mediated kidney diseases, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), and immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN).

In the completed Phase I clinical trial, a single subcutaneous administration of SGB-9768 achieved a dose-dependent, significant, and sustained reduction in C3 levels and inhibition of complement pathway activity, demonstrated favorable safety and tolerability, and exhibited best-in-class potential.

The advancement of SGB-9768 into hematological disease indications further underscores its broad therapeutic potential, presenting new opportunities to address the significant unmet clinical needs across various complement-mediated diseases.

Regarding the New Indication

PNH and aHUS are rare and severe hematological disorders driven by the aberrant overactivation of the complement alternative pathway (AP). This dysregulation can lead to immune-mediated injury to autologous blood cells. PNH is characterized by chronic hemolysis and a high risk of thrombosis, whereas aHUS is characterized by microvascular thrombosis that can result in multi-organ damage, particularly renal impairment.

Although currently approved complement inhibitors have significantly improved clinical outcomes for patients with PNH and aHUS, significant unmet clinical needs remain. Existing therapies primarily target the terminal pathway of the complement system, and some patients may not achieve complete disease control. Furthermore, long-term intravenous administration imposes a substantial treatment burden on patients.

AboutSANEGENEBIO

SANEGENEBIO is a company focused on innovationRNA interferenceA clinical-stage biotechnology company focused on the development of (RNAi) therapeutics. Founded in 2021 and led by a pioneering team in the RNAi field, the company operates R&D centers in Suzhou and Shanghai, China, and Boston, USA, and has secured backing from multiple globally renowned venture capital firms. We firmly believe that RNAi technology holds the potential to generate blockbuster drugs across multiple therapeutic areas, thereby improving the quality of life and extending the lives of patients worldwide. Leveraging an industry-leading and differentiated RNAi drug development platform (including the tissue-selective LEAD™ delivery technology), SANEGENEBIO is dedicated to developing innovative therapies with "Best-In-Class" and "First-In-Class" potential to address unmet clinical needs in immune-mediated diseases, obesity, and cardiometabolic diseases.

Reference: Company Announcement

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