BOSTON, SHANGHAI, and SUZHOU – February 24, 2026, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, announced that SGB-9768 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN). IC-MPGN is a rare kidney disease primarily caused by overactivation of the complement system. The disease has complex pathogenesis with rapid progression and very limited treatment options.
SGB-9768 is an experimental medicine targeting complement C3, currently in Phase 2 clinical studies for the treatment of complement-mediated kidney diseases, including IC-MPGN, IgA nephropathy (IgAN) and C3 glomerulopathy (C3G). In a Phase 1 clinical trial, a single subcutaneous administration of SGB-9768 achieved dose-dependent, significant, and sustained reduction in serum C3 and inhibition of complement pathway activity, as well as a favorable safety and tolerability profile, demonstrating its best-in-class potential.
Dr. Yuyan Jin, Senior Vice President of Clinical and Nonclinical Development at SanegeneBio, stated:
“SGB-9768 has now obtained ODDs for both IC-MPGN and C3G, marking a significant milestone in its development, and highlighting its potential for autoimmune diseases with high unmet need. We are advancing its clinical development to bring a transformative therapeutic to patients with complement-mediated kidney diseases as soon as possible.”
About FDA ODD
ODD is an FDA policy established under the Orphan Drug Act to encourage the development of drugs for the treatment of rare diseases or conditions. Under this policy, companies receiving ODD are eligible for various incentives, such as tax credits for clinical trials, FDA assistance in clinical trial design, exemption from user fees, and a potential 7 years of market exclusivity upon approval.
About SGB-9768
SGB-9768 is a GalNAc-conjugated experimental RNAi-based medicine designed to silence C3 mRNA in hepatocytes, thereby inhibiting complement activation. It is a potential treatment for various complement-mediated kidney diseases, including IgAN, C3G, and IC-MPGN. It has demonstrated significant, sustained reduction in C3 levels following a single subcutaneous dose, the potential for infrequent dosing and long-term efficacy. With a favorable safety profile and greater durability than comparator molecules, SGB-9768 may become a best-in-class RNAi therapeutic for complement-mediated diseases.
About SanegeneBio
SanegeneBio is a global, venture-backed, fully-integrated biotechnology company focused on developing RNAi-based therapeutics. Founded in 2021 and led by a team of RNAi veterans, the company has R&D operations in Boston, Shanghai and Suzhou. Their clear vision is that RNAi technology will power blockbuster medicines in diverse therapeutic areas, improving the quality and longevity of life for patients worldwide. This vision is being realized by advancing a fast-growing pipeline, which includes experimental medicines for autoimmune nephropathies, obesity, and cardiometabolic indications. SanegeneBio has initiated clinical trials for four experimental medicines to-date, and is committed to developing potential best-in-class and first-in-class therapeutics which leverage our industry-leading and differentiated LEAD™ tissue-selective RNAi delivery technology. For more information, please visit: www.sanegenebio.com and engage on LinkedIn.
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