SanegeneBio Initiates Phase 2 Trial of an Experimental RNAi-Based Medicine SGB-9768 Targeting C3 mRNA

Mar 7, 2025

— Phase 2 study evaluates efficacy and safety in complement-mediated kidney diseases —

BOSTON, SHANGHAI, and SUZHOU – March 7, 2025, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, today announced the initiation of a Phase II clinical trial in China for SGB-9768, its investigational siRNA targeting complement component 3 (C3). The trial is being led by Peking University First Hospital and will enroll patients across multiple centers.

SGB-9768 is the first RNAi medicine targeting C3 to enter Phase 2 in China, reinforcing SanegeneBio's leadership in complement-targeted RNAi drug development. The multicenter, open-label study will evaluate efficacy and safety in patients with IgA nephropathy (IgAN), C3 glomerulopathy (C3G), and IC-MPGN.

Developed using SanegeneBio's proprietary GalNAc platform, SGB-9768 delivers RNAi specifically to hepatocytes to suppress C3 expression, thereby downregulating complement activation. Preclinical and Phase I data presented at the 2024 Complement-Based Drug Development Summit demonstrated:

  • Robust, dose-dependent, and sustained reduction in C3 levels following a single subcutaneous dose

  • Superior knockdown potency and durability compared to benchmark siRNAs

  • Favorable safety and tolerability profile


  • "The strong Phase I data support advancing SGB-9768 into Phase 2 development,"

said Dr. Weimin Wang, Founder and CEO of SanegeneBio.

  • “This milestone brings us closer to delivering a new treatment option for patients with complement-driven kidney diseases and strengthens our foundation for advancing additional RNAi programs.”


About Complement-Mediated Kidney Diseases

The complement system is a key part of innate immunity. Dysregulation of the C3-dependent pathway contributes to kidney and systemic diseases including IgAN, C3G, and IC-MPGN. Targeting C3 offers a strategic point of intervention to broadly modulate complement activity upstream, addressing a significant unmet medical need in chronic kidney disease (CKD), which affects over 10% of adults in China.


About SGB-9768

SGB-9768 is a GalNAc-conjugated experimental RNAi-based medicine designed to silence C3 mRNA in liver cells. It has demonstrated potent, sustained C3 suppression in preclinical models, with 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, SanegeneBio is led by a team of RNAi pioneers with unrivaled experience in this Nobel Prize-winning technology. With R&D operations in Boston, Shanghai and Suzhou, our vision clear – RNAi technology will power blockbuster medicines in diverse therapeutic areas, improving the quality and longevity of life for countless patients in the coming years. Our fast-growing pipeline includes experimental medicines for autoimmune nephropathies, obesity, and cardiometabolic indications. SanegeneBio has initiated clinical trials for several experimental medicines, 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 with us on LinkedIn.


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