SanegeneBio Receives NMPA Approval to Initiate Clinical Trial of siRNA Candidate SGB-3383 for Complement-Mediated Kidney Diseases

— CFB-targeting RNAi-powered experimental medicine set to enter first-in-human studies in China —

BOSTON, SHANGHAI, and SUZHOU – May 20, 2025, SanegeneBio, a clinical-stage biotechnology company focused on RNAi therapeutics, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the company's Investigational New Drug (IND) application for SGB-3383, an experimental RNAi medicine targeting complement factor B (CFB).

SGB-3383 is being developed for the treatment of complement-mediated diseases. SGB-3383 incorporates SanegeneBio proprietary chemistry to selectively silence CFB expression in the liver and suppress complement alternative pathway (AP) overactivation.

Preclinical studies showed potent and sustained silencing of CFB mRNA in both liver and in circulation, with a favorable safety and tolerability profile. No RNAi-based medicines targeting the complement system have been approved globally, and SGB-3383 is positioned as a potential first- and best-in-class candidate.

• “The IND approval of SGB-3383 reinforces our company's leadership position in RNAi innovation for complement-related diseases,”
  

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

• “With four GalNAc-based candidates now in clinical development, we are continuing to build a differentiated pipeline targeting both hepatic and extrahepatic diseases.”
  

SanegeneBio is also advancing SGB-9768, a second siRNA targeting the complement cascade, which has entered Phase 2 trials following positive Phase 1 data demonstrating superior potency and durability.

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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