SanegeneBio Announces First Patient Dosed in Phase 1 Trial of SGB-3383
Jun 30, 2025
— SGB-3383 is an experimental RNAi medicine targeting complement factor B (CFB) and has demonstrated best-in-class potential for autoimmune nephropathies in preclinical models—
— SGB-3383 is being evaluated in a single-ascending dose study in healthy volunteers—
BOSTON, SHANGHAI, and SUZHOU – June 30, 2025, SanegeneBio, a clinical-stage biotech company focused on developing innovative RNAi therapeutics, announced that the first patient has recently been dosed in a Phase 1 clinical trial of SGB-3383 at Peking University Third Hospital in Beijing. SGB-3383 is an RNAi-based experimental medicine targeting complement Factor B (CFB) for the treatment of complement-mediated autoimmune diseases.
This randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SGB-3383 in healthy volunteers. Preclinical data demonstrated that SGB-3383 achieves significant and sustained reduction of circulating CFB protein, while exhibiting a favorable safety and tolerability profile.
Dr. Yuyan Jin, Senior Vice President of Clinical and Nonclinical Development at SanegeneBio, stated:
About Complement-Mediated Kidney Diseases
The complement system, a key component of innate immunity, serves critical immunological and physiological roles, protecting against infections and clearing cellular debris. CFB (Complement Factor B) plays a crucial role in the alternative pathway activation, and its inhibition effectively reduces cell damage and inflammation. CFB is involved in the occurrence and development of various diseases, including atypical hemolytic uremic syndrome, age-related macular degeneration, cardiovascular disease and cancer. CFB-targeted therapies, by regulating complement activation, may treat diseases caused by alternative pathway dysfunction without affecting the immune responses to microbial invasion mediated by other complement pathways, showing potential therapeutic effects while reducing the risk of infection in patients.
About SGB-3383
SGB-3383 is an RNAi-based experimental medicine targeting complement Factor B (CFB) mRNA for the treatment of complement-mediated kidney diseases. Complement-mediated diseases include IgA nephropathy (IgAN), C3 glomerulopathy (C3G), Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), and atypical Haemolytic Uraemic Syndrome (aHUS). SGB-3383 leverages SanegeneBio proprietary RNAi technology to achieve superior potency, duration and tolerability. Preclinical data demonstrated that SGB-3383 can effectively and continuously inhibit the production of CFB in the liver and bloodstream, while exhibiting an unparalleled safety profile. Currently, no RNAi-based medicines targeting the complement system have been approved globally.
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.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. Any statements in this release other than statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "could," "potential," "is/are likely to," "will," "plan," "intend," "aim," "expect," "anticipate," "believe," "hope," "estimate," "project," "forecast," "continue," "target," and similar expressions (or the negative of these terms) are intended to identify forward-looking statements. In addition, statements that refer to future results, trends in our business, expectations for our product pipeline or product candidates, or other characterizations of future events or circumstances are forward-looking statements.
These forward-looking statements are based on our current expectations and assumptions as of the date of this news release and speak only as of such date. They are not guarantees of future performance, and actual results may differ materially from those expressed or implied by forward-looking statements due to a variety of risks and uncertainties, many of which are beyond our control. These risks and uncertainties include, without limitation: risks in research and development and clinical trials; regulatory review, requirements, and timing; trial initiation, site activation, enrollment, and operational execution (including performance by third parties); manufacturing, supply, and quality risks; the impact of competition and new technologies; future market conditions; macroeconomic, political, legal, and social conditions; and our ability to obtain and maintain sufficient funding and other resources. Readers are cautioned not to place undue reliance on these forward-looking statements. We assume no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise, except as required by applicable law.
Medical Information
This press release is provided for informational purposes only and is intended to share scientific and disease-related information. It is not intended as advertising or commercial promotion of any product and does not constitute medical advice, a diagnosis, or a recommendation for any treatment or use of any product. For questions about medical conditions or treatment, please seek advice from a healthcare professional.