Suzhou Ribo Life Science Co., Ltd.'s ApoC3-targeting siRNA drug RBD5044 received implicit approval for phase II clinical trials in China -Suzhou Ribo Life Science Co., Ltd. Technology Co., Ltd.
Suzhou Ribo Life Science Co., Ltd. (Suzhou Ribo Life Science Co., Ltd., Hong Kong Stock Exchange Code: 06938) announced that the company's independently developed siRNA drug RBD5044 targeting ApoC3 received implicit approval for Phase II clinical trials from the National Medical Products Administration (NMPA) on January 22, 2026.
RBD5044 is a small nucleic acid drug developed based on the RiboGalSTAR TM liver-targeting technology platform for the treatment of hypertriglyceridemia. It is also the second siRNA targeting ApoC3 to enter clinical development in the world. Current phase I clinical trial results show that a single dose can achieve a significant inhibition of apolipoprotein C3 (ApoC3) of up to 84%, accompanied by a reduction of triglyceride (TG) levels of up to 70%. During a 6-month follow-up, the subjects' TG levels were still stably maintained below 50% of the baseline value. In addition, the subjects' blood lipids were comprehensively improved. At the same time, RBD5044 also showed good tolerance, and no dose-dependent adverse reactions or liver enzyme elevations were observed at the highest dose. Safety and efficacy clinical data show that RBD5044 has the potential to become a best-in-class therapy.
In October 2024, RBD5044 was approved for phase II clinical trials by the European Medicines Agency (EMA), and relevant trials are being carried out in patients with mixed dyslipidemia in Sweden. Relying on the policy support of the National Medical Products Administration’s “Announcement on Matters Concerning Optimizing the Review and Approval of Clinical Trials of Innovative Drugs”, RBD5044 was successfully included in the “30 working day review and approval” fast track and was successfully approved. Suzhou Ribo Life Science Co., Ltd. will accelerate the phase II clinical research of RBD5044 in China and strive to bring more precise, long-lasting and safe small nucleic acid treatments to patients with hypertriglyceridemia (HTG) as soon as possible.