RiboBio’s ApoC3-Targeting siRNA Drug RBD5044 Granted Implicit Approval for Phase II Clinical Trials in China

January 23, 2026  Source: drugdu 33

 

Suzhou RiboLife Sciences Co., Ltd. (RiboLife Sciences, Hong Kong Stock Exchange: 06938) announced that RBD5044, a novel siRNA drug targeting ApoC3 independently developed by the Company, 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 for the treatment of hypertriglyceridemia developed based on the RiboGalSTAR™ liver‑targeting technology platform, and is also the second ApoC3‑targeting siRNA globally to enter clinical development. Available Phase I clinical data show that a single administration achieved significant inhibition of apolipoprotein C3 (ApoC3) by up to 84%, accompanied by a reduction in triglyceride (TG) levels of up to 70%. Furthermore, during the 6‑month follow‑up period, subjects’ TG levels remained stably below 50% of baseline, and overall lipid profiles were comprehensively improved. Meanwhile, RBD5044 demonstrated favorable tolerability, with no dose‑dependent adverse events or elevated liver enzymes observed even at the highest dose tested. The safety and efficacy clinical data indicate that RBD5044 has the potential to become a Best‑in‑Class therapy.

"/Picture 1: from the Wechat Public Account “RiboBio Oligonucleotides”

In October 2024, RBD5044 received approval for Phase II clinical trials from the European Medicines Agency (EMA), and the relevant trials are currently underway in patients with mixed dyslipidemia in Sweden. Leveraging the policy support of the National Medical Products Administration’s Announcement on Matters Concerning Optimizing the Review and Approval of Clinical Trials for Innovative Drugs, RBD5044 was successfully included in the “30‑working‑day review and approval” fast‑track pathway and obtained approval smoothly. RiboBio will accelerate the advancement of Phase II clinical studies of RBD5044 in China, striving to bring more precise, long‑acting, and safe small nucleic acid treatment options to patients with hypertriglyceridemia (HTG) at an early date.

About RiboBio

Suzhou RiboLife Sciences Co., Ltd. (RiboLife Sciences, 6938.HK) is a global biopharmaceutical company focused on the development and commercialization of small interfering RNA (siRNA) therapeutics. Powered by its proprietary small nucleic acid technology platforms, the Company has established a rich and differentiated product pipeline focused on major disease areas such as cardiometabolic disorders, liver, and kidney diseases. RiboLife Sciences is committed to providing revolutionary treatment solutions for patients worldwide through continuous innovation. The Company was successfully listed on the Main Board of the Hong Kong Stock Exchange on January 9, 2026. For more information, please visit: www.ribolia.com.

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