Hengrui Pharmaceuticals has received a priority review designation from China's Centre for Drug Evaluation (CDE) for its ANGPTL3 inhibitor, SHR-1918, for the treatment of homozygous familial hypercholesterolaemia (HoFH) in adults and adolescents aged 12 and above. Developed by Hengrui's subsidiary Shengdi Pharmaceutical, the candidate works by inhibiting ANGPTL3 to lower levels of triglycerides and low-density lipoprotein cholesterol (LDL-C). SHR-1918 was previously granted breakthrough therapy designation (BTD) for HoFH in September 2024.

The priority review is supported by Phase II data showing a 59.09% reduction in LDL-C levels after 12 weeks of treatment at the 600mg dose in a non-randomised study. A separate randomised Phase II trial demonstrated dose-dependent LDL-C reductions across four dosing regimens after 16 weeks. The company has completed a registrational Phase III trial for HoFH, though results are not yet public. If approved, SHR-1918 would be the second ANGPTL3 inhibitor on the market, following Regeneron/Ultragenyx's evinacumab, which generated USD 158 million in global sales in 2024.

According to PharmCube's NextBiopharm® database, SHR-1918 is being developed in a total of six indications. Click here to request a free trial for NextBiopharm®.