Innovent’s SINTBILO Meets Phase 3 Endpoint in Hyperlipidemia Trial
Innovent Biologics said on November 8, 2026 that SINTBILO, or tafolecimab, met the primary endpoint in the Phase 3 CREDIT-5 study in China. In 198 participants, LDL-C fell by 65.19% with the 150 mg Q2W dose and 64.01% with the 450 mg Q4W dose at week 12, versus declines of 6.61% and 4.31% for the respective placebo groups. The company said secondary endpoints were also met, safety was favorable, and it plans to submit a new indication application to China’s NMPA.
Why it matters
The results support Innovent’s plan to seek a broader Chinese indication for SINTBILO as a first-line monotherapy option for hyperlipidemia. Approval would expand the drug’s potential use in China, but the filing and regulatory decision have not yet occurred.
Key facts
- 1CREDIT-5 randomized 198 Chinese participants to tafolecimab or placebo after a 4-week run-in period. prnewswire.com
- 2At week 12, LDL-C changed by −65.19% with 150 mg Q2W and −64.01% with 450 mg Q4W, compared with −6.61% and −4.31% for the corresponding placebo groups; each comparison had a p-value < 0.0001. prnewswire.com
- 3Tafolecimab achieved the study’s key secondary endpoints, including LDL-C thresholds and at least 50% LDL-C reduction, with inter-group p values all < 0.0001. prnewswire.com
- 4Innovent plans to submit a New Indication Application for SINTBILO to China’s National Medical Products Administration. prnewswire.com
- 5The trial reported no severe or serious TEAE, no adverse event leading to treatment discontinuation or interruption, and no new safety signal compared with previous studies. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.