Innovent Biologics

Innovent's Tafolecimab Cuts LDL-C 65% in Phase 3 Monotherapy Trial

Suzhou – November 08, 2026 -- Innovent Biologics (HKEX: 01801) said its PCSK9 antibody SINTBILO (tafolecimab) cut LDL-C by 65.19% at week 12 as monotherapy in the Phase 3 CREDIT-5 study, meeting the primary endpoint. The company plans to file a new-indication application with China's National Medical Products Administration (NMPA) "in the near future".

CREDIT-5 trial shows placebo-adjusted LDL-C drops above 58 points in both dosing regimens

The multi-center, randomized, double-blind, placebo-controlled study enrolled 198 Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. Of these, 131 received tafolecimab and 67 received placebo. Patients were randomized 2:1:2:1 to tafolecimab 150 mg every two weeks (Q2W), placebo Q2W, tafolecimab 450 mg every four weeks (Q4W) or placebo Q4W, after a 4-week run-in during which lipid-lowering products were prohibited.

Innovent's IBI3003 Hits 84.6% Response Rate in Myeloma Trial

San Francisco – September 29, 2026 -- Innovent Biologics reported an 84.6% overall response rate for its trispecific antibody IBI3003 at the recommended Phase 2 dose in heavily pretreated multiple myeloma patients, data presented in an oral session at the 23rd International Myeloma Society Annual Meeting 2026.

Trial identifies 360 μg/kg as the optimal dose after testing three dose levels

Among 26 patients treated at 360 μg/kg with a median follow-up of 7.57 months, median progression-free survival has not yet been reached. The cohort produced 11 stringent complete responses, 4 very good partial responses, and 7 partial responses. Response rates climbed to 94.7% among 19 patients who had received only 2 to 4 prior lines of therapy, and 92.3% among 13 patients without extramedullary disease.

Innovent to Unveil Phase 3 Gastric Cancer ADC Data at ESMO 2026

Suzhou, China – September 24, 2026 -- Innovent Biologics (HKEX: 01801) will present late-breaking Phase 3 data for its CLDN18.2-targeting antibody-drug conjugate IBI343/TAK-921 at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, running October 23-27.

Phase 3 gastric cancer trial secures late-breaking oral slot

Results from the registrational G-HOPE-001 study, comparing Arcotatug Tavetecan against treatment of physician's choice in previously treated advanced gastric or gastroesophageal junction adenocarcinoma, will be delivered as a late-breaking abstract (LBA77) during the October 23 proffered paper session. Dr. Kohei Shitara of Chiba, Japan, will present the first interim analysis of the randomized, open-label trial.