$IVBXF

Innovent Biologics (HKEX: 01801) announced that its drug SINTBILO® (tafolecimab) met the primary endpoint in a Phase 3 study, showing significant LDL-C reduction in hyperlipidemia patients. The study demonstrated over 60% mean LDL-C reduction after 12 weeks, with favorable safety profiles. Innovent plans to submit a new indication application to China's NMPA.

Innovent Biologics (HKEX: 01801) announced that the NMPA accepted its application for sintilimab in combination with Nolgileucel for treating advanced melanoma. The application is based on Phase II trial results showing improved progression-free survival. If approved, it would be the 11th indication for sintilimab, reinforcing its role in immuno-oncology.

Innovent Biologics presented Phase 2 data for IBI354, a HER2-targeted ADC, at the 2026 ESMO Congress. The drug, combined with pertuzumab, showed a 95% objective response rate and favorable safety in first-line HER2-positive breast cancer. Innovent has initiated Phase 3 trials for IBI354 and plans further studies. The company aims to expand its ADC pipeline and improve cancer treatments.

Innovent Biologics (HKEX: 01801) presented Phase 1 data for IBI3001, a first-in-class EGFR/B7H3 bispecific ADC, at the 2026 ESMO Congress. The study showed manageable safety and encouraging efficacy across multiple solid tumors, including NSCLC, pancreatic cancer, and SCLC. The overall ORR was 30.2%, and the DCR was 88.7%. IBI3001 is advancing to Phase 1b dose-optimization studies.

Innovent Biologics (HKEX: 01801) announced positive Phase 3 results for arcotatug tavatecan in CLDN18.2-positive gastric cancer, meeting primary endpoints of overall survival (OS) and progression-free survival (PFS). The study showed median OS of 10.2 months vs. 6.9 months for the control group, and median PFS of 7.1 months vs. 3.1 months. The drug demonstrated a favorable safety profile. Innovent collaborates with Takeda for global development outside Greater China.

Innovent Biologics (HKEX: 01801) announced that its drug SYCUME® (Teprotumumab N01 Injection) met its primary endpoint in a Phase 3 trial for inactive thyroid eye disease (TED). The study showed a 60.4% response rate and a -1.88 mm reduction in proptosis at Week 24, with a favorable safety profile. SYCUME® is the first IGF-1R antibody drug in China and the second approved worldwide, included in China's National Reimbursement Drug List.

Edwards Lifesciences (EW) received FDA approval for a pediatric heart valve. Ceribell (CBLL) and SI-BONE (SIBN) cleared new software and spinal fusion systems. Teva (TEVA) added a biosimilar to its portfolio. AbbVie (ABBV) and Mirum (MIRM) gained FDA approvals for Parkinson's and rare disease treatments. Merck (MRK) withdrew a lung cancer drug filing. Sanofi (SNY) and Regeneron (REGN) expanded their immunology alliance.

Innovent Biologics (HKEX: 01801) expanded its Phase 3 MarsLight-11 trial of IBI363/TAK-928 to include non-squamous NSCLC patients. The trial, co-developed with Takeda, evaluates the drug's efficacy against docetaxel. IBI363/TAK-928 has received FDA and NMPA designations.

Analysts from SDIC Securities and CMB International Securities maintained Buy ratings on Sichuan Kelun-Biotech (HK:6990) with price targets of HK$571.39 and HK$642.29, respectively. Innovent Biologics (IVBXF) also received Buy ratings from CSC Financial and DBS, with price targets of HK$148.34 and HK$144.00, respectively. Both stocks have Strong Buy consensus ratings.

Innovent Biologics' stock rose 13% to a record high after reporting strong first-half 2026 results. Revenue increased 45% to RMB 8.6 billion, and net profit rose 50% to RMB 1.3 billion. The company aims for RMB 35-40 billion in revenue by 2030. Innovent led gains on the Hang Seng index, which rose 0.8%.