INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics announced the approval of Pemazyre® (pemigatinib) in Taiwan for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. This marks Pemazyre as Taiwan's first approved tyrosine kinase inhibitor for this cancer type, following its prior FDA approval in the U.S. The approval is based on the FIGHT-202 study, which demonstrated a 35.5% overall response rate among participants. Innovent aims to leverage this approval to enhance its innovative drug portfolio.

Innovent Biologics has announced the publication of data from the ORIENT-32 study in The Lancet Oncology. This Phase 2/3 trial evaluated the combination of sintilimab and IBI305 (bevacizumab biosimilar) for treating advanced hepatocellular carcinoma (HCC) compared to sorafenib. The study showed significant improvements in overall survival and progression-free survival, marking it as a first-line treatment option for HBV-associated HCC. The findings reflect Innovent's commitment to enhancing treatment options for patients, aligning with China's Healthy 2030 goal.

Innovent Biologics announced the initiation of a Phase II basket trial for taletrectinib, targeting solid tumors with NTRK fusion, marking a significant milestone in cancer treatment. This trial follows an exclusive agreement with AnHeart Therapeutics to co-develop taletrectinib in Greater China. The trial aims to enroll approximately 40 patients and builds on promising results from previous trials on NSCLC with ROS1 fusions. Taletrectinib is a next-generation tyrosine kinase inhibitor, addressing a critical need for targeted therapies in rare cancer types.

Innovent Biologics announced the successful dosing of the first subject in a phase 2 clinical trial for IBI362, a dual GLP-1R and GCGR agonist, aimed at treating obesity in China. The trial, registered as NCT04904913, is randomized, double-blind, and placebo-controlled, focusing on weight loss over 24 weeks. The study aims to recommend optimal dosing for phase 3 trials. IBI362 shows potential for significant metabolic benefits and a favorable safety profile, addressing the growing obesity epidemic in China.

Innovent Biologics and IASO Biotherapeutics will present updated Phase I data on IBI326, a BCMA-targeted CAR-T therapy for relapsed/refractory multiple myeloma, at the EHA Congress on June 9-17, 2021. IBI326 has shown a 97.1% overall response rate among 35 patients, with 82.9% achieving at least very good partial response. The therapy has a strong safety profile with manageable adverse events. IBI326 received Breakthrough Therapy Designation from the NMPA in February 2021, highlighting its potential for patients with limited treatment options.

Innovent Biologics announced the results of a Phase 1 study of pemigatinib in Chinese patients with advanced solid tumors at the ASCO Annual Meeting 2021. The study included 12 patients from various cancer types who failed prior treatments. The most common adverse events were manageable, with no deaths linked to treatment. Among the 11 evaluable patients, there was a 16.7% objective response rate and a 41.7% disease control rate. Innovent is preparing a New Drug Application for pemigatinib in China, aiming to expand its use beyond FGFR2 mutations.

Innovent Biologics and HUTCHMED announced Phase 1b results for the combination of TYVYT® (sintilimab) and ELUNATE® (fruquintinib) in advanced colorectal cancer at the ASCO Annual Meeting. The study involved 44 patients with prior treatment failures, showing an objective response rate of 22.7%. Median progression-free survival was 5.6 months overall, with 6.9 months for the 5mg-intermittent dosage group. The safety profile was manageable, suggesting potential for future trials.

Innovent Biologics and AnHeart Therapeutics presented preliminary results from the TRUST phase II clinical trial of taletrectinib for treating ROS1 fusion positive non-small cell lung cancer at ASCO 2021. Data as of April 8, 2021, show a 93% overall response rate in treatment-naïve patients (n=15) and a 60% rate in pre-treated patients (n=5). Taletrectinib demonstrated a manageable safety profile. The companies aim to complete patient enrollment for the trial by Q3 2021 and are focused on global regulatory submissions.

Innovent Biologics announced results from the Phase Ia/Ib study of IBI110, an anti-LAG-3 monoclonal antibody, at the ASCO Annual Meeting 2021. The study involved 40 patients with advanced solid tumors, showing no dose-limited toxicity. Notably, one ovarian cancer patient achieved a partial response from IBI110 monotherapy, and 16.7% of patients in the combination group with sintilimab showed a partial response. Innovent is committed to advancing IBI110's potential, alongside a new bispecific antibody, IBI323, targeting LAG-3.