INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics has signed a non-exclusive license agreement with Synaffix for antibody-drug conjugate (ADC) technology, enhancing its oncology pipeline. This collaboration allows Innovent to leverage Synaffix's proprietary technologies, including GlycoConnect™ and HydraSpace™, to develop a best-in-class ADC. Innovent will oversee research, development, and commercialization, while Synaffix will provide technological support. The agreement includes potential milestone payments and royalties on future sales. Innovent aims to strengthen its position in the ADC space to offer innovative cancer treatments.

Innovent Biologics has received approval from China's NMPA for TYVYT® (sintilimab injection) combined with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment for advanced hepatocellular carcinoma (HCC). This marks the first regulatory endorsement for a PD-1 inhibitor combination therapy in this context. The approval was based on the ORIENT-32 clinical trial results, which demonstrated significant improvements in overall survival and progression-free survival compared to sorafenib, without new safety concerns. This adds to the growing list of indications for both drugs.

Innovent Biologics announced the results of a phase 1 clinical trial for IBI362, a dual agonist targeting GLP-1 and glucagon receptors, presented at the American Diabetes Association's 81st Scientific Sessions. The trial involved overweight or obese Chinese participants, showing that IBI362 was well tolerated with no significant adverse events. Participants experienced significant weight reductions: cohort 1 (3.80 kg), cohort 2 (5.77 kg), cohort 3 (5.12 kg) vs. a placebo gain of 0.37 kg. The study indicates IBI362's potential for effective weight loss and metabolic improvement, addressing an unmet need in obesity treatment.

Innovent Biologics announced the successful completion of the Phase 3 ORIENT-15 study, which evaluated sintilimab combined with chemotherapy for treating unresectable esophageal squamous cell carcinoma. The interim analysis reported a significant improvement in overall survival compared to placebo. The study included 659 patients, assessing outcomes regardless of PD-L1 expression. Sintilimab, a PD-1 inhibitor developed with Eli Lilly, aims to provide a new first-line treatment option for this cancer type, addressing a substantial unmet medical need.

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.