INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics announced the first patient dosing of IBI363, a PD-1/IL-2 bispecific antibody fusion protein, in a Phase I clinical trial in Australia. This study evaluates IBI363 for the treatment of advanced solid tumors and lymphomas. IBI363 aims to enhance anti-tumor immune response while minimizing IL-2 related side effects. The trial, which is open-label and multi-center, is also being conducted in China. Dr. Hui Zhou emphasized the importance of IBI363 in overcoming treatment resistances in patients with limited options.

Innovent Biologics has successfully dosed the first healthy volunteer in a Phase 1 study of IBI311, a monoclonal antibody targeting the IGF-1R receptor, intended for treating thyroid-associated ophthalmopathy (TAO). This study aims to evaluate the safety and tolerability of IBI311 in healthy Chinese subjects, filling a significant treatment gap as no targeted drugs have been approved for TAO in China. The company is committed to advancing clinical development to address the unmet medical needs for TAO, which significantly affects patient quality of life.

Innovent Biologics announced the successful results of a phase 2 clinical study of picankibart (IBI112), achieving its primary endpoint in treating moderate-to-severe plaque psoriasis. Out of 250 subjects, 52.0%-54.9% achieved a significant improvement (≥90% on PASI) at week 16. The drug was well-tolerated, with common adverse events being mild upper respiratory infections. The study suggests picankibart's long-term efficacy and potential advantages over current therapies, with only five doses needed annually. The ongoing phase 3 study aims to further validate these promising results.

Innovent Biologics announced the successful dosing of the first patient in its Phase 1 study for IBI324, a bispecific antibody targeting both VEGF-A and Ang-2, aimed at treating diabetic macular edema (DME). The study evaluates safety and tolerability, hoping to enhance treatment compliance by potentially extending dosing intervals for patients. IBI324 is designed to inhibit neovascularization and stabilize blood vessels, addressing a significant unmet need in DME therapy.

Innovent Biologics has announced a strategic collaboration with Sanofi to expedite the development and commercialization of oncology medicines in China. This partnership focuses on two key oncology assets, SAR408701 and SAR444245, which will be combined with sintilimab to tackle prevalent solid tumors in the region. Sanofi will initially invest €300 million in Innovent, marking a strong commitment to providing advanced cancer treatments in China. The collaboration aims to leverage both companies' R&D resources to address urgent medical needs for cancer patients.

Innovent Biologics and Laekna Therapeutics announced the first patient has been dosed in a Phase 1/2 trial of a three-drug combination treatment for solid tumors resistant to anti-PD-1/PD-L1 therapy. This trial, involving afuresertib, sintilimab, and chemotherapy, is a milestone in their partnership. Lead by Professor Lin Shen, the study aims to assess safety and efficacy in various solid tumors, including cervical cancer. Sintilimab, approved for six indications in China, and afuresertib, an AKT inhibitor, show promise in addressing significant unmet medical needs in cancer treatment.

Innovent Biologics and Ascentage Pharma announced that the China National Medical Products Administration has accepted and granted Priority Review designation for a New Drug Application supporting the full approval of olverembatinib, targeting chronic myeloid leukemia (CML) patients resistant to first- and second-generation therapies. This follows a conditional approval in November 2021. The recent decision highlights the urgency of addressing unmet medical needs in drug-resistant CML. Olverembatinib's efficacy was demonstrated in a Phase II study, significantly improving event-free survival compared to standard treatments.

Innovent Biologics announced that its phase 2 study of mazdutide (IBI362), a dual agonist targeting GLP-1R and GCGR, met its primary endpoint in Chinese patients with type 2 diabetes. The study demonstrated significant reductions in HbA1c levels across all dosage groups compared to placebo (p < 0.0001) and highlighted a dose-dependent weight loss effect. Mazdutide improved various metabolic metrics and showed a favorable safety profile with no severe hypoglycemic events. The company plans to proceed to phase 3 trials, aiming to address the urgent clinical need in diabetes treatment.

Innovent Biologics has successfully dosed the first patient in a Phase 2 study of IBI112, an anti-IL-23p19 monoclonal antibody, for treating moderate-to-severe active ulcerative colitis in China. This multi-center, double-blind trial aims to evaluate the drug's efficacy, safety, and pharmacokinetics. IBI112, developed independently by Innovent, shows promising safety profiles from previous studies and addresses a significant unmet need in ulcerative colitis treatment, particularly as there are no current self-developed IL-23p19 inhibitors in China.