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Innovent Biologics, Inc. (IVBIY) is a renowned biopharmaceutical company specializing in the development, manufacturing, and commercialization of high-quality medicines for various diseases, including oncology, cardiovascular, metabolic, autoimmune, and ophthalmology. The company's recent achievements include the publication of results from the Phase 2 TRUST-I study evaluating taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor, and the development of innovative therapies targeting CLDN18.2/CD3 and PD-1/IL-2 pathways.
Innovent Biologics has established itself as a leader in the biopharmaceutical industry, with a strong focus on empowering patients worldwide with affordable, effective treatments. With a diverse portfolio of products and ongoing clinical trials, the company continues to drive innovation and advance the field of biopharmaceuticals.
Innovent Biologics announced that its recombinant antibody injection, picankibart (IBI112), has successfully met all primary and key secondary endpoints in the Phase 3 CLEAR-1 clinical trial for moderate to severe plaque psoriasis. Conducted across multiple centers with 500 participants, the study demonstrated that over 80% of subjects achieved a ≥90% improvement in their Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of clear or almost clear (0 or 1) after 16 weeks. These positive results were sustained for 52 weeks, with no new safety signals identified. Innovent plans to submit a New Drug Application (NDA) to China's National Medical Product Administration (NMPA). This successful trial positions picankibart as a potential best-in-class treatment with convenient dosing every 12 weeks.
Innovent Biologics announced that the New Drug Application (NDA) for their recombinant anti-IGF-1R antibody, IBI311, has been accepted and given priority review by the China National Drug Administration for treating Thyroid Eye Disease (TED). This marks the first submission of an anti-IGF-1R antibody in China. The NDA acceptance is based on positive results from the Phase 3 RESTORE-1 trial, which showed significant improvements in proptosis, disease activity, and quality of life with a favorable safety profile. Detailed results will be presented in 2024. TED, an autoimmune disease affecting eye tissues, lacks effective treatment options in China, making IBI311's approval potentially impactful for patients. Innovent is enhancing its portfolio in ophthalmology, autoimmunity, and other major diseases.
Innovent Biologics announced that it will present clinical data on two of its innovative treatments, IBI363 and IBI343, at upcoming conferences in June 2024. IBI363, a PD-1/IL-2 bispecific antibody fusion protein, will be discussed at the ESMO Virtual Plenary on June 13-14, 2024. IBI343, an anti-Claudin18.2 antibody-drug conjugate, will be presented at the ESMO Gastrointestinal Cancers Congress on June 26-29, 2024. The presentations will focus on early-phase clinical studies in patients with advanced solid tumors and gastric/gastro-esophageal junction adenocarcinoma. Dr. Hui Zhou, Senior VP at Innovent, emphasized the potential efficacy and safety of these treatments, highlighting Innovent's commitment to addressing unmet medical needs in cancer therapy.
Innovent Biologics, Inc. announced the successful results of the Phase 3 clinical trial of mazdutide in Chinese patients with type 2 diabetes. Mazdutide demonstrated superior glycaemic control compared to dulaglutide, along with multiple cardiometabolic benefits such as weight loss, improved blood lipid, blood pressure, and liver enzymes. The study included 731 subjects and showed mazdutide's superior glucose-lowering efficacy and weight loss benefits. Mazdutide also displayed favorable safety and tolerability profiles, with gastrointestinal adverse reactions being the most common. The drug is the first GLP-1R/GCGR dual agonist in regulatory review status, with plans for an NDA submission for chronic weight management. Overall, mazdutide showcased promising results in the treatment of type 2 diabetes.
Innovent Biologics, Inc. receives NMPA Breakthrough Therapy Designation for IBI343 as monotherapy for advanced gastric cancer. The designation is based on promising Phase 1 study results showing safety, tolerability, and antitumor activity in advanced GC patients. Innovent plans to conduct a Phase 3 clinical trial soon. The company aims to provide effective third-line treatment options for GC patients in need.
Innovent Biologics, Inc. appoints Dr. Samuel Zhang as Global Chief Business Officer, bringing over 20 years of industry experience. Dr. Zhang will lead global strategy and business development, reporting to Dr. Michael Yu. His expertise includes identifying industry trends, R&D decision-making, and strategic transactions.
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