Welcome to our dedicated page for Innovent Biologi news (Ticker: IVBIY), a resource for investors and traders seeking the latest updates and insights on Innovent Biologi stock.
Innovent Biologics (IVBIY) is a global biopharmaceutical leader developing precision therapies for oncology, autoimmune disorders, and chronic diseases. This page provides investors and healthcare professionals with timely updates on clinical advancements, regulatory milestones, and strategic partnerships shaping the company's trajectory.
Access official press releases and curated analysis covering key developments including clinical trial results, drug approval updates, and collaboration announcements. Our repository simplifies tracking Innovent's progress in bringing innovative treatments to market through its robust pipeline of immune checkpoint inhibitors and targeted biologics.
Content spans financial disclosures, manufacturing expansions, and research breakthroughs across therapeutic areas. Bookmark this page for streamlined monitoring of Innovent's contributions to advancing treatments for lung cancer, metabolic conditions, and ophthalmologic diseases through its global network of 30+ healthcare partners.
Innovent Biologics presented Phase 1 clinical data for its novel PD-1/IL-2α bispecific antibody fusion protein (IBI363) at the 2024 ASCO Annual Meeting. The study targets advanced solid tumors, including melanoma, colorectal cancer, and other types. Key findings showed that IBI363 demonstrated promising efficacy and safety, with a 28.1% overall response rate (ORR) in melanoma and 12.7% ORR in colorectal cancer. A total of 25.4% of melanoma subjects had baseline liver metastasis, and 61.2% had received at least two prior systemic therapies. In colorectal cancer, 61.8% had liver metastases at baseline, and 76.5% had undergone three or more prior treatments. Common adverse events included arthralgia, hyperthyroidism, and anemia. No treatment-related deaths were reported. Additional data for non-small cell lung cancer will be presented at the ESMO Virtual Plenary later this month.
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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