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.
The news feed for INNOVENT BIOLGCS UNSP/ADR (IVBIY) aggregates company press releases and media updates from Innovent Biologics, Inc., a biopharmaceutical company focused on oncology, cardiovascular and metabolic, autoimmune and ophthalmology diseases. These announcements provide insight into clinical trial progress, regulatory milestones, product approvals and corporate strategy that can influence how investors and observers view IVBIY.
Recent news highlights include multiple updates on mazdutide, a dual GCG/GLP-1 receptor agonist licensed from Eli Lilly for development in China. Innovent has reported National Medical Products Administration approvals for mazdutide in chronic weight management for adults with overweight or obesity and for glycemic control in adults with type 2 diabetes, along with Phase 3 data from the GLORY and DREAMS clinical programs. Other cardiovascular and metabolic pipeline news covers tigulixostat, a xanthine oxidase inhibitor for gout, and IBI3032, an oral GLP-1 receptor agonist with U.S. FDA IND approval for Phase 1 trials.
Oncology news items describe the development of IBI363, a PD-1/IL-2α-bias fusion protein, including U.S. FDA clearance of an IND for a global Phase 3 trial in immunotherapy-resistant squamous non-small cell lung cancer and data presented at major oncology conferences. Additional coverage includes IBI343, an anti-CLDN18.2 ADC with Phase 1 results in gastric/gastroesophageal junction adenocarcinoma published in Nature Medicine and the launch of multi-regional Phase 3 studies.
Investors following IVBIY can use this page to review updates on Innovent’s broader pipeline, such as picankibart for psoriasis, IBI324 for retinal diseases, and other marketed products mentioned in interim results and R&D day communications. Bookmark this news section to monitor how clinical data releases, regulatory decisions and partnership announcements may shape the company’s long-term development and commercialization plans.
Innovent Biologics has presented promising Phase Ib clinical data for IBI939, an anti-TIGIT monoclonal antibody, at the 2022 European Society for Medical Oncology Immuno-Oncology Congress. The study evaluated the combination of IBI939 and sintilimab in treating PD-L1-selected non-small cell lung cancer (NSCLC). Among 40 evaluable patients, the objective response rate was 64.3% for the experimental group compared to 57.2% for the control. The median progression-free survival was significantly better at 11.2 months versus 6.4 months. Safety profiles showed a higher incidence of treatment-related adverse events in the experimental group.
Innovent Biologics announced the successful dosing of the first Chinese healthy volunteer in a Phase I study for orismilast (IBI353), a potential best-in-class PDE4 inhibitor. This study focuses on evaluating the drug's pharmacokinetics, safety, and tolerability in healthy subjects to support its development for psoriasis and atopic dermatitis. Innovent aims to accelerate orismilast's development in China, addressing a significant unmet need for effective oral treatments in dermatological diseases.
On November 27, 2022, Innovent Biologics announced it will present clinical data for multiple trials at upcoming international medical conferences, including the ESMO Immuno-Oncology Congress and the ASH Annual Meeting. Key topics include the efficacy of IBI110 in advanced lung cancer and the safety of IBI188 in myelodysplastic syndrome. Innovent, committed to high-quality biopharmaceuticals, has developed a robust pipeline with 35 assets, including 8 approved products. The company's strategic collaborations aim to enhance drug availability in China.
Innovent Biologics announced that the first participant has been dosed in the phase 3 clinical trial (GLORY-1) for mazdutide (IBI362), a dual agonist targeting GLP-1 and glucagon receptors, aimed at treating obesity in Chinese adults. The trial will enroll 600 subjects, assessing weight loss efficacy over 48 weeks. Previous phase 2 results showed a mean weight loss of 11.57%. Given China's rising obesity rates, mazdutide's potential for significant health improvements is crucial. Successful outcomes may lead to a new treatment option for obesity, promising better metabolic health for patients.
Innovent Biologics presented updated results from the Phase Ia trial of IBI351 (GFH925), a KRASG12C inhibitor, at the 2022 CSCO Annual Meeting. The trial included 67 patients with advanced solid tumors, predominantly non-small cell lung cancer (NSCLC). Key findings showed a 50.9% overall response rate (ORR) and 92.7% disease control rate (DCR) for evaluable NSCLC patients. No dose-limiting toxicities (DLTs) were reported, and treatment was well tolerated. A registrational trial is ongoing, aiming to further investigate IBI351's potential.
Innovent Biologics announced the results of a phase 3 clinical study (CREDIT-1) for tafolecimab (IBI306), a PCSK9 monoclonal antibody, in Chinese patients with non-familial hypercholesterolemia. The study enrolled 618 subjects and demonstrated significant reductions in LDL-C levels: -65.0% for 450 mg Q4W and -57.3% for 600 mg Q6W compared to placebo (both P < 0.0001). Tafolecimab had a favorable safety profile similar to other PCSK9 inhibitors. The drug's New Drug Application is under review in China, potentially leading to it being the first approved locally-developed PCSK9 inhibitor in the country.
Innovent Biologics has initiated a Phase I clinical trial for its anti-Claudin18.2 monoclonal antibody-drug conjugate, IBI343, marking a significant milestone as the first ADC candidate from Innovent's pipeline to enter clinical evaluation. The trial, taking place in Australia, aims to assess the safety and preliminary efficacy of IBI343 in patients with advanced solid tumors. Claudin 18.2 represents a promising target for treating gastric and pancreatic cancers, addressing a substantial unmet medical need given the limitations of current therapies.
Innovent Biologics has published results from a Phase 1b study of mazdutide (IBI362) for treating overweight or obesity in Chinese participants. The study demonstrated favorable tolerability and significant weight loss, with reductions of 9.5% and 11.7% in body weight for 10 mg and 9 mg cohorts, respectively. There were no serious adverse events reported. Ongoing clinical studies aim to further investigate mazdutide's efficacy as an innovative anti-obesity treatment, with Phase III studies recently initiated. This positions mazdutide as a potential alternative to bariatric surgery.
Innovent Biologics announced the approval of selpercatinib by China's NMPA for treating RET-driven cancers, including non-small cell lung cancer (NSCLC) and thyroid cancers. Selpercatinib, a RET kinase inhibitor, was co-developed with Eli Lilly and offers an 84.1% overall response rate (ORR) and 20.2 months of median duration of response for NSCLC patients. This approval enhances Innovent's oncology portfolio and positions the company to capitalize on a growing market. The approval marks a significant step for patients in China, providing new treatment options for those with limited choices.
Innovent Biologics has announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for CYRAMZA® (ramucirumab) for the treatment of hepatocellular carcinoma (HCC) in patients with an alpha fetoprotein level of ≥400 ng/mL previously treated with sorafenib. This approval is based on the positive results from the REACH-2 study, demonstrating improved overall survival and progression-free survival rates. This approval enhances Innovent's oncology portfolio and positions it to provide integrated patient solutions in China.