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Innovent Biologics Inc - IVBIY STOCK NEWS

Welcome to our dedicated news page for Innovent Biologics (Ticker: IVBIY), a resource for investors and traders seeking the latest updates and insights on Innovent Biologics.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Innovent Biologics's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Innovent Biologics's position in the market.

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Innovent Announces the Phase 3 ORIENT-16 Study Results Published in JAMA Evaluating Sintilimab in Combination with Chemotherapy for the First-Line Treatment of Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
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Innovent Biologics, Inc. (HKEX: 01801) announced the interim analysis results of ORIENT-16, the Phase 3 study evaluating sintilimab in combination with chemotherapy for the first-line treatment of advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The study has met its primary endpoint at the prespecified interim analysis, showing that sintilimab in combination with chemotherapy significantly prolongs overall survival in the first line treatment for overall population of gastric cancer. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies, and no additional safety signals were identified for the combination of sintilimab and chemotherapy in GC patients. Based on the study results, sintilimab in combination with chemotherapy was approved by the National Medical Products Administration (NMPA) of China as first-line treatment for G/GEJ in June 2022, and was included in the national reimbursement drug list (NRDL), becoming the first and only immunotherapy for gastric cancer covered by NRDL in China.
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Innovent Presents Clinical Data Update of IBI351 (KRAS G12C Inhibitor) Monotherapy in Lung Cancer and Colorectal Cancer at ESMO Asia Congress 2023
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Innovent Biologics, Inc. (HKEX: 01801) presents updated clinical data of IBI351 (KRAS G12C inhibitor) monotherapy in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) at the European Society for Medical Oncology Asia Congress (ESMO Asia) 2023. The data from a registrational Phase II study of IBI351 for NSCLC is accepted as a LBA (Late-breaking abstracts) program. The New Drug Application (NDA) for IBI351 monotherapy treating NSCLC was recently accepted by China's National Medical Products Administration (NMPA) and granted Priority Review Designation.
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Innovent's MSCI ESG Rating Upgraded to A
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Innovent Biologics, Inc. (Innovent) (HKEX: 01801) has been upgraded to 'A' according to MSCI's latest ESG rating, reflecting the capital market's recognition of Innovent's continued progress in ESG governance and sustainability, as well as of its long-term investment value. Innovent's performance in ESG and sustainable development stood out above the industry average level, with a robust product pipeline and a healthy business model.
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China's First NDA for a KRAS G12C Inhibitor: Innovent Announces the National Medical Products Administration of China Has Accepted and Granted Priority Review Designation to the New Drug Application for IBI351
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Innovent Biologics, Inc. (01801:HKEX) announces the acceptance of the New Drug Application (NDA) for IBI351, a KRAS G12C inhibitor, by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The NDA has been granted Priority Review designation for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. The NDA is based on the results from a single-arm registrational Phase 2 clinical study (NCT05005234) and will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2023.
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Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Accepted the New Drug Application for Taletrectinib (ROS1 Inhibitor)
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Innovent Biologics, Inc. (01801) and AnHeart Therapeutics announce the acceptance of the New Drug Application (NDA) for taletrectinib by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. The NDA acceptance is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients. Results from an interim analysis of the TRUST-I trial were presented at the European Lung Cancer Congress (ELCC) 2023.
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Innovent Announces Publication of Mazdutide (IBI362) Phase 2 Full Results in Chinese Patients with Type 2 Diabetes in Diabetes Care
Rhea-AI Summary
Innovent Biologics, Inc. (HKEX: 01801) has announced the full results from a Phase 2 clinical trial of mazdutide (IBI362), a GLP-1R and GCGR dual agonist, in Chinese patients with type 2 diabetes. The trial demonstrated robust efficacy in glycemic control and weight reduction, along with multiple cardiometabolic benefits and a favorable safety profile. Mazdutide significantly reduced HbA1c levels, fasting plasma glucose, and body weight, offering a potential novel treatment option for T2D patients. The Phase 3 studies of mazdutide in Chinese T2D patients are currently underway.
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Innovent Presents Clinical Data of Two Ophthalmic Bispecific Antibodies IBI302 (anti-VEGF/complement) and IBI324 (anti-VEGF-A/Ang-2) at American Academy of Ophthalmology (AAO) Annual Meeting 2023
Rhea-AI Summary
Innovent Biologics presents latest data of two ophthalmic bispecific antibodies at the AAO 2023 Annual Meeting. Phase 2 study of IBI302 for neovascular age-related macular degeneration (nAMD) showed noninferior BCVA gains compared to aflibercept. Preliminary signal observed for IBI302 in preventing macular atrophy and fibrosis occurrence. Phase 1 study of IBI324 for diabetic macular edema (DME) demonstrated safety and efficacy. Both drugs showed robust efficacy with no new safety risk signals.
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Innovent Announces Robust Weight Loss Efficacy, Multiple Metabolic Benefits and Favorable Safety Profile of Higher Dose 9 mg Mazdutide (IBI362) after 48-week Treatment in Phase 2 Study for Obesity
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Innovent Biologics announces positive results from a Phase 2 clinical study of mazdutide 9 mg in Chinese subjects with obesity. Mazdutide demonstrated significant weight loss efficacy, improved cardiometabolic indicators, and a 73.3% reduction in liver fat content. The study also showed favorable safety and tolerability. Phase 3 study expected to begin by the end of 2023.
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Innovent Announces First Patient Dosed in the Phase 3 Clinical Study (STAR) of Efdamrofusp Alfa (IBI302), a First-in-class Ophthalmic Anti-VEGF and Anti-Complement Bispecific Fusion Protein for the Treatment of Neovascular Age-related Macular Degeneration
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Innovent Biologics announces successful dosing of first patient in Phase 3 clinical study for neovascular age-related macular degeneration (nAMD) treatment
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Innovent and IASO Bio Present Updated Long-Term Follow-Up Data for BCMA CAR-T FUCASO® (Equecabtagene Autoleucel) at IMS 2023
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Innovent Biologics and IASO Bio announce updated long-term follow-up data on BMCA CAR-T therapy for multiple myeloma
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7.84B
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Research and Development in Biotechnology
Professional, Scientific, and Technical Services
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China (Mainland)
Suzhou