INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics announced on Aug. 15, 2021, that its sintilimab Phase 3 ORIENT-16 study achieved its primary endpoint, demonstrating significant improvement in overall survival for patients with advanced gastric cancer when combined with chemotherapy. This study is notable as it is the first Phase 3 trial in China showing an anti-PD-1 antibody's effectiveness in this setting. Innovent plans to file a supplemental new drug application based on the results, which are expected to provide a new treatment option for a patient population with limited options.

Innovent Biologics announced the successful meeting of the primary endpoint in the phase 3 CREDIT-2 study of IBI306, a recombinant human anti-PCSK-9 monoclonal antibody designed for treating heterozygous familial hypercholesterolemia in Chinese patients. After 12 weeks of treatment, participants exhibited a significant reduction in low-density lipoprotein cholesterol (LDL-C) levels compared to the placebo group, with a favorable safety profile. This pivotal study provides valuable evidence for the efficacy of IBI306, marking a critical step towards its registration and potential market entry.

Innovent Biologics has established a Scientific Advisory Board (SAB) to enhance its research and clinical pipelines, aiding in its mission to benefit patients globally. The SAB consists of three prominent scientists: Dr. Lewis L. Lanier, Dr. Lawrence Fong, and Dr. Carlos Garcia-Echeverria. This initiative seeks to advance Innovent's innovative biopharmaceuticals across cancer, autoimmune, and metabolic diseases. The company, listed on the Hong Kong Stock Exchange, has a robust pipeline with 25 assets and 5 approved products.

Innovent Biologics and Eli Lilly announced updated results from the ORIENT-11 study, highlighting the sustained overall survival (OS) benefit of sintilimab combined with pemetrexed and platinum chemotherapy for patients with nonsquamous non-small cell lung cancer (NSCLC). The study, published in the Journal of Thoracic Oncology, reported a median OS not yet reached for the sintilimab group, with a hazard ratio of 0.60. Biomarker analyses indicated that high MHC class-II expression correlated with improved progression-free survival. The ongoing trials underscore the potential of sintilimab as a front-line treatment.

Innovent Biologics has begun dosing the first patient in its Phase 1 study of IBI321, an anti-PD-1/TIGIT bispecific antibody aimed at treating advanced malignant tumors. This open-label, multi-center trial focuses on evaluating the safety and preliminary efficacy of IBI321 in patients whose cancer has progressed despite standard therapies. With potential advantages over existing treatments, IBI321 targets both PD-1 and TIGIT pathways to enhance anti-cancer efficacy. The IND for IBI321 has been approved by the NMPA in China, and the trial is currently underway.

Innovent Biologics announced the dosing of the first patient in a Phase 1a/1b study of IBI319, an anti-PD-1/CD137 bispecific antibody targeting advanced malignant tumors. This open-label trial, conducted in China, aims to evaluate safety, tolerability, and preliminary efficacy. Preclinical studies suggest IBI319 enhances anti-tumor activity. The IND for IBI319 is approved, and the drug has no direct competitors in clinical development globally. Innovent continues to build a robust pipeline, with multiple assets in various stages of clinical trials.

Innovent Biologics and Ascentage Pharma announced a strategic collaboration on July 14, 2021, focusing on joint commercialization and clinical development of novel cancer therapies. Key highlights include the collaboration on HQP1351, a promising treatment for drug-resistant chronic myeloid leukemia, with an NDA already submitted in China. Innovent will pay Ascentage $30 million upfront, plus potential milestone payments of up to $115 million. Additionally, Innovent will invest $50 million in Ascentage's equity, signaling confidence in their R&D capabilities.

Innovent Biologics has announced the first patient dosing in a Phase 1 study of IBI323, an anti-LAG-3/PD-L1 bispecific antibody. The trial aims to evaluate its safety, tolerability, dosage, and preliminary efficacy in patients with advanced malignant tumors who have progressed on standard treatments. IBI323 is designed to enhance T lymphocyte activation more effectively than existing treatments by blocking both PD-1/PD-L1 and LAG-3 pathways. Innovent plans to submit an IND application for IBI323 to the FDA soon.

Innovent Biologics (HKEX: 01801) announced that the National Medical Products Administration (NMPA) of China has accepted its New Drug Application (NDA) for pemigatinib, a FGFR1/2/3 inhibitor, aimed at treating adults with advanced cholangiocarcinoma. Pemigatinib, developed in partnership with Incyte, has shown promising efficacy with an overall response rate of 37% in clinical trials. The drug is already approved in Taiwan and represents Innovent's fifth innovative drug.