INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

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.

Innovent Biologics and Laekna Therapeutics have announced a collaboration to evaluate the combination of Innovent's PD-1 inhibitor sintilimab and Laekna's pan-AKT kinase inhibitor afuresertib. The clinical studies will focus on patients with refractory solid tumors. An IND application will be submitted to China's National Medical Products Administration. Sintilimab, approved for multiple indications, was the first PD-1 inhibitor included in China's National Reimbursement Drug List. This partnership aims to provide new treatment options for difficult-to-treat cancers.

Innovent Biologics has signed a non-exclusive license agreement with Synaffix for antibody-drug conjugate (ADC) technology, enhancing its oncology pipeline. This collaboration allows Innovent to leverage Synaffix's proprietary technologies, including GlycoConnect™ and HydraSpace™, to develop a best-in-class ADC. Innovent will oversee research, development, and commercialization, while Synaffix will provide technological support. The agreement includes potential milestone payments and royalties on future sales. Innovent aims to strengthen its position in the ADC space to offer innovative cancer treatments.

Innovent Biologics has received approval from China's NMPA for TYVYT® (sintilimab injection) combined with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment for advanced hepatocellular carcinoma (HCC). This marks the first regulatory endorsement for a PD-1 inhibitor combination therapy in this context. The approval was based on the ORIENT-32 clinical trial results, which demonstrated significant improvements in overall survival and progression-free survival compared to sorafenib, without new safety concerns. This adds to the growing list of indications for both drugs.

Innovent Biologics announced the results of a phase 1 clinical trial for IBI362, a dual agonist targeting GLP-1 and glucagon receptors, presented at the American Diabetes Association's 81st Scientific Sessions. The trial involved overweight or obese Chinese participants, showing that IBI362 was well tolerated with no significant adverse events. Participants experienced significant weight reductions: cohort 1 (3.80 kg), cohort 2 (5.77 kg), cohort 3 (5.12 kg) vs. a placebo gain of 0.37 kg. The study indicates IBI362's potential for effective weight loss and metabolic improvement, addressing an unmet need in obesity treatment.