INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

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.

Innovent Biologics announced positive second interim analysis results from the Phase 3 ORIENT-31 study, evaluating sintilimab plus chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) who failed prior EGFR-TKI therapy. The study showed median progression-free survival (PFS) of 7.2 months for the combination therapy compared to 4.3 months for chemotherapy alone. Key secondary endpoints, including objective response rate, also improved. This trial marks a significant advancement in treatment options for this patient population.

Innovent Biologics announced the successful dosing of the first participant in a phase 2 clinical trial for mazdutide, a dual agonist for GLP-1 and GCGR, targeting obesity in Chinese adults. This randomized study aims to assess the safety and efficacy of a 9 mg dose of mazdutide, following positive results in lower doses that demonstrated significant body weight loss and metabolic benefits. The trial will enroll 80 participants over 24 weeks. The drug has shown best-in-class potential, with earlier studies indicating over 11.5% body weight reduction.

Innovent Biologics, a leading biopharmaceutical company, reported impressive interim results for H1 2022 with total revenue of RMB 2,240 million, marking a 15.3% increase year-over-year. The product revenue also rose by 10.0% to RMB 2,041 million. The company upgraded its commercial model to Stage 2.0 and expanded its portfolio to include seven products. Innovent is actively pursuing global collaborations to enhance innovation, with a robust pipeline of 34 assets, including seven approved products and multiple candidates in clinical stages. Despite a loss of RMB 1,085 million, cash reserves are strong at approximately USD 1.5 billion.

Innovent Biologics announced the first patient dosing of IBI363, a PD-1/IL-2 bispecific antibody fusion protein, in a Phase I clinical trial in Australia. This study evaluates IBI363 for the treatment of advanced solid tumors and lymphomas. IBI363 aims to enhance anti-tumor immune response while minimizing IL-2 related side effects. The trial, which is open-label and multi-center, is also being conducted in China. Dr. Hui Zhou emphasized the importance of IBI363 in overcoming treatment resistances in patients with limited options.

Innovent Biologics has successfully dosed the first healthy volunteer in a Phase 1 study of IBI311, a monoclonal antibody targeting the IGF-1R receptor, intended for treating thyroid-associated ophthalmopathy (TAO). This study aims to evaluate the safety and tolerability of IBI311 in healthy Chinese subjects, filling a significant treatment gap as no targeted drugs have been approved for TAO in China. The company is committed to advancing clinical development to address the unmet medical needs for TAO, which significantly affects patient quality of life.

Innovent Biologics announced the successful results of a phase 2 clinical study of picankibart (IBI112), achieving its primary endpoint in treating moderate-to-severe plaque psoriasis. Out of 250 subjects, 52.0%-54.9% achieved a significant improvement (≥90% on PASI) at week 16. The drug was well-tolerated, with common adverse events being mild upper respiratory infections. The study suggests picankibart's long-term efficacy and potential advantages over current therapies, with only five doses needed annually. The ongoing phase 3 study aims to further validate these promising results.

Innovent Biologics announced the successful dosing of the first patient in its Phase 1 study for IBI324, a bispecific antibody targeting both VEGF-A and Ang-2, aimed at treating diabetic macular edema (DME). The study evaluates safety and tolerability, hoping to enhance treatment compliance by potentially extending dosing intervals for patients. IBI324 is designed to inhibit neovascularization and stabilize blood vessels, addressing a significant unmet need in DME therapy.

Innovent Biologics has announced a strategic collaboration with Sanofi to expedite the development and commercialization of oncology medicines in China. This partnership focuses on two key oncology assets, SAR408701 and SAR444245, which will be combined with sintilimab to tackle prevalent solid tumors in the region. Sanofi will initially invest €300 million in Innovent, marking a strong commitment to providing advanced cancer treatments in China. The collaboration aims to leverage both companies' R&D resources to address urgent medical needs for cancer patients.