INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics has successfully dosed its first patient in a Phase 3 clinical trial (CLEAR) for its anti-IL23p19 monoclonal antibody, picankibart (IBI112), targeting moderate-to-severe plaque psoriasis. This multicenter, double-blind study aims to enroll around 500 subjects over 68 weeks, assessing the drug's efficacy and safety against placebo. Previous Phase 2 results indicated significant clinical benefits, with up to 86% of participants achieving substantial improvements in skin condition. This trial marks a pivotal step in developing innovative psoriasis treatments in China, addressing unmet medical needs.

Innovent Biologics has successfully dosed its first patient in a Phase 2 clinical trial for IBI311, an anti-IGF-1R monoclonal antibody targeting thyroid-associated ophthalmopathy (TAO). This randomized, double-blinded, placebo-controlled study aims to evaluate IBI311's efficacy in improving proptosis in TAO patients. Currently, there are no approved treatments for TAO in China, creating a significant unmet medical need. IBI311's preclinical studies have shown promising safety and biological activity, with plans for further clinical development depending on Phase 2 results.

Innovent Biologics announced five products' inclusion in China's updated National Reimbursement Drug List (NRDL), effective March 1, 2023. Key additions include two new indications for its PD-1 inhibitor TYVYT (sintilimab), now covering gastric and esophageal cancer. Olverembatinib has made its first listing for T315I-mutant chronic myeloid leukemia (CML). Additionally, new indications for BYVASDA, HALPRYZA, and SULINNO expand reimbursement coverage for various cancers and autoimmune diseases. This progress aligns with China's healthcare reforms, aimed at enhancing drug access and affordability for patients.

Innovent Biologics has initiated the DREAMS-2 phase 3 clinical trial for mazdutide (IBI362), a dual agonist for treating type 2 diabetes in Chinese patients. The trial, designed to enroll about 720 participants, will compare mazdutide's efficacy and safety against dulaglutide. Preliminary phase 2 results showed promising outcomes: a mean HbA1c reduction of up to -1.67% and weight loss of up to -7.11% with mazdutide. The study aims to address the poor glycemic control rates among diabetic patients in China, potentially leading to a new treatment option with significant cardiovascular benefits.

Innovent announced the first dosing of a participant in the Phase 3 DREAMS-1 clinical trial for mazdutide (IBI362), a dual agonist for type 2 diabetes, in China. This study will enroll approximately 300 subjects to assess the drug's efficacy and safety over 48 weeks, focusing on changes in glycated hemoglobin (HbA1c) levels. Previous Phase 2 results showed promising effects with a mean HbA1c reduction of up to -1.67% and significant weight loss. The trial aims to further establish mazdutide's potential as a treatment option amidst rising diabetes prevalence in China.

Innovent Biologics has announced that China's National Medical Products Administration has accepted the New Drug Application (NDA) for parsaclisib, a PI3Kδ inhibitor, for treating adults with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The NDA has been granted Priority Review status, based on a Phase II study showing an 86.9% objective response rate. If approved, this could enhance Innovent's portfolio and provide additional treatment options for patients with FL, addressing a significant unmet need.

Innovent Biologics announced that the NMPA in China has granted Breakthrough Therapy Designation (BTD) for IBI351, a KRAS^G12C inhibitor, aimed at treating advanced non-small cell lung cancer (NSCLC). This designation is based on positive Phase I/II trial results showing a 50.9% objective response rate (ORR) and a 92.7% disease control rate (DCR) in evaluable NSCLC patients. The drug exhibited a favorable safety profile, with 92.5% experiencing treatment-related adverse effects primarily at manageable grades. Ongoing trials aim to confirm its efficacy in this challenging patient population.

Innovent Biologics announced its participation in the 41st Annual J.P. Morgan Healthcare Conference from January 9-12, 2023, in San Francisco. Dr. De-Chao Michael Yu, Founder and CEO, will present on January 11, 2023, at 10:00 AM PST. A live audio webcast will be available at this link. Innovent specializes in developing high-quality biopharmaceuticals, with a pipeline of 36 assets and 8 approved products. More details can be found on their website.

Innovent Biologics and LG Chem have formed a strategic collaboration for the development and commercialization of Tigulixostat, a novel non-purine xanthine oxidase inhibitor aimed at treating hyperuricemia in gout patients. Tigulixostat showed promising results in Phase 2 trials, achieving significant serum uric acid reduction compared to placebo and Febuxostat. Innovent will develop Tigulixostat exclusively in China and will pay LG Chem up to $95.5 million, including an upfront payment of $10 million. This collaboration addresses the significant unmet medical need in treating hyperuricemia, which affects approximately 13.3% of the Chinese population.