INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

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.

Innovent Biologics presented clinical data for IBI188, an anti-CD47 monoclonal antibody, at the 2022 ASH Annual Meeting. This Phase Ib study assessed IBI188 coupled with Azacitidine in newly diagnosed higher risk myelodysplastic syndrome (MDS). The results showed a 100% objective response rate (ORR) after 6 cycles and a 63.3% complete response rate (CRR) in 30 patients. 94.6% of participants experienced treatment-related adverse events, yet the therapy demonstrated promising anti-tumor activity. Further updates on clinical findings are expected as the study progresses.

Innovent Biologics has presented updated Phase Ib clinical data for IBI110, an anti-LAG-3 monoclonal antibody, at the 2022 ESMO-IO Congress. In a study of 20 treatment-naïve patients with advanced squamous non-small cell lung cancer (sqNSCLC), IBI110 combined with sintilimab and chemotherapy achieved an objective response rate (ORR) of 80% and a 12-month progression-free survival (PFS) rate of 60%. Safety results indicated manageable adverse events, with no treatment-related deaths reported. The study is ongoing, with further data expected at future academic conferences.

Innovent Biologics has presented promising Phase Ib clinical data for IBI939, an anti-TIGIT monoclonal antibody, at the 2022 European Society for Medical Oncology Immuno-Oncology Congress. The study evaluated the combination of IBI939 and sintilimab in treating PD-L1-selected non-small cell lung cancer (NSCLC). Among 40 evaluable patients, the objective response rate was 64.3% for the experimental group compared to 57.2% for the control. The median progression-free survival was significantly better at 11.2 months versus 6.4 months. Safety profiles showed a higher incidence of treatment-related adverse events in the experimental group.

Innovent Biologics announced the successful dosing of the first Chinese healthy volunteer in a Phase I study for orismilast (IBI353), a potential best-in-class PDE4 inhibitor. This study focuses on evaluating the drug's pharmacokinetics, safety, and tolerability in healthy subjects to support its development for psoriasis and atopic dermatitis. Innovent aims to accelerate orismilast's development in China, addressing a significant unmet need for effective oral treatments in dermatological diseases.