INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics (HKEX: 01801) announces the acceptance of a New Drug Application (NDA) for mazdutide, a GLP-1R and GCGR dual agonist, by China's NMPA for the treatment of type 2 diabetes (T2D). This marks mazdutide as the first GLP-1R/GCGR dual agonist to succeed in Phase 3 trials for T2D. The NDA is based on two Phase 3 studies (DREAMS-1 and DREAMS-2) demonstrating superior efficacy to placebo or dulaglutide in glycemic control, weight reduction, and cardiovascular and renal improvements. Mazdutide showed a safety profile similar to other GLP-1R agonists with no new concerns. If approved, it could offer a novel treatment option for China's diabetic population, providing comprehensive metabolic benefits.

Innovent Biologics (HKEX: 01801) and WeComput have announced a strategic partnership to advance AI-driven drug discovery and development. The collaboration aims to combine their respective strengths and technologies to accelerate the drug R&D process using AI technology. Innovent Academy will utilize WeComput's WeMol molecular design platform to enhance its computing infrastructure, while WeMol will integrate NVIDIA's BioNeMo to expand Innovent's AI systems' computing capability.

This partnership is expected to create a comprehensive, efficient, and intelligent AI-driven drug discovery system. The collaboration aims to reduce costs, shorten R&D cycles, and improve success rates in drug development, ultimately delivering more innovative treatments to patients.

Innovent Biologics (HKEX: 01801) announces that the Phase 3 clinical trial (DREAMS-1) of mazdutide, a GLP-1R and GCGR dual agonist, in Chinese adults with type 2 diabetes (T2D) met its primary endpoint and key secondary endpoints. The study showed superior glycemic control and weight loss compared to placebo. At week 24, HbA1c reduction in the mazdutide 4 mg (1.57%) and 6 mg (2.15%) groups was significantly better than placebo (0.14%). Mazdutide also demonstrated multiple cardiometabolic benefits and a favorable safety profile.

Innovent plans to submit a new drug application (NDA) for mazdutide to treat T2D to China's NMPA soon, following its first NDA for chronic weight management in February 2024. The DREAMS-1 results, along with the previously successful DREAMS-2 trial, provide strong evidence for mazdutide's efficacy in T2D treatment.

Innovent Biologics has launched an Environmental, Social, and Governance (ESG) website, emphasizing its commitment to sustainable development and corporate responsibility. The platform showcases the company's progress and achievements in governance, health, product quality, employee empowerment, and ecological stewardship. Innovent's key highlights include:

Governance: Transparent business practices and robust risk management.

Healthcare: Innovent's innovative drug development portfolio includes 36 assets and 10 launched products, benefiting over 2.5 million patients.

Quality: A robust quality management system with 140,000 liters of production capacity.

Employees: A diverse and inclusive work environment with over 50% female employees and a 98% satisfaction rate.

Ecology: ISO14001 certification and proactive climate change strategies.

CEO Dr. Michael Yu reaffirms the company's dedication to transparency and sustainability, aiming to create long-term value for stakeholders. For more details, visit the ESG website at Innovent's official page.

Innovent Biologics and IASO Bio have announced a strategic collaboration in cell therapy. IASO Bio will acquire Innovent's rights to FUCASO® (Equecabtagene Autoleucel), including global commercial rights and intellectual property licenses. Innovent will gain an 18% stake in IASO Bio. FUCASO®, a CAR-T product approved in China and the world's first fully human CAR-T product, will be developed, manufactured, and commercialized by IASO Bio. This partnership aims to enhance resources and team integration, focusing on advancing innovative therapeutic solutions.

Innovent Biologics presented its latest Phase 1 clinical data for the anti-CLDN18.2 ADC (IBI343) at the ESMO Gastrointestinal Cancers Congress 2024. This treatment targets advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) patients with high CLDN18.2 expression. Results showed an ORR of 36.7% and DCR of 93.3% at 6 mg/kg, and an ORR of 47.1% and DCR of 88.2% at 8 mg/kg. The median progression-free survival at 6 mg/kg was 6.8 months. Most treatment-related adverse events were grade 1-2, with low grade 3 gastrointestinal toxicities and no interstitial lung disease. Innovent plans to explore IBI343 in combination therapies and other tumor types.

Innovent Biologics provided updates on its Mazdutide GLORY-1 study and the company's biomedicine pipeline at an investor conference call on June 25, 2024. The Phase 3 GLORY-1 study, presented at the 2024 ADA Scientific Meeting, showed significant weight loss and liver fat reduction among overweight or obese adults in China. Mazdutide, a GLP-1R/GCGR dual agonist, reduced weight by 14.3% and liver fat by 80.2% after 48 weeks, also improving multiple cardiovascular risk indicators. The treatment proved safe and well-tolerated. Innovent is pursuing additional indications for mazdutide and advancing its cardiovascular and metabolic disease pipeline with products like SINTBILO, IBI128, and IBI3016. The company is also progressing in autoimmune and ophthalmological treatments with candidates like SULINNO, picankibart, and IBI311.

Innovent Biologics presented results from its first Phase 3 study of the drug mazdutide for weight management at the ADA Scientific Sessions 2024. The GLORY-1 study, involving 610 Chinese adults, demonstrated significant weight loss, reduced liver fat, and improved cardiometabolic risk factors compared to placebo. Mazdutide achieved weight reduction endpoints, with differences in mean weight loss reaching -14.31% at 48 weeks for the highest dose. The drug also showed favorable safety and tolerability. The new drug application for mazdutide is under review by China's National Medical Products Administration, with potential to offer a new treatment for obesity and related conditions.

Innovent Biologics announced results from their Phase 3 GLORY-1 study, revealing a significant reduction in liver fat content using mazdutide, a GLP-1R and GCGR dual agonist. The study involved 610 Chinese adults with obesity or overweight, showing an average liver fat reduction of 80.2% in participants with a baseline LFC ≥10%. The 48-week trial demonstrated dose-dependent improvements in liver fat content, body weight, and other metabolic parameters, outperforming placebo. These findings suggest mazdutide's potential in treating MAFLD and MASH.