Innovent Biologi (IVBIY) Stock News

Innovent Biologics (IVBIY) has received approval from China's NMPA for mazdutide, the world's first dual GCG/GLP-1 receptor agonist for chronic weight management in Chinese adults with overweight or obesity.

The approval is based on the GLORY-1 Phase 3 study, which demonstrated significant results at week 48: 14.8% mean body weight reduction with 6mg dose, 82.8% of participants achieving ≥5% weight loss, and 50.6% achieving ≥15% weight loss. The drug also showed impressive liver fat content reduction of up to 80.24% in the 6mg group.

This approval addresses a critical healthcare need in China, where over 500 million adults live with overweight or obesity, costing the country approximately $283.3 billion in GDP loss in 2020.

Innovent Biologics (IVBIY) presented Phase 3 clinical study results (DREAMS-1) for mazdutide, their dual GCG/GLP-1 receptor agonist, at the ADA 85th Scientific Sessions. The study, involving 319 Chinese patients with type 2 diabetes, demonstrated significant efficacy with HbA1c reduction of 2.15% and body weight reduction of up to 7.81% after 24 weeks of treatment.

The trial met its primary and secondary endpoints, showing superior results compared to placebo. 87.4% of participants receiving mazdutide 6 mg achieved HbA1c <7.0%. The drug also showed improvements in cardiometabolic risk factors with a favorable safety profile. Two NDAs for mazdutide are currently under review by China's NMPA for chronic weight management and glycemic control.

Innovent Biologics (IVBIY) presented multiple research findings at the ADA 85th Scientific Sessions, showcasing two key drug candidates. IBI3030, a novel antibody-peptide conjugate, demonstrated significant improvements in cardiovascular risk markers through its multi-target approach combining PCSK9 inhibition with GLP-1R/GCGR/GIPR activation. Preclinical studies showed notable reductions in LDL-c, Lp(a), and body weight, with improved glucose tolerance. Additionally, three investigator-initiated studies of mazdutide, their dual GCG/GLP-1 receptor agonist, revealed superior efficacy compared to semaglutide in reducing liver fat accumulation, alleviating MASH and hepatic fibrosis, and lowering serum uric acid levels through enhanced fatty acid oxidation and metabolic regulation.

Innovent Biologics has initiated dosing in GLORY-OSA, its seventh Phase 3 clinical trial of mazdutide in China. This double-blinded study evaluates mazdutide 9mg versus placebo in Chinese patients with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The trial aims to assess the drug's efficacy in reducing the apnea-hypopnea index (AHI) over 48 weeks. Mazdutide, a dual GCG/GLP-1 receptor agonist, previously demonstrated 18.6% weight loss in Phase 2 trials. With approximately 66 million moderate-to-severe OSA cases in China and low diagnosis rates (<1%), there is a significant unmet medical need as no approved OSA treatments exist in China. The study could potentially offer an alternative to positive airway pressure (PAP) therapy, which faces adherence challenges.

Innovent Biologics has initiated dosing in GLORY-OSA, its seventh Phase 3 clinical trial of mazdutide in China. The study evaluates mazdutide 9mg, a dual GCG/GLP-1 receptor agonist, for treating moderate-to-severe obstructive sleep apnea (OSA) in obese patients. The multicenter, randomized trial aims to assess efficacy against placebo, with primary endpoint measuring change in apnea-hypopnea index at 48 weeks. This development is significant as China has the highest OSA burden globally with 66 million cases, yet lacks approved treatments. Previous Phase 2 results showed mazdutide 9mg achieved 18.6% weight loss versus placebo, with cardiovascular and metabolic benefits. The drug could potentially offer an alternative to positive airway pressure therapy, addressing a major unmet medical need in China's OSA treatment landscape.

Innovent Biologics (IVBIY) will present multiple clinical study results at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025. The key highlight is the oral presentation of mazdutide's first Phase 3 study (DREAMS-1) in Chinese adults with Type 2 Diabetes. Additionally, four poster presentations will showcase mazdutide's mechanism exploration studies and preclinical research of IBI3030, a novel PCSK9-GGG antibody-peptide-conjugate. The presentations will demonstrate mazdutide's effectiveness in liver fat reduction, serum urine reduction, and its potential advantages over semaglutide in treating liver fat accumulation. The company aims to establish mazdutide as a next-generation GCG/GLP-1 dual receptor agonist while advancing innovative therapies in cardiovascular and metabolic diseases.

Innovent Biologics (IVBIY) has received a second Breakthrough Therapy Designation (BTD) from China's NMPA for IBI363, its PD-1/IL-2α-bias bispecific antibody fusion protein, targeting immunotherapy-resistant squamous non-small cell lung cancer (sqNSCLC). The drug has already received BTDs from China's NMPA and Fast Track Designations from the U.S. FDA for both sqNSCLC and melanoma indications. Phase 1 clinical study data presented at ASCO 2025 showed manageable safety profiles and encouraging efficacy in immunotherapy-resistant patients. IBI363 combines PD-1 blockade with IL-2-driven tumor-specific T-cell expansion mechanisms. The company is advancing global development with a registrational study in melanoma and plans for additional trials in lung and colorectal cancer.

Innovent Biologics presented updated Phase 1 clinical data for IBI363, their first-in-class PD-1/IL-2α-bias bispecific antibody, in treating advanced non-small cell lung cancer (NSCLC) at ASCO 2025. The study showed promising results, particularly in immunotherapy-resistant patients. In squamous NSCLC, the 3mg/kg dose group achieved 36.7% objective response rate (ORR), 90% disease control rate (DCR), and 9.3 months median progression-free survival (PFS). For EGFR wild-type lung adenocarcinoma, the 3mg/kg group showed 24% ORR, 76% DCR, and 5.6 months median PFS. Notably, IBI363 demonstrated efficacy in patients with low PD-L1 expression and those with smoking history. The drug maintained a manageable safety profile, with arthralgia and rash as the main grade 3+ adverse events. IBI363 has received Breakthrough Therapy Designation from China CDE and Fast Track Designation from the US FDA for squamous NSCLC.

Innovent Biologics presented updated Phase 1/2 clinical data for IBI354, their novel anti-HER2 ADC, at ASCO 2025. The study enrolled 368 patients with advanced solid tumors, including 178 breast cancer, 92 ovarian cancer, and other tumor types. In HER2-positive breast cancer (n=88), IBI354 showed a 59.1% ORR and 90.9% DCR, with 9mg/kg dose achieving 72.4% ORR. Median PFS was 14.1 months. In ovarian cancer (n=92), the treatment demonstrated 41.2% ORR and 82% DCR, with 12mg/kg dose reaching 55% ORR. The drug showed a favorable safety profile with only 1.9% incidence of ILD (all grade 1-2), and 27.4% of patients experiencing grade 3+ TRAEs. The Phase 3 study for platinum-resistant ovarian cancer has been initiated, marking a significant milestone in Innovent's IO+ADC oncology strategy.