Innovent Biologi (IVBIY) Stock News

Innovent Biologics presented Phase 1 clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at ASCO 2025. The study evaluated IBI363 both as monotherapy and in combination with bevacizumab for advanced colorectal cancer. As monotherapy (n=68), IBI363 achieved a median overall survival of 16.1 months, significantly higher than historical standard treatments (6.4-9.3 months), with a confirmed ORR of 13.6% at 1 mg/kg Q2W. In combination with bevacizumab (n=73), the treatment showed a 15.1% confirmed ORR and 61.6% disease control rate, with median PFS of 4.7 months. Notably, patients without liver metastases showed better outcomes with 31.3% ORR and 7.4 months PFS. The safety profile was manageable, with 27.9% and 35.6% of patients experiencing Grade 3+ TRAEs in monotherapy and combination therapy, respectively.

Innovent Biologics presented breakthrough Phase 1/2 clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at ASCO 2025. The drug showed promising results in treating immunotherapy-pretreated advanced melanoma, particularly in 'cold tumor' subtypes. Among 31 patients treated with 1 mg/kg Q2W, the confirmed objective response rate was 23.3%, with disease control rate reaching 76.7%. The median progression-free survival was 5.7 months, and overall survival was 14.8 months, with a 61.5% 12-month survival rate. IBI363 demonstrated a manageable safety profile, with mostly Grade 1-2 adverse events. A pivotal Phase 2 registration trial comparing IBI363 to pembrolizumab in 180 treatment-naive patients is now underway, marking a significant advancement in melanoma treatment options.

Innovent Biologics has initiated a Phase 3 clinical trial for picankibart, their anti-IL-23p19 antibody, with the first participant successfully dosed. The study will evaluate the efficacy of switching to picankibart in psoriasis patients who showed inadequate response to anti-IL-17 antibody treatment. The trial will enroll approximately 310 participants in a 1:1 randomization ratio. Previous Phase 2 results showed promising outcomes, with 48.2% of participants achieving the primary endpoint at week 16, and 54.2% maintaining response through week 44. Notably, 64.6% of participants with baseline sPGA ≥ 2 and BSA ≥ 3% achieved sPGA of 0 or 1, while 16.9% achieved complete skin clearance. Picankibart's new drug application for moderate-to-severe plaque psoriasis was submitted to NMPA in September 2024.

Innovent Biologics announces the publication of Phase 3 GLORY-1 clinical study results for mazdutide, their dual GCG/GLP-1 receptor agonist, in The New England Journal of Medicine. The study, involving 610 Chinese adults with overweight or obesity, demonstrated significant weight reduction over 48 weeks. The mazdutide 6 mg dose achieved -14.84% weight reduction compared to -0.47% for placebo. 84% of participants in the 6 mg group achieved ≥5% weight reduction at week 32. The drug also showed improvements in cardiovascular and metabolic indicators, including significant reductions in liver fat content (up to -80.24%). Common side effects included nausea, diarrhea, and vomiting, mostly mild to moderate. Mazdutide, ranked among FIERCE Pharma's 2025 Top 10 Most Anticipated Drugs, is expected to launch in China this year for weight management and glycemic control.

Innovent Biologics (IVBIY) has released its 2024 ESG Report, showcasing significant achievements in sustainable development and innovation. The company achieved an MSCI ESG rating of AAA, becoming the only biotech in China and one of three globally with this distinction. Key highlights include: 15 commercialized products benefiting 5 million patients, a robust pipeline with 3 NDAs under review and 19 molecules in development, and 6 medicines included in China's National Reimbursement Drug List. The company operates 140,000L of production capacity with plans to expand to 230,000L. Innovent demonstrated strong diversity metrics with 51% female employees and 44.2% women in management positions. Environmental achievements include a 29% reduction in energy consumption and 22% reduction in fresh water use per unit of production compared to the previous year.

Innovent Biologics has initiated the GLORY-3 Phase 3 clinical trial comparing mazdutide (IBI362) to semaglutide in Chinese adults with overweight/obesity and fatty liver disease (MAFLD). The study will enroll approximately 470 participants randomized 1:1 to receive mazdutide 9mg or semaglutide 2.4mg, measuring changes in liver fat content and body weight over 48 weeks. Previous Phase 2 results showed mazdutide 9mg achieved an 18.6% (17.8kg) placebo-adjusted weight reduction and a 73.3% reduction in liver fat content after 24 weeks in participants with baseline LFC≥5%. As a dual GCG/GLP-1 receptor agonist, mazdutide offers potential advantages over single GLP-1 receptor agonists through enhanced lipolysis and fatty acid oxidation.

Innovent Biologics (IVBIY) has initiated Phase 2 clinical trials for efdamrofusp alfa (IBI302), a first-in-class bispecific fusion protein targeting both VEGF and complement for treating diabetic macular edema (DME). The study will enroll 150 patients randomized into three groups: IBI302 4mg, IBI302 8mg, and Faricimab 6mg. The trial marks the first global comparison between two dual-target agents in DME treatment. Previous clinical studies have shown that high-dose (8mg) efdamrofusp alfa demonstrates significant improvements in visual acuity and retinal edema, with potential for extended dosing intervals of 12-16 weeks. The drug aims to address the limitations of current DME treatments, which require frequent injections every 4-8 weeks. The market opportunity is substantial, with China having over 140 million diabetic patients, of which approximately one-third develop diabetic retinopathy. The DME prevalence rate ranges from 7% to 14% among these patients, suggesting an estimated 4-5 million DME patients in China.

Innovent Biologics presented promising 1-year Phase 2 clinical trial results for efdamrofusp alfa (IBI302), their first-in-class anti-VEGF/complement bispecific fusion protein, at ARVO 2025. The study involved 132 patients with neovascular age-related macular degeneration (nAMD), comparing two IBI302 doses (6.4mg and 8.0mg) against Aflibercept 2.0mg. Key findings showed that over 80% of IBI302 patients maintained visual benefits with 12-week dosing intervals. Both IBI302 doses demonstrated noninferiority to Aflibercept, with visual acuity improvements of +10.8 and +11.3 letters at week 52. The drug showed superior anatomical improvements and potentially reduced macular atrophy incidence by 40% compared to Aflibercept (4.9% vs 8.3%). No new safety concerns were identified, positioning IBI302 as a promising treatment option with extended dosing intervals for nAMD patients.

Innovent Biologics has achieved a significant milestone with the first patient dosing of IBI3020, a groundbreaking dual-payload CEACAM5 ADC, in a Phase 1 clinical trial for advanced solid tumors. This marks a global first-in-class development in cancer treatment technology.

The multi-regional Phase 1 study, approved in both China and the U.S., will evaluate the safety, tolerability, and preliminary efficacy of IBI3020. The drug, developed from Innovent's proprietary DuetTx® dual-payload ADC platform, works by selectively binding to CEACAM5-expressing tumor cells and releasing two types of cytotoxic payloads to kill cancer cells.

Preclinical studies have shown promising results, with IBI3020 demonstrating strong antitumor activity and manageable safety profiles. The drug targets CEACAM5, a protein overexpressed in various solid tumors including colorectal cancer, non-squamous lung cancer, gastric cancer, and pancreatic cancer, while showing limited expression in healthy tissues.