Welcome to our dedicated page for Innovent Biologi news (Ticker: IVBIY), a resource for investors and traders seeking the latest updates and insights on Innovent Biologi stock.
Innovent Biologics (IVBIY) is a global biopharmaceutical leader developing precision therapies for oncology, autoimmune disorders, and chronic diseases. This page provides investors and healthcare professionals with timely updates on clinical advancements, regulatory milestones, and strategic partnerships shaping the company's trajectory.
Access official press releases and curated analysis covering key developments including clinical trial results, drug approval updates, and collaboration announcements. Our repository simplifies tracking Innovent's progress in bringing innovative treatments to market through its robust pipeline of immune checkpoint inhibitors and targeted biologics.
Content spans financial disclosures, manufacturing expansions, and research breakthroughs across therapeutic areas. Bookmark this page for streamlined monitoring of Innovent's contributions to advancing treatments for lung cancer, metabolic conditions, and ophthalmologic diseases through its global network of 30+ healthcare partners.
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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.
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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.
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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.
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Innovent Biologics presented updated Phase 1 clinical trial results for IBI343, a novel anti-CLDN18.2 ADC, for advanced pancreatic cancer treatment at ASCO 2025. The study showed promising results with a confirmed overall response rate of 22.7% and disease control rate of 81.8% in CLDN18.2-positive patients at 6mg/kg dose (N=44). Median progression-free survival was 5.4 months, with overall survival of 9.1 months. Notably, patients with one prior treatment line achieved 12.1 months median overall survival. IBI343 demonstrated a favorable safety profile with manageable side effects. The drug has received Breakthrough Therapy Designation from China's NMPA and Fast Track Designation from the US FDA. This development is significant given pancreatic cancer's poor prognosis, with global annual cases reaching 510,000 and a 5-year survival rate below 10%.
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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.
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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.
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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.
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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.
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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.
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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.
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FAQ
What is the current stock price of Innovent Biologi (IVBIY)?
The current stock price of Innovent Biologi (IVBIY) is $29 as of May 23, 2025.
What is the market cap of Innovent Biologi (IVBIY)?
The market cap of Innovent Biologi (IVBIY) is approximately 8.0B.
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