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.
The news feed for INNOVENT BIOLGCS UNSP/ADR (IVBIY) aggregates company press releases and media updates from Innovent Biologics, Inc., a biopharmaceutical company focused on oncology, cardiovascular and metabolic, autoimmune and ophthalmology diseases. These announcements provide insight into clinical trial progress, regulatory milestones, product approvals and corporate strategy that can influence how investors and observers view IVBIY.
Recent news highlights include multiple updates on mazdutide, a dual GCG/GLP-1 receptor agonist licensed from Eli Lilly for development in China. Innovent has reported National Medical Products Administration approvals for mazdutide in chronic weight management for adults with overweight or obesity and for glycemic control in adults with type 2 diabetes, along with Phase 3 data from the GLORY and DREAMS clinical programs. Other cardiovascular and metabolic pipeline news covers tigulixostat, a xanthine oxidase inhibitor for gout, and IBI3032, an oral GLP-1 receptor agonist with U.S. FDA IND approval for Phase 1 trials.
Oncology news items describe the development of IBI363, a PD-1/IL-2α-bias fusion protein, including U.S. FDA clearance of an IND for a global Phase 3 trial in immunotherapy-resistant squamous non-small cell lung cancer and data presented at major oncology conferences. Additional coverage includes IBI343, an anti-CLDN18.2 ADC with Phase 1 results in gastric/gastroesophageal junction adenocarcinoma published in Nature Medicine and the launch of multi-regional Phase 3 studies.
Investors following IVBIY can use this page to review updates on Innovent’s broader pipeline, such as picankibart for psoriasis, IBI324 for retinal diseases, and other marketed products mentioned in interim results and R&D day communications. Bookmark this news section to monitor how clinical data releases, regulatory decisions and partnership announcements may shape the company’s long-term development and commercialization plans.
Innovent (HG) reported Phase 3 results for mazdutide in Chinese adults with type 2 diabetes (DREAMS-2, N=731) after 28 weeks, showing superiority to dulaglutide on glycemic and weight endpoints. Mean HbA1c reductions were 1.69% (4 mg) and 1.73% (6 mg) versus 1.36% for dulaglutide. Mean weight loss was 9.24% (4 mg) and 7.13% (6 mg) versus 2.86%. Higher proportions achieved HbA1c <7.0% and ≥5% weight loss versus dulaglutide. Mazdutide improved multiple cardiometabolic markers, had no new safety signals, and currently has two NDAs under review in China (weight management and T2D).
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Innovent Biologics (IVBIY) has received approval from China's NMPA for mazdutide, the world's first dual GCG/GLP-1 receptor agonist for glycemic control in adults with type 2 diabetes (T2D). The approval is based on two Phase 3 clinical trials (DREAMS-1 and DREAMS-2) demonstrating superior efficacy over placebo and dulaglutide.
Key trial results showed mazdutide 6mg achieved HbA1c reductions of -2.15% and weight loss of -7.81% in DREAMS-1, while DREAMS-2 demonstrated HbA1c reductions of -1.73% and weight loss of -9.24%. The drug features an improved injection device with hidden needle design and X-cross-section technology for better patient comfort.
This approval is particularly significant for China, which has 140 million adults affected by T2D (1 in 4 global cases), addressing critical needs in long-term glucose management and complication prevention.
Innovent Biologics (IVBIY) announced clinical updates for IBI324 (OLN324), their next-generation VEGF/Ang2 bispecific antibody being developed with partner Ollin. The JADE Phase 1b trial has completed enrollment of over 150 patients with wet age-related macular degeneration (wAMD) or diabetic macular edema (DME).
The study aims to evaluate IBI324's potential advantages over faricimab, with topline results expected in Q1 2026. IBI324 features higher anti-Ang2 potency and higher molar doses than faricimab, potentially offering improved disease control and extended treatment durability. A previous Phase 1 study showed promising vision and anatomic improvements in DME patients with a favorable safety profile.
Innovent Biologics (IVBIY) announced it will present multiple research results at the 34th European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris from September 17-20. The presentations will showcase findings from Phase 2 and Phase 3 clinical studies of picankibart (IBI112), their IL-23p19 monoclonal antibody, along with preclinical study results of IBI3013 and IAR129.
The company will present seven ePosters focusing on picankibart's efficacy in treating various forms of psoriasis, including plaque, scalp, genital, and nail psoriasis. Picankibart, expected to receive marketing approval by end-2025, is positioned as a best-in-class IL-23p19 inhibitor offering quarterly dosing and durable efficacy for psoriasis treatment.
Innovent Biologics (IVBIY) has announced positive Phase 2 clinical trial results for tigulixostat (IBI128), its novel xanthine oxidase inhibitor for gout treatment, at the 2025 APLAR Congress. The study involved 84 Chinese participants comparing three tigulixostat doses (50mg, 100mg, 200mg) against febuxostat 40mg over 16 weeks.
The results showed significantly superior urate-lowering efficacy across all tigulixostat dose groups compared to febuxostat. At week 16, the proportion of participants achieving target serum uric acid levels ranged from 55.0% to 85.7% for tigulixostat groups, versus 18.2% for febuxostat. The drug demonstrated a favorable safety profile with no serious adverse events. Based on these positive results, Innovent plans to initiate Phase 3 trials in China in H2 2025.
Innovent Biologics (OTC:IVBIY) reported strong H1 2025 financial results, with total revenue reaching RMB 5.95 billion (up 50.6% YoY) and product revenue of RMB 5.23 billion (up 37.3% YoY). The company achieved a net profit of RMB 1.21 billion with an improved gross margin of 86.8%.
The company expanded its portfolio to 16 approved products, including three new oncology launches: Dovbleron®, Limertinib, and Jaypirca®. Notable progress includes SINTBILO®'s NRDL inclusion and SYCUME®'s approval as China's first new TED treatment in 70 years. Innovent maintains a strong cash position of approximately USD 2 billion and operates 140,000L of biopharmaceutical production capacity.
The company reaffirmed its strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030.
Innovent Biologics (OTC:IVBIY) has received FDA clearance for a global Phase 3 clinical trial (MarsLight-11) of IBI363, their novel PD-1/IL-2α-bias bispecific antibody, in IO-resistant squamous non-small cell lung cancer (NSCLC).
The trial will enroll approximately 600 patients globally across multiple regions including the U.S., China, Canada, EU, UK, and Japan. The study will compare IBI363 3 mg/kg monotherapy against docetaxel in patients with advanced squamous NSCLC who progressed after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
IBI363 has received Fast Track Designation from FDA and Breakthrough Therapy Designation from China's NMPA. Phase 1b/2 results presented at ASCO 2025 showed promising clinical activity in IO-resistant lung cancer, cold tumors, and microsatellite stable colorectal cancer.
Innovent Biologics (IVBIY) has received FDA approval for its Investigational New Drug (IND) application for IBI3032, a novel oral GLP-1 receptor agonist. The company plans to initiate Phase 1 clinical trials in both China and the U.S. during the second half of 2025.
IBI3032 demonstrated superior preclinical results, achieving 5-10 times higher oral exposure at equivalent doses compared to peer compounds. The drug showed improved efficacy and good tolerability in both GLP-1R KI DIO mice and obese monkey models, achieving comparable therapeutic effects at lower doses.
The upcoming trials will include both healthy volunteers and overweight/obese participants, targeting applications in diabetes, weight management, hypertension, and obstructive sleep apnea (OSA).
Innovent Biologics (OTC:IVBIY) announced the publication of Phase 1 clinical trial results for IBI343, their innovative anti-CLDN18.2 ADC, in Nature Medicine. The study focused on treating advanced gastric/gastroesophageal junction adenocarcinoma.
Key findings include a confirmed ORR of 32.3% at 6 mg/kg dose and 47.1% at 8 mg/kg dose in patients with high CLDN18.2 expression. The median PFS was 5.5 months for the 6 mg/kg group and 6.8 months for the 8 mg/kg group. The treatment showed manageable safety profile with 66.4% of patients experiencing grade ≥3 TEAEs.
Based on these promising results, Innovent has launched a multi-regional Phase 3 clinical trial (G-HOPE-001, NCT06238843) to further evaluate IBI343's efficacy.