Innovent Biologi Stock Price, News & Analysis

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.

Innovent Biologics (IVBIY) hosted its Oncology R&D Day, unveiling its strategic focus on dual innovation in next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) technologies. The event, which attracted over 500 participants, showcased the company's ambitious plans to advance at least five pipeline assets into MRCT Phase 3 by 2030.

The company highlighted its flagship product IBI363, a first-in-class PD-1/IL-2α-bias fusion protein, which demonstrated breakthrough potential in three hard-to-treat tumors with significant survival benefits: median overall survival up to 17.5 months in NSCLC, 16.1 months in later-line CRC, and 14.7 months in immune-resistant melanoma. IBI363 has received two Breakthrough Therapy Designations from NMPA CDE and two Fast Track Designations from FDA.

Innovent's pipeline includes nearly 10 next-generation molecules in global development, supported by R&D hubs in Shanghai and San Francisco, with antibody and ADC manufacturing capacity exceeding 140,000L. Key candidates include IBI343 (CLDN18.2 ADC), IBI3009 (DLL3 ADC), IBI3003 (tri-specific T-cell engager), IBI3001 (EGFR/B7H3 ADC), and IBI3020 (CEACAM5 dual-payload ADC).

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.