Innovent Biologi Stock Price, News & Analysis

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.

Innovent Biologics (HKEX: 01801) presented preclinical data for multiple novel cancer treatments at the AACR Annual Meeting 2025 in Chicago. The presentations showcased several groundbreaking developments including:

• IAR037: A novel CD40/PD-L1 bispecific antibody for treating advanced solid tumors resistant to immune checkpoint inhibitors
• IBI3010: A FRα targeting biparatopic antibody-drug conjugate showing superior results compared to existing treatments
• IBI3014: A TROP2xPD-L1 bi-specific ADC combining tumor killing with immune checkpoint blockade
• IBI3022: A bi-specific ADC targeting Trop2 and B7H4 for gynecologic cancers
• IBI3026: A first-in-class anti-PD-1/IL-12 fusion protein for immunotherapy-resistant tumors
• IBI3019: A novel tri-specific antibody targeting EGFR/CDH17/CD16A for colorectal cancer

These developments demonstrate Innovent's advancing global R&D capabilities and commitment to creating innovative cancer treatments.

Innovent Biologics (HKEX: 01801) announces NMPA approval of limertinib for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. The approval is based on a Phase 3 trial of 337 patients comparing limertinib to gefitinib.

Key trial results show limertinib significantly improved median progression-free survival (PFS) to 20.7 months vs 9.7 months for gefitinib, representing a 56% risk reduction. In patients with CNS lesions, median CNS PFS was 20.7 months vs 7.1 months, showing a 72% risk reduction.

The drug demonstrated a well-tolerated safety profile with predominantly mild to moderate adverse events. This approval follows Innovent's commercial collaboration with ASK Pharm in 2024 for limertinib in Mainland China.

Innovent Biologics will present breakthrough clinical data at the 2025 ASCO Annual Meeting from May 30 to June 3 in Chicago. The company will showcase seven oral presentations, highlighting significant developments in their oncology pipeline.

Key presentations include data for IBI363 (PD-1/IL-2α-bias) in three indications: melanoma, colorectal cancer, and non-small cell lung cancer. Additionally, IBI343 (CLDN18.2 ADC) Phase 1b data in pancreatic cancer will receive an oral presentation, building on its previous success at ESMO Asia.

The presentations will also feature results from various clinical trials, including the ORIENT-21 Phase 3 study of sintilimab plus ICE in Hodgkin lymphoma, the SPRING-01 trial in rectal cancer, and the EP-STAR trial in nasopharyngeal carcinoma. Multiple poster presentations will showcase additional data from the company's diverse oncology portfolio.

Innovent Biologics (HKEX: 01801) has received Breakthrough Therapy Designation (BTD) from China's NMPA for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, for treating unresectable locally advanced or metastatic mucosal or acral melanoma in treatment-naive patients.

Clinical trials involving 26 patients with advanced acral or mucosal melanoma demonstrated remarkable results, with an overall objective response rate (ORR) of 61.5% and a disease control rate (DCR) of 84.6%. These outcomes significantly exceed current domestic immunotherapy standards.

The company has initiated a pivotal study comparing IBI363 monotherapy versus pembrolizumab (Keytruda®). Additionally, IBI363 has secured two Fast Track Designations from the U.S. FDA for treating squamous non-small cell lung cancer and melanoma.