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, in advanced non-small cell lung cancer (NSCLC) at the 2024 World Conference on Lung Cancer. The study enrolled 134 patients, with 95.5% having received prior PD-(L)1 immunotherapy. Key findings include:

- Overall ORR of 20.8% and DCR of 74.4% in 125 evaluable patients
- In squamous NSCLC, 3 mg/kg Q3W dosing showed ORR of 34.5% and DCR of 89.7%
- Efficacy observed regardless of PD-L1 expression
- Manageable safety profile with 20.1% experiencing grade ≥3 TRAEs

IBI363 demonstrates promising antitumor activity in IO-resistant NSCLC, potentially offering a new treatment option for patients with alternatives.

Innovent Biologics (HKEX: 01801) presented updated results from a pivotal Phase 2 study of Dupert® (fulzerasib) in advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation at the 2024 World Conference on Lung Cancer. The study, involving 116 evaluable subjects, showed promising outcomes:

- Confirmed objective response rate (ORR): 49.1%
- Disease control rate (DCR): 90.5%
- Median progression-free survival (PFS): 9.7 months

Dupert® received NMPA approval in August 2024 for treating advanced NSCLC with KRAS G12C mutation after at least one systemic therapy. The drug demonstrated a favorable safety profile, with mostly Grade 1-2 treatment-related adverse events.

Innovent Biologics (HKEX: 01801) has received Fast Track Designation from the U.S. FDA for IBI363, a PD-1/IL-2α Bispecific Antibody Fusion Protein, for treating advanced melanoma. This designation applies to patients with unresectable locally advanced or metastatic melanoma who have progressed after at least one line of systemic therapy, including a PD-1/L1 inhibitor.

In ongoing Phase 1/2 trials, IBI363 has shown promising results: among 37 melanoma patients previously treated with immunotherapy, 11 achieved objective responses (1 CR, 10 PR), with an ORR of 29.7% and DCR of 73.0%. This is significant given the efficacy of current treatments for immunotherapy-resistant melanoma, which have an ORR of only 3.8% to 6.8%.

Innovent Biologics (HKEX: 01801) announces multiple clinical study results of mazdutide, a GLP-1R/GCGR dual agonist, to be presented at the EASD 60th Annual Meeting in Madrid, Spain from September 9-13, 2024. Key presentations include:

1. DREAMS-2 Phase 3 study results comparing mazdutide to dulaglutide in type 2 diabetes patients.

2. GLORY-1 study on mazdutide's efficacy and safety in Chinese participants with overweight or obesity.

3. Exploratory analysis of mazdutide's improvement of liver steatosis in overweight or obese participants.

4. Phase 2 study results of mazdutide 9 mg in Chinese adults with BMI≥30 kg/m2.

Dr. Lei Qian, VP of Clinical Development, highlighted mazdutide as the first GLP-1R/GCGR dual agonist to complete a Phase 3 study for diabetes, showing superior blood sugar-lowering and weight loss efficacy compared to dulaglutide.

Innovent Biologics (HKEX: 01801) will present nearly 20 clinical data sets of its novel oncology molecules at WCLC 2024 and ESMO 2024. Key highlights include:

• Updated Phase 1 results of IBI363 (PD-1/IL-2α-bias) in NSCLC and colorectal cancer
• Updated Phase 2 results of Dupert® (fulzerasib, KRAS G12C inhibitor) in NSCLC
• Phase 1 results of IBI354 (HER2 ADC) in HER2+ solid tumors
• Multiple clinical results of TYVYT® (sintilimab injection)

The presentations will showcase preliminary efficacy and safety signals for Innovent's innovative candidates, highlighting their potential for further development and clinical value in oncology treatment.

Innovent Biologics (HKEX: 01801) announced its 2024 interim results and business updates, showcasing strong commercial performance and significant pipeline milestones. Key highlights include:

1. Total revenue of RMB3,952.3 million, a 46.3% year-over-year growth.

2. Product sales revenue of RMB3,811.4 million, a 55.1% year-over-year increase.

3. Gross profit margin improved to 84.1%, up 1.8 percentage points.

4. EBITDA loss reduced by 39.9% year-over-year to RMB160.8 million.

5. Eleven approved products in the portfolio, including the new KRAS G12C inhibitor DUPERT®.

6. Seven new assets in NDA review or pivotal trials, and 18 in early-phase clinical studies.

7. Significant progress in oncology and general biomedicine, including NDAs for mazdutide and teprotumumab.

Innovent Biologics (HKEX: 01801) announces the approval of Dupert® (fulzerasib) by China's National Medical Products Administration (NMPA) for treating adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. This marks China's first approved KRAS G12C inhibitor, becoming Innovent's eleventh commercial product.

The approval is based on a Phase 2 clinical study (NCT05005234) showing promising results: 49.1% confirmed objective response rate, 90.5% disease control rate, and 9.7 months median progression-free survival. Fulzerasib demonstrated encouraging antitumor activity and was generally well-tolerated.

This approval represents a significant advancement in targeted therapy for KRAS mutations, offering new hope for NSCLC patients with treatment options.

Innovent Biologics (HKEX: 01801) and SanegeneBio have announced the dosing of the first participant in a Phase 1 clinical trial for IBI3016, an siRNA drug candidate targeting angiotensinogen (AGT) for hypertension treatment. The trial (NCT06501586) aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses in healthy volunteers and patients with mild hypertension.

Preclinical studies have shown that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers, resulting in marked and sustained blood pressure reduction without observed safety concerns. Developed using SanegeneBio's proprietary siRNA technology platform, IBI3016 demonstrates enhanced drug potency and durability while maintaining favorable safety profiles.

Innovent Biologics (HKEX: 01801) announces the acceptance of a New Drug Application (NDA) for mazdutide, a GLP-1R and GCGR dual agonist, by China's NMPA for the treatment of type 2 diabetes (T2D). This marks mazdutide as the first GLP-1R/GCGR dual agonist to succeed in Phase 3 trials for T2D. The NDA is based on two Phase 3 studies (DREAMS-1 and DREAMS-2) demonstrating superior efficacy to placebo or dulaglutide in glycemic control, weight reduction, and cardiovascular and renal improvements. Mazdutide showed a safety profile similar to other GLP-1R agonists with no new concerns. If approved, it could offer a novel treatment option for China's diabetic population, providing comprehensive metabolic benefits.