INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

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.

Innovent Biologics (HKEX: 01801) and WeComput have announced a strategic partnership to advance AI-driven drug discovery and development. The collaboration aims to combine their respective strengths and technologies to accelerate the drug R&D process using AI technology. Innovent Academy will utilize WeComput's WeMol molecular design platform to enhance its computing infrastructure, while WeMol will integrate NVIDIA's BioNeMo to expand Innovent's AI systems' computing capability.

This partnership is expected to create a comprehensive, efficient, and intelligent AI-driven drug discovery system. The collaboration aims to reduce costs, shorten R&D cycles, and improve success rates in drug development, ultimately delivering more innovative treatments to patients.

Innovent Biologics (HKEX: 01801) announces that the Phase 3 clinical trial (DREAMS-1) of mazdutide, a GLP-1R and GCGR dual agonist, in Chinese adults with type 2 diabetes (T2D) met its primary endpoint and key secondary endpoints. The study showed superior glycemic control and weight loss compared to placebo. At week 24, HbA1c reduction in the mazdutide 4 mg (1.57%) and 6 mg (2.15%) groups was significantly better than placebo (0.14%). Mazdutide also demonstrated multiple cardiometabolic benefits and a favorable safety profile.

Innovent plans to submit a new drug application (NDA) for mazdutide to treat T2D to China's NMPA soon, following its first NDA for chronic weight management in February 2024. The DREAMS-1 results, along with the previously successful DREAMS-2 trial, provide strong evidence for mazdutide's efficacy in T2D treatment.