INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics presented clinical data on IBI354, a HER2 monoclonal antibody-camptothecin derivative conjugate, at the 2024 ESMO Congress. The Phase 1/2 study involved 368 participants with advanced solid tumors, including 178 with breast cancer, 92 with ovarian cancer, and 38 with colorectal cancer. Key findings:

1. Excellent safety profile with no DLT events up to 18mg dosage.
2. In platinum-resistant ovarian cancer, 40.2% ORR and 81.6% DCR.
3. In HER2-positive breast cancer, 67.8% ORR and 88.1% DCR.
4. In HER2-positive gastrointestinal malignancies, 57.1% ORR and 91.4% DCR.

IBI354 showed promising efficacy in multiple tumor types, including HER2-low expressions, with a favorable safety profile.

Innovent Biologics (HKEX: 01801) presented Phase 3 clinical trial results for mazdutide, a GLP-1R and GCGR dual agonist, at the 60th Annual Meeting of EASD. The DREAMS-2 study demonstrated mazdutide's superiority over dulaglutide in both glycemic control and body weight reduction in Chinese patients with type 2 diabetes. After 28 weeks, mazdutide 4 mg and 6 mg showed mean HbA1c reductions of 1.69% and 1.73% respectively, compared to 1.36% for dulaglutide 1.5 mg. Weight reductions were 9.24% and 7.13% for mazdutide 4 mg and 6 mg, significantly outperforming dulaglutide (2.86%). Mazdutide also improved cardiometabolic risk factors and showed a favorable safety profile. The drug is currently under regulatory review in China for chronic weight management and type 2 diabetes treatment.

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.