Innovent Biologi - IVBIY STOCK NEWS

Innovent Biologics (IVBIY) announces the presentation of preclinical data for multiple novel cancer therapeutics at the 2025 AACR Annual Meeting in Chicago from April 25-30. The presentations include data on several groundbreaking molecules:

- IAR037: A novel CD40/PD-L1 bispecific antibody for advanced solid tumors
- IBI3010: A FRα targeting biparatopic antibody-drug conjugate
- IBI3019: A first-in-class EGFR/CDH17/CD16A tri-specific antibody for colorectal cancer
- IBI3026: A novel anti-PD-1/IL-12 fusion protein
- IBI3014: A TROP2xPD-L1 bi-specific ADC

The company will also present findings on combination therapies involving olverembatinib with lisaftoclax for leukemia treatment. These presentations showcase Innovent's expanding technological capabilities in developing first-in-class bispecific antibodies, multi-specific antibodies, and ADCs for oncology applications.

Innovent Biologics announces historic 2024 results with its first-ever positive profit, reporting Non-IFRS profit of RMB331.6 million and EBITDA of RMB411.6 million. Total revenue reached RMB9,421.9 million, growing 51.8% year-over-year, with product sales revenue at RMB8,227.9 million (+43.6%).

The company expanded its portfolio to 15 approved products, including new launches in oncology and chronic diseases. Key products include Dovbleron® (ROS1 inhibitor), Limertinib (EGFR TKI), and Jaypirca® (BTK inhibitor). The company achieved an 84.9% gross profit margin and reduced S,G&A expenses ratio by 7.1 percentage points.

Innovent targets RMB20bn product revenue by 2027 and aims to advance five pipeline assets to global MRCT Phase 3 stage by 2030. The company maintains strong financial position with RMB10,221.1 million in cash and short-term assets.

Innovent Biologics (HKEX: 01801) has initiated dosing in a Phase 3 clinical trial (HeriCare-Ovarian01) of IBI354, a HER2 ADC, for platinum-resistant ovarian cancer (PROC). The study will compare IBI354 against standard chemotherapy, focusing on progression-free survival and overall survival as primary endpoints.

Previous Phase 1/2 results showed promising outcomes with IBI354:

• 40.2% overall objective response rate (ORR) and 81.6% disease control rate (DCR) across 87 PROC patients
• 52.5% ORR and 90.0% DCR in 40 patients treated with 12mg/kg dose
• 55.6% ORR and 88.9% DCR in HER2 IHC 1+ subjects at 12mg/kg

The drug demonstrated a favorable safety profile with 21.5% grade 3+ treatment-related adverse events, low discontinuation rates (1.6%), and no treatment-related deaths. Common side effects included nausea, decreased white blood cell count, and anemia.

Innovent Biologics (IVBIY) and HUTCHMED have announced positive results from their FRUSICA-2 Phase 2/3 clinical trial, evaluating sintilimab combined with fruquintinib as second-line treatment for advanced renal cell carcinoma (RCC) in China.

The study met its primary endpoint of progression-free survival (PFS) and showed improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). The trial compared the combination therapy against axitinib or everolimus monotherapy for second-line RCC treatment.

The combination has previously received conditional approval from China's NMPA for treating advanced endometrial cancer with pMMR tumors based on the FRUSICA-1 study. The companies plan to proceed with NDA filings in the coming months, aiming to make this treatment option available to patients who have progressed on previous therapy.

Innovent Biologics has received NMPA approval for SYCUME® (teprotumumab N01), China's first and world's second IGF-1R antibody drug for treating thyroid eye disease (TED). This breakthrough ends a 70-year period without new TED treatments in China.

TED, an autoimmune disorder affecting orbital health, has an annual incidence of 16 per 100,000 in women and 2.9 per 100,000 in men. The Phase 3 RESTORE-1 study demonstrated that 85.8% of patients achieved ≥2 mm proptosis reduction at Week 24 with SYCUME® treatment.

SYCUME® offers advantages including a liquid injection formation, improved stability, and better patient compliance. This approval provides a more accessible treatment option compared to the existing IGF-1R antibody treatment available overseas, which costs approximately 3 million RMB per course.

Innovent Biologics (IVBIY) has initiated a pivotal study of IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, comparing it head-to-head with pembrolizumab in melanoma patients. The first patient has been dosed in this registrational trial for treating unresectable locally advanced or metastatic mucosal or acral melanoma in treatment-naive patients.

Early clinical trials of IBI363 showed promising results:

• 61.5% overall objective response rate (ORR)
• 84.6% disease control rate (DCR)
• Sustained tumor responses and long-term benefits observed

The safety profile has been manageable, with common treatment-related adverse events including arthralgia, anemia, thyroid dysfunction, and rash. The study's primary endpoint is progression-free survival (PFS), assessed by an Independent Radiology Review Committee using RECIST v1.1 criteria.

Innovent Biologics announces that its ipilimumab injection (IBI310) has received NDA acceptance and Priority Review designation from China's NMPA. The application is for combination use with sintilimab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer, marking China's first domestic CTLA-4 inhibitor NDA.

The approval is based on the Phase 3 NeoShot trial results, which met its primary endpoint. In the per-protocol population (n=101), the combination therapy showed significantly higher pathological complete response rates (80.0% vs 47.7%, p=0.0007) compared to sintilimab alone. All patients achieved R0 resection, with no disease recurrence at 5.65 months median follow-up.

The treatment could increase R0 resection rates, achieve pathological complete response, and potentially reduce the need for adjuvant chemotherapy without increasing safety risks or surgery delays.

Innovent Biologics announced that its PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, received its second Fast Track Designation from the FDA for treating advanced squamous non-small cell lung cancer (sqNSCLC) that has progressed after anti-PD-(L)1 therapy and chemotherapy.

Clinical trial results presented at WCLC 2024 showed promising efficacy: the 3 mg/kg dose group (n=18) achieved 50.0% objective response rate (ORR) and 88.9% disease control rate (DCR). The 1/1.5 mg/kg group showed 5.5 months median progression-free survival (PFS) with 30.7% 12-month PFS rate. Notably, IBI363 demonstrated effectiveness in both PD-L1 low and high expression populations, with ORRs of 36.4% and 31.8% respectively.

Innovent Biologics and ASK Pharm announce NMPA approval of limertinib, their third-generation EGFR TKI drug for treating adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). This marks Innovent's 14th commercial product.

A Phase 2b pivotal study with 301 patients showed impressive results: 68.8% overall response rate, 92.4% disease control rate, and 11.0 months median progression-free survival. For patients with CNS lesions, the response rate was 65.9% with 10.6 months median PFS.

Additionally, limertinib met its primary endpoint in a Phase 3 trial comparing it to gefitinib for first-line NSCLC treatment. A separate NDA for first-line treatment in patients with specific EGFR mutations is under NMPA review.