Innovent Biologi Stock Price, News & Analysis

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.

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.