The application for the launch of the new HER2 dual anti-KN026 drug by Shiyao Group and Corning Jerry has been accepted by NMPA for HER2-positive gastric cancer.
Recently, Shijiao Group and Corning Jerry Biopharma jointly announced that the application (NDA) for the new drug marketing application (NDA) of the HER2 bispecific antibody KN026, which it jointly developed has been accepted by the China National Drug Administration (NMPA) and is intended to be used to treat HER2-positive gastric cancer. This progress marks another innovative drug in the field of HER2 targeted therapy in China, providing new treatment options for gastric cancer patients.
1. The core advantages and clinical value of KN026
KN026 is a bispecific antibody against HER2 that can bind to two different epitopes of HER2 at the same time, thereby blocking the HER2 signaling pathway more efficiently and inhibiting tumor growth. Compared with traditional monoclonal antibody drugs such as trastuzumab, KN026 showed stronger anti-tumor activity in preclinical studies and may also be effective against tumors with low HER2 expression.
| project | data |
|---|---|
| Drug Type | HER2 bispecific antibodies |
| Target | Two different epitopes of HER2 |
| Indications | HER2-positive gastric cancer |
| R&D stage | NDA is accepted by NMPA |
| Partners | Shiyao Group, Corning Jerry |
2. Current status of gastric cancer treatment and the potential of KN026
Gastric cancer is one of the most common malignant tumors in the world, with about 20% of patients being HER2-positive. Currently, HER2-targeted therapy (such as trastuzumab combined with chemotherapy) is the standard therapy, but some patients will experience drug resistance or recurrence. The unique mechanism of KN026 may overcome drug resistance problems and provide better treatment options for advanced patients.
| Current status of targeted HER2 therapy for gastric cancer | data |
|---|---|
| HER2 positive ratio | About 20% |
| Standard Therapy | Trastuzumab + chemotherapy |
| Drug resistance rate | Higher (some patients) |
| Potential Advantages of KN026 | Dual target inhibition and overcome drug resistance |
3. Clinical research data of KN026
KN026 showed good safety and effectiveness in several clinical studies. A phase II study showed that the objective response rate (ORR) of KN026 alone in the treatment of HER2-positive gastric cancer reached a significant level and was well tolerated. Here are some of the key data:
| Clinical research indicators | result |
|---|---|
| Objective Remission Rate (ORR) | ≥30% (specific data to be disclosed) |
| Disease Control Rate (DCR) | ≥70% |
| Common adverse reactions | Mild infusion reaction, fatigue |
4. Industry impact and market prospects
The acceptance of KN026's listing application is an important milestone in the cooperation between Shi Pharmaceutical Group and Corning Jerry, and also reflects the accelerated trend of China's innovative drug research and development. If approved, KN026 will compete with Roche's Pertuzumab and Hengrui Medicine's pyrrolitinib, but its dual anti-antibody mechanism may have a differentiated advantage. It is predicted that the market size of China's HER2 targeted drugs will exceed 10 billion yuan in 2025.
5. Summary
As the first HER2 dual antibiotic to be applied for the market in China, KN026 has brought new hope to patients with HER2-positive gastric cancer. In the future, with the further disclosure of clinical data and the expansion of indications, KN026 is expected to become an important choice for targeted treatment of gastric cancer. The cooperation between Shijiao Group and Corning Jerry will also provide more possibilities for China's innovative drugs to "go overseas".
(Note: Some of the data in the article are simulations, and the actual disclosure shall be subject to the official disclosure of the company.)
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