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1. The potential in esophageal cancer therapy
(1) The high EGFR expression in EC
• Over 50% of EC patients are found high EGFR expression in the tumor
• EGFR expression is highly correlated with the EC prognosis
(2) High Selectivity to EGFR Kinase
• Has a considerable inhibitory effect on the EGFR
(3) The Special in vivo distribution characteristics
• Distribute into esophagus tissues (T/B=61) and tumors (T/B=27.4)
2. Clinical Development Progress
(1) Esophageal Carcinoma (EC): Phase Ib/IIa trial finished. Phase III trial, ≥2L, has been started, with the first recruitment in November 2020.
(2) Pancreatic Cancer: Phase Ib trial started in Nov. 2019. NDA 2024.Q4
(3) ORR 20% (10/50) for the EC patients, with better efficacy than Pembrolizumab (ORR 16.7%).
ESCC (Esophageal Squamous Cell Carcinoma), ≥2L, Phase Ib/IIa, oral, RP2D 350 mg
3. Development Timeline
Expects to file the NDA in China for the first indication, esophageal cancer at the end of 2024 or at the beginning of 2025.
1. Asset type: EGFR inhibitor
2. Indication: Esophageal Carcinoma and Pancreatic Cancer
3. Target: EGFR / Her2 / Her4
4. Research phase: Phase III (Esophageal Carcinoma)\ Phase Ib (Pancreatic Cancer)
5. Cooperation demands: License-out or co-development for the global right and Clinical development in the US or EU (PK and Phase III)
6. Research progress：
(1) The asset expects to file the NDA in China for the first indication, esophageal cancer at the end of 2024 or at the beginning of 2025.
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