Shanghai Fosun Pharmaceutical (02196) has applied for market approval for a new drug for type 1 lung cancer, with a 100% objective relief rate for intracranial symptoms.

On March 6, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China revealed that the application for the market approval of the Class 1 new drug corynitib fumarate capsules submitted by member company Fosun Pharma (02196) has been accepted. Public information shows that corynitib fumarate (SAF-189s, foritinib) is an innovative small molecule chemical drug developed by Shanghai Fosun Pharmaceutical, which is a new generation of highly efficient ALK/ROS1 inhibitors with high central nervous system (CNS) penetration and strong blood-brain barrier permeability. During the 2024 World Conference on Lung Cancer (WCLC), the interim analysis results of the Phase 3 REMARK study on the treatment of ALK-positive non-small cell lung cancer with corynitib were announced in the form of the latest breakthrough abstract (LBA). In this study, the objective response rate (ORR) for ALK-positive advanced NSCLC patients with baseline brain metastases treated with corynitib reached 100% (vs. 50% for the control drug). According to the research results previously disclosed by Shanghai Fosun Pharmaceutical, from December 2020 to March 2022, the study recruited 275 patients, with 139 receiving corynitib treatment and 136 receiving the control drug treatment. As of March 2024, the median follow-up time was 16.7 months. The study found that: The corynitib treatment group showed a significant improvement in progression-free survival (PFS) compared to the control drug treatment group, with a median PFS of 13.93 months for the control drug group, while the corynitib treatment group had not reached that point. Furthermore, corynitib significantly reduced the risk of CNS progression compared to the control drug. The median time to CNS progression (CNS-TTP) for the control drug group was 19.32 months, while the corynitib group had not reached that point. Additionally, corynitib showed a trend towards improved overall survival (OS). The research results also indicated that the objective response rate (ORR) in the corynitib treatment group reached 92.8%, which was 12% higher than that of the control drug treatment group (P=0.0035); and for patients with baseline brain metastases, the intracranial ORR in the corynitib treatment group reached 100%, while it was 50% for the control drug treatment group. In terms of safety, the incidence of Grade 3/4 treatment-related adverse events (TRAEs) in the corynitib treatment group was 37.7%, compared to 55.6% in the control drug treatment group. The most common Grade 3/4 TRAEs after corynitib treatment were high blood sugar, high blood pressure, and prolonged QT interval. There were no cases of interstitial lung disease or vision loss observed in the corynitib treatment group. No fatal TRAEs were reported in either group of patients after treatment. The researchers believe that the study results demonstrate the overall effectiveness of corynitib, which significantly improves PFS compared to the control drug treatment, reduces the risk of CNS progression, and is manageable in terms of safety, with no new safety signals emerging after treatment. The emergence of corynitib is expected to overcome the clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options for NSCLC patients.