Jiangsu Hengrui Pharmaceuticals Co., Ltd.: BLA 761308

Please refer to your May 31, 2023, biologics license application (BLA), and your amendments, submitted under for SHR1210 injection.

1. Because the safety and effectiveness of SHR-1210 has only been established in combination with rivoceranib, we will not approve SHR-1210 until a regulatory approval action is issued for rivoceranib.

, listed in this application, FDA conveyed deficiencies to the representative of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application.

Your complete response should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.

(5) Describe any information that suggests a substantial change in the incidence of common, but less serious, adverse events between the new data and the application data.

Form 483. The assessment of the application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.