Issued to Jiangsu Hengrui Pharmaceuticals Co., Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 9, 2026Application
BLA • 761308
Product
BLA 761308
Company
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Stage
Final Decision
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd. on July 9, 2026.
BLA 761308 is the application under which FDA issued this complete response letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd.. The letter is dated July 9, 2026.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.