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The FDA has once again delayed the approval for Jiangsu Hengrui Pharmaceuticals' PD-1 combination product.
Once again, it is a production compliance issue.
The "Double Ai" therapy has encountered obstacles again in its launch in the USA. Jiangsu Hengrui Pharmaceuticals responded that they will "quickly resubmit the listing application after confirming the reasons."
① The "Double Ai" therapy has received a complete response letter from the FDA upon the second submission of the application; ② Jiangsu Hengrui Pharmaceuticals responded to reporters stating: they will promptly resubmit the application for market approval after confirming the reasons; ③ Experts say, "This is just a minor setback, production-related issues are easy to resolve."
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