Hengrui Medicine's Factor XI Monoclonal Antibody SHR-2004 NDA Accepted by China's NMPA
nashnova research
Hengrui Medicine's Class 1 innovative drug SHR-2004 has had its New Drug Application accepted by China's NMPA — meaning this Factor XI antibody has formally moved from clinical trials into regulatory review, one step from commercialization.
What is SHR-2004, and where does it stand now?
SHR-2004 is a Factor XI (FXI) monoclonal antibody developed in-house by Hengrui Medicine (01276.HK) — an antibody drug targeting Factor XI in the clotting pathway to prevent blood clots.
It is classified as a Class 1 innovative drug by China's NMPA — the highest novelty tier, meaning no equivalent is approved anywhere globally.
The NDA has been accepted. This means → the drug has formally entered the marketing review process; clinical trials are complete, and the next milestone is approval.
Why does "acceptance" matter?
In plain terms = a new drug passes five gates from lab to pharmacy: clinical trials → submission → acceptance → review → approval. Acceptance is the start of gate four — it confirms the NMPA considers the filing complete enough to begin formal review.
For Hengrui, this is the pivotal node where SHR-2004 shifts from R&D cost to potential revenue.
This reflects Hengrui's pipeline velocity — the full cycle from clinic to NDA acceptance has been completed.
What comes next?
Acceptance ≠ approval. The NMPA will now enter its technical review phase, typically measured in months; timing depends on the review queue and any supplemental data requests.
The next signal investors should watch for: when the review conclusion lands — approve, request supplemental data, or reject.
If ultimately approved, SHR-2004 becomes a new commercialized asset in Hengrui's anticoagulation portfolio, opening another revenue stream for the company's innovative-drug business.
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