China accepts Shanghai RAAS’s SR604 clinical trial application for Glanzmann thrombasthenia
November 10, 2026
Source: drugdu
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On November 9, Shanghai RAAS announced that China’s National Medical Products Administration had accepted a clinical trial application for SR604 injection as a prophylactic treatment for Glanzmann thrombasthenia. SR604 is a humanized monoclonal antibody that binds human activated protein C with high affinity and selectively inhibits its anticoagulant activity.
For the prevention of bleeding in hemophilia A and B, SR604 met its prespecified primary endpoint in Phase II, and key data were presented at an international conference. Phase III is underway. Studies on the prevention of bleeding in congenital factor VII deficiency and von Willebrand disease are both in Phase II.
In a separate public notice, China’s Center for Drug Evaluation proposed including SR604 injection in the extended pilot program supporting innovative drug development for rare diseases.
Source: https://finance.eastmoney.com/a/202611093926395123.html
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