Henlius Announces the Acceptance of NDA Application by NMPA for Hansizhuang to Treat Esophageal cancer
Shots:
- The NDA was based on the results of P-III (ASTRUM-007) evaluating Hansizhuang + CT (cisplatin + 5-FU) vs PBO + CT as 1L treatment of locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
- The result of the study demonstrated significantly extended median PFS (5.8 vs. 5.3 mos.) and improved median OS (15.3 vs. 11.8 mos.), these findings met pre-defined efficacy criteria with favorable safety profiles and the absence of any new safety concerns
- Hansizhuang (serplulimab), an anti-PD-1 mAb developed by Henlius, has received approval from the NMPA for treating microsatellite instability-high (MSI-H).
Ref: Henlius | Image: Henlius
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
