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Henlius' Hansizhuang (serplulimab) Receives the NMPA’s Approval as 1L Treatment of Extensive Stage Small Cell Lung Cancer

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Henlius' Hansizhuang (serplulimab) Receives the NMPA’s Approval as 1L Treatment of Extensive Stage Small Cell Lung Cancer

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  • The NMPA has approved Hansizhuang (anti-PD-1 mAb) for ES-SCLC in combination with carboplatin & etoposide. The approval was based on the P-III trial (ASTRUM-005) results evaluating Hansizhuang + CT vs PBO + CT in a ratio (2:1) in 585 patients at 128 sites in multiple countries incl. China, Turkey, Poland & Georgia
  • The results showed a 38% reduction in risk of death, m-OS (15.8 vs 11.1mos.) & Asians subgroup also showed a 4.8mos. longer m-OS, m-PFS as assessed by IRRC per RECIST v1.1 (5.8 vs 4.3mos.). Hansizhuang + CT brings significant benefits to previously untreated ES-SCLC patients
  • The trial also met the pre-defined 1EPs criteria & had good safety and tolerability. The result were presented at ASCO 2022 & published in JAMA

Ref: PRNewswire | Image: Henlius

Related News:- Henlius Entered into an Exclusive License Agreement with Fosun Pharma for HANSIZHUANG in the US

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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