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Shinpoong Pharmaceutical Wins Approval to Amend Phase 3 Trial of Stroke Drug SP-8203

Shinpoong Pharmaceutical Wins Approval to Amend Phase 3 Trial of Stroke Drug SP-8203

BitgetBitget2026/10/22 05:43
  • Shinpoong Pharmaceutical received South Korean regulatory clearance on Oct. 22, 2026, to amend its Phase 3 SP-8203 trial for acute ischemic stroke.
  • The amendment incorporates newly authorized thrombolytic TNK (Metalase) into the trial protocol, updating exclusion criteria and treatment procedures.
  • The ongoing, placebo-controlled study plans to enroll 852 patients to assess SP-8203’s safety and efficacy alongside standard thrombolytic treatment.
  • Earlier Phase 2 safety and efficacy findings supported advancing the treatment into the larger study.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Shinpoong Pharmaceutical Co. Ltd. published the original content used to generate this news brief via DART, the regulatory disclosure system operated by the South Korea Financial Supervisory Service (FSS) (Ref. ID: 20261022800250), on October 22, 2026, and is solely responsible for the information contained therein.

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