Northeast Pharmaceutical's Subsidiary Receives Regulatory Clearance for Key Cancer Drug Trials

Deep News03-18 22:41

Northeast Pharmaceutical Group Co.,Ltd. announced on March 18 through an investor interaction platform that its controlling subsidiary, Dingcheng Peiyuan, has obtained a clinical trial approval notice from the National Medical Products Administration. The approval, referenced in the company's October 9, 2025 disclosure (Announcement No.: 2025-063), confirms that the DCTY0801 injection application submitted on July 9, 2025 meets drug registration requirements. The therapy is approved for clinical trials targeting EGFRvIII-positive recurrent or progressive high-grade glioma.

Dingcheng Peiyuan's core product, DCTY1102 injection, has received implicit clinical trial approval from the Center for Drug Evaluation. This positions the therapy to potentially become the world's second and China's first TCR-T cell drug targeting KRASG12D to enter Phase I clinical trials. Separately, another product, DCTY0801, has successfully obtained orphan drug designation from the U.S. Food and Drug Administration.

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