Shenzhen Salubris Pharmaceuticals Co., Ltd.

AG·尊龙凯时

Application for domestic clinical trial of SAL008 injection was accepted

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Recently, Salubris has received the acceptance notice issued by NMPA accepting the application for clinical trial of SAL008 injection, a self-developed innovative first-in-class anti-tumor biological drug with intellectual property.

 

SAL008 (JK08), a fusion protein of IL-15/IL-15Rα complex and anti-CTLA-4 antibody, was independently developed by SalubrisBio, a subsidiary of Salubris, for the treatment of advanced solid tumors.

Previously, JK08 started a phase I clinical study after submitting a CTA (European Application for Clinical Trials) in Europe, and recruiting is ongoing now.

 

Basic Information

Drug name: SAL008 injection

Registry Classification: 1 category

Application information: Registered clinical trials of domestic manufactured drugs

Acceptance number: CXSL2200503  

Acceptance instructions: According to the provisions of Article 32 of the Administrative Licensing Law of the People's Republic of China, it is decided to accept it after examination.