PaLin Biotech: Wholly-owned subsidiary received approval for clinical trial of intravenous immunoglobulin for humans.
Palin Biopharmaceuticals announced that its wholly-owned subsidiary, Guangdong Shuanglin, has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, approving its clinical trial to conduct clinical trials on the production process changes of intravenous human immunoglobulin. The drug is an injection with a specification of 2.5g per bottle. The application is for drug registration clinical trials, and the clinical trial protocol submitted by the applicant is titled "Evaluation of the Efficacy and Safety of intravenous human immunoglobulin in the treatment of primary immune thrombocytopenia in adults and adolescents: a single-arm, open-label, multicenter clinical study".
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