Hualan Bio Announces Its Affiliate Receives IND Application Acceptance Notice for Pembrolizumab Injection

Gelonghui December 16 | Hualan Biological Engineering, Inc. announced that recently, its participating company, Hualan Genetic Engineering Co., Ltd., received the "Acceptance Notice" (Acceptance No.: CXSL2501079) issued by the National Medical Products Administration for the clinical trial application of domestically produced Pembrolizumab Injection. The drug name is Pembrolizumab Injection, and the application is for the clinical trial registration of a domestically produced drug. The registration classification is therapeutic biological product category 3.3, with a specification of 100mg (4ml)/bottle. The drug indications include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, etc.