Hualan Biological’s application for clinical trial of pembrolizumab injection has been accepted
December 16, 2025
Source: drugdu
30
Hualan BiologicalOn December 16, the company announced at noon that its investee company, Hualan Gene Engineering Co., Ltd., received the "Acceptance Notice" from the National Medical Products Administration for its application for clinical trial registration of pembrolizumab injection for domestic production.
Hualan Biological stated that its pembrolizumab injection is a biosimilar. The original pembrolizumab product (trade name: Keytruda®) is manufactured by Merck.The company developed one of the world's first approved PD-1 inhibitors, which has been approved globally for dozens of important oncology indications, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, esophageal cancer, liver cancer, gastric cancer, and colorectal cancer. Its clinical value has been widely recognized.
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