SINO BIOPHARM (01177): Panitumumab injection solution approved by FDA for listing.

SINO BIOPHARM (01177) announced that the jointly developed Pembrolizumab injection has been approved for market by the U.S. Food and Drug Administration (FDA): 1) When used in combination with cisplatin or carboplatin and gemcitabine, it is indicated for the first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in adult patients; 2) As a monotherapy, it is suitable for adult patients with metastatic non-keratinizing nasopharyngeal carcinoma who have experienced disease progression during or after platinum-based chemotherapy and have received at least one prior treatment. Pembrolizumab is currently the only novel differentiated PD-1 monoclonal antibody that uses the IgG1 subtype and has been modified in the Fc segment. It can effectively enhance the efficacy of immunotherapy and reduce adverse reactions. Currently, Pembrolizumab has been approved by the China National Medical Products Administration (NMPA) for four indications, including: first-line treatment of metastatic nasopharyngeal carcinoma in combination with chemotherapy, first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer in combination with chemotherapy, monotherapy for relapsed or refractory classical Hodgkin lymphoma after at least two lines of systemic chemotherapy, and monotherapy for second-line and above metastatic nasopharyngeal carcinoma. In addition, in November 2024, the new drug application for Pembrolizumab in combination with Apatinib for the first-line treatment of advanced hepatocellular carcinoma has been accepted by the NMPA. The Group will actively promote the development of Pembrolizumab indications, accelerate the expansion into international markets, and meet the urgent clinical needs of patients worldwide.