Gelonghui July 14?Fuhong Hanlin (02696.HK) announced that Shanghai Fuhong Hanlin Biopharmaceutical Co., Ltd., a wholly owned subsidiary of the company, has today received the "Drug Supplement Application approval notice" (notice No. 2020B04026, 2020B04027) approved and issued by the State Drug Administration ("NMPA") for the new indication supplement application of HLX01 Hanlikang (rituximab injection).
HLX01 Hanlikang (rituximab injection) has added two new indications to the approved indications: 1) monotherapy for patients with follicular lymphoid cancer after complete or partial remission after rituximab combined with chemotherapy; 2) combined with fludarabine and cyclophosphamide (FC) to treat previously untreated or relapsed / refractory chronic lymphoblastic leukemia (CLL) patients. After obtaining the notice of approval of the Supplementary Drug Application, HLX01 Hanlikang (rituximab injection) has been approved for all indications of the original rituximab in China.
It is reported that HLX01 Hanlikang (rituximab injection), a biological analogue of rituximab independently developed by the company, was approved for listing in Chinese mainland on February 22nd, 2019. As of the announcement date, the indications approved by HLX01 Hanlikang (rituximab injection) in China are: (1) recurrent or drug-resistant follicular central lymphoma; (2) previously untreated CD20-positive III-IV stage follicular non-Hodgkin's lymphoma; (3) CD20-positive diffuse large B-cell non-Hodgkin's lymphoma (DLBCL). (4) patients with follicular lymphoid carcinoma were treated with rituximab combined with chemotherapy, (5) patients with previously untreated or recurrent / refractory chronic lymphoblastic leukemia (CLL) were treated with fludarabine and cyclophosphamide (FC). In addition, HLX01 Hanlikang (rituximab injection) for the treatment of rheumatoid arthritis is in phase III clinical trials in China.
As of the announcement date, rituximab injection listed in China is rituximab of Shanghai Roche Pharmaceutical Co., Ltd.®Han Likang of Shanghai Fuhong Hanlin Biopharmaceutical Co., Ltd. According to the information provided by IQVIACHPA, in 2019, the sales of rituximab injection in China was about 2.505 billion yuan.
According to the announcement, the supplementary application for new indications of HLX01 Hanlikang (rituximab injection) has been approved by NMPA, which will further expand the scope of indications of HLX01 Hanlikang (rituximab injection) and provide more drug options for domestic patients with follicular lymphoma and chronic lymphoblastic leukemia.