Another biological similar medicine report of Lizhu Pharmaceutical Co., Ltd., with R & D investment of nearly 100 million

On December 13, Lizhu pharmaceutical announced that the registration application for the production of recombinant human chorionic gonadotropin for injection submitted by Zhuhai Lizhu monoclonal antibody Biotechnology Co., Ltd., a holding subsidiary, had been officially accepted As a luteinizing hormone (LH) analogue, human chorionic gonadotropin (hCG) plays an important role in the diagnosis and treatment of female infertility and in vitro assisted reproductive technology (Art) Through gene engineering, Lizhu pharmaceutical department cloned the gene of human chorionic gonadotropin, transfected it into Chinese hamster ovary (CHO) cells, and then fermented it with the stable and high expression CHO cell line As of the date of this announcement, the cumulative R & D investment of recombinant human chorionic gonadotropin for injection is about 99.7 million yuan According to the source of preparation, human chorionic gonadotropin can be divided into UROGENOUS human chorionic gonadotropin (u-hcg) and recombinant human chorionic gonadotropin (r-hCG) At present, there is only one company in the world to market the recombinant human chorionic gonadotropin drug, trade name: iverel (English), which was approved for import in China in 2005 According to the iqvia database, the total domestic sales of HRP in 2017 (including urine source and recombination) was 152 million yuan, and the domestic sales in the first three quarters of 2018 was 128 million yuan In 2017, the sales volume of recombinant human hair stimulating hormone in China was 62.6667 million yuan, and in the first three quarters of 2018, the domestic sales volume was 53.0548 million yuan Up to now, no other manufacturers in China have applied for this product (including clinical application, listing application and import registration application) The full text of the announcement is as follows: