Huiyu Pharmaceutical's paclitaxel injection plans to be included in priority review

On December 25, CDE official website showed that Huiyu pharmaceutical's Paclitaxel injection was proposed to be included in the priority review for the reason that "the same production line has been listed in EU countries in 2019 and applied for domestic listing" According to the data of minenet, in 2018, the sales volume of paclitaxel in China's public medical institutions was 5.584 billion yuan At present, Paclitaxel injection has not been evaluated by the enterprise, and Huiyu pharmaceutical has applied for production of new 4 categories of chemical drugs If it is approved successfully, it will be deemed to have passed the consistency evaluation To be included in priority review publicity Paclitaxel injection is a kind of plant anti-tumor drug, which is used in the first-line and second-line treatment of ovarian cancer, breast cancer and non-small cell lung cancer (NSCLC) It has a certain effect on head and neck cancer, esophageal cancer, seminoma, recurrent non-Hodgkin's lymphoma and so on According to the data of minenet, in 2018, the sales volume of paclitaxel at the terminals of public medical institutions (urban public hospitals, county-level public hospitals, urban community centers and township health centers) in China was 5.584 billion yuan Paclitaxel liposomes for injection of LVYE pharmaceutical accounted for 47.45% of the market share, paclitaxel for injection (albumin binding type) of new base pharmaceutical accounted for 12.92%, Paclitaxel injection of heshengrui The proportion of liquid was 9.41% Sales of paclitaxel in public medical institutions in China (unit: 10000 yuan) Paclitaxel injection is a class a product of national medical insurance, and there are 42 domestic enterprises that have the production approval of this product At present, Paclitaxel injection has not been evaluated by any enterprise, only one enterprise in Yangzi River has submitted an application for conformity evaluation Paclitaxel injection of Huiyu pharmaceutical has applied for listing in the new 4 categories of chemicals If it is approved for listing in the future, it will be deemed to pass the consistency evaluation Review of Paclitaxel injection of Huiyu pharmaceutical