Heavyweight ┃ this antibody medicine is used to treat lymphoid cancer. Today, it has obtained clinical approval!

Source: from Dec 26, 2017 to Dec 27, 2017, the project of rituxim (anti-CD20) monoclonal antibody biological similar drug of China Bio Shanghai company obtained the approval document for clinical trials of drugs (approval document No 2017l05134) issued by the State Food and drug administration This is the first clinical research approval document of antibody drugs obtained by China biology, which has reached a high quality level of industrialization scale This product (hereinafter referred to as "CD20 antibody") is widely used in the treatment of lymphoma and other immune related diseases Lymphatic cancer is one of the ten most common malignant tumors in China The incidence rate is 4% annually It has become one of the fastest growing malignant tumors, and there are more than 100 thousand patients who have not received effective treatment After the product is successfully launched, it will benefit the vast number of patients and bring huge social benefits At the same time, the global sales volume of the original research drug has maintained nearly $10 billion for many years in a row, and the domestic market space of the drug is huge The high-quality CD20 monoclonal antibody similar drug mature product was developed by mabxience company in Spain and has been listed in many countries Shanghai company directly skips the pilot development process by introducing the mature process of listed products, quickly realizes industrialization, and establishes the necessary hardware conditions and technical platform for the relevant industrial chain In 2014, after the approval of the project, Shanghai company launched technology transfer training, workshop transformation, key equipment selection and commissioning, and the first trial samples of the new workshop were successfully put into use in May 2015 Through continuous batch process validation, the process and quality are stable, and the quality index is highly consistent with the original research drug It is highly appraised and recognized by mabxience company in Spain, and fully affirmed by the experts of China Academy of inspection After completing the safety assessment study, the project submitted the clinical research application to the State Food and Drug Administration in August 2016, and obtained the clinical research approval document in December 2017 It is expected to complete the clinical research and apply for listing at the end of the 13th five year plan Through the introduction of this project and the establishment of an industrial technology platform, the key channels of antibody series products have been through On this platform, the HER2 antibody independently developed by Shanghai company has also applied for clinical application and entered the CDE review status, paving the way for the subsequent development and introduction of new antibody drugs.