CLL / SLL is a common type of leukemia in adults, and ibotinib and rituximab are both important approved therapies for CLL / SLL. Last year, ibotinib was approved to be used with another CD20 monoclonal antibody, gazyva (obinutuzumab), as the first non chemotherapy combination therapy for CLL / SLL patients.

 

 

 

As the first Btk inhibitor listed in the world, ibutini was jointly developed by pharmacyclics and Johnson's Janssen biotechnology company. In March 2015, Aberdeen invested $21 billion to acquire pharmacyclics and obtained the US market development rights of ibutini, while Johnson & Johnson had the development rights of ibutini in other countries around the world. It was approved by FDA of the United States in 2013, EMA of Europe in 2014, PMDA of Japan in 2016 and CFDA of China in 2017. Its trade name is imbruvica ® / Yike ®. According to statistics, ibutini has been approved in more than 80 countries or regions.

 

 

 

In fact, in addition to being approved for marketing in many countries, ibotinib has many indications. At present, ibotinib has obtained 11 FDA approvals in 6 major diseases, such as relapsed refractory chronic lymphoblastic leukemia / small Lymphoid Lymphoma (CLL / SLL), relapsed refractory chronic lymphoblastic leukemia / small Lymphoid Lymphoma (CLL / SLL) and other indications. In addition, ibotinib is conducting clinical research on other indications, including diffuse large B-cell lymphoma, follicular lymphoma, non Hodgkin's lymphoma, pancreatic cancer, acute lymphocytic leukemia, acute myeloid leukemia, renal cell carcinoma, etc. In addition, there were six approvals for CLL treatment.

 

 

 

In addition, its market performance is also outstanding. According to some data, the total sales volume of ibutini in the six years since its listing has reached US $23.627 billion. According to the 2019 financial report, the global sales of ibutini in the past year reached US $8.085 billion, an increase of 30.30% over the same period. This is also the first time ibuprofen has surpassed rituximab in the market leading position, not only making it a very fast-growing product in the field of leukemia, but also smoothly entering the top 5 of the world's best-selling drugs.

 

 

 

Of course, in the face of such a huge drug market, domestic enterprises can't miss it. As of August 2019, domestic enterprises such as Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., Shandong Xinlu Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., Beijing shenlanhai Biomedical Technology Co., Ltd., Zhejiang Haizheng Pharmaceutical Co., Ltd. and Shanghai huilun Jiangsu Pharmaceutical Co., Ltd. have been approved to apply for the registration of ibtini Companies and so on, are registered in chemical 3.1 status, the conclusions are batch clinical.

 

 

 

In general, in the future, the potential of ibutini space expansion is huge. Whether ibutini can become a heavyweight product with annual sales of more than 10 billion dollars will be proved by time.