Zhongsheng pharmaceutical T790M new lung cancer drug approved clinical

Source: on December 25, 2017, Zhongsheng pharmaceutical announced that zsp0391, a new non-small cell lung cancer class 1 drug jointly developed with Wuxi apptec, obtained the clinical approval issued by CFDA Zsp0391 is an innovative drug for the treatment of EGFR sensitive mutations and T790M resistant mutations in non-small cell lung cancer The results of preclinical study showed that zsp0391 showed significant antitumor effect on multiple xenograft tumor models and in situ brain metastasis tumor models; it had weak inhibitory effect on wild-type EGFR, higher selectivity and better than azd9291; the results of GLP toxicology study showed that it was safe and high safe treatment window In the announcement of Zhongsheng pharmaceutical industry, it was pointed out that zsp0391 has a clear mechanism of action and has been clinically verified It has a brand-new chemical structure Its activity in vitro and in vivo is equivalent to that of reference compound azd9291, but its selectivity is significantly better than that of azd9291, indicating that its clinical toxicity may be lower than that of azd9291, and it has the potential to become a best in class drug According to the GLOBOCAN2012 report issued by the International Cancer Research Center (IARC) of the World Health Organization in 2012, in 2012, the world expects 1 million 800 thousand new lung cancer cases (accounting for 12.9% of all new cancer cases), and non-small cell lung cancer accounts for about 85% of the total lung cancer cases According to the statistics of the National Cancer Center in 2015, there are about 700000 new cases of lung cancer in China every year, and non-small cell lung cancer accounts for about 80% - 85% of the total number of lung cancer A number of studies show that the mutation rate of EGFR in Chinese non-small cell lung cancer patients reaches 40% - 50%, so the number of potential EGFR inhibitors has reached more than 200000 Although oshitinib has been listed in China this year, its monthly medication cost is 51000 yuan Even if it is included in the corresponding drug donation plan (four months for purchase and eight months for free), the annual treatment cost still needs 204000 yuan, and the patients are under great pressure to pay for drugs The mechanism of zsp0391 is clear and has been verified clinically, so the possibility of clinical transformation is very high In the future, the market of zsp0391 raw materials and tablets will fill in the domestic gap of the third generation EGFR inhibitors, and provide patients with low-cost, safe and efficient therapeutic drugs, with a huge market prospect.