Another innovative drug against advanced solid tumor has entered the clinic!

This week (2016.10.8-10.16), only one drug is in the review status, i.e Beida Pharmaceutical imported and declared its innovative drug x-396 capsule, acceptance No jxhl160000114 This product was reviewed as early as August 2016, and should have been approved for clinical use However, the clinical trial registration center of CDE did not find the registered clinical information X-396 capsule is jointly developed by Beida Pharmaceutical Co., Ltd and xccovery company in the United States Xccovery company will obtain equity investment of 20 million US dollars from Beida Pharmaceutical Co., Ltd and Beida Pharmaceutical Co., Ltd will obtain the development right of x-396 project of xccovery company in China X-396 capsule is a new generation of ALK inhibitor for lung cancer The clinical phase 1 / 2 study shows that x-396 has good tolerance in human body and its antitumor activity in non-small cell positive (NSCLC) patients with ALK Compared with other ALK inhibitors, x-369 developed by xccovery is likely to have significant advantages in antitumor efficacy and safety Two weeks this week, only 3 drugs were reviewed, including approval, 1 chemicals, 1 Traditional Chinese medicines and 1 biological products, namely, Caffeine Citrate Injection (Chengdu No CYHS1400461), Beijing ginseng light 101 (three), CXZL1400085, and Tanezumab injection of Pfizer (JXSL1500026) Tanezumab injection targets nerve growth factor (NGF) If approved, it will represent a new type of drug for chronic pain (including osteoarthritis and cancer-related pain) At present, the product is jointly developed by Pfizer and Lilly Lilly obtained the joint development right of the product from Pfizer in 2013 In 2010, tanezumab was shelved due to a thorough clinical restriction of FDA At that time, the drug was considered to be related to a rare side effect - osteonecrosis However, a later Advisory Group concluded that there was no evidence that the reported case was caused by the drug As a result, the trial of the drug was lifted However, after the effects of peripheral nervous system were observed in the animal studies of anti NGF drugs in 2012, a new part of the clinical trial restrictions for this type of drugs appeared At present, there are 7 3-stage clinics in the United States, 6 of which are in recruitment In June 2015, Pfizer's four clinical applications in China have been continuously approved, presumably approved Point 3 of this week: 12 drugs have been approved this week, all of which are chemical drugs, including 1 copy and 1 import Four things to watch this week This week, 19 drugs have been certified, including 2 batch varieties: ambroxol hydrochloride injection of Xi'an Hanfeng Pharmaceutical Co., Ltd., acceptance No cyhs1000955, batch No Guoyao Zhunzi h20163341; acceptance No cxzs0603416, batch No Guoyao Zhunzi z20160002, batch No Jiuwei Huanglian antidote ointment of Chengdu Shengkang Pharmaceutical Co., Ltd Point 5 of this week: the indication of ACP in this study is advanced malignant solid tumor The main purpose is to investigate the effect of food on the pharmacokinetics of the test drug in healthy subjects The secondary objectives were to evaluate the safety and tolerance of single oral test drug in healthy subjects, and to evaluate the plasma pharmacokinetics characteristics of test drug metabolites in healthy subjects under different dietary conditions The purpose of the study was to evaluate the excretion of the test drug and its metabolites in the urine and feces of healthy people In this study, 14 healthy male and female subjects were enrolled by cross design, randomization and openness The trial has passed the examination of the ethics committee of Xuhui District Central Hospital of Shanghai in September 2016 and has not yet been recruited.