[weekly] chemical class 1 new drug boom, continued unabated!

1 The reduced glutathione for injection with specifications of 0.6g and 1.2g declared by Hainan Jinrui Pharmaceutical Co., Ltd was not approved 2 The specification of 2.5G ornithine aspartate for injection and the API clopidogrel bisulfate submitted by Fuan Pharmaceutical Group Hubei people's Pharmaceutical Co., Ltd did not meet the registration requirements and were not approved 3 Last week (2017.06.26-2017.6.30), 150 drugs (calculated by acceptance number, the same below) entered the CDE evaluation center, including 4 traditional Chinese medicines, 131 chemical drugs, 14 biological products and 1 pharmaceutical excipients 1 The new chemical class 1 drug nb001 and its tablets (acceptance No.: cxhl1700087-89) declared by Zhejiang Yongzhan Pharmaceutical Technology Co., Ltd have recently been undertaken by CDE Nb001 is a new type 1 cancer analgesic Yongzhan pharmaceutical owns the world's leading nb001 technology for chronic pain treatment and its core patents and independent intellectual property rights worldwide Nb001 is applying for China's top 10 innovative class 1 drug programs 2 The clinical trial registration application of zsp0391 and tablet (acceptance No.: cxhl1700123-25), a class 1 innovative drug for non-small cell lung cancer, jointly developed by Guangdong Zhongsheng Pharmaceutical Co., Ltd and Shanghai yaomingkant new drug development Co., Ltd., was accepted by CDE this week This project is the fourth small molecule class 1 innovative drug with independent intellectual property rights submitted by Zhongsheng Pharmaceutical Co., Ltd for clinical trial registration, mainly for the treatment of non-small cell lung cancer patients with EGFR sensitive mutation and T790M resistant mutation According to the data, international pharmaceutical companies such as AstraZeneca, Novartis and Pfizer have project layout for the research and development of EGFR inhibitors Among them, AstraZeneca's oshitinib has been listed globally in 2016, and evaluatepharma predicted that the sales value of oshitinib in 2020 will be USD 1196 million 3 The apg-1252 and its injection (acceptance No.: cxhl1600253-54), a new chemical class 1 drug submitted by Suzhou Yasheng Pharmaceutical Co., Ltd., recently obtained the approval of clinical trial issued by CFDA This product was undertaken by CDE in December 2016, and only half a year has passed the clinical trial approval At the same time, at the end of 2016, it was approved by the US FDA to enter clinical trials, and became the first Bcl-2 / Bcl-xL inhibitor to enter clinical trials in the US and independently developed by Chinese enterprises Apg-1252 can restore the programmed cell death mechanism (apoptosis) by selectively inhibiting Bcl-2 and Bcl XL, which are the members of Bcl-2 protein family, so as to kill the tumor It is intended to be used in the treatment of small cell lung cancer and other solid tumors At present, this product is in phase I clinical trials in the United States 4 The new chemical class 1 drug xy0206 and its tablet (acceptance No.: cxhl1600270-72) declared by Shijiazhuang Yiling Pharmaceutical Co., Ltd obtained clinical approval this week The indications of xy0206 tablet are: This product is intended to be used for the induction, remission and maintenance of acute myeloid leukemia (AML), and also for the treatment of lung cancer and other malignant tumors Yiling pharmaceutical has applied for domestic patent and international patent of 15 countries, such as the United States and Japan, for this variety The content of application is compound patent At present, the domestic patent is in the substantive examination stage of the national patent office, and PCT patent is also in the examination of patent departments of various countries Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!