[weekly] Jiangsu Hengrui SHR series, another new chemical class 1 drug has been undertaken

1 Recently, Zhejiang XinHeCheng Co., Ltd and Zhejiang University and other units jointly completed the project of "key technology innovation and industrialization of ultra-fine manufacturing of important fat soluble nutrients" and won the second prize of 2016 National Technology Invention Award 2 The morphine-6-glucosidic acid and its injection declared by Yichang humanwell Pharmaceutical Co., Ltd have been accepted by the Provincial Bureau 3 The group A and group C meningococcal conjugate vaccine of 15 new drugs of biological products for prevention submitted by Hualan biological vaccine Co., Ltd has obtained clinical approval this week 4 This week (2017.01.09-2017.01.13), 44 drugs (calculated by acceptance number, the same below) entered the CDE evaluation center, including 4 traditional Chinese medicine, 37 chemical drugs and 3 biological products Key introduction: 1 The new chemical class 1 drug shr1459 (acceptance No.: cxhl1600293) submitted by Jiangsu Shengdi Pharmaceutical Co., Ltd has been undertaken by CDE this week Jiangsu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd., once again applied for SHR series drugs The specific mechanism and indications are unknown According to SHR series, it is generally monoclonal antibody or anti-tumor drug 2 The chemical 6-class generic everolimus tablets (acceptance No.: cyhs1501358-59) and the new Chinese medicine 6.2-class new drug Zhipu Runchang capsule (acceptance No.: cxzl1400084) submitted by Jichuan Pharmaceutical Group Co., Ltd have recently obtained the clinical trial approval Everolimus is suitable for advanced renal cell carcinoma which failed to be treated by sunitinib or sorafenib and subependymal giant cell astrocytoma with tuberous sclerosis which needs to be treated but cannot be resected by radical operation Everest is developed by Novartis, Switzerland It was listed in Sweden in 2003 and in China in 2013 The mechanism of action of everolimus mainly includes immunosuppression, antitumor, antiviral and vascular protection Everolimus is often used in combination with cyclosporine and other immunosuppressants to reduce toxicity According to the data, no domestic enterprises have been approved for production Zhipu Runchang capsule is mainly used for functional constipation It is used for constipation caused by toxin and evil, qi stagnation and yin deficiency The symptoms are constipation due to defecation, bad breath, abdominal distention, dry red tongue and fine pulse Through data inquiry, no enterprise has produced and sold Zhipu Runchang capsule Except for Jichuan pharmaceutical, there are no other applications for registration 3 Beijing Sihuan Pharmaceutical Co., Ltd applied for the approval of clinical trial of cabalastine heavy tartrate capsule in January 2016, which has been registered recently with clinical registration No ctr20170020 Kabalatin heavy tartrate capsule is used to treat mild and moderate Alzheimer's dementia The purpose of this experiment is to evaluate the bioequivalence of the two preparations by measuring the relative bioavailability of the two preparations in healthy people by single oral administration on an empty stomach, i.e kabalanine heavy tartrate capsule produced by Beijing Sihuan Pharmaceutical Co., Ltd and kabalanine heavy tartrate capsule (trade name: eisneng) produced by Novartis Pharmaceutical Co., Ltd The pharmacokinetic (PK) characteristics and safety of the single oral administration of cabalastine heavy tartrate capsule produced by the company Target enrollment: 64, recruitment has been completed 4 A total of 10 products of Jichuan Pharmaceutical Co., Ltd., a subsidiary of Hubei Jichuan Pharmaceutical Co., Ltd., and Shaanxi Dongke Pharmaceutical Co., Ltd were newly included in the medical insurance catalogue of Hebei Province The 10 products newly listed in the medical insurance catalogue belong to category B of medical insurance, 8 of which are exclusive varieties or exclusive dosage forms, all of which are produced and sold normally Pudilan Xiaoyan oral liquid of Jichuan Pharmaceutical Co., Ltd belongs to the exclusive dosage form and Chuanxiong Qingnao Granule belongs to the exclusive variety Huanglong Zhike granules, Shengui Yangxue tablets, xinxinshu capsules and compound zusima Zhitong ointment of dongke pharmaceutical are exclusive varieties, while ganhaiweikang capsules and Qinchuan Tongbi tablets are exclusive dosage forms.