Drug intelligence review weekly report (2016.8.10-2016.8.15)

Introduction: 1.67 (calculated by acceptance number, the same below) drugs enter CDE evaluation center, including 2 traditional Chinese medicine, 53 chemical drugs, 10 biological products and 2 pharmaceutical excipients 2 The clinical approval documents of Yizai cereal declared by Kunming Pharmaceutical Group Co., Ltd 3 The raw materials and tablets of rivaroxaban submitted by Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd obtained the clinical approval 4 The intravenous immunoglobulin (pH4, 10%) (chromatography) declared by Chengdu Rongsheng Pharmaceutical Co., Ltd has obtained the clinical approval this week At present, the product has not been listed in China 5 The immunoglobulin of rabies patients (300iu / bottle) submitted by Chengdu Rongsheng Pharmaceutical Co., Ltd was withdrawn by the enterprise independently, the reason is not clear 6 Telmisartan dispersible tablets submitted by Hainan Meilan Shike Pharmaceutical Co., Ltd also obtained clinical approval this week Only Zhejiang talison Pharmaceutical Co., Ltd obtained production approval in China 7 Jiangsu Tianshili Diyi Pharmaceutical Co., Ltd received the approval for clinical trial of temozolomide for injection issued by the State Administration 8 The clinical trial of recombinant anti HER2 humanized monoclonal antibody composition for injection declared by Shanghai Pharmaceutical Group Co., Ltd has been accepted 9 The recombinant anti EGFR human mouse chimeric monoclonal antibody injection submitted by Shanghai Fuhong Hanlin Biotechnology Co., Ltd has obtained clinical approval Key points: 1 Recombinant anti-HER2 humanized monoclonal antibody composition for injection (acceptance No.: cxsl1600070): a class 1 new therapeutic biological product jointly developed by Shanghai Pharmaceutical Group Co., Ltd and its subsidiary Shanghai cross-linked drug R & D Co., Ltd., and the recombinant anti-HER2 humanized monoclonal antibody composition for injection has been accepted This product is suitable for HER2 positive metastatic breast cancer and neoadjuvant treatment of HER2 positive breast cancer At present, the drug is not marketed in the same kind of products in China, and there is no application for registration 2 Aprost tablets (acceptance No.: cxhl1501807, cxhl1501858, cxhl1501859, cxhl1501860): This product is applied for class 3.1 new drug by Harbin Jingquan Pharmaceutical Technology Co., Ltd and has been undertaken by CDE It is suitable for the treatment of adult patients with active psoriatic arthritis and adult patients with moderate to severe plaque psoriasis with phototherapy and systemic therapy The drug is the first FDA approved PDE4 inhibitor and the only PDE4 inhibitor obtained for the treatment of plaque psoriasis Ruiyang pharmaceutical is the first one to apply in China, and has obtained clinical approval this year According to evaluatepharma, the sales volume of Aptian tablets in 2018 is estimated to be $1219 million But after the FDA approves its new indications, it is expected to exceed $2 billion 3 Yizheimaibu tablet (acceptance No.: cyhs1501141): This product is a class 6 chemical drug, which is declared by Kunming Pharmaceutical Group Co., Ltd and has obtained the approval of clinical trial The drug is suitable for primary hypercholesterolemia, homozygous familial hypercholesterolemia (hofh), homozygous sitosteronemia (or phytosteroemia) Ejie cereal was developed by Merck in cooperation with Schering plough and was approved by FDA in 2002 On April 6, 2006, the company approved the marketing of imported Eze cereal in China, which has been paid close attention to since its listing, and the sales prospect is also very considerable Up to now, no domestic enterprise has obtained the production approval of the drug 4 Temozolomide for injection (acceptance No.: cxhl1500610): Jiangsu Tianshili Diyi Pharmaceutical Co., Ltd applied for class 3.3 new drugs and received the clinical approval issued by the State Administration This product is suitable for the treatment of the newly diagnosed glioblastoma multiforme At first, it is combined with radiotherapy, and then as an auxiliary treatment Glioblastoma multiforme or anaplastic astrocytoma recurred or progressed after routine treatment The advantages of temozolomide are wide antitumor spectrum, easy to pass through the blood-brain barrier, safe, oral, no toxicity with other drugs, and it can be used in patients with nitrosourea resistance In 2015, according to IMS data, the total sales of temozolomide capsules in China was 894 million yuan However, temozolomide for injection was researched and developed by Schering plough company In 2009, FDA was approved to be listed in the United States, but it has not yet been listed in China 5 Recombinant anti EGFR human mouse chimeric monoclonal antibody injection (acceptance No.: cxsl1400129): a class 2 new therapeutic biological product declared by Shanghai Fuhong Hanlin Biotechnology Co., Ltd and approved by the State Administration for clinical trials This product is used for the indication of metastatic colorectal cancer In addition, in May 2015, the company applied to the National Bureau for clinical trial for the first time and was accepted In addition, in July 2016, Fuhong Hanlin cooperated with Shanghai Jingze Biotechnology Co., Ltd to license Jingze biotechnology to use the materials for clinical application in China, and transferred the clinical trial approval of the drug.