[drug Kajun] with the rapid development of the domestic tumor market, Qilu bevacizumab biological analogues have applied for listing, the new generation of ALK inhibitor alatinib has come to China, and Hengrui class 1 breast cancer new drugs have come to the market

Important news of new drugs in China: one of the new drugs reported to be produced this week (August 11-17) has been undertaken, and seven of them have been updated, as shown in the figure below: Bevacizumab biological similar drugs of Qilu pharmaceutical have been declared for listing On August 15, Qilu's application for the listing of recombinant anti VEGF humanized monoclonal antibody injection was accepted, and the first biological analogue of bevacizumab may accelerate its listing Avastin / Avastin bevacizumab was approved by FDA in 2004 It is the first vascular endothelial growth factor (VEGF) inhibitor approved in the world The initial indication is the treatment of advanced colorectal cancer After continuous development of indications, it has gradually become the first anti angiogenic drug widely used in the treatment of advanced cancer, covering colon cancer, breast cancer, lung cancer, kidney cancer, brain cancer With ovarian cancer and so on, its sales reached 7.21 billion US dollars in 2017 In 2017, avidin entered China and entered the national health insurance through negotiation in the same year, with a price reduction of 62% - from 5210 yuan per bottle to 1998 yuan According to industry analysis, with the continuous implementation of medical insurance policy and the continuous release of indications, the market share of this variety will exceed 5 billion yuan in the future If Qilu's bio similar drugs have to be listed, they will share this market At present, the domestic enterprises applying for monoclonal antibody targeting VEGF include Xinda biology, Shanghai Fuhong Hanlin (Fosun medicine), Sansheng Guojian pharmaceutical, baiaotai and so on Pyrrolidine maleate, a new class 1 drug of Hengrui, was conditionally approved for market on August 13 Pyrrolidine maleate, which was declared by Jiangsu Hengrui, was approved for production It is an innovative drug independently developed by Hengrui Because of its excellent clinical performance, it was approved for market through the priority review and approval process The indications for this approval of pyrrolidine maleate tablets are: combined with capecitabine, it is suitable for the treatment of recurrent or metastatic breast cancer patients with positive epidermal growth factor receptor 2 (HER2), who have not received or received trastuzumab before Patients should have received anthracycline or taxol chemotherapy before using the drug According to the drug intelligence data, the application for listing of this drug started in July 2017 In September, it was included in the 23rd batch of drugs to be included in the priority review procedure list published by CDE on the basis of "significant clinical value, major special projects" Now it has been approved for more than one year, which is a significant effect driven by the new policy of accelerating review and approval Olacetam sodium chloride injection of Harbin Sanlian showed "delivered" on August 13, and olacetam sodium chloride injection, a class 3.3 new drug of Harbin Sanlian, showed "delivered" According to the pharmaceutical intelligence data, in addition to Harbin Sanlian, Fuzhou haiwangfu Pharmaceutical Co., Ltd., Guangdong Shixin Pharmaceutical Co., Ltd and Jilin Sichang Pharmaceutical Co., Ltd were once produced However, the application of Guangdong Shixin and Fuzhou haiwangfu Pharmaceutical Co., Ltd was not approved Now it is up to whether Harbin Sanlian can be approved this time and become the first approved enterprise of the drug Other important developments this week are also noteworthy that among the imported drugs reported for production, 1 drug was registered and 1 drug was approved In addition, the consistency evaluation also updated the handling status of 3 drugs, as follows: the import application of trazodone hydrochloride sustained-release tablets for depression drug was registered On August 15, the import application of trazodone hydrochloride sustained-release tablets applied by Zhaoke Pharmaceutical Co., Ltd was accepted Trazodone hydrochloride is an antidepressant It is mainly used for the treatment of depression, anxiety accompanied with depression and emotional disorders of drug addicts after withdrawal According to the network information, in the 2015 clinical trial verification, Zhaoke pharmaceutical took the initiative to withdraw the drug application The highly anticipated new generation of ALK inhibitor aleatinib was approved on August 13, and the new generation of ALK inhibitor ansanza (common name, aleatinib), which is expected by many lung cancer patients, was approved for import The drug is used to treat anaplastic lymphoma kinase (ALK) - positive local advanced or metastatic non-small cell lung cancer As a new generation of ALK inhibitors, raletinib has brought new therapeutic options for ALK positive NSCLC patients It is worth noting that the application for this drug started in January 2018, and it was included in the 27th batch of priority review in March with "obvious treatment advantages compared with existing treatment methods" It has been 5 months since it was approved, and it is basically listed in the same time with Europe and the United States On August 17, the first new systemic therapy approved by the FDA of international pharmaceutical industry in ten years, the US FDA announced that lenvatinib developed by Eisai company was approved as the first-line therapy for unresectable liver cancer (HCC) This is the latest indication of lenvatinib addition after approval for treatment of thyroid and renal cancer Lenvatinib is an oral inhibitor that can inhibit the function of receptor tyrosine kinase (RTK) It can inhibit the kinase activity of VEGF receptor and other receptor tyrosine kinases related to pathological angiogenesis and tumor growth, including FGFR1, 2, 3, 4, PDGFR α and ret Dry eye therapy has been approved for marketing, which can significantly improve the secretion of tears A few days ago, sun Pharma announced that FDA approved cequa (cyclosporine eye drops) 0.09%, which is used to improve the production of tears and treat dry keratoconjunctivitis (dry eye) Cequa of sun Pharma is a kind of cyclosporine A (CSA) nano micelle preparation The preparation is a gelatinous aggregate formed by two affinity (hydrophobic and hydrophilic) molecules at specific concentrations It is worth mentioning that it is the highest concentration approved by FDA so far, and the only CSA drug using patented nano micelle technology Cequa's approval was based on the positive results of its phase 3 trial After 12 weeks of treatment, cequa achieved a statistically significant improvement in Schirmer score, a measure of tear production, compared with vehicle The new drug also resulted in statistically significant improvements at several secondary endpoints, including the assessment of ocular staining On July 11, the first RNAi therapy was approved, the US FDA announced the approval of onpattro (paisiran) infusion therapy for adult patients with peripheral neuropathy (polyneuropathy) caused by hereditary transformation of thyroxine protein amyloidosis (HTTR) It is worth mentioning that this is the first FDA approved treatment for patients with multiple neuropathy caused by hattr, and also the first FDA approved small interfering RNA (siRNA) drug First and only drug approved by FDA for treatment of cystic fibrosis in children 12 to 24 months old August 16, vertex Pharmaceutical company announced that the U.S Food and Drug Administration (FDA) approved kalydeco ® (ivacftor) for use in infants with cystic fibrosis (CF) for 12-24 months Based on clinical and / or in vitro measurement data, the infants showed that at least one mutation in their cystic fibrosis transmembrane transfer regulator (CFTR) gene was responsive to kalydeco Kalydeco ® (ivacaftor) is the first drug to treat CF patients with CFTR gene specific mutations The drug, known as CFTR synergist, is an oral drug designed to keep the CFTR protein open for a longer time on the cell surface, so as to improve the transport of salt and water on the cell membrane, thus helping to hydrate and remove the mucus in the airway On August 17, regeneron pharmaceuticals and Teva pharmaceutical Industry) jointly announced that the fasinumab jointly developed by the two sides reached the common primary end point and all the key secondary end points in the clinical phase 3 trials for the treatment of chronic pain caused by hip and knee osteoarthritis (OA) Compared with placebo, patients receiving fasinumab had significantly less pain and improved motor ability Fasinumab, developed jointly by Zaiyuan and TIWA company, is a humanized monoclonal antibody against nerve growth factor (NGF) It can block the function of NGF in pain production by combining with NGF Information source: Pharmaceutical intelligence data, pharmaceutical intelligence network, Wuxi apptec, Sina pharmaceutical, bureau of health and knowledge