Great news! Heavyweight new drugs are on the market, domestic anti-cancer new drugs enter FDA, drug frontier good information is continuous, a number of new drugs phase 3 clinical active

Good news: the US FDA approved the listing of Gilead new drug On February 8, Gilead Sciences announced that the US FDA approved the listing of its new drug biktarvy as a single tablet therapy once a day to treat HIV-1 infection Biktarvy is composed of three components: bioctegravir (50mg), emtricitabine (200mg), and tenofovir alafenamide (25mg) Compared with descent (FTC / TAF), Gilead's other anti HIV drug, biktarvy has more biocegravir This is a new kind of unsubstantiated integrated enzyme chain transfer inhibitor (insti) The efficacy and safety of the new drug have been verified in four ongoing phase 3 clinical trials New blood tumor drugs are on the market in China Baiji Shenzhou recently announced that vidaza ® (vidasa ®, azacytidine for injection) has been on the market and began to be sold in China Vedasha ® is a nucleoside metabolic inhibitor, which has been approved in China for the treatment of MDS, AML and CMML with 20-30% myeloblasts Vidasha ® is recommended as a first-line treatment by the National Cancer Network guidelines Vedasha ® is the third approved drug in China's commercial product line of Baiji Shenzhou According to the pharmaceutical intelligence data, azacytidine for injection of new base medicine has been approved for import in May 2017 In addition, at present, the new drug applications of Qilu, Nanjing Shenghe, Shanghai huilun Jiangsu pharmaceutical, Nanjing Huawei pharmaceutical technology, Shenzhen Deshang pharmaceutical and Hangzhou Rongli pharmaceutical have been approved for clinical application, and the priority review of generic drug applications by Zhengda Tianqing is still in progress Fig 1 recent development of domestic new anticancer drugs approved by FDA of the United States, funded by Shenzhen Haiwang pharmaceutical science and Technology Research Institute, Tianjin Pharmaceutical Research Institute conducted a full set of preclinical evaluation of a new anti-tumor drug "naprotinic xylenesulphonate tablets", approved by FDA of the United States (food and Drug Administration), and agreed to conduct clinical research in the United States This indicates that the pre clinical evaluation technology of new drugs in China has reached the international advanced level The drug is targeted at non-small cell lung cancer drugs, and has been approved for clinical use in June 2017 in China, and has been accepted as a special approved variety Figure 2: the procedure of CFDA priority review and approval for olapalee, a new drug targeted for ovarian cancer On February 5, AstraZeneca China and MSD China jointly announced that CFDA will include olapari, the first PARP inhibitor for platinum sensitive recurrent ovarian cancer, in the priority review and approval process According to the drug intelligence data, domestic import applications are still under review and approval, and this inclusion will be accelerated for approval Recently, olapali has been approved in the United States and Japan This time, it will enter the priority review, which is expected to further shorten the gap with Europe, the United States and Japan, fill the treatment gap of nearly 30 years for ovarian cancer, and benefit domestic platinum sensitive recurrent ovarian cancer women Figure 3 zogenix new drug for rare diseases was recognized by FDA on February 7 Zogenix, a pharmaceutical company developing new drug for rare central nervous system diseases, announced that FDA has issued a breakthrough treatment for zx008 (low-dose fluoroamphetamine), a new drug under development, to treat epilepsy related to Dravet syndrome Dravet's syndrome is a rare, catastrophic life-long epilepsy that occurs frequently or permanently in the first year of life Once known as severe myoclonic epilepsy in infants (SMEI), it affects 1 in 15700 people, 80% of whom have mutations in the SCN1A gene It is known that the antiepileptic mechanism of fluamphetamine is mainly regulated by serotonin mechanism However, the latest mechanism of action shows that, apart from the role of fluoroamphetamine in serotonin, it also shows the activity of sigma-1 receptor Fluoroamphetamine is a positive allosteric modulator of this receptor Recently, it has been shown that activation of sigma-1 receptor can alleviate convulsion in animal models On February 6, the anti antibody drug coupling drug "dp303c" developed by Shiyao group was awarded the qualification of orphan drug for the treatment of gastric cancer including gastroesophageal junction tumor by FDA Dp303c is a highly selective antibody to HER2 coupled with a cytotoxin It is a new targeted drug for the treatment of HER2 positive gastric cancer Antibody drug coupling drug dp303c is independently developed by the group, with independent intellectual property rights, and has applied for a number of patents in the United States and China and other countries The most important significance of orphan drug qualification recognition is to get more guidance from FDA, have the opportunity to communicate with FDA extensively, and in some cases, reduce part of clinical trials, and accelerate the speed of product marketing In addition, orphan drugs in the United States can enjoy 7 years of market monopoly and up to 50% tax relief of R & D expenses New drugs for severe depression were recognized by FDA as breakthrough therapies On February 8, sage therapeutics, a biomedical company that developed new drugs for central nervous system (CNS) diseases, announced that FDA issued breakthrough therapies for sage-217 in the treatment of severe depression (MDD) This is the second breakthrough treatment determination awarded to sage since 2016 Severe depression is a common but serious emotional disorder, in which patients show depression or loss of fun in daily activities for at least two weeks, and have obstacles to social, vocational, educational or other important activities Sage-217 is the next generation of forward allosteric modulator, which optimizes the selectivity of synaptic and extrasynaptic GABA receptors and the pharmacokinetic characteristics of daily oral administration GABA system is the main inhibitory signal pathway of brain and central nervous system, which is of great significance to regulate the function of central nervous system Sage-217 is currently being developed for MDD and some other emotional and motor disorders For the treatment of multiple blood cancers, PI3K oral inhibitors submitted to the market on February 8, verasteme announced that it had submitted the market application of duvelisib, a leading candidate drug, to the US FDA Verastem expects the new drug to be fully approved for the treatment of recurrent or refractory chronic lymphoid leukemia / small lymphoid lymphoma, as well as accelerated approval for the treatment of recurrent or refractory follicular lymphoma Duvelisib is a first in class new drug under development, which can inhibit both PI3K Delta and PI3K gamma simultaneously These two enzymes play a key role in the growth and survival of malignant B cells and T cells: their signal pathway can cause the proliferation of malignant B cells and T cells, and may also play a role in the formation and maintenance of tumor microenvironment As a new drug with innovative mechanism, researchers are evaluating the efficacy of duvelisib in a number of clinical trials Based on the positive results of clinical trials, duvelisib has obtained the fast track qualification and orphan drug qualification issued by the US FDA On February 8, SIgA technologies (sIgA) announced that the FDA of the United States accepted the new drug application (NDA) submitted by the company for the oral formula of tpoxx (tecovirimat) for smallpox treatment, and granted the priority review qualification Tecovirimat developed by SIgA company can block the transmission of smallpox virus, and it can prevent smallpox symptoms in the animal model of smallpox Experimental studies have shown that tecovirimat may play a role without hindering the patient's immune ability Clinical trials in healthy volunteers have shown that taking tecovirimat will not cause any side effects Progress in research and development in the treatment of migraine, the key phase 3 clinical success of new drugs February 7, pharmaceutical company Allergan today announced the positive results of its new drug ubrogepant in the treatment of migraine in phase 3 clinical trial acieve I, which is the first of two key phase 3 clinical trials The results showed that in the single migraine attack of adults, the efficacy, safety and tolerance of oral administration of ubrogepant 50mg or 100mg showed positive results compared with placebo Ubrogepant is a new oral calcitonin gene-related peptide (CGRP) receptor antagonist, which has been developed for the treatment of acute migraine Melanoma combination therapy phase 3 clinical positive on February 7, array biopharma and Pierre Fabre published the results of total survival (OS) plan analysis of Columbus, a key phase 3 clinical trial The trial evaluated the efficacy of the combination therapy of encorafenib 450 mg and bimetinib 45 mg (combo450) in patients with BRAF mutant melanoma Metastatic melanoma is the most serious and life-threatening type of skin cancer, with a very low survival rate BRAF and MEK are key protein kinases in MAPK signaling pathway (RAS-RAF-MEK-ERK) This pathway regulates several key cell activities, including proliferation, differentiation, survival and angiogenesis Studies have shown that inappropriately activating proteins in this pathway occur in many cancers, including melanoma and colorectal cancer Encorafenib and bimetinib, respectively, are late small molecule inhibitors of BRAF and MEK, both targeting key enzymes in this pathway At present, the two drugs are being studied in patients with advanced cancer, including the 3-phase beacon CRC test and 3-phase Columbus test On February 6, Eisai, Japan, published the results of a subgroup analysis of a key phase 3 clinical study, which compared eribulin mesylate Efficacy of mesylate (halaven injection) and dacarbazine in patients with advanced liposarcoma (LPS) and leiomyosarcoma (LMS) who had previously been treated The 309 subgroup analysis of the study, published in Journal of Clinical Oncology, supports the FDA approved halaven treatment of patients with advanced liposarcoma.