Prospects for new drug research and development in 2014

Source: which new drugs are under development in the coming year of 2014 in China Medical Journal December 31, 2013? Cancer, heart failure, obesity and diabetes, hepatitis C, or new antibiotics? In fact, every field of disease treatment has promising new drugs that attract the attention of the pharmaceutical industry Although the mode of new drug development in pharmaceutical enterprises may change, many pharmaceutical enterprises still adhere to the belief of creating "heavy bomb" products Cancer drugs: tumor diagnosis and treatment under the guidance of tumor gene mutation genomics can greatly improve the immune response of patients, and may ultimately affect the prognosis of cancer treatment, which is crucial for the development of new drugs in the future The clinical trial design of new drugs has also begun to shift from cancer types for patients to specific tumor gene mutations In the short term, immunotherapy is still the focus of researchers' attention, mainly based on the research that programmed death factor 1 (PD1) can inhibit the immune response of activated T cells This kind of drug has nivolumab of Bristol Myers Squibb, which has been awarded the qualification of fast channel evaluation for the treatment of malignant melanoma, renal cell carcinoma and non-small cell lung cancer by the US Food and Drug Administration (FDA) in April 2013 In addition, lambrolizumab of mosadon and mpdl 3280a of Roche (target is PD-L1, PD1 ligand) are also PD1 drugs Ibrutinib from Johnson & Johnson / pharmaceuticals, as the first oral Btk inhibitor and FDA recognized "breakthrough therapy", plays a role by inhibiting the tyrosine kinase (Btk, which can regulate B cell survival), and has been approved by FDA To submit an application for marketing for the treatment of two rare disease indications (chronic lymphoblastic leukemia and mantle cell lymphoma) Idelalisib, a phosphoinositide 3 kinase (PI3K) inhibitor from Gilead science, and fostamatinib, a spleen tyrosine kinase (Syk) inhibitor from Rigel pharmaceutical, also act on the B-cell pathway Gilead has submitted a new drug application for the indication of non Hodgkin's lymphoma of idelalisib in the United States Obinutuzumab, the CD20 inhibitor of Roche and Addis Ababa, was also recognized as "breakthrough therapy" by FDA in the test of treating chronic lymphocytic leukemia as a single drug or combined chemotherapy, and was granted the priority review qualification The potential heavyweight drugs in the field of breast cancer are palbociclib developed by Pfizer and Amgen At present, the drug has entered phase III clinical trials Ramucirumab, an anti angiogenic monoclonal antibody of vascular endothelial growth factor (VEGF) used to treat gastric cancer by Lilly, was approved by FDA in October Heart failure drugs: success is not far away The incidence rate of heart failure has been rising in the past 25 years, but drug development in this field is still standing still In the past 15 years, about 20 related candidate compounds have been tested, but no new drug has been launched yet Now, the potential drugs for chronic heart failure are: Novartis serelaxin, which is currently under review by drug regulators in the United States and Europe In 2009, the drug was approved by the FDA quickly, and this summer, it was awarded the qualification of "breakthrough therapy" by the FDA Asholda treatment's ggf2 is a neuregulin growth factor Ggf2, like serelaxin, is a peptide with many functions in vivo, including the influence on cyclin, apoptosis, central nervous system, and even slightly affect the cellular program China's Shanghai Zesheng Technology Development Co., Ltd is also testing neucardin, a candidate drug for the treatment of chronic heart failure Phase II clinical trials of the drug have been completed in the United States and production applications have been submitted in China New antibiotics: in the past, many large pharmaceutical companies were not interested in the development of new antibiotics or anti infective drugs against superbugs, because the development of new antibiotics is often long and expensive; in addition, the price of antibiotics is greatly reduced by the attack of generic drugs, and the treatment cycle is very short However, due to the attention of the medical industry and the government in recent years, the development of antibiotics has a great potential to pick up At present, the potential heavy-duty antibiotics bombs are: Cubist's new generation of oxazolidinone antibacterial agent, tedizolid phosphate, has obtained the qualification of rapid approval, and submitted to FDA in October this year We have submitted an application for the market of indications for the treatment of acute bacterial skin and skin structural infections, and are currently testing its efficacy in the treatment of severe Gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA) Another product of cubist, cxa-201, is used to treat complex intraperitoneal infection and complex urinary tract infection It has entered the phase III clinical trial If the test results are good, it is expected to submit the listing application at the end of this year Ceipra's solithromycin is currently in phase III clinical trial, and the indication is community acquired pneumonia Obesity and diabetes: two potential blockbusters for obesity and diabetes are recently approved by the FDA: arena / Weicai's chloranthine and vivus's qsymia, which is the first time in 15 years that weight-loss drugs have been approved by the FDA Orexigen's contract (naltrexone / bupropion combination) may be the most promising in the development of oral weight-loss drugs Although the curative effect is equivalent to belviq and qsymia, the sales volume of contract is still expected to reach the level of "heavy bomb" in the future Novo Nordisk is preparing to submit the listing application of human glucagon like peptide-1 (GLP-1) analogue lilalutide 3mg for obesity indication in the United States (FDA approved the drug in 2010 for the treatment of type 2 diabetes, and the recommended daily dose is not more than 1.8mg) In addition, Novo Nordisk's phase II clinical trial is also trying to prove its preventive effect on type 2 diabetes If positive results can be achieved, its sales will definitely exceed belviq and qsymia Afrezza, developed by mannkind, is an insulin inhaled powder and is expected to receive FDA approval in April 2014 Lilly and Boehringer Ingelheim are trying to work together to develop biomimetic insulin The European Drug Administration (EMA) accepted the two companies' application for long-acting insulin glargine biosimilars in July The product has entered phase III in the United States, and is a generic of Sanofi's best-selling product (insulin glargine) Sanofi's recombinant insulin glargine U300 will submit new drug applications in the United States and Europe in the first half of 2014 And tresiba, a Novo Nordisk long-acting insulin drug with market share, will be approved for marketing in the United States in 2016 Oral insulin ormd-0801 from oramed pharmaceutical company is also in the early stage of research Analysts believe that if ormd-0801 can be launched in the next four or five years, it will replace afrezza of man kind Hepatitis C: focus on the treatment of hepatitis C heavy bombs are relatively concentrated: as a focus in the field of hepatitis C, Gilead's nucleoside analogue polymerase inhibitor sofosbuvir targets all six hepatitis C (HCV) Several analysts believe that sofosbuvir will be approved by the FDA by the end of this year Anta / Abbott life's antiviral drug combination abt-450 was awarded "breakthrough therapy" by FDA in May this year Simeprevir, Johnson & Johnson's protease inhibitor, was recently approved in Japan and is expected to be approved in the United States by the end of this year In addition, daclatasvir of Bristol Myers Squibb was recognized as "breakthrough therapy" by FDA in April this year Other fields: in addition to the traditional treatment fields mentioned above, there are also some potential varieties in other treatment fields For example, amr001 candidate drug of amorcyte (acquired by neostem in 2011) is currently in the early research stage It is a bone marrow derived stem cell product under development for emergency treatment of serious heart attack Martin Sullivan of Inc research, an intellectual property consulting firm, said amr001 represents a new generation of cell therapy with a promising future Novartis secukinumab is a monoclonal antibody for the treatment of psoriasis According to analysts' forecast, secukinumab's sales volume will reach the "blockbuster" level by 2018 from the perspective of biological drugs The drug suvorexant, an insomniac drug from mosadon, has filed for marketing in the United States and Japan, but was rejected by the FDA this summer In its full response, the FDA expressed concern that the dosage was too large MSD plans to resubmit the application in the first half of 2014, and FDA does not need additional tests GW's cannabis extract, sativex, has been approved for severe cancer pain in 22 countries The phase III trial of the drug in the United States will be completed next year, and the application for new drug listing is expected to be submitted in early 2015 Sebelipase Alfa from synageva biopharmaceutical company has been used to treat rare disease walman's disease, and now it has entered phase III clinical trial Most infants with walman's disease can't survive for more than one year Adult patients have abdominal swelling, hepatomegaly and severe even life-threatening digestive problems Sebelipase Alfa will be the first drug to be approved for the treatment of walman's disease FDA has granted it the qualification of rare disease drug, rapid approval and "breakthrough therapy" Given the pricing environment for rare diseases, synageva is able to reap substantial rewards for the drug.