New drug development is second only to the United States and Japan. These 33 drugs are only available locally!

New drug research and development is a long and arduous process As the second largest innovative drug research and development country in the world, Japan is second only to the United States From 1996 to November 2019, a total of 406 new drugs were approved New drugs that have only been on the market in Japan within 10 years have also been accepted by Japanese companies New drugs exclusively launched in Japan in recent 10 years Japanese pharmaceutical companies, including Ono, kylin, and Chinese and foreign pharmaceutical companies, have successfully developed a number of innovative biopharmaceuticals and independently or jointly listed them in Japan, Europe and the United States In the Japanese drug market, the proportion of sales of biological drugs, including antibodies, is only about 1 / 3 of that in the world About 70% of the approved antibody drugs are also from non Japanese pharmaceutical companies, and 90% of the small and medium-sized molecular drugs of new drugs are only listed in Japan Due to the imperfect policy of encouraging the commercialization of biotechnology research in Japan, the main new drug R & D enterprises are mainly internal development, and the R & D speed of biological new drugs is slower than that of small innovative pharmaceutical enterprises in Europe and America In the past 10 years, the proportion of anti-tumor drugs approved by Japan is the highest, and only three anti-tumor drugs are exclusively listed in Japan Quizatinib, the AML small molecule drug targeting at flt3-itd rare mutation, is the only anti-tumor drug only listed in Japan this year It has high selective inhibition activity to flt3-itd and is expected to obtain orphan drug and accelerated review qualification in EMA, breakthrough therapy and rapid review channel qualification in FDA However, due to the internal deviation of regulatory agencies in these two regions, it does not With the approval, the first three companies lagged behind Novartis' midostaurin and anstelai's gilteritinib in the development of FLT3 mutant AML Clinical trials of quizatinib in Europe, America and China are still in progress Forodesine was approved for use in pediatric patients with T-cell lymphoma in 2017 It targets purine nucleic acid phosphatase (PNP) to regulate the phosphorolysis of guanosine nucleic acid, which leads to the imbalance of nucleic acid metabolism in cells, and then induces T cell death There is no significant change in the number of B cells The evidence at the gene level only supports the application of PNP as a therapeutic target, but it cannot fully reflect the target's Security information The decrease of T cell number directly leads to the increase of infection risk, and some patients also have secondary tumors caused by EBV infection, which greatly limits the clinical application value of the drug As a result, follow-up development stopped in the United States and Japan Miriplatin hydrate is a lipid soluble platinum It is soluble in the special suspension iodized oil and the third generation of platinum anticancer drugs administered in the hepatic artery It is used in the traditional hepatic artery chemoembolization Because cisplatin and doxorubicin are commonly used in Europe and the United States, miplatinum has not much development and replacement value in Europe and the United States, so it is only used in Japanese patients After kymriah of Novartis, the second section was approved to be listed in Japan this year Collaegene, a gene therapy independently developed by Japan, uses hepatocyte growth factor cDNA and transfects it into human cells to generate new blood vessels for the treatment of severe limb ischemia About 150000 diabetic patients in Japan face the risk of amputation every year This treatment needs to be fully approved within 5 years after the completion of post marketing evaluation, and now it has also been granted breakthrough treatment at FDA Japan also has various similar policies to those of Europe and the United States to speed up the review of new drugs A comparative study on the accelerated evaluation policies of new drugs in the United States, Europe and Japan Only in Japan, the highest proportion of innovative drug indications is the endocrine and metabolic diseases dominated by type II diabetes Diabetes is a highly satisfactory disease in Japan It has high incidence rate and high drug expenditure, and is the driving force for new drug marketing At present, there are six sglt-2 inhibitors and three compounds in the Japanese market There is no significant difference in the effectiveness and safety of various sglt-2 inhibitors The first IPO of ipragliflozin, with its first mover advantage, and the launch of the compound with MSD's heavy bomb drug sitagliptin in 2018, the sales volume continues to rise On March 24, 2014, three sglt-2 inhibitors were approved Canagliflozin, a joint venture of Johnson and tagbian Mitsubishi, and luseogliflozin and tofogliflozin, which are only listed in Japan, have relatively less sales experience than Johnson and tagbian Mitsubishi Sales volume of major sglt-2 inhibitors in Japanese market (unit: 100 million yen) In Japan, the research and development of new anti infective drugs are mainly focused on solving the existing virus resistance and neglected tropical diseases The research and development of new anti infective drugs is relatively slow Based on the traditional quinolones, lascufloxacin is modified to ensure the clinical efficacy and reduce the side effects, including Staphylococcus, Streptococcus, catarrhal Moraxella, Haemophilus influenzae, Klebsiella, enterobacter, Legionella pneumophila, Prevotella, and other mycoplasma, such as Mycoplasma pneumoniae Lascufloxacin has a good inhibitory effect on the above pathogenic microorganisms, but other critical pathogenic microorganisms of who have no effect Lascufloxacin is a quinolone antibiotic, and it is also applying to FDA Fosravuconazole is an oral benzotriazole antifungal drug, which was approved for use in onychomycosis in 2018 It is a new oral therapy approved for onychomycosis in the past 20 years At the same time, fosravuconazole is the only new drug for the development of mycopodium It is an important neglected tropical disease Many patients with moderate and severe diseases are at risk of amputation or even death Currently, ketoconazole and Yi are available The efficacy of traconazole is limited and the adverse reactions are serious Fosravuconazole is in the process of weekly treatment and daily treatment of itraconazole Favipiravir polymerase inhibitor, whose mechanism of action is mainly to interfere with the synthesis of the virus, is upstream of oseltamivir, which can inhibit the release of the virus It is approved to be used in the patients with influenza A who are not effective with oseltamivir In addition, it has a famous anti Ebola virus effect, and it is used as Ebola haemorrhagic fever treatment in Congo In 2010, Japan approved two anti influenza drugs, both of which are neuraminidase inhibitors One is the injection of peramivir, and the other is the dry powder inhaler laninamivir, which is currently only listed in Japan, which can be used for influenza resistant to oseltamivir The former has a faster fever reduction rate, while the latter is a long-acting inhibitor, which can only be treated by single administration At present, it is also in urgent need of foreign new drugs in China List (second batch).