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    Home > Medical News > Latest Medical News > These 94 new drugs approved in the past ten years are still exclusive to the United States. China can only look forward to it.

    These 94 new drugs approved in the past ten years are still exclusive to the United States. China can only look forward to it.

    • Last Update: 2019-12-03
    • Source: Internet
    • Author: User
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    The United States is still a hot spot for innovative drug research and development From 1996 to November 2019, the cumulative number of new drugs approved by the United States, Europe and Japan reached 498, while the number of drugs approved by the European Union and Japan was 104 and 119 respectively From 2009 to November 2019, 94 innovative drugs were only listed in the United States, but not in the European Union, Japan and China The list of innovative drugs that have only been listed in the United States within 10 years, some of which are currently only listed in the United States, are listed in the United States earlier than other countries and regions On the one hand, U.S pharmaceutical companies and universities are also more active in the research and development of new drugs In the list, U.S pharmaceutical companies account for the vast majority On the other hand, the incentive mechanism of FDA in the innovation of drug supervision is more perfect, especially in the rare diseases, tumors and blood diseases, FDA will grant the recognition of breakthrough therapy earlier than EMA 。 In addition, the real-time Oncology Review (RTOR), which started last year, is faster than the priority review, and can be shortened to several weeks from the completion of data submission to approval Last month, the FDA approved the launch of zanubrutinib in Baiji, China, based entirely on experimental data from patients with mantle cell lymphoma in China Many pharmaceutical companies submit EMA listing applications later, but they usually include more mature or more test data than those submitted to FDA In these cases, EMA may be approved according to the standard path (and FDA grants accelerated review), or approve more extensive indications, or even refuse approval For example, the FDA approved the first new drug for DMD through accelerated review, eteplirsen of Sarepta therapeutics, which is an antisense oligonucleotide, but the EU rejected the approval because of insufficient data on the effectiveness of the drug In addition, elelyso (taligluceraselfa), a drug developed jointly by Pfizer and rotalix biotherapeutics, was rejected by the European Union, but it has nothing to do with the efficacy and safety, and it is related to the specific requirements of the European Union for the supervision of orphan drugs belonging to the disease These two examples respectively represent innovative drugs from innovative pharmaceutical companies and multinational pharmaceutical companies At present, only about 1 / 4 of the innovative drugs listed in the United States are multinational pharmaceutical companies They have more experience in the development and commercialization of innovative drugs In the early stage of clinical research and development, they also have earlier global layout, so as to achieve rapid and simultaneous listing in major countries other than the United States The product pipeline that is not conducive to the company's strategic development will also be rapidly adjusted to focus on a wider range of treatment areas, or give up listing in other regions to reduce losses In the past 10 years, most of the small innovative pharmaceutical companies, which are only listed in the United States, focus on a certain field of treatment and dig new drugs with more therapeutic potential This is an opportunity as well as a challenge For example, Alnylam, a leading enterprise in the field of RNAi therapy development, took the lead in listing the only two RNAi drugs in the world in the United States However, it is undeniable that there is a great risk for small pharmaceutical companies to independently develop and commercialize drugs, especially in the field of rare diseases Soliris ® (eculizumab) is the most successful rare disease drug commercialized so far, but alexion pharmaceutical is also under great pressure of drug price criticized by patients' organizations and insurance in this process Therefore, although Alnylam has won the first prize in RNAi drugs, it will have a market in the future The pressure is not small Even in the potential market, tymlos (abaloparatide), a PTH1 receptor agonist for postmenopausal osteoporosis treated by radiushealth, was expected to be promising However, in 2018, it was rejected by the European Union due to safety issues that may increase the risk of cardiac toxicity, making its market performance lower than expected Distribution of innovative drug diseases only listed in the United States in recent 10 years From the perspective of the field of innovative drug diseases only listed in the United States, tumor is still the main target of innovative drug development Currently, most of the innovative drugs only listed in the United States are tumor, followed by infectious diseases, neuroscience diseases and genetic diseases, and there are two auxiliary agents for tumor imaging diagnosis, most of which are niche markets, including AML, which has not been breakthrough in treatment drugs for many years In 2017 and 2018, the FDA approved the ivasidenib for rare IDH1 mutation and enasidenib for idh2 mutation The former was signed by the cornerstone from Agios for the exclusive right of clinical development and commercialization of blood and other solid tumors in Greater China, which eased the pressure of independent development of Agios Now, the latter has entered the list of clinically urgent new drugs on the market outside China In addition to innovative new drugs for genetic diseases, there are also some drugs to be used in potentially undervalued treatment areas, including Xiaer's xiidra (lifegrad, liferst), which is the world's first dry eye drug for signs and symptoms At present, most of the clinical manifestations of dry eye disease in China are artificial tears and sodium hyaluronate eye drops There is no anti-inflammatory drug for patients with moderate or severe dry eye disease on the market Pfizer's eucrisa (crisaborole ointment) is the world's first PDE-4 inhibitor for the treatment of eczema, which is used for the treatment of moderate and severe eczema patients who have failed in the past In particular, the incidence rate of children over 2 years old is about 10% At present, the drug has also entered the second batch of list of clinically urgent new drugs that have been listed outside China A new drug, orilissa, developed by abbvie and neurocrine bioscience for moderate and severe endometriosis pain Gamma Elagolix is the only oral gonadotropin releasing hormone (GnRH) antagonist, and the first oral drug approved by FDA for this indication in ten years It has not been used in clinical practice in China Endometriosis is one of the common gynecological diseases, the prevalence rate of which is about 10% in women of childbearing age The previous treatment is usually oral contraceptives, non steroidal anti-inflammatory drugs (NSAIDs), opioid analgesia or surgical hysterectomy, and there is a lack of drugs for endometriosis In the past 10 years, with the continuous improvement of drug regulatory environment and the assistance of capital market, the number of Chinese innovative drugs entering clinical research and being approved for marketing has increased year by year However, the development indications mainly focus on solid tumors, and there are more diseases that do not meet the treatment needs to be unlocked Reference materials of target points and indication keywords of class 1 new drugs in China from 2000 to 2018: 1 FDA, EMA, PMDA official website 2 Penicillin database of pharmadigger this article is the content reprinted by pharma.com, the copyright belongs to the original author, the purpose of reprinting is to transmit more information, and does not represent the view point of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.
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