echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > In the first three quarters, there were 77 ind of class 1 new drugs in China!

    In the first three quarters, there were 77 ind of class 1 new drugs in China!

    • Last Update: 2019-10-15
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    In 2018, more than 100 inds were accepted and undertaken by the State Drug Administration, setting a new record In a flash, 2019 has gone through three quarters, and 77 domestic innovative drug class 1 registration applications have entered the ind stage In terms of the number, the number of ind applications in the whole year will be relatively equal to that in 2018 In terms of the region, Beijing, Tianjin, Hebei, Jiangsu, Zhejiang and Shanghai economic circle are the main regions for new drug ind applications, with momentum Strong! In the first three quarters / overall situation of class 1 ind for new drug registration in the first three quarters of 2019, there are about 77 kinds of ind registered and declared for domestic class 1 new drugs (domestic drugs), and the development situation of innovative varieties is in an overall growth trend, among which the month with the largest number of registered and declared in the first three quarters is still January, with a total of 16 varieties entering the ind stage, and the month with the least number is just the past September, and only one kind of ind for domestic class 1 new drugs (PS: in order to reflect the innovative water products of domestic class 1 new drugs, the inds registered and applied by foreign enterprises are not included in the statistics) in terms of enterprises, the enterprises with relatively large number of applications are Shiyao and Zhengda Tianqing, all of which have 5 kinds of applications for inds; then dongyangguang, which has 3 kinds of applications for inds; most of other registration and application enterprises have 1-2 kinds of applications for inds Beijing Tianjin Hebei Economic Circle In the first three quarters of 2019, the main registered owner of ind for innovative drugs in Beijing Tianjin Hebei economic circle is Shiyao group, with 5 varieties applying for ind in addition, Zhikang Hongren and Yiling pharmaceutical in Shijiazhuang have new drug varieties applying for registration; in Beijing, military academy, Beida pharmaceutical, first pharmaceutical holding, gaoruiyao, jiakesi and shuobai pharmaceutical have 1-2 varieties applying for clinical application; in Tianjin, only Tianjin HongRi has applied for clinical application for innovative varieties Jiangsu Zhejiang Shanghai Economic Circle In the first three quarters of 2019, five new drug ind varieties were registered and applied in Jiangsu, Zhejiang and Shanghai economic circle Meanwhile, new drug ind applications in Suzhou, Jiangsu Province were strong, nearly 10 new drug ind varieties were registered and applied, and the corresponding enterprises were Paige biomedical, Suzhou xinnuowei pharmaceutical, Suzhou strategic biology, Suzhou development, etc there were more than 20 new drug species I in Jiangsu Province Nd registration application is much larger than other provinces PS: in the first three quarters of 2019, there are 9 ind varieties in Zhejiang and 6 ind varieties in Shanghai In the first three quarters / part of ind varieties in China, the varieties in the stage of new drug ind were briefly introduced Due to various reasons, the information disclosed was often not much Through query, some ind varieties were listed as follows, in reverse chronological order Gst-hg141 Fujian guangshengtang Pharmaceutical Co., Ltd has completed all data and complete set of data required for gst-hg141 to apply for clinical trials in four years In August 2019, it received the acceptance notice issued by the State Drug Administration The clinical application of gst-hg141, a global innovative drug for hepatitis B treatment, was accepted, and the application stage was "clinical" This project is one of the most important components of the hepatitis B functional cure "climbing plan" proposed by guangshengtang under the guidance of many basic research scientists It is the result of cooperation with Shanghai Pharmaceutical mingkant new drug development Co., Ltd., which has the leading strength in new drug research and development At present, there is no such target drug in the world, and it is expected to become the best in class project Objective: to challenge the functional cure of hepatitis B Gst-hg141 core compound has applied for PCT international patent, and it is planned to enter 24 countries and regions including China, the United States, Japan and Europe Htd1801 htd1801, developed by Shenzhen junshengtai biology Co., Ltd., has been awarded the qualification of fast channel evaluation of its research small molecule innovative drug htd1801 in the treatment of nonalcoholic steatohepatitis (NASH) Previously, FDA also awarded htd1801 orphan drug qualification and fast track review qualification for the treatment of primary sclerosing cholangitis (PSC) At present, the phase II clinical trial of htd1801 for PSC is being carried out in the United States, and the phase II research plan for NASH treatment will soon start patient recruitment in the United States Ty-9591 is the first national class 1 anti-tumor targeted new drug in clinical trials, the third represents skin growth factor receptor (EGFR) inhibitor, and the counterpart is oxitinib Its compound invention patent has been authorized Ty-302, another anti-tumor targeting new drug independently developed by the company, has also submitted an ind application and is expected to receive a notice of clinical trial in the near future Dn1508052-01 Shanghai Dino Pharmaceutical Development Co., Ltd., a high-efficient small molecule tlr8 agonist (the first tlr8 agonist submitted to ind in China), is intended to be used for immunotherapy of cancer In November 2018, Shanghai Dino pharmaceutical received the letter that FDA has completed the review of dn1508052-01 new drug clinical research application (ind) In late May 2019, Shanghai Dino pharmaceutical launched an open, multi center phase I clinical trial to recruit 25 subjects to preliminarily evaluate the safety tolerance, pharmacokinetics and antitumor activity of dn1508052-01 single drug injected subcutaneously for solid tumor patients Jab-3312 jab-3312 can block kras-mapk signal pathway and be used to treat solid tumors such as non-small cell lung cancer, colorectal cancer and pancreatic cancer Meanwhile, it can also relieve tumor immunosuppressive microenvironment and enhance the efficacy of existing tumor immunotherapy On July 3, 2019, the small molecule oral jab-3312 independently developed by Garth obtained the FDA clinical trial license for new drugs, which is the second small molecule anticancer drug of the company to enter the clinical phase IIa after jab-3068 Obitazidine fumarate, developed jointly by Central South University and Shenzhen Zhenxing Pharmaceutical Technology Co., Ltd., can specifically activate Caspase-3, the key enzyme of apoptosis signal transduction pathway of tumor cells, and activate it into Caspase-3, the key executive molecule of tumor apoptosis, leading to rapid death of tumor cells The main clinical indications were non-small cell lung cancer Tern-201 tern-201, originally developed by Eli Lilly In 2018, topaz biology signed a global exclusive agreement with Lilly to develop, manufacture and commercialize tern-201 for NASH treatment At the international liver conference held in Vienna in the first half of 2019, tophen biology published the data of tern-201 preclinical study, which showed that it significantly improved the NAS score and fibrosis of liver in NASH rodent model Topaz has recently obtained exclusive rights from genfit to develop, manufacture and commercialize PPAR α / δ double agonist elafibranor for the treatment of nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC) in Greater China The results of elafibranor's preclinical trials showed positive results for NASH and PBC indications, and may become an important part of future combination therapy Ast-3424 ast-3424 is a first-in-class anticancer drug jointly developed by AI xindawei and Taiwan Haoding, targeting at overexpression of akr1c3 Under the action of akr1c3, ast-3424 will selectively release strong DNA alkylating agent and start the mechanism of killing cancer cells; this selective starting mechanism makes akr1c3 highly behave in a variety of drug-resistant and refractory cancer cells, such as liver cancer, castration resistant prostate cancer, T-cell acute lymphoid leukemia and other tumor cells Taiwan Haoding is conducting phase I / II clinical study on solid tumor treatment in the United States In July 2018, obi-3424 obtained the FDA orphan drug qualification In April 2019, nmpa accepted the clinical trial application of this product Tsl-0319 tsl-0319 capsule is a dipeptidyl peptidase 4 (DPP-4) inhibitor independently developed by Tianshili By inhibiting the inactivation of glucagon like peptide-1 (GLP-1) and Glucose dependent insulin secretion peptide (GIP), it can promote the release of insulin from the islets of Langerhans, so as to improve the level of insulin and reduce blood sugar The drug belongs to class 1 Chemical drug, with full independent intellectual property rights, and is an innovative drug not listed at home and abroad At present, the R & D cost of the project is about 16.9465 million yuan Ttp273 ttp273 is a non peptide, highly selective glucagon like peptide-1 receptor (GLP-1R) agonist found by vtv company using its small molecule drug development platform It is the first in class of vtv company At present, it has completed phase IIB clinical research in the United States The results show that ttp273 has obvious effect on reducing glycosylated hemoglobin in diabetic patients and has good tolerance The biggest feature and highlight of ttp273 project is that GLP-1 and its analogues are all injection type, while ttp273 product is the first small molecule non peptide oral dosage form China, the United States and East China introduced the ttp273 project in the form of authorization and license, and as a supplement to the company's GLP-1 diabetes product line, it has complementary advantages with the company's existing lilalutide injection under research Lh021 lh021 is a class 1 new drug independently developed by Guangzhou Lingsheng Medical Technology Co., Ltd for the treatment of osteoarthritis Founded in 2012, Guangzhou Lingsheng Medical Technology Co., Ltd is engaged in the research and development of new target innovative drugs The company is founded by overseas students and domestic elites in the pharmaceutical industry At present, there are 12 new drug projects in the company's research and development pipeline, covering major chronic disease fields such as oncology, digestive department and aging related specialized diseases Lx-039 lx-039 is a new class 1 new drug in the field of breast cancer developed by Shandong Luoxin Pharmaceutical Group Co., Ltd It is a new and effective oral selective estrogen receptor down regulating agent, which will be mainly used for the treatment of advanced breast cancer At present, there is no oral drug with this mechanism on the market at home and abroad, and similar products are in clinical I / II stage Cs3003 cs3003, a selective inhibitor of HDAC6 developed for cornerstone pharmaceutical industry, can be used as single drug therapy or combined with conventional standard therapy, and has the potential to show better efficacy in multiple myeloma The preclinical data and preclinical and early clinical studies of similar products also found that cs3003 may have better safety than broad-spectrum HDAC inhibitors, as well as the potential to develop the combination therapy with immunocheckpoint inhibitors in different indications Asc21 asc21, developed by Geli pharmaceutical, is a nucleotide inhibitor combined with NS5B polymerase, which can prevent chronic hepatitis C virus infection by inhibiting the activity of NS5B polymerase Preclinical studies show that asc21 is an effective pan genotype drug with high resistance gene barrier GOLLY plans to use it in combination with ravidavir to treat patients with refractory, cirrhosis and HCV / HIV co infection Attached table: ind data of class 1 new drugs in the first three quarters of 2019 / domestic (based on the date of the first undertaking of varieties, foreign enterprises are not included in the statistical scope; statistical time: September 26, 2019) data source: drug intelligence data; acceptance announcement; official websites of major companies; official websites of securities companies This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view 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.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.