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    Home > Medical News > Latest Medical News > 75 "Class 1 New Drugs" for the first time IND! Zhengda sunny, Howson, Chongqing re-creation...

    75 "Class 1 New Drugs" for the first time IND! Zhengda sunny, Howson, Chongqing re-creation...

    • Last Update: 2020-07-31
    • Source: Internet
    • Author: User
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    Guide: 2020, in the global life and health of all mankind is seriously threatened and the global economy is hit hard under the environment, China's pharmaceutical industry has carried this cold current, and in innovation shines!2020, in the global life and health of all mankind is seriously threatened and the global economy is hit hard in the environment, China's pharmaceutical industry has carried this cold snap, and in innovation! In the first half of 2020, nearly 75 new drugs in China class 1 were accepted by China's CDE in the first half of the year, exceeding 2019 and 2018, while the number of varieties was relatively ahead, while Hengrui, Baison, Goida, Goli, Enhua, Shanghai Pharmaceuticals, Huino Bio, Shijiazhuang Zhikangren and others were followed by Hengrui, Bastille, And Iepharmaceutical.the first half of 2020 - China's first class 1 new drug IND overall trendthrough drug intelligence data query, the first half of 2020 the national CDE accepted the number of China's first class of new drug IND application number of 250, varieties and 100;among these 75 varieties, the relatively large number of enterprises received for Zhengda Qing, Jiangsu Hausen, Chongqing re-creation, have 3 varieties declared IND;Schedule 1.1: First half of 2020 - China's first class 1 new drugIND declaration - accepted variety statistics(data updated to 2020.06.29)the first declaration in the first half of 2020 - the specific varieties accepted introductionthe new drug IND stage varieties, due to various reasons, the disclosure of information is often not much, through inquiries, some IND varieties information as follows (in chronological order).. NO.1AB-106-Yuyuan Bio Development Co., Ltd. is a unique anti-cancer drug introduced from Japan's No. 1 Sangang Co., Ltd., a double-target inhibitor for ROS1-NTRK, whose preclinical research has been published to Nature Communications. Studies have shown that AB-106 has relatively low active inhibition concentrations of ROS1 tyrosine kinase and NTRK tyrosine kinase (NTRK1, NTRK2 and NTRK3), and that the most common ROS1-G2032R mutants with grameainresistance and mutants with partial NTRK inhibitor resistance are also inhibited, and the range of clinical indications will be concentrated in patients with ketini resistance. Currently, the project has completed two Phase I clinical trials in Japan and the United States.. NO.2ASC09F - Clarico PharmaceuticalsDevelopment Company for The Pharmaceuticals, the new crown pneumonia clinical trials of this variety have been launched in Wuhan, Zhejiang, Chongqing and other serious affected areas, Goli for the above-mentioned clinical trials to provide material support and comprehensive technical support. February 2020 China Clinical Trial Registration Center showed that a comparison of ASC09/Litonevir compound and Lopinavir/Litonevir (Clit)) confirmed cases of new coronavirus pneumonia (COVID-19) were registered Random, open, multi-center clinical studies on efficacy and safety to compare the efficacy and safety of ASC09/Litonevir compounds (code-named ASC09F) and Lopinavir/Litonevir for confirmed cases of pneumonia with new coronavirus infection. The drug group is: Group 1 for ASC09F tablets , group 2 for lopinavir / Litonavir , a-interferon, group 3 for Abidor - a-interferon.. NO.3LPM3480392 - Green Leaf PharmaceuticalsDevelopment Company for Green Leaf Pharmaceuticals, for the company based on the new compound (NCE/NTE) platform independently developed analgesic innovative drug, is intended for postoperative treatment of moderate to severe pain and cancerous outbreak pain. LY03014 (Project Code) is a new type of small molecule Gi protein bias opioid receptor (MOR) agonist that achieves the separation of respiratory inhibition and analgesic action. Current and completed pharmacodynamics and pharmacokinetic studies have shown that LY03014 significantly inhibits postoperative pain and cancerous pain and reduces respiratory suppression, constipation, and opioid tolerance. In addition, completed toxicology studies and long-range telemetry tests of the cardiovascular system showed that LY03014 did not cause changes in liver toxicity and cardiac QT period.. NO.4BPI-43487- Beida PharmaceuticalsDevelopment Company, which has completely independent intellectual property rights, for a new type of powerful, highly selective fibrous cell growth factor receptor-4 (FGFR-4) oral small molecule inhibitor, through specific suppression of FGFR 4 catalytic activity Reduce the phosphorylation level of its downstream protein, block the activation of the downstream signaling pathway to regulate tumor cell proliferation and survival, so as to achieve anti-tumor effect, is intended to be used in the growth of fibroblast growth factor 19 (FGF19) amplification of liver cell cancer (HCC), bile duct cell carcinoma and other solid tumor treatment. . NO.5 NP-01-ShiSi Pharmaceutical Group Development Company for Shi Shi Si Pharmaceutical Group, KDR/MET/Axl multi-target kinase inhibitors, for the Group and domestic research institutions jointly developed, with independent intellectual property rights of new small molecular compounds, its patents have been licensed in China, the United States and Europe, belonging to the chemical class 1 new drug. The research shows that NP-01 shows excellent anti-tumor activity in gastric cancer, liver cancer, lung cancer, prostate cancer and other tumor animal models, has good pharmacokinetic characteristics, has good safety and tolerance, especially in the gastric cancer PDX model (human-derived tumor xenotransplant model) shows better than the anti-gastric cancer small molecular target drug anti-tumor anti-tumor anti-tumor anti-tumor anti-tumor anti-tumor anti-tumor anti-tumor activity, and is expected to expand to liver cancer, lung cancer, prostate cancer and other tumors, the world has not been approved for the same target. . NO.6 GW117 - Beijing Widely Medical Development Company is widely used in Beijing, the variety is the existing melatonin antidepressant agomeratin structural optimization, in order to ensure the same (or higher) good efficacy with agomeratin, in order to overcome agomeratin's very low oral bioavailability and very high mutation coefficient, and is expected to solve the resulting increased risk of liver enzymes. . NO.7 SPH3261 capsules - Shanghai Pharmaceutical Development Co., Ltd., Shanghai Pharmaceutical Group Co., Ltd., independent research and development and has full intellectual property rights, the drug was launched in May 2015, the end of August 2019 to complete pre-clinical research; SPH3261 is an oral, small molecule selective ErbB2 inhibitor, proposed to use indications for HER2-positive malignancies, there is no similar products listed in the world. . NO.8 FCN-207 - Fosun Pharmaceuticals Development Company is a Fosun Pharmaceutical subsidiary of Chongqing Fucheng Pharmaceuticals, the Group's independent research and development of innovative small molecule chemical drugs, intended to be mainly used for the treatment of hyperureus emis or gout. As of January 2020, Fosun Pharma has invested approximately RMB 20.3 million (unaudited) in research and development of the new drug at this stage. . NO.9 ASC41 - Goli pharmaceutical development company for Clariand Pharmaceuticals, indications for non-alcoholic fatty hepatitis (neptic), the variety is expected to be in conjunction with the company's other innovative drug ASC40 to treat non-alcoholic fatty hepatitis. ASC41 is an oral thyroid hormone beta receptor agonist, while ASC40 is an oral fatty acid synthase inhibitor. . NO.10 BPI-28592 - Beda Pharmaceuticals Development Company is Beida Pharmaceuticals, with fullindependent intellectual property rights, for a new type of powerful, highly selective promylified primary myoglobulin receptor kinase second generation oral small molecular inhibitors, can cover a variety of cancer species, intended to carry TRK gene variants of local advanced or metastatic solid tumor patients treatment, is Beida independent research and development of the third PROJECT. At present, Larotrectinib and Entrectinib 2 TRK inhibitors are listed in the United States and Japan respectively, there are no TRK inhibitors listed in China NO.11 Shititini- Henan Real Biology Development Company for Henan Real Biotech Co., Ltd., is an innovative drug for the treatment of advanced non-small cell lung cancer, the treatment of non-small cell lung cancer heavy new drug Ohititini optimization products, real biotechnology has full independent intellectual property rights. The results of the completed preclinical study show that the drug is expected to show its clinical advantages by reducing the production of toxic metabolites of existing drugs and improving the safety of the drug, and providing new and better choices for patients with advanced non-small cell lung cancer. . NO.12 CS3005 - Keystone Pharmaceuticals Development Company is a cornerstone pharmaceutical company, a adenosine A2a receptor antagonist that reverses immunosuppression mechanisms by blocking the binding of adenosine and adenosine A2a receptors, potentially activating anti-tumor immunity and improving response to immunocheckpoint inhibitors. CS3005 is the company's first tumor immuno-microenvironment regulator coming into clinical trial phase and has been clinically approved by HREC Australia to assess The safety, tolerance, pharmacokinetics and initial antitumor activity of CS3005 in patients with advanced solid tumors; . NO.13 TG-1000- Taijing Pharmaceuticals Development Company for Taijing Pharmaceuticals, a new antiviral drug for the new mechanism of nucleic acid incise inhibitor influenza, with Japan's newly listed Japanese salty anti-flu drug baloxavirmarboxil (Xofluza) effect, can effectively block the replication and spread of the virus. Animal experimental data have shown that TG-1000 is more safe, and blood concentration is better, not susceptible to influenza virus mutations and drug resistance. If successfully listed in the future, or will seize the domestic broad anti-flu virus drug market. . NO.14 ICP-723 - Norse Development Company is Norse, a second-generation pan-tyrosine receptor kinase (pan-TRK) small molecular inhibitor used to treat neurotrophic tyrosine receptor kinase (NTRK) fusion cancer patients and patients who develop resistance to the first-generation tyrosine kinase (TRK) inhibitordue due to mutations in the anti-TRK gene. . NO.15 RO7020531 - Roche Development Company for Roche, TLR7 agonisant, is the first drug RO7011785, clinically intended for chronic hepatitis B cure therapy program. Preclinical studies showed that the dominant i interferon response in the rodent mouse model stimulated the spleen and lymph nodes, and the dose-dependent action against HBV significantly reduced the levels of HBVDNA and HBsAg, while the congenital immune response caused by RO7020531, such as cytokines and interferon stimulation genes, was reproduced in the AAV-HBV model. . NO.16 CS12192-Shenzhen micro-core biological CS12192, is a high-selectivity JAK3 kinasse inhibitor independently developed by micro-core bio-developed patent granted by the global compound invention patent; With obvious efficacy activity, it shows different drug efficacy characteristics different from other JAK kinase inhibitors in some disease models, and compared with the listed JAK kinase inhibitors, CS12192 can not only effectively suppress the inflammation mediated by overactivation of immune cells, but also reduce the tissue invasion of immune cells by inhibiting TBK1, bring better efficacy and safety, and is expected to provide a new differentiated treatment option for clinical treatment of autoimmune-related diseases. . NO.17 SPH4336 to Shanghai Pharmaceutical Group SPH4336 tablets, independently developed by Shanghai Pharma, the company has full intellectual property rights. Preclinical studies have shown that the project has better invivity and anti-tumor activity and better safety for the treatment of advanced solid tumors. The SPH4336 tablet was launched in March 2015, completed preclinical research in October 2019, and submitted a clinical trial application to the State Drug Administration, which has obtained the "Clinical Trial Notice" approved by the State Drug Administration. So far, the project has invested about RMB4,650.47 million in research and development. . NO.18 GP681 - Ginkgo Tree Pharmaceuticals GP681, a new influenza treatment drug of Ginkgo Tree Pharmaceuticals, based on pre-clinical data, can be reported directly without a pre-IND meeting; Unlike traditional drug neuraminidase inhibitors such as oseltamivir, flu can be cured in just 40 to 80 mg, and the range, effectiveness, safety, compliance and convenience of the drug are improved. . NO.19 TGRX-678-Shenzhen Tagire Biological TGRX-678, is a fourth-generation tyrosine kinase inhibitor targeting the Bcr-Abl fusion gene, developed by Shenzhen Tagire Bio, for the treatment of chronic granulocytic leukemia (CML). In the positioning of the product, TGRX-
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