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    Home > Medical News > Latest Medical News > Inventory of clinical trends of China's Class 1 new drugs in December 2019

    Inventory of clinical trends of China's Class 1 new drugs in December 2019

    • Last Update: 2020-06-19
    • Source: Internet
    • Author: User
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    In December 2019, a total of 8 Chinese class 1 Chemicals obtained the implied permission of clinical trials from the National Drug Administration (nmpa), and the specific information is shown in the table below: < br / > 1, < br / > tqb3602 < br / > tqb3602 was developed by Zhengda Tianqing, which is currently in the phase I clinical trial for the treatment of multiple myeloma< br / > R & D milestone < br / > on October 23, 2019, the ind application of the drug was undertaken by the National Drug Administration (nmpa) (chemical medicine category 1)< br / > in December 2019, tacit permission of CDE clinical trial was obtained for the treatment of relapsed or refractory multiple myeloma< br / > the current Chinese class 1 drugs for the treatment of multiple myeloma are shown in the following table: < br / > data sources: drug delivery database < br / > 2, < br / > hsk21542 < br / > hsk21542, developed by HISCO Pharmaceutical Group Co., Ltd., its wholly-owned subsidiary Sichuan HISCO Pharmaceutical Co., Ltdand Liaoning HISCO Pharmaceutical Co., Ltd., is a selective agonist of peripheral kappa opioid receptor, It is intended to be used for the treatment of acute and chronic painOn October 24, 2019, the State Drug Administration accepted the clinical trial application of this product (chemical medicine class 1)In December 2019, tacit permission for clinical trials was obtained< br / > at present, one kind of drugs targeting kor1 in China is shown in the table below: < br / > data source: drug delivery database < br / > 3, < br / > in10018 < br / > in10018 is an adhesion spot kinase (FAK) inhibitor developed by Yingshi Biotechnology Co., Ltd< br / > R & D milestone < br / > in December 2019, the drug was implicitly approved by clinical trials of CDE, and is intended to be used for the treatment of locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma< br / > in October 2019, the National Drug Administration (nmpa) accepted the clinical trial application of this product (chemical medicine class 1)< br / > in August 2019, the drug was approved for clinical trials by the food and Drug Administration (FDA)< br / > the current Chinese class 1 drugs for the treatment of adenocarcinoma are as follows: < br / > 4, < br / > zanubrutinib (zebutinib) < br / > zebutinib has been approved by the US Food and Drug Administration (FDA) on November 14, 2019The drug was developed by Baiji Shenzhou and the trade name is brukinsaBrukinsa is a small molecule Btk (Bruton tyrosine kinase) inhibitor, which can block the related signal transmission, so as to inhibit the growth of malignant proliferation B cells and kill tumor cellsIt is used in the treatment of adult mantle cell lymphoma (MCL)< br / > in October 2019, the National Drug Administration (nmpa) accepted the application for clinical trial of this product (chemical drug category 1)< br / > in December 2019, tacit permission of CDE clinical trial was obtained < br / > at present, one kind of drugs targeting Btk in China is shown in the following table: < br / > data source: drug delivery database < br / > 5, < br / > sacubitril / Allisartan isoproxil (s086) < br / > s086 (sacubatral / Allisartan) was developed by Shenzhen xinlitai for the treatment of essential hypertension and chronic heart failure < br / >, In the process of gastrointestinal absorption in vivo, it is completely hydrolyzed by esterase to the only pharmacological metabolite exp3174 This is the first class 1 anti heart failure drug in China Its patent publication number is cn105963296a < br / > R & D milestone < br / > in March 2019, the clinical trial application for the treatment of essential hypertension (chemical class 1) was accepted by nmpa, and the implied permission for clinical trial was obtained in December 2019 < br / > in March 2018, the clinical trial application (chemotherapeutic class 1) for the treatment of chronic heart failure was accepted by nmpa, and the clinical trial approval was obtained in October 2018 < br / > 6, < br / > y-302 < br / > ty-302 is a cyclin-dependent kinase 4 / 6 (CDK4 / 6) inhibitor developed by Zhejiang tongyuankang Pharmaceutical Co., Ltd (a subsidiary of Zhengzhou taijihongnuo Pharmaceutical Co., Ltd.), which is currently in the first phase of clinical trials for the treatment of breast cancer < br / > R & D milestone < br / > on October 8, 2019, the ind application of the drug was undertaken by the National Drug Administration (nmpa) (chemical medicine category 1) < br / > in December 2019, it obtained the implied permission of clinical trial and was intended to be used for the treatment of HR + / HER2 - locally advanced or metastatic breast cancer and other advanced solid tumors or hematological system tumors < br / > at present, one kind of Chinese drugs targeting at CDK4 / 6 is shown in the following table: < br / > data source: drug delivery database < br / > 7, < br / > fluzoparib (fluzoparib) < br / > fluzoparib is a PARP1 / 2 inhibitor developed by Hengrui medicine and hausen medicine, which is intended to treat recurrent ovarian cancer, triple negative breast cancer, advanced gastric cancer, small cell lung cancer and other advanced solid tumors At present, the application for listing of the drug has been undertaken by CDE, and the indication is recurrent ovarian cancer < br / > in October 2019, the National Drug Administration (nmpa) undertook the clinical trial application of this product (chemical medicine class 1) < br / > in December 2019, the tacit permission of CDE clinical trial was obtained, and it is intended to be used in combination with shr-1316 in the treatment of small cell lung cancer (SCLC) patients who have received first-line platinum containing chemotherapy and whose disease has progressed < br / > at present, one kind of drugs targeting PARP in China is shown in the following table: < br / > data source: drug delivery database < br / > 8, < br / > tqb303 < br / > tqb303 was developed by Zhengda Tianqing, and it is currently in the first phase of clinical trials for the treatment of breast cancer and other advanced solid tumors < br / > in September 2019, the National Drug Administration (nmpa, the former CFDA) accepted the clinical trial application of this product (chemical medicine class 1) In December 2019, tacit permission for CDE clinical trials was obtained In December 2019, a total of 9 Chinese class 1 therapeutic biological products obtained the implied license of clinical trials from the National Drug Administration (nmpa) The specific information is shown in the table below: < br / > 1, < br / > wbp3425 < br / > wbp3425 is a tim3 (havcr2) antibody developed by Wuxi zhikanghongyi Biotechnology Co., Ltd., which is in the first phase of clinical trials, It is intended to be used in the treatment of advanced colon cancer < br / > in October 2019, the ind application of the drug was undertaken by the National Drug Administration (nmpa), which is a class of biological products for treatment In December 2019, tacit permission for clinical trials was obtained < br / > at present, one kind of drugs targeting havcr2 in China is shown in the following table: < br / > data source: drug delivery database < br / > 2, < br / > shr-1316 < br / > shr-1316 developed by Jiangsu Hengrui is a humanized IgG4 monoclonal antibody, targeting at programmed death ligand (PD-L1) Currently, the research on the treatment of small cell lung cancer (SCLC) is in the third phase of clinical practice The research on the treatment of esophageal cancer is in the second stage < br / > R & D milestone < br / > in October 2019, the ind application of the drug was undertaken by the National Drug Administration (nmpa), and shr-1316 combined with carboplatin and etoposide was used in the initial treatment of patients with extensive small cell lung cancer In December, the implied permission of clinical trial was obtained < br / > in July 2019, the indications were irinotecan hydrochloride liposome combined with shr-1316 and 5-FU for the first-line treatment of advanced esophageal cancer In September, the implied permission of clinical trial was obtained < br / > in June 2019, the indication was submitted as shr-1704 combined with shr-1316 for advanced cancer patients who failed in standard treatment In August, the implied permission of clinical trial was obtained < br / > in May 2019, clinical trial application (biological products for treatment class 1) was submitted to nmpa The indication of this application is that shr-1501 and shr-1316 were used for advanced cancer patients who failed in standard treatment In July, the implied permission of clinical trial was obtained < br / > in November 2018, irinotecan liposomes combined with shr-1316 and 5-FU in the phase II clinical study of esophageal cancer (ctr20181966, nct03732508, iri-shr-1316-201) began to recruit patients in China < br / > in October 2018, the information of randomized, double-blind, placebo-controlled multicenter clinical phase III study (ctr20182176, nct03711305, shr-1316-iii-301) was released, indicating that it has not been recruited, and will start in December 2018 The purpose of this study was to evaluate the efficacy and safety of carboplatin and etoposide in combination with or without shr-1316 in untreated patients with extended stage (ES) SCLC < br / > in March 2018, the phase I clinical study (ctr20180040, nct03474289, shr-1316-i-101) to evaluate the safety and tolerance of PD-L1 antibody shr-1316 in patients with advanced cancer was completed in China for the first time, which is expected to be completed in October 2019 < br / > in June 2017, the open label, dose increasing, multicenter phase I clinical trial (nct03133247) was launched in Australia, mainly for advanced or metastatic solid tumors that failed to be treated by the current standard anti-tumor program < br / > in February 2017, the application for the new drug clinical trial (ind) in China was accepted by CDE, and the clinical approval was obtained in September 2017 < br / > at present, 1 class of Chinese drugs targeting PD-L1 are shown in the following table: < br / > data sources: drug delivery database < br / > 3, < br / > gr1501 < br / > gr1501, developed by Zhixiang (Shanghai) Pharmaceutical Technology Co., Ltd and its wholly-owned subsidiary Chongqing Zhixiang Jintai biopharmaceutical Co., Ltd., which is an anti IL17A monoclonal antibody drug and is intended to be used for the treatment of plaque psoriasis and spinal arthritis, At present, it is in phase I clinical stage < br / > R & D milestone < br / > in October 2019, the National Drug Administration (nmpa, the former CFDA) accepted the clinical trial application of this product (chemical category 1) In December 2019, the tacit permission of CDE clinical trial was obtained for the treatment of patients with active axial type of spine arthritis < br / > in September 2018, gr1501 injection in plaque psoriasis patients tolerance, pharmacokinetics, immunogenicity, safety of dose increase, preliminary efficacy evaluation clinical study (ctr20181154) was launched in China < br / > in July 2017, the application for clinical trials of new drugs (ind) in China (Class 1 biological products for treatment) was accepted by CDE, and the clinical approval was obtained in May 2018 < br / > at present, one kind of Chinese drugs targeting IL17A is shown in the following table: < br / > data source: drug delivery database < br / > 4, < br / > klt-1101 (recombinant human interleukin-12) < br / > klt-1101 is a recombinant human interleukin-12 developed by kanglitai pharmaceutical industry, whose main effect is to reduce the white blood cells and platelets produced by cancer patients after radiotherapy and chemotherapy, It can not complete the treatment cycle or even death, promote the recovery of the whole blood picture, so as to improve the immunity of patients, but also to some extent inhibit the growth of cancer cells < br / > R & D milestone < br / > in September 2019, the National Drug Administration (nmpa, former CFDA) accepted the clinical trial application of this product (Class 1 biological products for treatment) In December 2019, tacit permission for clinical trials was obtained for the treatment of advanced solid tumors < br / > in May 2017, the application for the new drug clinical trial (ind) of the drug was submitted to the drug review center of the National Drug Administration (nmpa), and the clinical approval was obtained in October 2017 < br / > the current Chinese drugs targeting il12r are shown in the following table: < br / > data sources: drug delivery database < br / > 5, < br / > pcar-019 (Anke Biotechnology) (targeting CD19 autochimeric antigen receptor T cells (Anke Biology)) < br / > cd19-car developed by bosenggianko (a joint stock company of Anke Biology) is a chimeric antigen receptor (car) T cell therapy, The product is currently in the phase I / II clinical research stage, and is used in the clinical trial of adult refractory and relapsed acute B-cell lymphocytic leukemia and non-Hodgkin's lymphoma (nct02851589) < br / > in January 2018, the application for new drug clinical trials (ind) of the drug was submitted to the drug review center of the National Drug Administration (nmpa, formerly CFDA) (Class 1 biological products for treatment)
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