The clinical trends of China's Class 1 new drugs in October 2019, 23 drug trends display

In October 2019, a total of 13 Chinese class 1 Chemicals obtained the implied permission of clinical trials from the National Drug Administration (nmpa, the former CFDA)The specific information is shown in the table below: < br / > 01, < br / > hpp737 capsules < br / > hpp737 were developed by vtvttherapeuticsOn August 16, 2019, the clinical trial application of hpp737 was undertaken by CDE, and in October, the implied permission of clinical trial was obtained for the treatment of moderate and severe chronic obstructive pulmonary disease (COPD)< br / > at present, the Chinese class 1 drugs with the same indications are shown in the table below: < br / > 02, < br / > shr6390 tablets < br / > shr6390 are CDK4 / 6 selective inhibitors developed by Jiangsu Hengrui< br / > R & D milestone: < br / > on August 1, 2019, shr6390's clinical trial application was undertaken by CDE, and in October, it was implicitly approved by the clinical trialIt is proposed to combine with fluvectin for HR positive and HER2 negative recurrent or metastatic breast cancer treatment after endocrine treatment< br / > in April 2019, the multi center, randomized, double-blind, placebo-controlled phase III clinical study (ctr20190619) of shr6390 combined with fluvectin in the treatment of second-line HR +, HER2 - advanced breast cancer began in China< br / > in March 2018, the phase Ib / II clinical study of shr6390 combined with letrozole in the treatment of hormone receptor positive and HER2 negative advanced breast cancer (nct03481998, ctr20180174, shr6390-ib / ii-201) began in China< br / > in April 2016, the phase I clinical study on the tolerance and pharmacokinetics of shr6390 tablets in patients with advanced solid tumors (nct02684266, shr6390-i-101, ctr20160066) was launched in China< br / > in April 2016, the phase I clinical study on the tolerance and pharmacokinetics of shr6390 tablets in patients with advanced melanoma (nct02671513, shr6390-i-102, ctr20160067) was launched in China< br / > in June 2014, Jiangsu Hengrui and Shanghai Hengrui jointly submitted clinical trial application (chemical 1.1) to CFDA, and obtained chemical 1.1 clinical approval document in October 2015< br / > 03, < br / > donafinil toluenesulfonate tablets < br / > donafinil toluenesulfonate is a deuterium substituted sorafenil derivative developed by Zejing biology, which is an oral multi kinase inhibitor, It has dual antitumor effects: directly inhibit the proliferation of tumor cells by inhibiting the signal transduction pathway of serine threonine kinase (RAF / MEK / ERK); indirectly inhibit the growth of tumor cells by inhibiting the formation of tumor neovascularization by inhibiting VEGFR and platelet-derived growth factor receptor (PDGFR)< br / > R & D milestone: < br / > on August 22, 2019, the clinical trial application of donafinil mesylate tablets was undertaken by CDE, and in October, the implied permission of clinical trial was obtained in combination with treprizumab injection for the treatment of advanced liver cancer< br / > in March 2018, a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial (ctr20180191, zgdd3) was conducted in China to evaluate the efficacy and safety of donafinil mesylate in the treatment of locally advanced / metastatic rair-dtc patients (n = 204)< br / > in December 2016, the randomized, double-blind, placebo-controlled, multicenter phase III clinical study (ctr20160482, zgdc3, nct02870582) of donafinil mesylate in the treatment of advanced colorectal cancer began in Chinese patients (n = 510) to evaluate the efficacy and safety of donafinil< br / > in November 2016, the open, single center IB phase clinical study (ctr20160252, zgdn1b, nct02698111) of donafinil mesylate in the treatment of second-line advanced NPC patients (n = 44) was launched in China< br / > in March 2016, the open, randomized, parallel controlled, multicenter phase II / III clinical study (nct02645981, zgdh3, ctr20160184) of donafinil toluenesulfonate in the first-line treatment of patients with advanced liver cancer (n = 600) was launched < br / > in October 2015, Suzhou Zejing entrusted tiger pharmaceutical to carry out the phase III clinical study of donafinil toluenesulfonate tablets on HCC < br / > in June 2015, donafinil toluenesulfonate tablets (n = 19) in the open, single center Ib / II phase clinical study (nct02489201, zgde1b, ctr20160257) was launched in patients with advanced esophageal cancer (n = 19) < br / > in May 2015, the randomized, open, parallel controlled, single center phase I / II clinical study (nct02489214, zgdg1b, ctr20160190) of donafinil mesylate in the treatment of advanced gastric cancer patients above the second line (n = 17) was launched in China < br / > in December 2011, the clinical trial application submitted by Suzhou Zejing biopharmaceutical Co., Ltd to the National Drug Administration (nmpa, formerly CFDA) was undertaken by CDE, and the clinical trial approval document was obtained on November 29, 2012 < br / > 04, < br / > htd1801 < br / > htd-1801 was developed by Shenzhen junshengtai It is in the second phase of clinical practice and is used to treat primary sclerosing cholangitis Htd-1801 is in the first / second phase of clinical trials in the treatment of hypercholesterolemia In September 2018, htd-1801 was qualified for FDA fast track review for the treatment of primary sclerosing cholangitis This may be the first fast track review qualification granted by FDA in the field of indications On August 1, 2019, the clinical trial application of htd1801 tablet was undertaken by CDE and tacit permission for clinical trial was obtained in October 2019 < br / > 05, < br / > zebutinib capsule < br / > zebutinib is a powerful and highly selective small molecule Btk (Bruton tyrosine kinase) inhibitor, which can block the related signal transmission, thus inhibiting the growth of malignant proliferation B cells and killing tumor cells It was developed by Baiji Shenzhou < br / > R & D milestone: < br / > on August 20, 2019, the clinical trial application of the drug was undertaken by CDE, and in October, it was implicitly approved by the drug review center (CDE) for the treatment of relapsed / refractory diffuse large B-cell lymphoma < br / > on August 22, 2019, Baiji Shenzhou announced that the FDA of the United States has accepted the application for marketing of new drugs for the treatment of relapsed / refractory mantle cell lymphoma patients by lizzebutinib and has been awarded the priority review qualification < br / > on January 15, 2019, zebutinib, a Btk inhibitor from Baiji Shenzhou, was approved by the FDA as a breakthrough therapy It was used to treat adult mantle cell lymphoma (MCL) patients who had received at least one treatment before, and became the first Chinese native anti-cancer drug approved by the US breakthrough therapy < br / > in November 2018, bgb-3111, a phase II open study (ctr20180823) for recurrent or refractory borderline lymphoma (R / rmzl), will be conducted in China < br / > in February 2019, the global phase II clinical study for R / rmzl was launched < br / > in October 2018, NDA of zebutini capsule for potential therapy in patients with relapsed / refractory chronic lymphoblastic leukemia (CLL) or small Lymphoid Lymphoma (SLL) was accepted by nmpa In August 2018, bgb-3111 was accepted by CFDA for the treatment of relapsed / refractory mantle cell lymphoma (MCL) < br / > in July 2018, bgb-3111 obtained FDA's fast track qualification for the treatment of patients with megaglobulinemia Fahrenheit (WM) < br / > in February 2017, a phase II clinical trial (ctr20160888) was conducted in patients with relapsed / refractory mantle cell lymphoma (MCL), and the first patient was enrolled < br / > in January 2017, bgb-3111 launched the global phase III clinical trial of primary megaglobulinemia (WM) < br / > in 2016, bgb-3111 was approved by FDA for three orphan drugs, which were used to treat mantle cell lymphoma, megaglobulinemia Fahrenheit and chronic lymphocytic leukemia < br / > 06, < br / > shr0302 base ointment < br / > shr-0302 is a Jak1 inhibitor developed by Jiangsu Hengrui for the treatment of rheumatoid arthritis, ulcerative colitis, atopic dermatitis and Crohn's disease Jiangsu Hengrui granted arcutis part of the rights and interests in the field of external dermatology, and Ruishi Biology (the company invested by Hengrui) the global rights and interests in the field of external dermatology in addition to rheumatoid arthritis < br / > R & D milestone: < br / > on August 7, 2019, the clinical trial application of the drug was undertaken by CDE In October, RSB received the clinical trial notice of shr0302 alkali ointment approved and issued by the National Drug Administration (nmpa, the former CFDA), which is intended to be applied to the treatment of atopic dermatitis < br / > in May 2019, nmpa phase II clinical approval was obtained for the treatment of moderate and severe atopic dermatitis < br / > on April 12, 2019, Ruishi biomedical Co., Ltd has received the approval letter issued by the Polish Registration Bureau of drugs, medical devices and biological products, and will carry out clinical trials in the near future < br / > in January 2019, Ruishi biomedical Co., Ltd submitted clinical trial application (chemical medicine class 1) to National Drug Administration (nmpa, former CFDA) < br / > in April 2019, tacit permission for clinical trials was obtained < br / > on December 20, 2018, the clinical trial application submitted by Ruishi biomedical Co., Ltd to the Polish drug, medical device and biological product registration bureau was accepted for ulcerative colitis and Crohn's disease < br / > in December 2018, the application for phase II clinical study of Crohn's disease of shr-0302 was approved by the US FDA < br / > in October 2018, shr-0302's phase II clinical research application in the United States was approved by FDA and is intended to be used for the treatment of ulcerative colitis < br / > in August 2018, clinical application will be submitted again in China < br / > in September 2017, a multicenter, randomized, double-blind, placebo-controlled phase II study (nct03254966, shr0302-201, ctr20170943) was initiated in China to evaluate the efficacy and safety of shr-0302 tablets in patients with moderate to severe active rheumatoid arthritis < br / > in May 2015, single center, randomized, double-blind, placebo-controlled clinical phase I study (nct02423538, ctr2015, 021, shr0302-101) of single dose human tolerance and pharmacokinetics of shr-0302 healthy subjects was launched in China and completed in January 2018 < br / > in July 2013, Jiangsu Hengrui Pharmaceutical Co., Ltd and Shanghai Hengrui Pharmaceutical Co., Ltd jointly submitted the clinical trial application (chemical medicine 1.1) to CFDA for the first time, and obtained the clinical trial approval document in February 2015 < br / > 07, < br / > ty-9591 < br / > ty-9591 is the third representative skin growth factor receptor (EGFR) inhibitor independently developed by Zhejiang Yuankang Pharmaceutical Co., Ltd., which is used to treat non-small cell lung cancer On August 1, 2019, the National Drug Administration (nmpa, the former CFDA) accepted the clinical trial application of this product (China class I), and in October, it obtained the implied permission of CDE clinical trial < br / > the current Chinese class 1 drugs targeting EGFR with the same target and indication are shown in the table below: < br / > 08, < br / > dzd9008 tablets < br / > dzd9008 were developed by Dizhe (Jiangsu) Pharmaceutical Co., Ltd in April 2019, nmpa (the former CFDA) accepted the clinical trial application of this product (chemical medicine class 1), and in July, they were implicitly approved for clinical trials, It is proposed to treat advanced non-small cell lung cancer with EGFR or HER2 mutation; in August 2019, the clinical trial application (chemotherapeutic class 1) of the drug was accepted again, and in October, it was implicitly approved for clinical trial to treat non-Hodgkin B-cell lymphoma < br / > the current Chinese class 1 drugs for the treatment of non Hodgkin B-cell lymphoma are shown in the following table: < br / > data sources: drug delivery database < br / > 09, < br / > azd4205 capsule < br / > azd-4205 is a Jak1 kinase inhibitor jointly developed by AstraZeneca and Dizhe (Jiangsu) Pharmaceutical Co., Ltd (a company jointly invested and founded by AstraZeneca and sinoventure), At present, AstraZeneca is in the first / second phase of clinical trials for the treatment of non-small cell lung cancer and peripheral T-cell lymphoma, as well as for the treatment of autoimmune diseases and inflammatory bowel diseases < br / > in December 2018, the National Drug Administration (nmpa, the former CFDA) accepted the clinical trial application (chemical medicine class 1) submitted by Dizhe (Jiangsu) Pharmaceutical Co., Ltd In March 2019, we obtained the implied clinical permission to treat autoimmune diseases (inflammatory bowel diseases including ulcerative colitis and Crohn's disease) In August 2019, the clinical trial application (chemical class 1) of the drug was accepted again, and in October 2019, it was implicitly approved for the treatment of peripheral T-cell lymphoma.