echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > 5 domestic "tinib" drugs advance to NDA

    5 domestic "tinib" drugs advance to NDA

    • Last Update: 2019-08-12
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    NDA, as the final test before the batch production and marketing of drugs, is undoubtedly lucky to be able to reach this link of new drugs At present, more than 30 domestic innovative drugs have entered the NDA stage, among which more than 10 are in the field of tumor, while the hot "TiNi" drugs account for 5 These 5 domestic "TiNi" drugs have a lot to look at, which is very worthy of attention! In the list of global drug sales in 2018, the sales of TiNi drugs is ibotinib, with global sales of more than US $6.2 billion, ranking 11th in the list and 3rd in the list of small molecules Among the varieties introduced in this paper, there are strong competitors of ibutini Five domestic "TiNi" drugs have entered the NDA stage by August 2019, and a total of five domestic TiNi drugs have entered the NDA stage, including flumatinib and ometinib (generation 3) from hausen, Jiangsu Province, zebutini (impact FDA) from Baiji, ensatinib from Beida pharmaceutical industry, and ivetinib (generation 3) from Eisen pharmaceutical See the table below for target points and indications Table 1: 5 domestic "TiNi" drugs in the NDA stage 5 domestic "TiNi" drugs detailed introduction of flumatenide mesylate Flumatenib mesylate, developed by Haosen, Jiangsu Province, first submitted the clinical trial application (chemical 1.1) of the drug to CFDA in September 2006; in September 2007, it was approved for clinical application; in March 2013, it first submitted the production application in China; in July 2018, it again submitted the production application in China, and in September 2018, it obtained the priority review qualification of nmpa in China Flumatinib mesylate, which can inhibit the activity of BCR ABL tyrosine kinase in cells, is proposed to be used in the treatment of Philadelphia chromosome positive chronic myeloid leukemia Table 2: some important clinical information of flumatinib, ometinib mesylate, in August 2016, Jiangsu hausen submitted the clinical trial application (chemical class 1) to CFDA, and approved the clinical trial in March 2017; in April 2019, NDA was accepted by CDE Ometinib mesylate, belonging to the third generation EGFR-TKI, is intended to be used in the treatment of T790M mutation positive non-small cell lung cancer In 2018, randomized, controlled, double-blind, multicenter, phase III clinical trials were initiated to evaluate the efficacy and safety of ometinib versus gefitinib in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR sensitive mutations (ctr20181951) Table 3: some important clinical information of ometinib Zebudinib was developed by Baiji Shenzhou; in 2016, zebudinib obtained three orphan drug qualification certificates from FDA, respectively, for the treatment of mantle cell lymphoma, Fahrenheit megaglobulinemia and chronic lymphocytic leukemia; in July 2018, zebudinib obtained fast channel qualification from FDA for the treatment of patients with Fahrenheit megaglobulinemia (WM); in August 2018, it was used for the treatment of relapsed / refractory mantle cell lymphoma (MCL) )The NDA of patients was accepted by CFDA; in October 2018, the NDA for potential therapy of patients with recurrent / refractory chronic lymphoblastic leukemia (CLL) or small lymphoblastic lymphoma (SLL) was accepted by nmpa; on January 15, 2019, zebutini, Btk inhibitor of Baiji Shenzhou, was recognized by FDA as a burst therapy for adult mantle cell lymphoma that had received at least one treatment before MCL patients have become the first Chinese native anticancer drug recognized by us breakthrough therapy Zebotinib, a small molecule Btk inhibitor, shows higher selectivity for Btk in biochemical tests compared with ibotinib, a Btk inhibitor approved by the FDA of the United States and EMA of Europe Compared with the data of phase I trials published by the two groups, zanubrutinib showed higher drug exposure and 24-hour continuous inhibition effect on targets in blood and lymph nodes Relevant clinical trials are shown in the table below Table 4: some important clinical information of zanubrutinib In the latest Q2 quarterly financial report released by Baiji Shenzhou today, the expected milestone events of zebutinib are also published: · NDA for R / rmcl patients and NDA for R / RCLL or SLL patients are expected to be approved in China in the first half of 2020 The production site inspection will start after the completion of the technical review In addition, the company provides supplementary non clinical and pharmaceutical information upon the request of the review department; · submits the first NDA in the United States in 2019 or early 2020; · submits the new indication listing application (SNDA) for the treatment of WM patients in China in 2019; ·In 2019, the main data of global phase 3 Aspen clinical trials of zebotinib versus ibotinib were published; the main interim analysis of Sequoia clinical trials of zebotinib versus bendamostine combined with rituximab in the treatment of tncll or SLL patients was published as early as 2020; ·In 2019, a phase 3 clinical trial (clinical trials Gov registration number: nct04002297) of zebutinib combined with rituximab versus bendamostine combined with rituximab in the treatment of MCL patients who have not been previously treated and are not suitable for stem cell transplantation was launched Ensatinib hydrochloride Ensatinib hydrochloride, initially developed by xccovery, was authorized to be used by Beida pharmaceutical for NSCLC treatment in 2014; in November 2015, the compound was applied by Beida pharmaceutical for class 1.1 clinical research of Chinese chemical drugs in China, and obtained the clinical trial approval in August 2016; on December 26, 2018, the NDA in China was accepted by nmpa, which was used for the progress after receiving the treatment of clozatinib or for the gram Zoltinib intolerant anaplastic lymphoma kinase (ALK) - positive locally advanced or metastatic non-small cell lung cancer (NSCLC) was proposed to be included in the priority review process by nmpa in February 2019 Ensatinib hydrochloride, a small molecular inhibitor of anaplastic lymphoma kinase ALK, has potential inhibitory activities on TrkA fusion, trkC, ros1, EphA2 and c-Met In June 2012, the phase I clinical study of open label and dose escalation for advanced solid tumors and NSCLC patients (n = 100) was launched in the United States; in June 2016, the phase III study of comparing ensatinib and clozatinib in patients with anaplastic lymphoma kinase positive non-small cell lung cancer (n = 402) was started in the United States, Europe, Australia, Hong Kong, Israel, South Korea and Turkey for 36 months PFS index was the main endpoint In June 2018, the results of a study were published at the ASCO meeting; the study was conducted in 20 countries, involving 98 test centers; in this global multi center, open label, randomly assigned study, there were about 270 NSCLC patients who did not receive previous alk-tki and had received at most one chemotherapy regimen and had positive ALK; the patients were randomly received ensatinib (225 mg, once a day) Or clozatinib (250mg, twice a day) until disease progression or intolerable toxicity; the study shows that the probability of ensatinib superior to clozatinib in PFS efficacy index is 80% (the α level on both sides is 0.05) Table 5: part of the important clinical information of ensatinib avitinib maleate, independently developed by Essen medicine, is used to treat non-small cell lung cancer with EGFR mutation or drug-resistant mutation In August 2013, ivetinib's clinical trial application (chemical medicine class 1) was accepted by CDE; in September 2014, ivetinib obtained clinical approval; in June 2018, Eisen pharmaceutical submitted the listing application of ivetinib maleate in China; in August 2018, ivetinib maleate was included in the third eleven priority review procedures of CDE Ivetinib maleate, the first three generations of EGFR-TKI in China, can inhibit egfrl858r, exon19del and T790M mutations at the same time In October 2014, the clinical phase I / II trial of open label, single group and dose discovery for patients with advanced NSCLC was launched in China; in 2015, ivetinib launched the clinical I / II trial in the United States (nct02448251); in 2016, ivetinib launched the treatment of EGFR inhibitors The key clinical phase II trial of non-small cell lung cancer patients with T790M resistant mutation after treatment Table 6: summary of some important clinical information of avetinib 5 "TiNi" drugs that have entered the NDA stage, each with its own characteristics In terms of indications, more attention is focused on non-small cell lung cancer (the largest cancer), among which the competition of two 3-generation drugs is worthy of attention; in terms of varieties, zebutini from Baiji, China, is the first domestic anti-cancer drug recognized by FDA breakthrough therapy, which is exciting As a whole, domestic "TiNi" drugs have more and more characteristics, and are constantly breaking through "me too", expecting them to be approved as soon as possible, so that domestic patients can have more drug choices! Reference: 1 Yaozh data 2 Chinese clinical trial data 3 Official websites of major pharmaceutical companies 4 Data disclosure of ASCO / CSCO annual meeting
    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.