Strongest HER2-ADC :DS-8201 domestic start-up with T-DM1 Phase III Head-to-Head
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Last Update: 2019-07-10
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Source: Internet
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Author: User
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original title: Strongest HER2-ADC: DS-8201 Domestic Start with T-DM1 Phase III Head-to-HeadJune 27, 2019, Japan's First Tri-Scounprecin bid "a HER2 positive, unrecutable and/or Metastatic breast cancer subjects compared DS-8201A (anti-HER2 antibody drug conjugate) and ado-quto-bead monoantigen-emtansine (T-DM1) treatment phase III, multi-center, randomization, open label, active drug control study" in the country through genetic office approval, phase III clinical start immediatelyproduct development plan disclosed in April 2019, Pipeline1.1.13-3-3-3-1-3-1-1/2201A (anti-HER2 antibody conjugate drug)1.
Prior to March 28, 2019, Japan's Daiichi Sankyo Company, Limited (referred to as: First Three) announced a global development and commercialization agreement with AstraZeneca (AstraZeneca) for the first three-year-old antibody-linked drug HER2-ADCAstraZeneca is weighing heavily on areas such as breast cancer2.
Under the terms of the agreement, AstraZeneca will make a down payment of $1.35 billion to First IiiThe total amount of payments under the agreement is likely to reach $6.9 billion3.
the company previously anticipated at the end of March that the new drug would accelerate the submission of a U.Smarketable application (BLA) (using key Phase 2 clinical data) in the first half of 2019 for HER2-positive metastatic breast cancer patients who have previously been treated with Roche T-DM1(But as of July 2019, no company disclosure has been seen)Roche Kadcyla (ado-trastuzumabemtansine, T-DM1)1.
Roche Pharmaceuticals' Kadcyla (ado-trastuzumammtansine, T-DM1), an antibody-linked drug (ADC) consisting of the teratoglou monoantigen (HER2 monoantigen) and the cytotoxic drug emtansine via linker In March 2019, an application for listing will be submitted to The State Drug Administration (NMPA) Kadcyla was approved by the U.S FDA in 2013, when it was approved for her2-positive metastatic breast cancer, either with a single drug, or in combination with previous treatments 2 clinical 3.
currently carried out in China Kadcyla, sales for fiscal 2018 were CHF 979 million, up 8% from 2017 reference: NMPA/CDE; Pharmaceutical Melting Data, Pharnex Datamonitor; Pharmaceutical Syntagdo
FDA/EMA; Related Companies Public Disclosure; https:// https:// http://
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