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    Home > Medical News > Latest Medical News > Under the local pharmaceutical company License-in model, another new drug was approved clinically

    Under the local pharmaceutical company License-in model, another new drug was approved clinically

    • Last Update: 2022-09-30
    • Source: Internet
    • Author: User
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    Recently, Genting Xinyao announced that its application for clinical trial of its new BTK inhibitor EVER001 capsule was approved by the Drug Evaluation Center (CDE) of the State Food and Drug Administration of China, and plans to carry out a Phase 1b clinical trial
    for the treatment of glomerular diseases.

    EVER001 capsules (aka: XNW1011) is a new generation of covalent, reversible BTK inhibitors, Genting Xinyao earlier reached a total of more than 560 million US dollars with Sinovid, China Antibody to develop, manufacture and commercialize XNW1011 for the treatment of kidney disease
    worldwide.

    According to public information, EVER001 capsules are a new generation of covalent and reversible BTK inhibitors, which are being developed worldwide for the treatment of kidney disease
    .

    The results of Phase 1 study conducted by Chinese antibody pharmaceuticals in healthy subjects in China show that EVER001 has high selectivity, excellent pharmacokinetic characteristics, good target participation and good safety characteristics, and the results support its further clinical development
    .

    The industry believes that the approval of the application for clinical trials of EVER001 for the treatment of glomerular diseases in China highlights Genting Xinyao's long-term development strategy
    of providing innovative, high-quality therapies for patients whose medical needs are not met worldwide.

    In fact, in recent years, a large number of pharmaceutical companies are introducing foreign new drugs in order to accelerate innovation and broaden product pipelines
    .

    It is understood that in the near future, in addition to Genting Xinyao, many enterprises have introduced innovative therapies
    .

    For example, on September 21, Inventiva announced that it has entered into a cooperation agreement with Chia Tai Tianqing Pharmaceutical Group Co.
    , Ltd.
    , a subsidiary of China Biopharma, to jointly develop and commercialize Inventiva's self-developed pan-PPAR agonist lanifibranor for the treatment of non-alcoholic steatohepatitis (NASH) and potential other metabolic diseases
    .

    Under the agreement, Chia Tai Tianqing will pay Inventiva an advance payment of $12 million and an additional $
    5 million if certain clinical milestones are met.

    At the same time, it will also obtain exclusive license rights
    for lanifibranor to develop, import, manufacture, commercialize and sell in Greater China.

    On August 8, Hansen Pharmaceutical and TiumBio jointly announced that they have reached an exclusive license agreement
    for the development, registration and commercialization of TiumBio's in-research drug TU2670 in China.

    Data show that TU2670 is an oral non-peptide GnRH receptor antagonist, and early clinical trials have shown good safety and tolerance
    .

    Under the terms of the agreement, TiumBio will receive a down payment of $4.
    5 million, a technology transfer fee of $1.
    5 million, and potential payments for development, registration, and commercialization milestones of up to $164 million, as well as tiered royalties
    based on net product sales.

    Industry analysts believe that a large number of Chinese pharmaceutical companies are currently seeking to innovate
    through License-in.

    It is expected that in the future, under the background of increasing support for pharmaceutical innovation at the policy level, the popularity of the innovative drug capital market will continue to rise
    .

    At the same time, a large number of listed pharmaceutical companies will also accelerate the introduction of new drugs to continuously enrich product pipelines and further enhance their competitiveness
    .

    Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
    to any person.

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