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    Home > Medical News > Latest Medical News > Keystone Pharmaceuticals RET inhibitor Platinib's listing application has been accepted and included in the priority review.

    Keystone Pharmaceuticals RET inhibitor Platinib's listing application has been accepted and included in the priority review.

    • Last Update: 2020-09-22
    • Source: Internet
    • Author: User
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    Guide: It is expected to become the first reT targeted therapeutic drug approved in China.
    September 7, 2020, Keystone Pharmaceuticals (Suzhou) Co., Ltd. announced that China's State Drug Administration (NMPA) has accepted the application for the listing of Keystone Pharmaceutical Platini capsules as a new class 1.1 drug of the country and included them in the priority review for the treatment of patients with RET fusion positive non-small cell lung cancer (NSCLC) with platinum-containing chemotherapy.
    Platini is an oral (once-a-day) oral,strong and highly selectively targeted cancer-causing RET variant developed by Blueprint Pharmaceuticals Corporation, a strategic partner of Keystone Pharmaceuticals, that includes predictable drug-resistant mutations.
    In a registered bridging trial being conducted by Keystone Pharmaceuticals, Platini showed superior and long-lasting anti-tumor activity and good safety and tolerance in RET fusion-positive NSCLC Chinese patients with platinum-containing chemotherapy, consistent with data reported by patients worldwide in previous ARROW studies.
    it took only two months from the publication of data on the results of the Chinese patient study in the key global I/II ARROW trial in July to the submission of the NDA. Professor Wu Yilong of Guangdong Provincial People's Hospital, lead researcher in the
    ARROW study, said:
    The development of RET targets in the field of precision treatment of lung cancer is another huge breakthrough after targets such as EGFR, ALK, ROS1 and NTRK.
    , there is no selective RET inhibitor approved in China.
    for RET fusion positive NSCLC patients, there is still a huge unsolt clinical treatment needs.
    platinib's global trials and research in patients with NSCLC in China make us look forward to its domestic launch and the benefits it brings to patients. Dr. Jiang Ningjun, Chairman and CEO of
    Keystone Pharmaceuticals, said, "We are pleased to see that NMPA has accepted and included Pratinib's adaptation application for the treatment of RET fusion-positive NSCLC with platinum-containing chemotherapy as a priority review.
    this is the third new drug market application submitted by Keystone Pharmaceuticals worldwide this year, and the second new drug application submitted by Chinese mainland, which is a clear indication that Keystone Pharmaceuticals is accelerating on the path of commercialization strategy transformation.
    we look forward to Platini's early domestic listing, for China's vast number of RET fusion positive NSCLC patients to bring new treatment hope.
    Jianxin Yang, Chief Medical Officer, keystone Pharmaceuticals, said:
    Wour is pleased to see Platinib demonstrate rapid and long-lasting anti-tumor activity and good safety and tolerance in clinical trials.
    note that it took only two years from our partnership with Blueprint Medicines Corporation to Platini's successful domestic filing of a listing application.
    We will continue to make every effort to advance Platinib's research and development in China and more broadly evaluate the efficacy of the product in patients with RET fusion-positive NSCLC, thyroid myelin and other solid tumors without platinum-containing chemotherapy to meet the clinical needs of this group of cancer patients at an early resolution."
    " under an exclusive partnership and licensing agreement between Cornerstone Pharmaceuticals and Blueprint Pharmaceuticals Corporation, Keystone Pharmaceuticals has the right to clinical development and commercialization of Platini monodone or combined therapy in Greater China, including Chinese mainland, Hong Kong, Macau and Taiwan.
    in Greater China, Blueprint Medicines Corporation has entered into a global partnership with Roche and Genentech, members of the Roche Group.
    through the partnership, Roche will obtain global exclusive licenses for pralsetinib in Greater China (including Chinese mainland, Hong Kong, Macau and Taiwan) and markets outside the United States, as well as the rights to jointly develop and commercialize Pralsetinib in the United States and Blueprint Medicines.
    ARROW study ARROW is a global clinical study designed to assess the safety, toerability, and efficacy of pralsetinib in patients with RET fusion-positive NSCLC, thyroid cancer, and other advanced solid tumors with RET variants.
    according to a previous announcement from Keystone Pharmaceuticals, the China Research Center achieved the first retinal-positive NSCLC patients with platinum-containing chemotherapy in August 2019, and completed the last patient's entry in December of the same year.
    Program will present the results of the ARROW study on RET fusion-positive NSCLC Chinese patients at future academic conferences.
    the study is that Pralsetinib is an oral (once-a-day), powerful and highly selective, targeted carcinogenic RET variant.
    Blueprint Medicines Corporation is in the process of clinically developing pralsetinib for the treatment of patients with RET variants of non-small cell lung cancer, thyroid cancer and other solid tumors.
    The FDA has awarded pralsetinib breakthrough therapies for the treatment of RET fusion-positive non-small cell lung cancer that progresses after platinum-containing chemotherapy, and for patients with RET mutation-positive thyroid myelin-like cancer who require systematic treatment and have no alternative treatment option.
    Blueprint Pharmaceuticals Corporation announced in May 2020 that its application for the listing of pralsetinib for the treatment of RET fusion-positive partial progress or metastasis NSCLC submitted in the United States and the European Union has been formally accepted and certified by the FDA and the European Medicines Agency, respectively.
    Pralsetinib was designed by a team at Blueprint Medicines Corporation based on its proprietary compound library.
    in preclinical studies, pralsetinib consistently showed the effect of subnamor levels for the most common RET gene fusion, activation mutations, and prediction of drug-resistant mutations.
    , pralsetinib is 80 times more selective of RETs than VEGFR2.
    addition, pralsetinib's selectivity to RET was significantly improved compared to approved multi-kinase inhibitors.
    by inhibiting primary and secondary mutations, pralsetinib is expected to overcome and prevent the occurrence of clinical resistance.
    therapy is expected to achieve long-lasting clinical relief in patients with different RET variants and is safe.
    About Keystone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative cancer immunotherapy and precision therapy drugs to meet the ardent medical needs of cancer patients in China and around the world.
    founded at the end of 2015, Keystone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercialization.
    company has established a rich product pipeline consisting of 15 tumor candidate drugs, with the combination therapy of tumor immunotherapy as its core.
    currently five late-stage drug candidates are in critical clinical studies.
    With an experienced management team, extensive pipeline, a business model focused on clinical development and ample capital, Cornerstone Pharmaceuticals' vision is to become a world-renowned leading chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
    .
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