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    Home > Medical News > Latest Medical News > Recently, there has been good news in the field of anti-tumor drugs, involving clinical and marketing...

    Recently, there has been good news in the field of anti-tumor drugs, involving clinical and marketing...

    • Last Update: 2023-02-01
    • Source: Internet
    • Author: User
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    With the continuous expansion of the oncology drug market, pharmaceutical companies are intensifying
    the "involution" of new oncology drugs.
    At the same time, pharmaceutical companies have begun to usher in more and more new progress
    in research and development.
    For example, there has been good news in the field of anti-tumor drugs in China recently, involving clinical and marketing
    .

     
    Recently, Hengrui Pharmaceutical received the "Drug Registration Certificate" approved and issued by the State Medical Products Administration, approving the company's cyclophosphamide capsules (25mg, 50mg) for marketing
    .
    At present, there are no cyclophosphamide capsules on the market
    in China.
    The company's cyclophosphamide capsules (25mg) were included in the priority review and approval process in October 2021, and the approval of both specifications (25mg and 50mg) is deemed to have passed the consistency evaluation
    of the quality and efficacy of generic drugs.

     
    It is reported that the approved indications of Hengrui Pharmaceutical's cyclophosphamide capsules are "suitable for adults and children aged 6 and above, for the treatment of malignant lymphoma (Ann Arbor stage III and IV.
    ), Hodgkin lymphoma, lymphocytic lymphoma (nodular or diffuse), mixed cell lymphoma, histiocytic lymphoma, Burkitt lymphoma, etc
    .
    " Up to now, there are no cyclophosphamide capsules on the market
    in China.
    Hengrui Pharma cyclophosphamide capsules (25mg) were included in the priority review and approval process in October 2021, and the approval of both specifications (25mg and 50mg) is deemed to have passed the consistency evaluation
    of the quality and efficacy of generic drugs.

     
    On January 13, Roche Pharmaceuticals China announced that its world's first antibody-conjugate (ADC) targeting CD79b, Yourohua (generic name vepotuzumab for injection), has been approved by the State Food and Drug Administration for two indications: combination rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of previously untreated adult patients with diffuse large B-cell lymphoma (DLBCL); Combined with bendamustine and rituximab is used to treat adult patients
    with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplantation.

     
    Based on the efficacy results achieved in multiple clinical studies, the combination regimen has previously been included in the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines 2022 as the recommended treatment for
    patients with treatment-naïve and R/R DLBCL.

     
    On January 6, the Singapore subsidiary of Dongcheng Nuclear Drug Innovation R&D Platform Lannacheng received the drug clinical trial approval notice for 177Lu-LNC1004 injection approved by the US Food and Drug Administration (FDA), and will soon start phase I clinical trial
    .
    It is reported that 177Lu-LNC1004 injection is a radioactive in vivo therapeutic drug targeting fibroblast activating protein (referred to as "FAP"), which is a new target drug intended to be used to treat adult patients with FAP-positive expression of advanced solid tumors.


     
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    From the current new progress in the research and development and marketing of a large number of new anti-tumor drugs, it can be seen that the innovative research and development of anti-tumor innovative drugs in China, as well as the review and review, are advancing rapidly, and the market will undoubtedly have more and more broad development space
    in the future.
    It is worth noting that some time ago, the National Health Commission issued the "Guidelines for the Clinical Application of New Antitumor Drugs (2022 Edition)
    ".
    It clearly points out that the clinical application of antitumor drugs needs to consider four major elements
    : drug accessibility, patients' willingness to treat, disease prognosis and drug safety.
    Whether the clinical application of antitumor drugs is reasonable mainly depends on whether there are indications for the use of antitumor drugs, and whether they have safety, efficacy, economy and appropriateness
    .

     
    In this regard, analysts believe that in the future clinical application of anti-tumor drugs, domestic pharmaceutical companies need to fully consider the cost-effect ratio of anti-tumor drugs, and give priority to varieties with superior evidence of pharmacoeconomic evaluation under the premise of strictly following the indications
    .

     
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