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    Home > Active Ingredient News > Drugs Articles > Zhengda Sunny Class 1 new drug atrotinibs 4th adaptive disease is about to be approved!

    Zhengda Sunny Class 1 new drug atrotinibs 4th adaptive disease is about to be approved!

    • Last Update: 2021-01-04
    • Source: Internet
    • Author: User
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    Recently, Zhengda Tianqing Class 1 new drug atrotinib 4th adaptive disease listing application (receiving number: CXHS1900040, 41, 42) has been changed to "in the approval", a single drug applicable to the treatment of non-surgical local late stage or metastatic thyroid myelin-like cancer patients, is expected to be approved for the market in the near future.
    2019, Andrrotini's sales at PDB sample hospitals were 770 million yuan, considering a magnification of about four times, and the actual sales are expected to be around 3 billion yuan, a well-deserved bombshell.
    (Source: CDE) Heavy Class 1 new drug with annual sales of about 3 billion Aroteinib hydrochloric acid (commodity name: Focovi) is a new class 1 drug developed independently by Zhengda Tianqing, is a new small molecule multi-target tyrosine kinase inhibitor, can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, with anti-tumor angiogenesic and tumor-suppressing effects.
    also blocked signal path paths such as VEGFR, FGFR1-4, PDGFR alpha/β, c-KIT, etc. to multi-directionally inhibit tumor angiogenesty and promote apoptosis.
    drug has broad-spectrum anti-cancer effect in theory, and is therefore one of the most popular tumor targets.
    Atrotini inhibition c-Kit pathland Anrotini inhibition VEGFR path (Source: Doverpress, Science) Androtini was first approved for non-small cell lung cancer (NSCLC) in May 2018 In the same year, Aroteni was negotiated into the national category B health insurance catalogue, the standard of payment for health insurance is 487 yuan (12mg/granules), 423.6 yuan (10mg/granules) and 357 yuan (8mg/granules).
    sales for the year exceeded 1.2 billion yuan.
    with excellent clinical efficacy, the drug has been recognized by experts in the therapeutic fields of non-small cell lung cancer, small cell lung cancer, soft tissue sarcoma, esophageal cancer, etc., and recommended by the latest CSCO guidelines for the 2019 edition.
    's 2019 edition of CSCO Guidelines recommends (Source: CSCO) Three adaptations have been approved so far, and three adaptations have been approved for listing: third-line treatment of non-small cell lung cancer (NSCLC), third-line treatment of small cell lung cancer (SCLC) and second-line treatment of soft tissue sarcoma.
    (Source: NMPA) All three-line therapies for lung cancer Aretini's approved two adaptations, third-line treatment for non-small cell lung cancer and small cell lung cancer.
    cancer is the most morbid and mortality of all cancers.
    incidence of lung cancer in China is about 57 people / 100,000 people, that is, about 780,000 new patients per year.
    Lung cancer is broadly divided into two categories: (1) non-small cell lung cancer (NSCLC), including large cell carcinoma, malignant adenoma, squamous cell carcinoma;
    according to U.S. NCCN treatment guidelines, NSCLC treatment options typically require the identification of the driver gene before developing a targeted dosing program.
    in addition to the initial chemotherapy drugs, about 65% of the targeted drugs (excluding PD-(L)1 drugs) need to confirm the driving gene before administration.
    EGFR is the most common driving gene, accounting for about 50%.
    And arotetinib as an angiogenesic inhibitor can be seen as a broad-spectrum anti-cancer drug, theoretically as long as non-small cell lung cancer patients can use, the audience will not be limited by the driving gene, do not need to do genetic testing.
    (Source: CSCO) Arondini is included in the 2019 edition of CSCO guidelines for the treatment of non-small cell lung cancer as a three-line standard therapy.
    from ALTER0303 Study Phase III clinical data, the overall survival period (OS) of patients in the Arotini group was extended from 6.3 months to 9.6 months, and the progress-free lifetime (PFS) was extended from 1.4 months to 5.37 months.
    overall response rate (ORR) and disease control rate (DCR) were 9.18% vs.0.7% and 81% vs.37%, respectively, significantly higher than in the placebo group.
    2018, Arodini declared third-line therapy for small cell lung cancer with Excellent Phase II Clinical Data (ALTER1202) and was successfully approved for market on September 4, 2019.
    Atrotini officially contracted all third-line treatments for lung cancer.
    to fill the gap in second-line treatment of soft tissue sarcoma In July 2019, Anrotini's second adaptive soft tissue sarcoma was officially approved for the market.
    subsequently, it was included in the 2019 edition of the CSCO Guidelines for the Diagnosis and Treatment of Soft Tissue Sarcoma: Arotetinib received a Class III.3 recommendation (Class 2B evidence) for second-line treatment of late-stage or non-removable soft tissue sarcoma, where a first-line treatment of adenoplasty soft tissue sarcoma received a Class II.1 recommendation (Class 2B evidence).
    atrotini to fill the gap in the second-line treatment of soft tissue sarcoma in China, and is likely to become the standard treatment of soft tissue sarcoma second-line treatment.
    the results of the phase II clinical study (NCT01878448) of the treatment of metastatic soft tissue sarcoma (NCT01878448) showed that the progression-free survival rate (PFR) of the disease after 12 weeks of treatment was 57.23 percent, which was effective for a variety of soft tissue sarcoma subtypes, especially for adenobladden soft tissue sarcoma and glioblastoma, or 46.15 percent and 12.77 percent, respectively.
    details of the "domestic 1.1 class of new drug atrotinie is about to be approved for future growth of new adaptive disorders."
    's 4th Adaptive Declaration was submitted in December 2019 for the listing of the 4th Allergan capsule and was included in the priority review in January 2020.
    November 20-22, 2020, the 6th European Society of Oncology-Asia Annual Meeting was held, in which more detailed data were released in oral reports on the treatment of locally advanced or metastatic iodine retardative differentiated thyroid cancer in Arodini, led by Professor Ihobari Chi.
    results showed that the mid-level PFS in the Arodini and placebo groups was 40.54 months (95% CI, 28.29-NE) and 8.38 months (95% CI, 5. 59-13.80), HR s 0.21 (95% CI, 0.12-0.37), P slt;0.0001, the study reached the main end point.
    PFS curves in two groups of patients (pictured from publicly available data) and anrotinis significantly improved PFS in patients with recent disease progress.
    subgroup analysis showed that atrotinis reduced the risk of disease progression by 82% and 87% in patients with disease progression within the first 12 months and 3 months of group entry.
    according to different pathological types, thyroid cancer is divided into four major categories, such as thyroid papyroid cancer, thyroid fig-like cancer, thyroid myelin-like cancer and thyroid undifferentiated cancer.
    Thyroid papyroid and fig-like cancers are called differentiated thyroid cancers, accounting for more than 90% of all thyroid cancers and the main body of treatment for thyroid cancer;
    treatment for thyroid cancer varies depending on the pathological type.
    thyroid myelin cancer is a more special type of thyroid cancer, originated in the thyroid bubble side cells, about 1/4 of the family hereditary.
    treatment of thyroid myelin-like cancer is relatively single, mainly surgical treatment.
    it is not sensitive to iodine-131, endocrine therapy and chemotherapy, so once the opportunity to operate is relatively limited treatment, targeted treatment may be an effective way to treat advanced thyroid myelin-like cancer.
    is expected to be a new option in the treatment of iodine-131 incurable differentiated thyroid cancer.
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