New hope has been expressed for patients with ALK-positive non-small cell lung cancer

Crizotinib Xalkori, a competitive multi-target protein kinase inhibitor developed by Pfizer to inhibit Met, ALK, and ROS, was approved by the FDA for the treatment of ALK-positive late/metastasis NSCLC (2011/08) and ROS1-positive late/metastasis NSCLC (2016/03).
it is worth mentioning that clontini is one of the fastest drugs in the history of cancer drug development, and its inventor is Chinese scientist Dr. Cui Jingrong, who won the 38th National Inventor of the Year Award.
date, Xalkori has been approved for the treatment of ALC-positive NSCLC in more than 90 countries worldwide, and for the treatment of ROS1-positive NSCLC in more than 70 countries worldwide.
Pfizer reported that the drug's market performance was poor, with sales peaking at $594 million.
this may be due to the approval of the same mechanism drug and its generic drugs, as well as its own disadvantages.
is generally resistant after 10-11 months of use, and its blood-brain barrier pass rate is low, can not effectively inhibit brain metastasis of tumor cells.
, however, ketini is expected to see new sales growth.
September 2020, the drug's new adaptation to treat APK-positive patients with interdessional large cell lymphoma has been accepted by the FDA and is expected to be approved by the FDA in January.
, in China, kerazine was approved in January 2013 for the treatment of ALK-positive late-stage/metastasis NSCLC, a product called Sekorri, and in November 2017 NMPA approved for the treatment of ROS1-positive late-stage NSCLC.
2018, the two adaptations of clotinib were negotiated to be included in category B of the National List of Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drugs (2017 edition), with payment standards of 260 yuan (250 mg/granules) and 219.2 yuan (200 mg/granules), valid until 30 November 2020.
and the successful renewal of the contract in the 2020 health care negotiations, the price is confidential, given the price reduction of the drug chosen in the health care negotiations, it is expected that the new health care payment will make more patients affordable.
, two companies in Bangladesh have introduced kerazine generics, BEACON and INCEPTA.
in China, the patent for the compound expires in 2024, and no kerazine generics have yet been approved.
According to insight, the domestic only positive Day Qing and Wanbang Pharmaceutical two enterprises layout of the ketinistine generic drug market, which Zhengda Tianqing layout earlier, in 2015 was approved clinical, but did not see the registration of clinical trials.
and Wanbang Pharma submitted a market application for four classes of generic drugs by completing the BE trial.
about ALK inhibitor ALK, a mesolytic lymphoma kinase, is one of the important carcinogenic drivers of NSCLC, studies have shown that ALK activation can lead to the activation of downstream signaling path paths, which in turn can lead to tumor occurrence and survival.
statistics, the positive rate of ALK fusion protein gene in NSCLC patients is about 5%, mostly in young, non-smoking or mild smoking lung adenocarcinoma patients.
since its approval in 2011, three generations of ALK tyrosine kinase inhibitors have been approved worldwide, as detailed in the table below.
among them, clotini belongs to the first generation, Aletinib, Serrettini, Bugatini and Nsatini belong to the second generation, and Laratini belongs to the third generation.
of the six ALK inhibitors mentioned above, Aladini has performed well, with sales of CHF 876 million in 2019, clotini in recent years between US$500 million and US$600 million, Bugatinib and Serrettinie in sales of less than US$100 million, and Lorratini and Nsatini later in the market, the specific sales situation is unknown.
And Altinib's excellent market performance, the author speculates that because it is excellent clinical performance, and in the major guidelines, Altini is recommended by the major clinical guidelines as ALC-positive NSCLC first-line treatment options.