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On February 13, 2021, Beijing time, G1 Therapeutics announced that its main product, Trilaciclib (trade name: COSELA), has been approved by the FDA to prevent bone marrow inhibition in adult patients with diffused stage small cell lung cancer due to the platinum-based etoposide solution or topological tetosine therapy.
it is known that Trilaciclib is a "First-in-Class" small molecule short-acting CDK 4/6 inhibitor discovered and developed by G1, a comprehensive bone marrow protector that has been awarded FDA priority review qualification and breakthrough therapy.
trilaciclib's approval means it is the world's first and only product to take preventive medication during chemotherapy to protect bone marrow and immune system function.
June 2020, G1 signed a cooperation agreement with Grigg Ingham to sell Trilaciclib in markets such as the United States.
, Synth Pharmaceuticals reached an exclusive licensing agreement with G1 to develop and commercialize all of Trilaciclib's adaptations in Greater China and will participate in its clinical trials around the world.
According to the website of the Drug Review Center (CDE) of the State Drug Administration of China, the application for a solid tumor-related clinical trial of Trilaciclib for a high myeloid toxic chemotherapy program jointly declared by Synthesizing and G1 Therapeutics was approved in January this year.
improving the prognostication of chemotherapy patients, the market is promising in China, with more than 4 million new cancer cases each year, and more than half of cancer patients may need medication, which remains the most basic treatment for drug treatment.
chemotherapy drugs do not distinguish between healthy cells and cancer cells, so they affect to some extent the white blood cells, red blood cells and plate plates produced in the bone marrow, leading to a side effect of bone marrow inhibition.
In the event of bone marrow inhibition, resuscitation interventions, such as blood transfusions or infusions of growth factors/plateplates, are usually required, and may also lead to reduced or discontinued chemotherapy, affecting the patient's survival benefits. figure
: Trilaciclib bone marrow protection and anti-tumor mechanism preventive use of Trilaciclib before chemotherapy, can briefly block bone marrow cells in the G1 stage of the cell cycle, significantly reduce the killing of bone marrow cells by chemotherapy drugs, protect bone marrow cells and immune system function, its significance not only improves the quality of life of patients, but also increases the number of chemotherapy cycles in some patients, improve the overall survival of small cell lung cancer (SCLC), triple negative breast cancer (TNBC) and other difficult tumors.
at the San Antonio Breast Cancer Forum (SABCS) in December, a Phase II clinical study submitted by G1 for the treatment of relapsed or metastasis triple negative breast cancer in combination with the Gissitham/Carpina Chemotherapy Programme (GC Program) "raised academic concerns and showed that: The total survival time (OS) of patients who could be used was increased from 12.6 months to 19.8 months (p.lt;0.0001) compared to the mere use of the Gissythabin/Carpential chemotherapy.
's improved OS data has brought a clean stream of the current generally poor treatment of triple-negative breast cancer, with G1 shares up more than 50 per cent since the December announcement, in the expectation of clinical experts and investors.
based on the findings, G1 will launch Trilaciclib's key research on mTNBC in the first half of this year.
Trilaciclib could complement the underlying chemotherapy approach in the future and cover a wide range of patients, with analysts estimating peak sales of the drug at more than $2 billion, given the potential for both the domestic and TNBC markets.