Baekje Shenzhou’s independent research and development of BTK inhibitor Zebutinib was approved by the FDA.
In recent years, it has been a blowout period for new anticancer drugs. From 2014 to 2018, the FDA approved a total of 57 new anti-cancer drugs, covering 23 cancers and 89 indications. But unfortunately, none of them is developed in China.
Now, this record is over. Hong Kong stock listed company on November 15, 2019Bazi China announced that its self-developed BTK inhibitor zebutinib (English name: BRUKINSATM, English common name zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for the treatment of at least one Patients with mantle cell lymphoma (MCL).
Zebutini Product Chart
This marks that Zebutinib has become the first anti-cancer drug that has been independently researched and developed by Chinese companies and approved for marketing in the FDA. Strong>; In addition, this is also the first approved independent research and development product in Baekje China.
“New Hope for Lymphoma”
Lymphoma is a group of malignant tumors originating from the lymphoid hematopoietic system. It is one of the fastest growing malignant tumors worldwide. According to the 1818 survey data of the Lancet, 2012 The annual incidence of lymphoid malignancies is about 450,000 . Among the more than 70 subtypes of lymphoma currently known, mantle cell lymphoma (MCL) is more invasive, with a median survival of only three to four years. Most patients are at an advanced stage of diagnosis at the time of diagnosis, and face the dilemma of limited treatment and poor prognosis.
In the past, treating these diseasesThe main use of chemotherapy drugs, response rate and response rate is not high, side effects are not small, the effect is not ideal. This was not a breakthrough until the discovery of the BTK protein (a new target).
It is reported that BTK protein is the core switch of B cell growth, which controls cell expansion, differentiation, apoptosis and migration. And In order to maintain rapid growth, malignant B cells cleverly abduct BTK protein, causing it to continue to activate and promote the growth and spread of cancer cells.
In other words, if develops a targeted drug targeting BTK, thereby inhibiting its activity, it may be able to smoothly control the growth of malignant B cells, thereby blocking related cancers. According to the above principles, the world’s first listed BTK inhibitor (named Idbutinib) was launched in the US in 2013, 2017 Listed in China in the past year, the clinical trial results are excellent. For example, when it is used for chronic leukemia, more than 98% of patients have survived for more than two years, far exceeding the effect of chemotherapy.
Zebutinib, which is introduced today, is a new potent BTK inhibitor. It is also a targeted drug, mainly used to treat some blood cancers caused by malignant proliferation of immune B cells, such as mantle cell lymphoma, chronic lymphocytic leukemia, and Waldorf macroglobulinemia. is currently being used as a single drug or in combination with other therapies to conduct clinical trials in a variety of lymphoma treatments.
Data show that in clinical trials for mantle cell lymphoma, more than 84% of patients treated with zebutinib achieved overall remission.
It is reported that Zebbutinib can be approved by the FDA based on the validity of two clinical trials, including a multicenter Phase 2 clinical trial of patients with relapsed/refractory MCL. In 206, patients received a total response rate (ORR) of 84% after treatment with zebinib, including 59% complete remission (CR), and the median duration of remission (DOR) for this trial was 19.5 months. The median follow-up time was 18.4 months.
Thanks to these data feedbacks, zebbutini has received four “passes” from the FDA before it was officially approved (also known as history) The first Chinese new drug for these four passes: