Enzaluamine will also have a new adaptation after it was approved at home

The text Dopine recently, Astellas prostate cancer drug Nzaluamine softgel in the country's second listing application (the relevant acceptance number is JXHS1900163) in the NMPA status changed to "in-approval", which means that its new adaptive disease will soon be approved, and according to the listing application to be included in the priority review of the reasons for its upcoming approval of the new adaptation is non-transferable despotic prostate cancer (nmCRPC).
Xtandi is an androgen-induced signaling inhibitor that directly targets androgen-transmitted (AR) and functions in three steps along the AR signaling path: (1) inhibits androgens Binding - androgen binding induces structural changes that trigger the activation of the subject; (2) preventing nuclear transfer - AR shift to the nucleation is an essential step in ar-mediated gene regulation; and (3) weakening DNA binding - AR-DNA binding is essential for regulating gene expression.
the drug was first developed jointly by Medivation and Astellas, but in August 2016 Pfizer made revenue from its $14 billion acquisition of Medivation.
Xtandi was first approved by the FDA in August 2012 for the treatment of metastatic desopathic prostate cancer (mCRPC) that had been treated with dositroxine and yew alcohol, and in 2014 was approved for mCRPC without chemotherapy.
July 2018, the drug was approved by the FDA for the treatment of non-metastatic desopathic prostate cancer (nmCRPC), and then in December 2019 it was approved by the FDA for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
in countries already on the market, Nzaluamine is the standard treatment for men with metastatic desopathic prostate cancer.
2012, more than 420,000 patients worldwide have used the drug.
Xtandi's sales are also growing year-on-year, with global sales expected to be $3.624 billion in 2018 and $4.3 billion in 2019.
However, the drug was approved late in the country and was only approved by the NMPA in November 2019 for adult patients with androgen deprivation therapy (ADT) who failed asymptomatically or had mild symptoms and did not receive chemotherapy for metastatic desopathic prostate cancer (CRPC), known as an acotatin.
the future, with the approval of the new condition, Nzaluamine will become the first oral drug in the country to be approved for the treatment of metastatic and non-metastatic destay resistance to prostate cancer.
In addition, according to the insight database, Astellan Zaluamine registered a total of four clinical trials in China, including mCRPC, nmCRPC and mHSPC, the drug is also expected to be submitted in the future mHSPC new adaptive applications.
according to the Insight database, Nzaluamine's compounds are patented domestically until 2026.
however, the domestic Howson Pharmaceuticals has submitted a listing application for Nzaluamine softgels under four generic drugs.
, Sichuan Colum, Qilu Pharmaceuticals and Shenyang Red Flag Pharmaceuticals are also conducting BE trials.
, referring to Nzaluamine, another second-generation AR inhibitor, apatamine, had to be mentioned.
is also a heavyweight drug in prostate cancer, with renowned pharmaceutical market researcher Evaluate Pharma predicting global sales of $2.115 billion by 2024.
apatamine was approved in China earlier than ntzaluamine and was approved by the NMPA in September 2019 for the treatment of nmCRPC, a product called Anson.
, in August this year, the drug was approved for the treatment of mCSPC.
the two drugs are expected to stage a "fairy fight" in the domestic prostate cancer field in the future, given the complexity of the adaptive population.