Just now, 4.4 billion prostate cancer blockbuster varieties, Hausen won the first imitation in China

On August 30, according to the official website of the National Medical Products Administration (NMPA), Hausen Pharmaceuticals enzalutamide soft capsule was officially approved for marketing, becoming the first new generic drug for prostate cancer

According to the latest global cancer burden data released by the World Health Organization's International Agency for Research on Cancer (IARC) in 2020, prostate cancer is the second most common male tumor, second only to lung cancer, and its high incidence is 65-80 years old

In addition, due to the low penetration rate of PSA screening and digital rectal examination in China, more than 50% of Chinese prostate cancer patients have metastasized when they are first diagnosed

1.

Enzalutamide was approved by the FDA as early as 2012 for use in metastatic castration-resistant prostate cancer (CRPC) that has been treated with docetaxel, and has since been approved for metastatic CRPC and metastatic hormone-sensitive prostate cancer (MCSPC) patients, becoming the first oral therapy that can simultaneously treat three different forms of advanced prostate cancer including non-metastatic CRPC, metastatic CRPC, and mCSPC

In 2015, the sales of enzalutamide exceeded the 1 billion U.

In November 2019, Enzalutamide was approved by the National Medical Products Administration for use in metastatic castration-resistant prostate cancer (mCRPC) with asymptomatic or mild symptoms after failure of androgen deprivation therapy (ADT) and not receiving chemotherapy.

In addition, enzalutamide has also entered the medical insurance category B catalog through a price reduction of 78% through negotiation.

With the approval of Hausen's enzalutamide generic drug, domestic prostate cancer patients will also usher in a new choice

2.

Johnson & Johnson's Abiraterone Acetate (Zytiga) is an oral AR inhibitor that can block CYP17-mediated androgen production in testis, adrenal glands and prostate tumor tissues, thereby blocking the growth of prostate cancer cells

Erleada is a new generation of androgen receptor (AR) inhibitors that can help block the activity of male hormones (such as testosterone hormone) and delay the progression of the disease

Dalolutamide (Nubeqa) is a non-steroidal androgen receptor (AR) inhibitor with a chemical structure unique to other androgen receptor inhibitors, and consists of two pharmacologically active diastereomers Composition, can competitively inhibit the binding of androgen and AR, AR nuclear translocation and AR-mediated transcription, thereby inhibiting the proliferation of prostate cancer cells and reducing tumor volume

Olapanib is an oral polyadenosine diphosphate ribose polymerase (PARP) inhibitor.

Since 2014, olaparib has been approved for use in four major indications for ovarian cancer, pancreatic cancer, breast cancer and prostate cancer.
Its sales in 2020 have exceeded US$1.
7 billion, ranking first in sales of PARP inhibitors
.

Lukapanib is the first PARP inhibitor approved for marketing.
In May 2020, the FDA accelerated its approval for the use of BRCA gene mutations that have previously received androgen receptor targeted therapy and taxane chemotherapy.
Adult patients with potential resistant prostate cancer (mCRPC)
.
However, although Lucapani can be used for breast and prostate cancer treatment at the same time, its sales have not exceeded 200 million US dollars
.

summary

According to Nature statistics, the total prostate cancer market in 2020 is 11.
2 billion U.
S.
dollars, of which AR targeted therapy dominates (57% of sales)
.
With the impact of the research and development of new drugs and generic drugs, the market will grow at a compound annual growth rate of 11.
6% to $30.
1 billion in 2029.
Among them, abiraterone acetate and enzalutamide are the main androgen receptors ( AR) antagonist market share will continue to grow.
With the approval of PARP inhibitors for prostate cancer indications, it is expected to become the second-largest sales-leading drug category, accounting for 16% of total sales in the main market
.

Back in China, in addition to Hausen, Qilu, Kelun and Shenyang Hongqi Pharmaceutical's generic enzaluamide have all submitted applications for listing, which is expected to change the prostate cancer market
.