In 2020, it will sell for 1.776 billion U.S. dollars, and AstraZeneca Olapali will be approved for new indications in China

Recently, the official website of NMPA showed that the domestic 5.
1-type listing application of AstraZeneca PARP inhibitor olaparib (the relevant acceptance number is JXHS2100002) has entered the administrative approval stage, and it is expected to be officially approved soon.
The new indications are: single Drug treatment of adult patients with metastatic castration-resistant prostate cancer who carry BRCA1/2 mutations (germline and/or somatic cell lines) and who have progressed after previous treatment with new hormone drugs
.

Olaparib (Lynparza) is a pioneering oral poly ADP ribose polymerase (PARP) inhibitor developed by AstraZeneca, which uses defects in the DNA repair pathway to preferentially kill cancer cells
.

In July 2017, AstraZeneca and Merck reached a global strategic cooperation in oncology to jointly develop and commercialize Lynparza and another MEK inhibitor selumetinib

Lynparza is the first PARP inhibitor approved globally, and has been approved for multiple indications in the United States so far:

(1) BRCA germline mutant advanced ovarian cancer patients who have failed at least 3 chemotherapy treatments in the past (2014/14);

(2) For the maintenance treatment of adult patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, these patients are in complete or partial remission after previous platinum chemotherapy (2017/08);

(3) For the treatment of BRCA-positive and HER2-negative metastatic breast cancer patients who have received chemotherapy in the past (2018/01);

(4) As a maintenance therapy, it is used for BRCA mutation (BRCAm) advanced ovarian cancer patients who have received first-line platinum-containing chemotherapy and are in complete or partial remission (2018/12);

(5) As a single-agent therapy, it is used as the first-line maintenance treatment for adult patients with metastatic pancreatic cancer who have received first-line platinum chemotherapy for at least 16 weeks without progression and carry germline BRCA mutations (gBRCAm) (2019/12);

(6) Combination with bevacizumab, first-line maintenance therapy, first-line platinum-containing chemotherapy, complete or partial remission, HRD-positive advanced ovarian cancer (epithelial cancer) defined by harmful or suspected harmful BRCA mutations and/or genomic instability Adult patients with sexual ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (2020/05);

(7) It is used for the progress of the disease after receiving new hormone therapy (NHT) enzalutamide or abiraterone (abiraterone), carrying harmful or suspected harmful germline or somatic homologous recombination repair gene mutations (HRRm) , Patients with metastatic castration-resistant prostate cancer (mCRPC) (2020/05)
.

In addition, OlympiA, a phase 3 study of Lynparza for the treatment of high-risk HER2-negative early breast cancer with germline BRCA mutations (gBRCAm), also achieved positive results: After 3 years of treatment, 85.
9% of patients in the olaparib group did not have cancer recurrence.
Or new cancer (77.
1% of the Vs control group), and olaparib also reached the key secondary endpoint of remote disease-free survival, reducing the risk of remote disease recurrence or death by 43%
.

It is expected that Lynparza is expected to be approved for the treatment of early breast cancer in the future

       Since its launch, Lynparza has been approved for the treatment of ovarian cancer in 78 countries around the world, 76 countries have been approved for the treatment of metastatic breast cancer, and 55 countries have been approved for the treatment of pancreatic cancer
.

According to AstraZeneca’s financial report, Lynparza’s sales have increased year by year, reaching US$1.

       In China, olaparib was first approved by the NMPA in December 2018 for the maintenance of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in adult patients with platinum-containing chemotherapy after achieving complete or partial remission.
Treatment, the trade name is Lipzol
.

In December 2019, the drug was approved by the NMPA for first-line platinum-based chemotherapy in newly-treated adult patients with germline or somatic BRCA mutations (gBRCAm or sBRCAm) advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer Maintenance treatment after complete remission or partial remission is achieved

       In the future, with the approval of new indications for prostate cancer in China and the expansion of the scope of medical insurance payment, olaparib's domestic sales are expected to reach new highs
.

In 2020, thanks to the promotion of olaparib and other drugs, AstraZeneca's revenue in China ranked first in the revenue ranking of global pharmaceutical companies in China with 5.

Domestic PK imports, domestic PARP inhibitor competition is fierce

       Speaking of PARP inhibitors, 4 types of PARP inhibitors have been approved in China, namely AstraZeneca/Mersk’s olaparib, Merck/Tesaro/Zi Lab’s nirapa, Hengrui Medicine’s fluzoparib and BeiGene’s Pascal Mipali
.

Among them, niraparib has also been approved for two indications in China, namely, maintenance treatment for adult patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that are completely or partially remitted by platinum-containing chemotherapy, and advanced epithelial cancer Adult patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer are maintenance treatment after first-line platinum-containing chemotherapy has achieved complete or partial remission

       PARP inhibitors approved in China

       According to public information, the price of a box of olaparib (56 tablets, 150mg) has dropped from 24,790 yuan at the beginning of the market to 5712 yuan.
According to the patient's self-pay ratio (5%-40%), the monthly treatment fee is between 571 and 4570.
Yuan between
.

The average monthly treatment cost of Nirapali before being included in the medical insurance was about 25,000 yuan.

       In terms of indications, there is a crossover between domestic PARP inhibitors and imported PARP inhibitors, and fierce competition is bound to start in the future, but who is the ultimate winner depends on market performance
.
In addition, there are still many PARP inhibitors under study in China, such as Senaparib of Yingpai Pharmaceutical and SC10914 of Qingfeng Pharmaceutical
.