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You are here:  Home >>  News >>  Editors’ Picks >>  Sales of Zai Lab’s PARP Inhibitor Reaching RMB46.90 Million in Macao and Hong Kong of China in 2019

Sales of Zai Lab’s PARP Inhibitor Reaching RMB46.90 Million in Macao and Hong Kong of China in 2019

march 31, 2020 By Caicai

According to the 2019 results and company progress released by Zai Lab on Mar. 19, the total sales revenue of niraparib (trade name: Zejula) reached USD6.60 million (around RMB46.90 million) in Hong Kong and Macao region of China in 2019. Niraparib has been approved in Dec. 2019 in Mainland China and its sales revenue is expected to largely increase in 2020.

As a highly potent and selective poly (ADP-ribose) polymerase (PARP)-1/2 inhibitor, niraparib can bind to PARP and inhibit the dissociation of PARP from DNA-PARP compound to block subsequent DNA repair and play the anti-tumor role.

R&D process of niraparib:

  • Zai Lab reached a strategic cooperation agreement with TESARO in Sep. 2016 to obtain the exclusive R&D and marketing rights of niraparib in the Chinese market, and TESARO reserves the option to participate in the cooperative marketing of niraparib in China;
  • The drug was first approved in the U.S. in Mar. 2017 and in Europe in November of the same year for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy;
  • The drug was successively approved for marketing in Hong Kong and Macao Region of China in Oct. 2018 and June 2019;
  • The drug was approved by the NMPA for marketing in Mainland China in Dec. 2019 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy;
  • The marketing application for a new indication of niraparib has been officially accepted by the CDE in Mar. 2020, which is the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to the first-line platinum-based chemotherapy.

Excellent clinical effects

The large-scale Phase 3 ENGOT-OV16/NOVA Clinical Trial was conducted for niraparib and recruited both patients with BRCA mutations and patients without BRCA mutations.

Clinical trial design: 553 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who were in response to platinum-based treatment were recruited, including 203 with BRCA mutations and 350 without BRCA mutations; they separately received niraparib or placebo treatment according to the ratio of 2:1, with the starting dose of niraparib being 300mg/day.

According to the clinical data:

In patients with gBRCA (germline BRCA) mutations: The median progression-free survival (PFS) of patients in the niraparib group reached up to 21 months, while that of patients in the placebo group reached 5.5 months, meaning that the maintenance treatment with niraparib could reduce the disease progression or death risk by 73%;

In patients without gBRCA mutations but whose tumors tested positive for homologous recombination deficiency (HRD): The median PFS of patients in the niraparib group reached 12.9 months, while that of patients in the placebo group reached 3.8 months, meaning that the maintenance treatment with niraparib could reduce the disease progression or death risk by 55%;

In patients without gBRCA mutations and whose tumors tested negative for HRD: The median PFS of patients in the niraparib group reached 9.3 months, while that of patients in the placebo group reached 3.9 months. See the following figure for the details:

高级别浆液性卵巢瘤

High grade serous ovarian cancer

HRD阳性

HRD positive

tBRCA突变

tBRCA mutation

gBRCA突变

gBRCA mutation

We can see from the above clinical data that niraparib could significantly prolong patients’ PFS as a maintenance treatment no matter in patients with or without gBRCA mutations. Based on this, patients may consider not taking gene detection, however, different gene types correspond to different effects, and gene detection can help doctors or patients estimate the effects. After all, the drug can have better effects in patients with gBRCA mutations.

A total of 4 PARP inhibitors are marketed in the world

A total of 4 PARP inhibitors are marketed in the world, separately olaparib, rucaparib, niraparib, and talazoparib; wherein, olaparib is marketed in Mainland China, and niraparib is marketed in Hong Kong Region of ChinaRegion of China.

Pharmaceutical product name

Trade name

Company

Approval time and indication

Olaparib

Lynparza

AstraZeneca

Dec. 2014: Approved by the FDA and EMA to treat patients with BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy;

Sep. 2017 and May 2018: Separately approved by the FDA and EMA as a second-line maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based drugs;

Jan. 2018: Approved by the FDA to treat patients with BRCA-mutated HER2-negative metastatic breast cancer;

Aug. 2018: Approved by the NMPA as a maintenance treatment of platinum-sensitive relapsed ovarian cancer;

Dec. 2018: Granted by the FDA the orphan drug designation for the treatment of pancreatic cancer

Rucaparib

Rubraca

Clovis

Dec. 2016: Approved by the FDA as a third-line treatment of patients with gBRCA-mutated ovarian cancer;

Apr. 2018: Approved by the FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Niraparib

Zejula

GSK, Zai Lab

Mar. 2017: Approved by the FDA for the maintenance treatment of female patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (the first FDA-approved PARP inhibitor that can be used for treatment without the detection for BRCA mutation or other biomarkers and applies to a broader population; it is the world’s first PARP inhibitor for the second-line treatment of ovarian cancer);

Oct. 2018: Approved in Hong Kong Region of China for the treatment of patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer, who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy;

Dec. 2019: Approved for marketing in Mainland China

Talazoparib

Talzenna

Medivation, Pfizer

Oct. 2018: Approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer (it is called the “most potent” drug in the same class, however, it has not been formally marketed)

 (Source: FDA, EMA, NMPA )

Wherein, olaparib has entered the latest national reimbursement drug list (NRDL) of China, with the related agreement valid until Dec. 31, 2021.

Medical insurance region

No.

Pharmaceutical product name

Dosage form

Pharmaceutical product category

Medical insurance category

Supplementation

Remarks

NRDL (2019)

69 (negotiated)

Olaparib

Oral regular dosage form

Oncology drugs and immunomodulatory agents>Oncology drugs>Other oncology drugs>Other oncology drugs

(XL>XL01>XL01X>XL01XX)

Category B

View

*; Only for platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary…

 (Source: db.yaozh.com)

Hengrui’s PARP inhibitor: fluzoparib has been applied for marketing

It is worth mentioning that Hengrui’s PARP inhibitor: fluzoparib has been applied for marketing and is expected to also be approved for marketing in 2020.

Acceptance No.

Pharmaceutical product name

Pharmaceutical product type

Application type

Registration class

Enterprise name

Acceptance date

CYHS1900033

Fluzoparib Capsules

Chemical drug

New drug

1

Jiangsu Hengrui Medicine Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd.

Oct. 29, 2019

 (Source: CDE)

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