On December 3, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported that the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include ZEJULA (niraparib) as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status (Press release, Zai Laboratory, DEC 3, 2021, View Source [SID1234596445]).
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"A key part of Zai Lab’s mission is to bring transformative medicines to patients in China," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The inclusion of ZEJULA in the NRDL for first-line maintenance treatment of ovarian cancer is an important step in achieving that mission. We are grateful for this action by the NHSA to make ZEJULA more accessible to Chinese patients with ovarian cancer."
"NHSA reimbursement will increase ZEJULA’s availability for many patients in need across China," said William Liang, Chief Commercial Offer. "It is the only PARP inhibitor approved as monotherapy for first-line and recurrent maintenance therapy for ovarian cancer patients regardless of biomarker status in China. This action underscores ZEJULA’s clinical value for a broad range of ovarian cancer patients."
In November 2021, Zai Lab announced that the Phase 3 PRIME study of ZEJULA as maintenance therapy met its primary endpoint and demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit with a manageable safety profile in Chinese patients with newly diagnosed advanced ovarian cancer following a response to platinum-based chemotherapy, regardless of biomarker status.
In December 2020, ZEJULA was included in the NRDL as a maintenance treatment of adult patients with platinum-sensitive, recurrent ovarian cancer.
About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic cancers in China, with over 55,000 newly diagnosed cases and 37,000 deaths in China annually1. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. New agents that prolong the duration of response following platinum-based treatment and delay the relapse of ovarian cancer will benefit patients with ovarian cancer in China.
Globocan 2020.
About ZEJULA (niraparib)
ZEJULA (niraparib) is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the maintenance treatment of adult patients with advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first- and second-line platinum-based chemotherapy.
Zai Lab has completed several studies in Chinese patients with ovarian cancer:
In November 2021, Zai Lab announced positive topline results from the company’s Phase 3 PRIME study of ZEJULA as maintenance therapy for Chinese patients with first-line platinum-responsive, advanced ovarian cancer, regardless of biomarker status.
In September 2020, Zai Lab announced that ZEJULA demonstrated a significant PFS benefit with an improved safety profile in the company’s Phase 3 NORA study of ZEJULA as maintenance therapy for Chinese patients with platinum-sensitive, recurrent ovarian cancer, regardless of biomarker status.
A Phase 1 pharmacokinetic (PK) study of ZEJULA was conducted in Chinese patients with ovarian cancer.
ZEJULA is also being evaluated in China in a Phase 1b/2 study in combination with tebotelimab (PD-1 x LAG-3 DART molecule) for advanced gastric cancer, triple negative breast cancer, biliary tract cancer, and endometrial cancer.
Zai Lab has a collaboration and license agreement with GSK for the development and commercialization of ZEJULA in mainland China, Hong Kong, and Macau.