PRODUCTS

This information is only for healthcare professionals' reference. These products may not be approved and/or licensed in all countries where this website is accessible.

Zejula?

Niraparib

Zejula? (niraparib, ZL-2306) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2inhibitor.


In September 2020, Zejula? was approved by the China National Medical Products Administration as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. In December 2019, the China NMPA approved the New Drug Application for Zejula? as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Zai Lab obtained the approval for marketing Zejula? in Hong Kong in October 2018 and Macau in June 2019. 


In December 2020, Zejula? was included in the China National Reimbursement Drug List as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

In April 2020, Zejula? was approved by the US FDA as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. It was approved in March 2017 by the US FDA and in November 2017 by the EMA in the European Union under the trade name Zejula? as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. 


For inquiries about Zejula?, please email medinfo@zailaboratory.com

Optune?

Tumor Treating Fields

Optune?, a portable device that delivers tumor treating fields(TTFields), is a novel cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division leading to inhibition of tumor growth and death of tumor cells.


Optune? is intended for the treatment of patients with newly diagnosed glioblastoma (GBM), after surgery and radiotherapy with adjuvant Temozolomide, concomitant to maintenance Temozolomide, and the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and Temozolomide treatment for their primary disease.


In May 2020, the China National Medical Products Administration approved the Marketing Authorization Application for Optune? in combination with temozolomide for the treatment of patients with newly diagnosed GBM, and also as a monotherapy for the treatment of patients with recurrent GBM. Since Dec. 2018, Optune? has been available in Hong Kong (China) for the treatment of GBM. Hong Kong is the fourth market after the United States, the European and Japan to have access to this important new medical technology. 


For inquiries about Optune?, please email medinfo@zailaboratory.com

Qinlock?

Ripretinib

Qinlock? is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. 

 

In March 2021, the NMPA approved Qinlock? for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. In March 2021, the Hong Kong Department of Health approved Qinlock? in Hong Kong for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. In May 2020, the U.S. FDA approved Qinlock? for the treatment of adult patients with advanced GIST who received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.

For inquiries about Qinlock?, please email medinfo@zailaboratory.com