The product information on this website is for use only by healthcare professionals and does not constitute promotion or recommendation of any product or treatment. These products may not be approved and/or licensed in all countries where this website is accessible. The registered trademarks are the property of their respective owners. We will from time to time update this website based on actual business conditions. Please refer to the latest version.
Zejula®
Niraparib
ZEJULA (niraparib) is a once-daily small molecule poly (ADP-ribose) polymerase 1/2inhibitor. A PARP inhibitor blocks the ability of cancer cells to repair themselves after cancer cell DNA has been damaged. This inhibition of DNA damage repair can induce synthetic lethality in cancer cells especially with homologous recombination deficiencies (HRDs).
ZEJULA is currently marketed in the United States, Europe, Canada, Australia, Greater China and certain other countries/regions. ZEJULA was first approved in March 2017 by the United States Food and Drug Administration (FDA) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who exhibit a complete or partial response to platinum-based chemotherapy. In 2020, the FDA approved ZEJULA as a monotherapy maintenance treatment for 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, regardless of biomarker status.
ZEJULA was approved in Hong Kong (China) in October 2018 for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete response or partial response to platinum-based chemotherapy, without the need of BRCA testing. In June 2019, ZEJULA was approved in Macau. The China National Medical Products Administration (NMPA) approved ZEJULA in December 2019 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 September 2020, ZEJULA was approved by the NMPA as a maintenance treatment for 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. ZEJULA is the only PARP inhibitor approved by the EMA and the NMPA for newly diagnosed advanced and platinum-sensitive relapsed maintenance treatment for adult patients with platinum-responsive ovarian cancer regardless of biomarker status.
For inquiries about ZEJULA in Greater China, please email medinfo@zailaboratory.com.
Optune®
Tumor Treating Fields
Tumor Treating Fields (TTFields) therapy is a cancer treatment that uses electric fields tuned to selectively target and kill cancer cells by multiple mechanisms (A. Disruption of mitosis B. Downregulation of DNA damage response C. Downstream enhancement of anti-tumor immunity D. Interference of cell movement and migration). TTFields therapy is delivered through a portable medical device. The complete delivery system, called Optune Gio® or Optune Lua®, includes a portable electric field generator, arrays, rechargeable batteries and accessories. Sterile, single-use arrays are placed directly on the skin in the region surrounding the tumor and connected to the electric field generator to deliver therapy.
TTFields is currently marketed in the United States, Europe, Japan, Greater China and certain other countries/regions. In 2015, Optune Gio was approved by the FDA for the treatment of adult patients with newly diagnosed glioblastoma (GBM) in combination with temozolomide (TMZ), a chemotherapy drug, and for adult patients with GBM following confirmed recurrence after chemotherapy as monotherapy treatment. Optune Gio was launched in Hong Kong in 2018. The China NMPA approved Optune Gio in May 2020 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.
In May 2019, Novocure received FDA approval for use of Optune Lua as a Humanitarian Use Device in combination with chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM). In August 2020, Optune Lua was launched in Hong Kong for the treatment of unresectable, locally advanced or metastatic MPM.
For inquiries about Optune in Greater China, please email medinfo@zailaboratory.com.
Qinlock®
Ripretinib
QINLOCK (ripretinib) is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in gastrointestinal stromal tumors (GIST). QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.
QINLOCK is currently marketed in the United States, Canada, Australia, Greater China and certain other countries/regions. In May 2020, the FDA approved QINLOCK for adult patients with GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
In March 2021, the China 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.
For inquiries about QINLOCK in Greater China, please email medinfo@zailaboratory.com.
NUZYRA®
Omadacycline
NUZYRA (omadacycline), a novel tetracycline-class antibacterial with both once-daily oral and IV formulations, is specifically designed to overcome tetracycline resistance and to improve activity across a broad spectrum of bacterial infections, such as those caused by Gram-positive, Gram-negative, atypical, and many other pathogens.
NUZYRA is currently marketed in the United States and Chinese mainland. It was approved by the FDA in October 2018 as a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). It was approved in June 2021 by the FDA as an oral-only dosing regimen for the treatment of adults with CABP. In December 2021, the China NMPA approved NUZYRA as a category 1 innovative drug for the treatment of patients with CABP and ABSSSI.
For inquiries about NUZYRA in Greater China, please email medinfo@zailaboratory.com.
VYVGART®
Efgartigimod
Efgartigimod is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies.
Efgartigimod is currently marketed in the United States, Europe, Japan and China. In December 2021, VYVGART (efgartigimod alfa-fcab) was approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. In June 2023, VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) was approved by the FDA as an injection for subcutaneous (SC) use for the treatment of gMG in adult patients who are AChR antibody positive. In June 2023, VYVGART (efgartigimod alfa injection) was approved by the China NMPA as an add on to standard therapy for the treatment of adult patients with gMG who are AChR antibody positive.
For inquiries about efgartigimod in Greater China, please email medinfo@zailaboratory.com.