Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the Taiwan, China Food and Drug Administration (FDA) has granted Pediatric and Rare Severe Disease Priority Review Designation for sacituzumab govitecan-hziy (SG), an investigational treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
"Receiving Pediatric and Rare Severe Disease Priority Review Designation for SG in Taiwan, China is an important milestone in the ongoing development of this novel drug candidate, and follows the Orphan Drug Designation previously granted by the Ministry of Food and Drug Safety in South Korea," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We look forward to working closely with regulatory authorities to bring this treatment to patients in Taiwan, China as quickly as possible as we continue to pursue our goal of advancing potentially first-in-class medicines for patients in Greater China and other parts of Asia."
Pediatric and Rare Severe Disease Priority Review Designation is granted by the Taiwan, China FDA to new drugs intended to address unmet medical need and treat a serious condition in which the prevalence of the disease is less than five per ten thousand. According to the Taiwan, China FDA, if a drug meets the criteria required to receive this designation, the drug shall be approved by expedited review process.
Under the trade name Trodelvy®, the U.S. FDA previously granted accelerated approval to SG in April 2020 and then expanded its previous indication with full approval in April 2021 for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. In May 2021 Everest announced China National Medical Products Administration accepted Biologics License Application with priority review for SG for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. That application is currently under review.
About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.
About Everest Medicines
Everest Medicines is a bio pharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.
About Sacituzumab Govitecan-hziy
Sacituzumab govitecan-hziy (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy®.
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