Everest Medicines Receives Orphan Drug Designation from the Ministry of Food and Drug Safety in South Korea for Sacituzumab Govitecan-Hziy in Metastatic Triple-Negative Breast Cancer

Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, announced today that the Ministry of Food and Drug Safety  (MFDS) in South Korea has granted Orphan Drug Designation (ODD) 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.

"We are very pleased that the Ministry of Food and Drug Safety in South Korea has granted Orphan Drug Designation for SG, which we believe has the potential to become a transformative treatment for patients around the world living with metastatic triple-negative breast cancer – a highly aggressive disease with limited treatment options," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "Breast cancer is the leading cause of cancer death in women in South Korea, and the incidence for this disease continues to climb rapidly in the region. As we work closely with local regulatory bodies to bring this innovative treatment to patients in South Korea as quickly as possible, we look forward to continuing to expand our international footprint outside of China and adding to our recent New Drug Application submission for SG in Singapore earlier this year."

Orphan Drug Designation is granted by the MFDS to pharmaceuticals used to treat diseases with a prevalence of 20,000 patients or less in the Korean population, pharmaceuticals used to treat diseases for which appropriate therapy and pharmaceuticals have not been developed, or pharmaceuticals that have been significantly improved in terms of safety and/or efficacy, compared to existing alternative therapies.

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.

In South Korea, the growth in breast cancer incidence in recent decades has been one of the fastest in the world.[1] It is the leading cause of cancer death in South Korean women. Statistics from the International Agency for Cancer Research indicate that breast cancer was the leading cause of cancer diagnoses in South Korea in 2020, accounting for 23.7% of total cases.[2]

About Sacituzumab Govitecan-Hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. SG is approved in the United States under the trade name Trodelvy®.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

About Everest Medicines

Everest Medicines is a biopharmaceutical 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. For more information, please visit its website at www.everestmedicines.com. 

[1] Kang SY, Kim YS, Kim Z, Kim HY, Kim HJ, Park S, et al. Breast Cancer Statistics in Korea in 2017: Data from a Breast Cancer Registry. Journal of breast cancer. 2020;23(2):115-28. doi: 10.4048/jbc.2020.23.e24. PubMed PMID: 32395372.

[2] Factsheet, Korea: Globocan 2020: https://gco.iarc.fr/today/data/factsheets/populations/410-korea-republic-of-fact-sheets.pdf