Everest Medicines Initiates Submission Of New Drug Application In Singapore For Sacituzumab Govitecan-Hziy For The Treatment Of Metastatic Triple-Negative Breast Cancer

Shanghai /PRNewswire/ - Everest Medicines (HKEX 1952.HK), 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 it has initiated the submission of a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

"Breast Cancer is Singapore's number one leading cause of cancer death in women and TNBC accounts for 15-20% of all breast cancer in Singapore. This milestone marks the first of a series of planned NDA submissions for sacituzumab govitecan-hziy in Everest's licensed territory, which also includes Greater China, South Korea, and certain additional Southeast Asian countries/regions," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "We look forward to making progress towards approval of sacituzumab govitecan-hziy in Singapore as we simultaneously advance our clinical development and regulatory programs in other parts of the territory in an effort to make this innovative treatment available to patients with this devastating disease across a broad range of emerging Asia Pacific."

"We are excited to achieve this important submission, which supports our larger business strategy to build a strong commercial presence in international markets in and outside of China as we work to connect and accelerate global pharmaceutical innovation for patients in the Asia Pacific region," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

About Sacituzumab Govitecan-Hziy
Sacituzumab govitecan-hziy 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. Sacituzumab govitecan-hziy was granted accelerated approval by the U.S. FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. According to data from the pivotal Phase 3 ASCENT trial, treatment with sacituzumab govitecan-hziy reduced the risk of death by 52% (p <0.0001), reduced the risk of disease progression by 59% (p <0.0001) and increased median overall survival (12.1 vs. 6.7 months) compared with chemotherapy. Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

In October 2020, sacituzumab govitecan-hziy 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 Triple-Negative Breast Cancer
Triple-Negative Breast Cancer (TNBC) is a highly aggressive disease and accounts for approximately 15-20% of all breast cancer types worldwide.^i-iii The median age of breast cancer diagnoses tends to be younger in China 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.^iv-viii

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.

^i. DeSantis CE, Fedewa SA, Goding Sauer A, Kramer JL, Smith RA, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin 2016;66:31-42.

^ii. 4. Plasilova ML, Hayse B, Killelea BK, Horowitz NR, Chagpar AB, Lannin DR. Features of triple-negative breast cancer: analysis of 38,813 cases from the National Cancer Database. Medicine (Baltimore) 2016;95(35):e4614.

^iii. Kohler BA, Sherman RL, Howlader N, et al. Annual report to the nation on the status of cancer, 1975-2011, featuring incidence of breast cancer subtypes by race/ ethnicity, poverty, and state. J Natl Cancer Inst 2015;107(6):djv048.

^iv. Khosravi-Shahi P, Cabezón-Gutiérrez L, Custodio-Cabello S. Metastatic triple negative breast cancer: optimizing treatment options, new and emerging targeted therapies. Asia Pac J Clin Oncol 2018;14: 32-9.

^v. Brufsky A, Valero V, Tiangco B, et al. Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial. Breast Cancer Res Treat 2012;133: 1067-75.

^vi. Perez EA, Patel T, Moreno-Aspitia A. Efficacy of ixabepilone in ER/PR/HER2- negative (triple-negative) breast cancer. Breast Cancer Res Treat 2010;121:261-71.

^vii. Park IH, Im SA, Jung KH, et al. Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: PROCEED trial (KCSG BR 11-01). Cancer Res Treat 2019; 51:43-52.

^viii. Twelves C, Awada A, Cortes J, et al. Subgroup analyses from a phase 3, openlabel, randomized study of eribulin mesylate versus capecitabine in pretreated patients with advanced or metastatic breast cancer. Breast Cancer (Auckl) 2016;10:77- 84.