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, today announced its financial results for full year ended December 31, 2020, along with corporate progress.
"Despite the macro challenges and volatility experienced around the world throughout 2020, Everest Medicines continues to position itself for tremendous long-term growth, including the significant momentum we have gained across our promising pipeline of innovative drug candidates," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We have continued to progress a number of our lead therapeutic candidates, initiating late-stage clinical trials for sacituzumab govitecan-hziy in two difference breast cancer indications with high unmet medical need, completing a Phase 3 bridging trial, and this month, had our New Drug Application (NDA) of eravacycline accepted by the China National Medical Products Administration (NMPA) for the treatment of complicated intra-abdominal infections (cIAI). We have also obtained Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgA nephropathy (IgAN) in China."
"Looking forward, we expect 2021 to be another fruitful year for Everest Medicines," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We will continue to focus on executional excellence across our clinical development programs as we also prepare the Company to become a commercial organization and build on our plans to expand our international business, manufacturing and discovery efforts. We are confident Everest Medicines is well positioned to deliver value for our patients and stakeholders."
Business Review
The Company was successfully listed on The Stock Exchange of Hong Kong, S.A.R., China Limited (the "Stock Exchange") on 9 October 2020 (the "Listing Date"). Since then, the Company has made significant progress advancing its product pipeline and enhancing its business operations.
Sacituzumab govitecan-hziy (TrodelvyTM), our anchor drug candidate in oncology therapeutic area, is a first-in-class TROP-2 directed antibody-drug conjugate (ADC).
Development achievements during the Reporting Period:
- On 2 November 2020, the China NMPA approved a Clinical Trial Application (CTA) for sacituzumab govitecan- hziy for a regional Phase 3 registration clinical trial, EVER-132-002, designed to assess and compare the efficacy and safety of sacituzumab govitecan-hziy versus Treatment of Physician's Choice (TPC) in Asian patients with hormone receptor positive, HER2 negative metastatic breast cancer (HR+/HER2- mBC) who received at least two, and no more than four, systemic chemotherapy regimens. The trial will enroll approximately 330 HR+/HER2- mBC patients in Mainland China, Taiwan, China Region of China and South Korea. On 9 December 2020, the first patient was dosed in this Phase 3 study.
- On 3 November 2020, the first patient was dosed in China into our EVER-132-001 Phase 2b registration clinical trial evaluating 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. EVER-132-001 will enroll approximately 80 mTNBC patients in China. It is worth mentioning that sacituzumab govitecan-hziy has also been included in the newly updated 2020 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.
Post-Reporting Period (expected) milestones and achievements:
- On 6 January 2021, we submitted a NDA to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy for the treatment of patients with mTNBC who have received at least two prior therapies for metas...
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