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Public company info - Everest Medicines Limited , 01952.HK

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Everest Medicines Limited, 01952.HK - Company Profile
Chairman Wei Fu
Share Issued (share) 293,000,000
Par Currency U.S. Dollar
Par Value 1.0E-4
Industry Biotechnology
Corporate Profile Business Summary: The group is a biopharmaceutical company that integrates licensing, clinical development and commercialization of potentially novel or differentiated therapies to address critical unmet medical needs in Greater China and other emerging Asia Pacific markets. Performance for the year: Net loss for the year ended 31 December 2020 increased to RMB5,658.2 million, from RMB214.5 million for the year ended 31 December 2019. Business Review Since the Company listed on The Stock Exchange of Hong Kong Limited (the “Stock Exchange”) on 9 October 2020 (the “Listing Date”), the Group has made significant progress with respect to its drug pipeline and business operations, including the following milestones and achievements: Sacituzumab govitecan-hziy (TrodelvyTM), the group’s anchor drug candidate in oncology therapeutic area, is a first-in-class TROP-2 directed antibody-drug conjugate (“ADC”). • New drug application (“NDA”) for sacituzumab govitecan-hziy for the treatment of metastatic triple negative breast cancer (“mTNBC”) was submitted and accepted by the Health Sciences Authority (“HSA”) of Singapore in January 2021. • A Phase 2b registrational clinical trial for sacituzumab govitecan-hziy for mTNBC in China was initiated in November 2020, and is currently ongoing. • A Phase 3 Asia study 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 have failed at least two prior chemotherapy regimens was initiated in December 2020, and is currently ongoing. • 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, in October 2020. • China Clinical Trial Application (“CTA”) approval for TROPiCS-04, a global Phase 3 registration clinical trial of sacituzumab govitecan-hziy for metastatic urothelial cancer (“mUC”) was granted by the China National Medical Products Administration (“NMPA”) in January 2021. Nefecon, the group’s anchor drug candidate in cardio-renal therapeutic area, is a novel oral formulation of budesonide in the development for the treatment of IgA nephropathy (“IgAN”). • Nefecon was granted Breakthrough Therapy Designation (“BTD”) for the treatment of IgAN by the China Center for Drug Evaluation (“CDE”) of the NMPA in December 2020. Eravacycline (XeravaTM), is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as first-line empiric monotherapy for the treatment of multidrug resistance (“MDR”) infections, including MDR Gram-negative infections. • China NMPA accepted a NDA for eravacycline for the treatment of complicated intraabdominal infections (“cIAI”) in March 2021. • A Phase 3 bridging clinical trial of eravacycline for the treatment of cIAI in China was completed in October 2020. Prospects: The group will continue to build a leading biopharmaceutical company focused on the development and commercialization of globally innovative therapies, initially in Greater China and other Asia Pacific markets. To achieve the goal, the group will strive to advance the group’s existing drug candidates into and through registrational trials and will seek the most efficient approval pathways. In the meantime, the group will continue to expand the group’s innovative drug portfolio in areas of high unmet medical needs across the group’s chosen therapeutic areas through in-licensing and building organic discovery capabilities. To support the group’s anticipated commercial launch of multiple late-stage products, the group have commenced building a commercial team with deep knowledge of sales, marketing and market access strategies across a range of therapeutical areas. In addition, the group are building the group’s own GMP/GSP manufacturing facilities in China in order to ensure stable and sufficient long term drug supply and to optimize the cost of goods.

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