Aug.17.2022, Singapore ------ Everest Medicines (HKEX: 1952.HK, Everest), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has entered into an agreement with Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc. (Nasdaq: GILD), whereby Immunomedics will obtain exclusive rights to develop and commercialize Trodelvy® (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.
In China mainland and Singapore, Trodelvy is approved in June and January 2022 for the treatment of 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. Gilead continues to work closely with regulatory bodies in Hong Kong, South Korea and Taiwan, where New Drug Applications, filed by Everest Medicines for metastatic TNBC, are currently under review.
Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.
Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of 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. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Under Everest’s licensing agreement with Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, Trodelvy was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer and was also included in the updated 2022 Guidelines for Breast Cancer Diagnosis and Treatment of the Chinese Society of Clinical Oncology in April.
*The TRODELVY trademark is used under license from Gilead Sciences, Inc.
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in 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 eleven 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.
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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.