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Everest Medicines Announces Approval of Clinical Trial Application by China National Medical Products Administration to Initiate China Registration Study of Sacituzumab Govitecan for the Treatment of

April 22, 2020

APRIL 22, 2020

  • - Approval allows Everest Medicines to enroll patients in registration clinical study in China
  • - The US FDA granted Fast Track Designation and Breakthrough Therapy Designation to sacituzumab govitecan for patients with metastatic triple-negative breast cancer (mTNBC), who have failed prior therapies for metastatic disease

SHANGHAI, China, April 22, 2020 (GLOBE NEWSWIRE) -- 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 that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China approved a Clinical Trial Application (CTA) in China for sacituzumab govitecan. With this CTA, Everest Medicines plans to initiate in the first half of 2020 a pivotal Phase 3 clinical trial of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

Sacituzumab govitecan is a novel, potential first-in-class antibody-drug conjugate targeting the Trop-2 receptor expressed by many solid cancers and delivering the moderately-toxic drug, SN-38, directly to the tumor and the tumor micoenvironment. The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Breakthrough Therapy Designation to sacituzumab govitecan for the treatment of patients with mTNBC who have received prior therapies for metastatic disease. The FDA is currently reviewing a biologics license application for the therapeutic candidate submitted by Immunomedics for later-line mTNBC.

“Metastatic triple-negative breast cancer is a devastating disease with limited therapeutic options and an overall survival rate that has remain unchanged for two decades,” said Yang Shi, MD, Chief Medical Officer for Oncology and Immunology at Everest Medicines. “We are pleased to receive CTA approval of sacituzumab govitecan, which represents an opportunity to advance a potential novel treatment option for patients win China.”

Under a licensing agreement with  licensing agreement with Immunomedics, Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

“Everest is excited to advance development of this important medicine for patients. The speed at which this regulatory milestone was achieved is a testament to our team’s leadership and commitment to bring the latest therapeutic innovations to people in Greater China in disease areas with urgent medical need,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “We look forward to realizing the full potential of sacituzumab govitecan and its novel mechanism of action across other important cancer indications in China and other Asia geographies.”

TNBC is a highly aggressive disease and accounts for approximately 15% 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 TNBC molecular subtype has increased to 20.3% 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 Sacituzumab Govitecan

Sacituzumab govitecan is an antibody–drug conjugate (ADC) that links SN-38, the active metabolite of irinotecan, via a hydrolyzable linker to a humanized monoclonal antibody against the human trophoblast cell-surface antigen 2 (Trop-2). Trop-2 is a membrane antigen that is frequently over-expressed in many common epithelial cancers. Sacituzumab govitecan delivers high concentrations of the SN-38 payload to tumors. Sacituzumab govitecan has been granted Breakthrough Therapy designation by the US FDA and its BLA is under FDA review as a treatment for patients with metastatic triple-negative breast cancer in the later-line setting.

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. For more information, please visit its website at www.everestmedicines.com.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Media in US and Europe:
Darcie Robinson
Vice President
Westwicke PR
(203) 919-7905
darcie.robinson@icrinc.com

Media in China:
Edmond Lococo
Senior Vice President
ICR Asia
+86 (10) 6583-7510
edmond.lococo@icrinc.com

Jianfeng Pei
Vice President
ICR Asia
+86 139 1182 4874
jianfeng.pei@icrinc.com

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