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Everest Medicines (HKEX 1952.
HK), a biopharmaceutical company focusing on the development and commercialization of innovative drugs, is committed to meeting the unmet medical needs of Greater China and other Asian markets, today announced the China National Medicines The Supervisory Administration has accepted the application for marketing authorization of Gosartuzumab (sacituzumab govitecan-hziy), a new drug for the treatment of locally unresectable advanced or metastatic triple-negative breasts that have received at least two lines or more of previous treatment Adult patients with cancer (at least one of which is a metastatic disease) is currently in the research stage in China
.
Shi Yang, Chief Medical Officer of Genting Xinyao's Oncology Field, said: "This is a highly aggressive and difficult-to-treat disease.
There have always been very limited treatment options.
The overall survival of patients has not changed in the past two decades
.
Global Phase 3 The excellent and robust efficacy and safety results of the ASCENT trial indicate that Gosartuzumab has the potential to become a new and important treatment option for patients with metastatic triple-negative breast cancer in China
Dr.
Bo Kerui, CEO of Genting Sunshine, said: “We are committed to providing this first and leading treatment method for patients with metastatic triple-negative breast cancer in China and the Asia-Pacific region.
We feel very much about saving patients’ lives by achieving this important milestone.
Exciting
.
The speed of achieving this milestone expresses our commitment to accelerate the advancement of global drug innovation in the field of disease treatment that has great clinical demand
The English trade name of Gosartuzumab is Trodelvy®.
It received accelerated approval from the U.
S.
Food and Drug Administration in April 2020 and was fully approved in April 2021.
It is used for treatment that has received at least two lines or more.
At least one of the previously treated locally unresectable advanced or metastatic triple-negative breast cancer is a metastatic disease
.
The Ministry of Food and Drug Safety of South Korea recently granted gosartuzumab the rapid review program designation and orphan drug designation for the treatment of metastatic triple-negative breast cancer
.
In addition, Genting Shinyao announced in January 2021 that it had submitted a new drug listing application for gosartuzumab to the Singapore Health Sciences Authority for the treatment of patients with metastatic triple-negative breast cancer who had received at least two lines of previous treatment.
