Antengene Announces NDA for ATG-010 (Selinexor) Granted Priority Review by China's NMPA

By Benzingaabout 24 hours ago

SHANGHAI and HONG KONG, Feb. 23, 2021 /PRNewswire/ -- Antengene Corporation Limited (“Antengene“, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, today announced that China's National Medical Products Administration (NMPA) has granted priority review to the New Drug Application (NDA) for ATG-010 (selinexor, XPOVIO®), a first-in-class selective inhibitor of nuclear export (SINE) compound, for the treatment of patients with relapsed/refractory multiple myeloma (rrMM).

ATG-010 is the first approved SINE compound in the world. It induces the apoptosis of cancer cells in vitro and in vivo by causing the nuclear storage and activation of tumor suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins while normal cells are not affected. The US Food and Drug Administration (FDA) has approved ATG-010 (selinexor) as a novel treatment in three indications within eighteen months. Five ATG-010 regimens for patients with multiple myeloma or diffuse large B-cell lymphoma have also been added to the National Comprehensive Cancer Network (NCCN®) Guidelines. Antengene has completed patient enrollment for the registrational clinical trial in rrMM in mainland China and has submitted NDAs for ATG-010 in five APAC markets including Australia, South Korea and Singapore over the past six months.

“ATG-010 is a novel option for the treatment of rrMM and we are pleased that it has been granted priority review by the NMPA. The target of ATG-010, XPO1, is the only proven nuclear export protein target in clinical development and we believe that ATG-010 has potential to meet the huge unmet medical needs in hematological malignancies and solid tumors.“ said Dr. Jay Mei, M.D., PhD., Founder, Chairman and CEO of Antengene. “rrMM still remains ...

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