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Shanghai with Hong Kong, July 13, 2021 /PRNewswire/ – Antengene Corporation Limited (“Antengene”, HKEx code: 6996.HK), a leading innovative biopharmaceutical company dedicated to the discovery, development and commercialization of world-class and/or first-class hematology And/or the oncology company announced today that it has submitted a new drug application (NDA) to the Taiwan Food and Drug Administration (TFDA) for Selinexor, a first-in-class XPO1 inhibitor for three indications: and Combination of bortezomib and dexamethasone (XVd), or combined with dexamethasone (Xd) for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM); as a single agent for the treatment of relapsed and/ Or adult patients with refractory diffuse large B-cell lymphoma (rrDLBCL), including DLBCL caused by follicular lymphoma, have received at least two lines of systemic therapy.
Antengene has submitted multiple new drug applications (NDAs) for selinexor Asia-Pacific The market includes China, Australia, Korea, with SingaporeAnd was granted priority review status China’s Orphan drug certification by National Medical Products Administration (NMPA) and Ministry of Food and Drug Safety Korea (MFDS).The confidentiality agreement was submitted in Taiwan This marks another milestone in Antengene’s expansion in the Asia-Pacific market and the company’s efforts to address the unmet clinical needs of patients with hematological malignancies.
Dr. MajorThe founder, chairman and CEO of Antengene commented: “In just nine months, we have submitted NDAs in six Asia-Pacific markets, which demonstrates our commitment to addressing the unmet needs of patients in the Asia-Pacific region. We are experienced The team has extensive experience and in-depth insights into product registration and commercialization Asia-Pacific market. I believe that Antengene will fulfill our promise to bring our innovative therapy portfolio to patients in the Asia Pacific market. “
“Selinexor is an anti-tumor drug with a highly novel mechanism of action. In less than two years, it has been approved by the FDA for three indications for two tumor types (MM and DLBCL), proving its wide range Anti-tumor effect,” said Kevin…
The full story on Benzinga.com
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