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Antengene Files New Drug Application for Selinexor in Taiwan to Treat Three Indications in Hematologic Malignancies

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Antengene Files New Drug Application for Selinexor in Taiwan to
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SHANGHAI and HONG KONG, July 14, 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 therapies in hematology and oncology, announced today that it has filed a New Drug Application (NDA) with the Taiwan Food and Drug Administration (TFDA) for selinexor, a premium XPO1 inhibitor, for three indications: in combination with bortezomib and dexamethasone ( XVd), or in combination with dexamethasone (Xd) for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM); and as monotherapy in adult patients with relapsed and/or refractory diffuse large B-cell lymphoma (rrDLBCL), including DLBCL arising from follicular lymphoma, who have received at least two lines of systemic therapy.

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(PRNewsfoto/德琪医药有限公司)

Antengene has filed multiple new drug applications (NDAs) for selinexor Asia-Pacific markets including: China, Australia, South Korea, and Singapore, and was given Priority Review status by China’s National Medical Products Administration (NMPA) and Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFD). This NDA filed in Taiwan marks another milestone in Antengene’s expansion into the APAC markets and the company’s efforts to address the unmet clinical needs of patients with hematologic malignancies.

dr. Jay MeiFounder, Chairman and CEO of Antengene, commented, “Within just nine months, we filed NDAs in six APAC markets, demonstrating our commitment to meeting the unmet needs of patients in the APAC region. Our experienced team has a wealth of experience and in-depth understanding of product registration and commercialization in the Asia-Pacific markets. I am confident that Antengene will deliver on our promise to bring our portfolio of innovative therapies to patients in the APAC markets.”

“Selinexor is an anti-tumor agent with a very novel mechanism of action. It has been approved by the FDA in less than two years for three indications in two tumor types (MM and DLBCL), demonstrating its broad anti-tumor effects.” said Kevin Lynch

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, Chief Medical Officer of Antengene. “Selinexor treatment in combination with dexamethasone continues to have a 25.3% overall response rate (ORR) in patients who have failed five established therapies (penta-refractory) myeloma; and for patients with multiple myeloma who have received at least one prior line of treatment. received, the median progression-free survival (PFS) is 13.9 months, which is significantly higher than that of the control group who received bortezomib-based standard of care. In the subgroup analysis, patients were 65 years of age or older, with renal impairment or high cytogenetics risk still significant benefits from the XVd regimen These are patients who are otherwise very difficult to treat Finally, selinexor monotherapy may enable patients with rrDLBCL to obtain deep and durable responses with a median response time of 23.0 months for patients with complete response We are therefore very optimistic about the potential efficacy benefits of combination schedules with selinexor at DLBCL.”

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Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI) have entered into an exclusive collaboration and licensing agreement to develop and commercialize selinexor and other two XPO1 inhibitors, and a PAK4/NAMPT inhibitor in 17 APAC markets, including mainland China.

About Selinexor (XPOVIO®)

Selinexor, a first-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm, is currently being developed by Antengene, which has exclusive development and commercial rights in certain Asia-Pacific markets, including: Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In july 2019, the U.S. Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of RRMM and in June 2020 approved selinexor as a single agent for the treatment of rrDLBCL. In Dec 2020selinexor also received FDA approval as a combination treatment (XVd) for MM after at least one prior therapy. In February 2021selinexor was approved by the Israeli Ministry of Health for the treatment of patients with RRMM or rrDLBCL and in March 2021, the European Commission (EC) has granted a conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.

Selinexor is the first and only oral SINE compound to be approved by the FDA to date and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid- and late-stage clinical trials of multiple solid tumor indications, including liposarcoma and endometrial cancer. In Nov 2020, at the Connective Tissue Oncology Society 2020 (CTOS 2020) annual meeting, Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double-blind, placebo-controlled, crossover SEAL trial evaluating monotherapy, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO study of selinexor in patients with endometrial cancer has passed the planned interim futility analysis and that the Data and Safety Monitoring Board (DSMB) has recommended that the study proceed as planned without any changes. Top-line SIENDO study results are expected in the second half of 2021.

Antengene is currently conducting five late-stage clinical trials with selinexor in China for the treatment of MM, DLBCL, non-small cell lung cancer and peripheral T and NK/T cell lymphoma.

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About Antengene

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading clinical stage biopharmaceutical company driven by R&D focused on innovative drugs for oncology and other life-threatening diseases. Antengene is committed to providing the most advanced cancer drugs to patients in the Asia-Pacific region and around the world. Since its inception in 2017, Antengene has built a broad and growing pipeline of clinical and preclinical phase assets through partnerships and internal drug discovery, and has obtained 15 new drug discovery approvals (IND) and 6 new drug applications (NDA) submissions in multiple markets in Asia-Pacific. Antengene’s vision is to “Treat patients across borders”. Antengene is focused on and committed to addressing important unmet medical needs by discovering, developing and marketing first-class/best-in-class therapies.

Forward-Looking Statements

The forward-looking statements in this article speak only as of the date on which the statements in this article are made. Except as required by law, we assume no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date the statements are made or to events. You should read this article in its entirety and understand that our actual future results or performance could differ materially from what we expect. In this article, statements of or references to our intentions or those of any of our directors or our company are made as of the date of this article. Each of these intentions may change in light of future developments.

SOURCE Antengene Corporation Limited

The post Antengene Files New Drug Application for Selinexor in Taiwan to Treat Three Indications in Hematologic Malignancies appeared first on Notesradar.

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