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Antengene’s Xpovio Receives Marketing Approval in Indonesia
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced receiving marketing approval in Indonesia for its Xpovio (selinexor). The approval grants the drug three indications in the Southeast Asian country. Indications ApprovedThe drug is approved for: Drug BackgroundXpovio, the world’s first and only FDA-approved oral XPO1 inhibitor, was discovered by US-based…
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Antengene to Boost T Cell Engager Platform with AI Investment and DeepSeek Deployment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced plans to increase investment in establishing a specialized artificial intelligence (AI) department. The move includes deploying DeepSeek, a Chinese advanced AI model for complex reasoning and natural language processing, to accelerate the development of its T cell engager (TCE) platform with spatial…
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Antengene’s Xpovio Included in Taiwan’s NHI Drug List for Myeloma Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that its Xpovio (selinexor), the world’s first FDA-approved oral XPO1 inhibitor, has been included in Taiwan’s National Health Insurance (NHI) drug list. The approved indication is for use in combination with bortezomib and dexamethasone in adults previously treated with one therapy for…
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Antengene’s Xpovio Showcases Positive Results in Phase III BENCH and Phase I/II TOUCH Studies at ASH 2024
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China-based Antengene Corporation Limited (Antengene, HKG: 6996) announced the presentation of the latest results from two clinical studies for its Xpovio (selinexor) at the 2024 American Society of Hematology Annual Meeting (ASH 2024). Phase III BENCH Study ResultsThe Phase III BENCH study evaluated the efficacy and safety of the selinexor,…
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Antengene’s Xpovio Receives NDA Approval in Thailand for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
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Antengene’s Xpovio Receives NDA Approval in Malaysia for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval of its New Drug Application (NDA) for Xpovio (selinexor) in Malaysia. The drug is now approved for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (r/r…
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Antengene’s Xpovio Secures NMPA Approval for R/R Diffuse Large B-Cell Lymphoma
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received new indication approval from the National Medical Products Administration (NMPA) for its drug Xpovio (selinexor). The drug is now approved for the treatment of adult patients with recurrent or refractory (R/R) diffuse large…
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Antengene’s Xpovio Included in South Korea’s NHIS Reimbursement Drug List
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that South Korea’s National Health Insurance Service (NHIS) has included its drug Xpovio (selinexor) in the medical insurance reimbursement drug list, effective from July 1, 2024. The drug is indicated for the treatment of adult patients with…
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Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
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Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic…
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Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
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Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval from the regulatory authority in Macau for its product Xpovio (selinexor). This approval is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R…
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Antengene’s Anti-CD24 Antibody ATG-031 Gets Green Light for Phase I Study at MD Anderson
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Antengene Corporation Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that the Institutional Review Board (IRB) of The University of Texas MD Anderson Cancer Center in Houston, Texas, has approved a Phase I study for its best-in-class anti-CD24 antibody, ATG-031. The clinical study, codenamed the PERFORM trial and led…
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Antengene’s Xpovio Price Reduced by 37% in China, Aiding Patient Access
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Antengene Corp., Ltd (HKG: 6996) has announced a significant price reduction for its drug Xpovio (selinexor) in China, cutting the cost by 37%. The new pricing for the 20mg*12 tablet box is RMB 14,135, and for the 20mg*16 tablet/box, it is RMB 18,649.67, down from the previous prices of RMB…
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Antengene Corp. Secures Licensing Deal with Hansoh Pharmaceutical for Xpovio in China
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced a significant licensing agreement with compatriot firm Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) concerning the drug Xpovio (selinexor). This agreement outlines the roles and responsibilities of both companies in the Chinese market. Responsibilities and Financial Terms of the AgreementAccording…
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Antengene Corp. Receives FDA Fast-Track Designation for Xpovio in Myelofibrosis Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving fast-track designation from the US Food and Drug Administration (FDA) for its drug Xpovio (selinexor) in the treatment of myelofibrosis (MF), an indication that covers primary myelofibrosis, myelofibrosis after primary thrombocytosis, and myelofibrosis after polycythemia vera. Background on Xpovio and…
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Antengene Initiates Phase I ERASER Study for ATG-017 in Combination with Nivolumab
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced the first patient dosing in its Phase I ERASER study. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ATG-017 in combination with nivolumab for the treatment of advanced solid tumors. The trial is conducted…
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Antengene Corp., Ltd Receives Hong Kong NDA Approval for Xpovio in Relapsed Multiple Myeloma
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA) approval from the Department of Health of Hong Kong. The approval is for the use of Xpovio in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior…
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Antengene’s Xpovio Combination Therapy Approved for Reimbursement in Australia for R/R MM
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China-based biotech Antengene Corp., Ltd (HKG: 6996) has revealed that Australia’s Pharmaceutical Benefits Scheme (PBS) will reimburse the firm’s Xpovio (selinexor) plus bortezomib and dexamethasone combination therapy for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM), specifically for those who have previously received one other therapy. This…
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Antengene’s ATG-022 Earns FDA Orphan Drug Designations for Gastric and Pancreatic Cancers
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China-based Antengene Corporation Limited (HKG: 6996) has announced that its in-house discovered and developed antibody drug conjugate (ADC), ATG-022, targeting Claudin 18.2, has been granted two Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. This brings the…
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Antengene’s First-in-Class CD24 mAb ATG-031 Gets US FDA Approval for Phase I Study
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Antengene Corp., Ltd (HKG: 6996) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its first-in-class CD24 monoclonal antibody (mAb), ATG-031. The Phase I PERFORM study is designed to assess the safety, tolerability, pharmacological properties, immunogenicity,…
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Antengene Submits Market Approval Filing for Xpovio in Indonesia for Multiple Myeloma and Lymphoma
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Antengene Corp., Ltd (HKG: 6996) has announced a market approval filing in Indonesia for its drug Xpovio (selinexor). The company is seeking approval for the treatment of relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Background on Xpovio and Its ApprovalsDiscovered…
