공시 • May 16
Antengene Announces Commercial Availability of XPOVIO® (Selinexor), for the Treatment of Relapsed/Refractory Multiple Myeloma, Prescribed for the First Time Across Mainland China
Antengene Corporation Limited announced that its first commercialized product, the oral XPO1 inhibitor XPOVIO® (selinexor) approved for the treatment of relapsed/refractory multiple myeloma (R/R MM), has officially entered multiple hospitals, online-hospitals, and direct-to-patient (DTP) pharmacies in mainland China and widely prescribed in the country for the first time at Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai Jiaotong University School of Medicine Renji Hospital, Tongji Hospital of Tongji University, Shanghai Sixth People's Hospital, Shanghai Jiaotong School of Medicine St. Luke's Hospital, and the PLA Naval Medical Center. By the end of May, selinexor will be expeditiously rolled out to approximately 600 hospitals and 105 DTPs in over 30 provinces, autonomous regions, and municipalities including Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang, Henan, and Shandong, providing Chinese MM patients across the country with an easy to access to this new treatment option. Multiple myeloma (MM) is the second most common hematologic malignancy in China, accounting for approximately 10% of all hematologic malignancy incidences. The number of new diagnoses of MM has been rising year after year, thus presenting a rapidly growing medical need.[1] Strikingly, more patients are diagnosed at younger ages. The prior standard of care for MM has been based on treatment with a combination of therapies including dexamethasone, proteosome inhibitors, immunomodulatory agents and an anti-CD38 monoclonal antibody. Despite the availability of these therapies, MM remains a hard-to-treat cancer. Most patients with MM experience at least one relapse,[2][3] with each relapse resulting in a shorter duration of response. In particular, those patients relapsed after third- or forth-line treatments have a poor prognosis and limited treatment options,[4][5] with a median progression-free survival (PFS) of only 3-6 months and an overall survival (OS) of about 6 months. In July 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application (NDA) for XPOVIO®, the world's first oral selective inhibitor of nuclear export protein-1 (XPO1) approved for combination use with low-dose dexamethasone for the treatment of patients with R/R MM who have received at least four prior therapies and whose disease is refractory to at least two proteosome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody. Less than a year after that, the FDA granted approval for another indication for XPOVIO®, as a monotherapy for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). In December 2020, XPOVIO® obtained its third FDA-approved indication, for combination use with bortezomib and dexamethasone in treatment of adult patients with MM who previously received at least one prior therapy. To address the urgent medical need of MM patients in China, Antengene raced against time and dedicated significant resources to bringing this novel drug to the country. On December 14, 2021, selinexor was approved through a priority review process by the China National Medical Products Administration (NMPA), for the treatment of adults with R/R MM who previously received treatment with at least three agents including a proteosome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. To make selinexor available to Chinese patients as swiftly as possible, Antengene has built world-class operations and commercial teams and established extensive strategic collaborations with Shanghai Pharmaceutical Lin-Gang Special Area Co., Ltd, the exclusive importer and national distributor of selinexor in China, and the provincial subsidiaries of Shanghai Pharmaceutical Co., Ltd, a Tier I distributor of selinexor in China, as well as a few other leaders in the across the product supply chain, such as DTP pharmacies under SPH Health Commerce Co., Ltd, the headquarters and provincial subsidiaries of SinoPharm Distribution Co., Ltd, China Resources Hunan Ruige Pharmaceutical Co., Ltd, Medbanks, LinkDoc, and Zhejiang INTYN Pharmacy Franchise Co. Ltd. Upon approval, Antengene promptly mobilized an internal team and external partners to secure supply chain readiness covering customs clearance, warehousing, quality assurance, distribution, and transportation. This coordinated effort paved the way for the rapid clinical application of selinexor across mainland China, hence benefiting many patients in need.Selinexor is the world's first orally-available, selective inhibitor of the nuclear export protein XPO1. Selinexor promotes the intra-nuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, down-regulating the levels of multiple oncogenic proteins, and activating the glucocorticoid receptors (GR) pathway, ultimately resulting in antitumor effects. Utilizing this innovative mechanism of action, selinexor has demonstrated combinatory potential with multiple therapeutic agents including dexamethasone, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), daratumumab, cyclophosphamide, adriamycin, and melphalan. To date, six selinexor-based regimens have received a total of 11 recommendations by numerous leading medical societies, including the National Cancer Care Network (NCCN) Guidelines, the Guidelines for the Diagnosis and Danagement of Multiple Myeloma in China, and the European Society of Medical Oncology (ESMO) Guidelines. At present, Antengene is conducting a total of 10 clinical studies of selinexor in mainland China (3 are being jointly conducted by Antengene and Karyopharm Therapeutics Inc., including several late-stage clinical trials, for the treatment of a range of relapsed/refractory hematologic malignancies and advanced solid tumors such as relapsed/refractory multiple myeloma, relapsed/refractory diffused large B-cell lymphoma and indolent lymphoma, relapsed/refractory T and NK-cell lymphoma, and recurrent/metastatic cervical/endometrial/ovarian cancers.
