Shanghai, January 6, 2025 /PRNewswire/ — Asiris Pharmaceutical Company (Stock Code: 688176.SH), a leading global biopharmaceutical company dedicated to developing innovative treatments for genitourinary oncology and women's health with significant unmet medical needs, announced the signing of an Investigational Drug Supply Agreement under Expanded Access Newer Drug (IND). program with Centers for Disease Control and Prevention (Center for Disease Control) in US for APL-1202 (Nitroxoline) which was independently developed and is being evaluated by Center for Disease Control Experts, for its use in treating free-living amoebae (FLA) infections.
Infections caused by free-living amoeba (FLA), e.g Acanthamoeba species (spp.), Palamuthia mandrillarisand Naegleria fowlerirare. However, FLA infections are often fatal (>90%), especially when they cause amoebic meningoencephalitis. Treatment options are limited for FLA infection, and currently, there is no product approved by the World Health Organization US Food and Drug Administration (FDA) specifically for the treatment of FLA infections in US (we). An Expanded Access IND request was submitted by Center for Disease Control To the US Food and Drug Administration to provide APL-1202 for the treatment of laboratory-confirmed or suspected non-keratitis infections caused by FLA including Acanthamoeba Prosecution., for. Mandrillarisand n. Follieri.
Nitroxoline has not been approved by the US Food and Drug Administration, so its use is under investigation US. FLA patients will receive treatment with APL-1202 under specific conditions. Following the agreement, Asieris immediately arranged drug transportation to ensure the supply of clinical drugs to FLA patients.
“We are grateful for this opportunity to collaborate with Center for Disease ControlThis agreement provides new treatment options for FLA patients in we“, stated the lady. Joanna Changpresident medical (TASE:) officer Asiris Pharmaceutical Company. “We look forward to cooperating closely with Center for Disease Control In the future, share clinical experiences of treating FLA infections with APL-1202 to address unmet patient needs. “We will continue to support our company’s mission of bringing innovative treatments to patients.”
Since 2021, the Food and Drug Administration (FDA) has granted single-patient emergency IND (e-IND) applications for APL-1202 as an investigational drug for the treatment of… Palamuthia mandrillaris and Acanthamoeba Infections. Two patients who received this treatment in we They have fully recovered from their injuries.
on June 24, 2024A separate investigational new drug (IND) application for APL-1202 for the treatment of FLA has been approved by China National Medical Products Administration (NMPA) to ensure the supply of clinical medicines to local patients in China.
About Asiris
Asiris Pharmaceutical Company(688176.SH), founded in March 2010is a global biopharmaceutical company specializing in the discovery, development and commercialization of innovative medicines for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient dignity. We aim to become a leading global pharmaceutical company integrating R&D, manufacturing and marketing into our focus areas, providing best-in-class integrated diagnostic and treatment solutions to patients across the world. China And all over the world.
The company is advancing its R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and global drug development expertise, Asieris is committed to launching first-in-class medicines and other innovative products to address the huge unmet needs in its focus areas.
Asieris is also strengthening its product line for genitourinary diseases through proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and treatments. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach to product planning and lifecycle management. We aim to create a premium portfolio covering diagnosis and treatment in a bid to benefit more patients China And on a global level.
