CARRY OFF, January 6, 2025 /PRNewswire/ — Asieris Pharmacy (Stock code: 688176.SH), a leading global biopharmaceutical company dedicated to advancing innovative therapies for genitourinary tumors and the health of women with significant unmet medical needs, announced the signing of a drug supply agreement in research under the Expanded Investigational New Drug (IND). Program with Centers for Disease Control and Prevention (Centers for Disease Control and Prevention) in the united states for APL-1202 (nitroxoline), independently developed, subject to evaluation by Centers for Disease Control and Prevention experts, for use in the treatment of free-living amoebae (FLA) infections.
Infections caused by free-living amoebae (FLA), such as acanthamoeba species (spp.), Balamuthia mandrillarisand Naegleria fowleriThey are rare. However, FLA infections are usually fatal (>90%), especially when they cause amoebic meningoencephalitis. Treatment options for FLA infections are limited and there are currently no FDA-approved products. United States Food and Drug Administration (FDA) specifically for the treatment of FLA infections in the united states (US). An IND request for expanded access was submitted by the Centers for Disease Control and Prevention to the FDA to provide APL-1202 for the treatment of suspected or laboratory-confirmed nonkeratitis infections caused by FLA, including acanthamoeba species, B. mandrillarisand N fowleri.
Nitroxoline has not been approved by the FDA and therefore its use is considered investigational in the united states. FLA patients will be treated with APL-1202 under specific conditions. Following the agreement, Asieris quickly organized the transportation of medicines to ensure the supply of clinical medicines to FLA patients.
“We are grateful for this opportunity to collaborate with the Centers for Disease Control and Preventionand this agreement allows new treatment options for patients with FLA in the US“said Ms. Juana ZhangBoss Doctor (TASE:) Official Asieris Pharmacy. “We look forward to working closely with the Centers for Disease Control and Prevention In the future, share clinical experiences in treating FLA infections with APL-1202 to meet the unmet needs of patients. “We will continue to uphold our company’s mission of delivering innovative treatments to patients.”
Since 2021, the FDA has granted single-patient emergency IND (e-IND) applications for APL-1202 as an investigational drug for the treatment of Balamuthia mandrillaris and acanthamoeba infections. Two patients who received this treatment in the US They have fully recovered from their infections.
In June 24, 2024A separate investigational new drug (IND) application for APL-1202 for the treatment of FLA was approved by China National Medical Products Administration (NMPA) to ensure the supply of clinical medicines for national patients in Porcelain.
About Asieris
Asieris Pharmacy(688176.SH), founded in March 2010is a global biopharmaceutical company specialized in the discovery, development and commercialization of innovative drugs 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 global pharmaceutical leader integrating R&D, manufacturing and marketing in our focus areas as we provide best-in-class integrated diagnostic and treatment solutions for patients in Porcelain and all over the world.
The company has been developing its own R&D platform and core technologies, exploring new mechanisms of action and efficiently detecting and evaluating drug candidates. With a well-established internal R&D system and global drug development expertise, Asieris is committed to launching world-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its product portfolio for genitourinary diseases through proprietary R&D and strategic partnerships, while closely monitoring cutting-edge technologies and therapies. The company strives to discover and identify unmet clinical needs and takes a forward-thinking approach to product planning and lifecycle management. We aim to establish an exceptional portfolio covering diagnosis and treatment in a bid to benefit more patients in Porcelain and worldwide.
