Shanghai, China, January 4, 2026 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announced that its self-developed drug APL-1202 (nitroxoline tablets) has received approval from Health Canada’s Special Access Program (SAP). Under this approval, and subject to expert assessment for suitability, APL-1202 can be used for the treatment of Free-living Amoebae (FLA) infections. The first batch of the drug has been dispatched from China today and will soon be administered for the treatment of Canadian patients.
Infections caused by FLA are relatively rare and primarily include Acanthamoeba species (spp.), Balamuthia mandrillaris, and Naegleria fowleri. FLA infections are often fatal (> 90%), especially when they cause amoebic meningoencephalitis. Treatment options are limited for FLA infections, and currently no product specifically indicated for treating FLA infections has been approved for marketing globally. Asieris will provide APL-1202 in accordance with SAP provisions to meet urgent medical needs, based on eligible applications approved by Health Canada on a case-by-case basis.
Since 2021, the U.S. FDA has approved multiple single-patient expanded access investigational new drug (e-IND) applications in the United States for APL-1202, with all investigational drug supply provided by Asieris. To date, two patients treated at the University of California, San Francisco (UCSF) and UT Southwestern Medical Center have achieved complete recovery.
“We attach great importance to the approval of APL-1202 under Health Canada’s Special Access Program. This provides a vital support channel for us to offer potential treatment to patients in Canada who are in urgent need of new therapeutic options,” said Ms. Yun Zhang, Chief Medical Officer of Asieris Pharmaceuticals. “We will fully cooperate with Canadian health authorities and medical professionals to support the accessibility of this drug and continue to monitor the treatment progress of patients.”
Furthermore, APL-1202 received approval from China’s National Medical Products Administration (NMPA) on June 24, 2024, to conduct an Investigational New Drug (IND) clinical study for the treatment of FLA infections, ensuring clinical drug supply for patients both domestically and internationally. In January 2025, Asieris also signed a study drug supply agreement with the U.S. Centers for Disease Control and Prevention (CDC) under an Expanded Access Investigational New Drug Program to address related urgent medical needs.
About the Special Access Program (SAP)
In Canada, compassionate use is primarily facilitated through the SAP pathway. Under Canada’s Food and Drugs Act, the Minister of Health may authorize the sale of drugs not yet approved for sale in medical emergencies. The SAP is intended to provide healthcare practitioners with access to unapproved drugs for the treatment of patients with serious or life-threatening conditions, when conventional therapies are ineffective, unsuitable, or unavailable, and the patient cannot obtain treatment through participation in a clinical trial. Through the SAP, drug manufacturers may be authorized to sell drugs that are not yet approved for marketing in Canada. The program applies not only to treatment, but also to the diagnosis or prevention of serious or life-threatening diseases.
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and women’s health. We strive to improve human health to preserve patient’s dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus.
Through proprietary R&D and strategic collaborations, the company is committed to developing first-in-class drugs and other innovative technologies and products that address significant unmet medical needs, building a robust portfolio spanning from disease diagnosis to treatment within its focused therapeutic areas. Driven by patient needs, we are comprehensively advancing Commercialization 2.0 to improve the accessibility and affordability of innovative products, thereby benefiting more patients in China and globally.