BioNova Pharmaceuticals (Shanghai) Limited

Available Therapies via Single-Patient EA BioNova Pharmaceuticals (Shanghai) Limited (hereinafter referred to as BioNova) is currently not providing BN104 Tablets for Expanded Access use. BN104 is a novel, highly selective and potent oral menin inhibitor developed by BioNova and currently being investigated as a potential treatment for acute leukemias patients who harbor a mixed-lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation. On October 23, 2023, BN104 was designated as a Fast Track product by the FDA. A phase 1 clinical study constitutes the Part 1 dose-escalation and Part 2 dose-optimization will be conducted in eligible patients with acute leukemias. The study is designed to establish a safe and optimized dose and appropriate dosing schedule for BN104. Once RP2D established, and with agreement from the FDA, the company will initiate the phase 2 program in patients with acute leukemias who harbor a MLLr or NPM1 mutation. BioNova will review its EA policy annually to determine if a change in policy is warranted and feasible. Disease/Category-Specific EA Policies/Criteria BioNova will respond to all Expanded Access requests within 14 business days. All requests for Expanded Access or additional information may be sent by email to info@bionovapharma.com . For email requests, please indicate EXPANDED ACCESS REQUEST in the subject line.