AH-008 Achieves Dual Regulatory Milestones with U.S. FDA IND Clearance and Taiwan CDE Index Case Designation

TAIPEI, June 22, 2026 /PRNewswire/ -- AnHorn Medicines today announced that its lead neuroprotective candidate AH-008, being developed for the prevention of chemotherapy-induced peripheral neuropathy (CIPN), has achieved two major regulatory milestones: Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and Index Case designation by the Taiwan Center for Drug Evaluation (CDE).

These milestones validate the scientific and translational strategy behind AH-008 and mark a significant step toward advancing a first-in-class preventive therapy for CIPN into clinical development.

Addressing a Critical Unmet Need in Oncology

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and dose-limiting toxicities associated with widely used cancer treatments, including taxanes, platinum-based agents, vinca alkaloids, and antibody-drug conjugates (ADCs). CIPN can cause irreversible nerve damage, leading to pain, sensory dysfunction, and long-term impairment that severely impacts patients' quality of life.

Beyond patient suffering, CIPN often forces chemotherapy dose reductions, delays, or discontinuation - compromising treatment outcomes. Despite its prevalence and burden, no approved therapies currently exist to prevent CIPN, highlighting a major unmet need in oncology supportive care.

Regulatory Milestones: IND Clearance and Index Case Designation

The U.S. FDA IND clearance authorizes AH-008 to advance into human clinical trials, following a comprehensive review of its preclinical pharmacology, toxicology, and manufacturing data. This clearance affirms the robustness of the program's safety package and development strategy.

The Taiwan CDE Index Case designation recognizes AH-008 as a reference program for novel drug development in its category. This designation reflects the candidate's scientific innovation and potential to address an unmet clinical need, while facilitating efficient regulatory interaction and advancement of innovative therapies.

Together, these milestones demonstrate strong regulatory alignment across major agencies and reinforce the translational strength of the AH-008 program.

Regulatory and Translational Validation

Preclinical studies for AH-008 were designed in accordance with the U.S. FDA Draft Guidance (January 2025), "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." This guidance outlines FDA expectations for CIPN preventive therapies, emphasizing the use of clinically relevant neurotoxicity models and translational endpoints that connect nerve protection to meaningful functional outcomes.

AH-008 consistently demonstrated robust neuroprotective effects across multiple chemotherapy-induced neuropathy models, preserving peripheral nerve integrity while maintaining chemotherapy efficacy. These prevention-first studies were designed to halt the onset of neuropathy rather than treating established symptoms, underscoring AH-008's potential as a proactive therapeutic approach.

Coupled with U.S. FDA IND clearance, these data validate AH-008 as a first-in-class neuroprotective candidate ready for clinical evaluation under current regulatory expectations.

Rapid Translation from Preclinical to IND

AnHorn Medicines advanced AH-008 from preclinical stage to FDA IND clearance in just 12 months, underscoring the company's integrated development capabilities. This accelerated timeline reflects AnHorn's ability to unify translational science, regulatory strategy, and CMC development into a streamlined execution framework—demonstrating its strength in efficiently advancing first-in-class programs that address urgent unmet medical needs.

About AH-008

AH-008 is a first-in-class neuroprotective therapeutic candidate designed to prevent chemotherapy-induced peripheral neuropathy by targeting the underlying mechanisms of chemotherapy-related nerve damage. Unlike symptomatic treatments, AH-008 intervenes early in the disease cascade to preserve peripheral nerve function during cancer therapy.

About AnHorn Medicines

Founded in 2020, AnHorn Medicines is an AI-driven biotech company specializing in novel small molecules and protein degraders for aesthetic medicine, oncology, and cancer supportive care. The company's proprietary AIMCADD AI platform integrates generative AI and molecular simulation to design highly potent, safe, and patentable drug candidates with unprecedented efficiency.

AnHorn is redefining how AI integrates into drug discovery—accelerating innovation, advancing precision medicine, and enabling a more sustainable therapeutic development ecosystem.

Forward-Looking Statements

This press release contains forward-looking statements regarding the development, regulatory status, and potential clinical and commercial benefits of AH-008. Actual results may differ materially due to risks and uncertainties inherent in drug development, regulatory review, and clinical outcomes.

Website: www.anhornmed.com

LinkedIn: https://www.linkedin.com/company/anhorn-medicines/

SOURCE AnHorn Medicines