AnHorn Medicines Advances Development of Groundbreaking New Small Molecule Drug "AH-008" Aimed at Preventing Chemotherapy-Induced Peripheral Neuropathy (CIPN)

TAIPEI, Taiwan – June 23, 2026

AnHorn Medicines Co., Ltd. (AnHorn Medicines) announced today that it has received approval for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) and has been designated an Index Case by Taiwan's Center for Drug Evaluation (CDE) for its novel neuroprotective drug candidate, "AH-008," which is being developed for the prevention of Chemotherapy-Induced Peripheral Neuropathy (CIPN).

These significant regulatory milestones allow AH-008 to advance into the clinical development phase, demonstrating its potential as a first-in-class therapy to address a critical unmet medical need in cancer supportive care.

CIPN: A Major Challenge in Cancer Treatment

Chemotherapy-Induced Peripheral Neuropathy (CIPN) is one of the most common and severe adverse events associated with current cancer chemotherapy.

It has been reported not only with taxanes, platinum agents, and vinca alkaloids but also with antibody-drug conjugates (ADCs), which have rapidly gained popularity in recent years. CIPN can lead to irreversible nerve damage, chronic pain, sensory abnormalities, and a decline in quality of life (QOL) for patients.

Furthermore, CIPN is recognized as a significant issue that impacts the efficacy of cancer treatment itself, as it can lead to dose reductions, treatment delays, or even discontinuation of chemotherapy.

However, there are currently no approved drugs to prevent CIPN, creating a strong demand for the development of new therapeutic options.

In Japan, interest in the medical and economic value of CIPN prevention has been growing in recent years, but many development programs have focused on symptomatic relief, such as pain management. In this context, AH-008 is anticipated as a novel approach that intervenes in the very mechanism of neuropathic damage.

AH-008: A Novel Small Molecule Drug Targeting Disease Progression Itself

Unlike conventional treatments aimed at alleviating symptoms after nerve damage has occurred, AH-008 is a novel small molecule compound designed to intervene in the early stages of chemotherapy-induced nerve damage.

Preclinical studies have confirmed its ability to maintain peripheral nerve structure and function in multiple CIPN models without compromising the inherent anti-tumor activity of anticancer drugs.

This disease-modifying approach differentiates it from existing symptomatic treatments and highlights its potential as a next-generation cancer supportive therapy.

Development and Commercialization Advantages of a Small Molecule Drug

AH-008 is being developed as a small molecule drug, offering the following strategic advantages:

Established international regulatory and approval processes

Easily scalable and efficient manufacturing

Feasible stable supply chain construction

Flexible pricing strategies and access to global markets

Potential for combination with various anticancer drug regimens

These features are expected to support broad patient access and sustainable commercialization in Japan, the United States, Europe, and the Asia-Pacific region.

FDA IND Approval and Taiwan CDE Index Case Designation

The U.S. FDA IND approval obtained signifies that the safety and development data package for AH-008 is sufficient for initiating clinical trials.

The Index Case designation by Taiwan's CDE indicates that the development program has been recognized for its novelty and clinical significance, facilitating smooth communication with regulatory authorities.

These two milestones demonstrate that the scientific validity and development strategy for AH-008 are aligned with international regulatory requirements.

Development Program Aligned with International Regulatory Trends

The development of AH-008 is proceeding in accordance with the principles outlined in the draft guidance "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology," published by the U.S. FDA in January 2025.

Consistent neuroprotective effects and maintenance of anticancer activity have been confirmed in preclinical studies, supporting its potential as a first-in-class preventive drug that intervenes in disease progression before irreversible nerve damage occurs.

From Preclinical to FDA IND Approval in 12 Months

AnHorn Medicines achieved the milestone from the start of preclinical development to FDA IND approval in just 12 months.

This rapid development showcases the company's drug discovery capabilities, integrating translational research, CMC development, and regulatory strategy, and proves its ability to efficiently create innovative new drugs for diseases with high unmet medical needs.

About AH-008

AH-008 is a novel neuroprotective small molecule drug that targets biological pathways involved in chemotherapy-induced neuropathy.

It is being developed to maintain peripheral nerve function, improve patient QOL, and ensure the continuity of cancer treatment.

About AnHorn Medicines

AnHorn Medicines is an AI-driven drug discovery biotechnology company founded in 2020.

The company is engaged in the research and development of novel small molecule drugs and protein degraders for aesthetic medicine, oncology, and cancer supportive care.

Its proprietary AI drug discovery platform, "AIMCADD," integrates generative AI and molecular simulation technologies to create novel compounds with high activity, safety, and patentability.

By merging AI and drug discovery, AnHorn Medicines is committed to accelerating the development of innovative medicines and realizing precision medicine.

Forward-Looking Statements

This press release contains forward-looking statements regarding the development status of AH-008, regulatory progress, and future clinical and business potential. These statements are based on current predictions and actual results may differ due to uncertainties associated with drug development, regulatory review, clinical trial outcomes, and other factors.

Website: www.anhornmed.com

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

*AnHorn Medicines is a Taipei-based company supported by StartUP@Taipei. StartUP@Taipei is a comprehensive startup promotion platform operated by the Taipei City Department of Economic Development, aimed at strengthening the international market expansion of Taipei companies and fostering collaboration with overseas startup ecosystem partners to promote business linkages and cooperation opportunities.

*AnHorn Medicines is a Taiwanese startup supported by Startup Island TAIWAN. Startup Island TAIWAN is a national startup brand operated through public-private partnerships under the guidance of Taiwan's National Development Council.