Taipei, April 24, 2025 – AnnJi Pharmaceutical Co., Ltd., a Taiwanese clinical-stage drug development company dedicated to the unmet needs in dermatology, neurology, and rare diseases (“AnnJi” or the “Company”), today announced that it has entered into a license termination and program transfer agreement with Avenue Therapeutics, Inc. (“Avenue”).

On February 28, 2023, AnnJi entered into an exclusive license agreement with Avenue for the development and commercialization of AJ201, its first-in-class Phase 1 clinical asset for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy’s Disease in the U.S., Canada, European Union, Great Britain, and Israel.

It has been a value-added collaboration for AJ201 between AnnJi and Avenue to advance AJ201 from a Phase 1 asset toward the completion of the Phase 2a clinical study in SBMA patients.

Under the terms of the new agreement, Avenue will receive up to USD 7 million in a combination of upfront and milestone payments contingent upon the NDA approval in the US. Avenue will also repurchase the shares of its common stock currently held by AnnJi upon the agreement’s execution. AnnJi will assume full authority for the continued global development and commercialization of AJ201. This realignment supports AnnJi’s broader mission to deliver first-in-class and best-in-class small molecules in dermatology, neurology, and rare diseases.

Both companies firmly believe that AnnJi is optimally positioned to lead AJ201 through its next stages with its strong foundation of ongoing SBMA research, continued engagement with global KOLs, and operational readiness. AnnJi is committed to unlocking the full potential of AJ201. “This is not merely a transactional agreement; it represents a strategic handoff and enforced commitment to the AJ201. AnnJi remains open to future licensing and partnership discussions contingent upon positive clinical results.”, said Wendy Huang, Ph.D., Chief Executive Officer and Chairperson of the Board of AnnJi.

About Spinal and Bulbar Muscular Atrophy (SBMA, or Kennedy’s Disease)

The disease is a rare, inherited, X-linked genetic neuromuscular disease, and typically an adult-onset disease, where symptoms occur mainly between the ages of 20 and 50, primarily affecting men. The genetic defect underlying the disease is the expansion of a polyQ encoding CAG repeat in the first exon of the AR gene. The accumulation of pathological mutant AR aggregates is believed to be responsible for the cytotoxicity, excessive oxidative stress and chronic neuroinflammation, leading to the muscle atrophy and death of neurons. The disease is characterized by symptoms such as muscle weakness leading to difficulty in walking and injury caused by falling. Patients have difficulty in speaking, chewing and swallowing, which often result in airway infection. Kennedy disease affects approximately 1/35,000 males worldwide. Currently, there is no effective treatment for the disease, nor is there an US FDA approved therapy.

About AnnJi Pharmaceutical

Founded in 2014, AnnJi Pharmaceutical Co., Ltd. (“AnnJi”) is an R&D based, clinical-stage new drug company dedicated to the development of first-in-class small molecules focusing on indications with highly unmet needs in the therapeutic areas of neurology, dermatology, and inflammatory disorders, including rare diseases such as idiopathic pulmonary fibrosis and Kennedy’s disease, or SBMA (Spinal and bulbar muscular atrophy). AnnJi’s mission is to develop innovative therapeutics to improve the quality of life of patients with neglected diseases. AnnJi is headquartered in Taipei, Taiwan and was backed by prestigious venture capital firms and financial institutions, including Taiwania Capital, Fubon Financial Holding Venture Capital Corp., President International Development Corp., Mega International Commercial Bank and Cathay Venture Inc. For more information, please visit www.ajpharm.com.

Forward-Looking Statements

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Contact:
Anne Yu
AnnJi Pharmaceutical Co., Ltd.
(+886) 2- 2365-5677
anne.yu@ajpharm.com