Anki Biotechnology’s AJ201 enters SBMA Phase 3 clinical trial and becomes the world’s only First-in-Class innovative drug

Huang Wenying, Chairman of Anji Biotech. (File photo)

[Reporter Chen Yongji/Report from Taipei] Anji Biotechnology (7754), a new drug research and development company in Taiwan, announced last Friday (3) that the company's independently developed core new drug AJ201 has submitted an application to the U.S. Food and Drug Administration (FDA) for the third phase of human clinical trials for spinobulbar muscular atrophy (SBMA, also known as Kennedy's disease). After the 30-day review period expires and no comments are made, Anji will officially launch the third phase clinical trial of SBMA patients in the United States. AJ201 has become the only innovative SBMA drug in the world that has entered the third phase of clinical trials and has a first-in-class mechanism of action.

Anji said that SBMA is a rare hereditary neuromuscular degenerative disease that mainly affects men. The prevalence rate in men is conservatively estimated to be about one in 40,000. Because the early symptoms are easily confused with other motor neurone diseases, European, American and Japanese clinical experts generally believe that the actual number of patients has been underestimated, and there are currently no approved effective treatments in the world. According to a survey by international strategic consulting firm L.E.K., there are more than 12,000 confirmed patients in Europe, the United States and Japan.

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Anji pointed out that AJ201 promotes the degradation of mutated androgen receptor (mAR) proteins and activates multiple mechanisms of the Nrf2 antioxidant pathway, which is different from existing research directions. It has obtained the Orphan Drug Designation (ODD) for Kennedy's Disease from the US FDA and the EU EMA, and received expedited review designation from the US FDA. This Phase III trial plans to enroll 200 patients worldwide, and the actual schedule will be adjusted based on the progress of enrollment.

Anji stated that AJ201 has officially entered the third phase of clinical trials, which means that product development has entered the most critical stage before the launch of a new drug. Based on this significant progress, the company will actively promote international licensing negotiations for AJ201, and strive for the most favorable cooperation conditions while maintaining global intellectual property dominance, maximize the value of AJ201, and continue to create value for investors.

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