[Featured Stock] Biotoxtech Rises on Aribio's Oral Dementia Drug Phase 3 Clinical Trial Plan Approved in 11 Countries

Biotoxtech is showing strong performance. This is interpreted as being influenced by the news that Aribio's oral dementia drug Phase 3 clinical trial plan has been approved in 11 countries.

As of 11:11 AM on the 14th, Biotoxtech is trading at 5,770 KRW, up 4.72% compared to the previous day.

According to the industry, Aribio announced on the 14th that it has officially received approval for the Phase 3 clinical trial plan (IND) of AR1001 from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China.

With approval from China, a major country in the global pharmaceutical and bio market, the AR1001 global Phase 3 clinical trial (Polaris-AD) is expected to proceed as planned, targeting a total of 1,150 participants across more than 200 clinical centers in 11 countries.

The 11 countries include the United States, where the U.S. Food and Drug Administration (FDA) approved it in December 2022 and the first patient dosing began, as well as South Korea, the United Kingdom, Germany, France, Spain, Italy, Denmark, the Netherlands, the Czech Republic, and China.

With the completion of approval for the Phase 3 clinical trial plan for AR1001 in each country, Aribio stated that the topline results announcement within 2026 and subsequent procedures such as new drug application (NDA) will proceed smoothly.

Meanwhile, Biotoxtech is known to have agreed in 2020 to develop the combined dementia treatment ARBT01 using its antioxidant 'BTT-105' and Aribio's AR1001 candidate substance.

This content was produced with the assistance of AI translation services.