Date: 2025.09.24

Held continuously for over two decades and attracted nearly a thousand outstanding biotech projects in competition, the Taipei Biotech Awards has evolved into a premier platform for cutting-edge innovation and collaboration in the industry. This year, AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) stood out as the only recipient to earn dual honors—winning both the prestigious “Taipei Biotech Star” award and the Silver Award in the Pharmaceutical and Applied Biotechnology category for its therapeutic breakthrough, AJ201, the first-in-class therapy for Kennedy’s disease.

AJ201, a novel curcumin analog, was developed by AnnJi using spray-drying technology and oral suspension formulation to overcome the challenge of low oral bioavailability commonly seen with curcumin derivatives. By incorporating inventive formulation and manufacturing technology, AJ201 achieved enhanced bioavailability with favorable and consistent pharmacokinetic properties.  More importantly, it makes drug administration easier and safer for Kennedy’s disease (SBMA) patients with swallowing difficulties.

AJ201 exerts multiple mechanisms of action—including Nrf2 activation, oxidative stress modulation, and induction of heat shock proteins to promote the degradation of mutant protein aggregates—providing a therapeutic approach for PolyQ neurodegenerative disorders.

In the Phase 2 clinical study, AJ201 showed clinically meaningful improvements within 12 weeks of treatment, such as an average gain of 17 meters in the 6-minute walk distance and a significant reduction in serum creatine kinase levels. In fact, this is the first clinical trial in the past 20 years to demonstrate positive functional outcomes in SBMA patients, underscoring AJ201’s breakthrough potential as a first-in-class therapy for Kennedy’s disease.

AJ201 has received Orphan Drug Designation for Kennedy’s disease from both the U.S. FDA and the European Medicines Agency (EMA). It has also been granted FDA Orphan Drug Designation for Huntington’s disease and spinocerebellar ataxia. In addition, patents for the AJ201 formulation have been filed across multiple countries worldwide, creating a robust intellectual property portfolio and leveraging patent protection strategies to secure strong market exclusivity for this first-in-class therapy.

“We are delighted to have received this recognition. Built on a solid foundation in translational medicine, AJ201 not only has high potential to be developed as the first-in-class treatment of Kenedy’s Disease, it also holds promise for future expansion into other neuromuscular degenerative disorders associated with oxidative stress or chronic inflammation. This honor comes just ahead of the World Muscle Society (WMS) Annual Congress, adding to the excitement as AJ201’s Phase 1/2a clinical trial results have also been selected as a Late-Breaking Abstract—an exclusive recognition awarded to only six studies globally each year. We look forward to presenting this first-in-class therapy for Kennedy’s disease (SBMA) and sharing our promising clinical data with leading experts worldwide at this prestigious event.” Wendy Huang, CEO and Chairperson of the Board stated.

Through a clearly defined global R&D strategy, AnnJi is committed to advancing AJ201 to the international market, aiming to become a representative success story of Taiwan’s new drug industry on the world stage. From translational research, clinical trial design and execution, and regulatory strategy consulting to drug synthesis, analytical method development, and manufacturing processes, AnnJi collaborates with both local Taiwanese resources and leading U.S. CDMOs, adhering to the highest international standards. These efforts are driving AJ201 into Phase 2/3 clinical development and global licensing partnerships, with the goal of making AJ201 the world’s first effective treatment for Kennedy’s disease, thereby enhancing patients’ fundamental right to effective therapies and realizing universal human values.

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About Kennedy’s Disease (SBMA)

Kennedy’s disease, also known as Spinal and Bulbar Muscular Atrophy (SBMA), is a rare and serious inherited neuromuscular degenerative disorder. It is characterized by the progressive degeneration of lower motor neurons in the spinal cord, brainstem, and skeletal muscles. The disease primarily affects males between the ages of 30 and 40, with an estimated prevalence of 1 in 40,000. As the disease progresses—typically by age 50—patients often develop difficulties with chewing and swallowing, and ultimately, recurrent aspiration pneumonia becomes a common cause of death. Currently, there are no approved treatments for SBMA.