Dr. Tzu-Wen Lin joined ALPS Biotech in 2020 to develop botanical new drugs. ALPS first applied the active components of Antrodia cinnamomea to Huntington's disease research, with encouraging results in the R6/2 disease mouse model. At the invitation of Chairman Dr. Shui-Tien Chen, members of the Taiwan Spinocerebellar Ataxia Association (TSCAA) visited ALPS to review the research progress, and food-grade Antrodia products were provided for patients to try. According to data released by ALPS at the 2024 Antrodia Symposium, 187 patients registered for the product experience program and 890 questionnaires were collected; self-assessments over 25 months showed improved ratings in 9 of 10 measures. This feedback became a key driver for ALPS, and the association helped connect the company with Dr. MingChe Kuo for a more rigorous clinical study.
TSCAA Chairman Lin Hsiu-Cheng shared that the association received ALPS Antrodia products free of charge for two consecutive years. He noted that no clearly effective treatment for spinocerebellar ataxia exists today, and that the question patients ask most is "When will a new drug be available?" - the commitment of industry, government, and academia has brought courage and hope to the community.
Responding to patients' questions about the price gap among commercial Antrodia products, Dr. Lin explained that Antrodia cinnamomea is produced through several methods - fruiting bodies, culture, and liquid fermentation - which differ greatly in cost and triterpenoid content. ALPS focuses on fruiting-body triterpenoids as its core active ingredient, which is more costly to produce. Most commercial products are droplet pills; considering that some patients have difficulty with fine hand movements, the clinical study switched to capsules with a bitterness-mimicking placebo to preserve the rigor of double-blinding.
Dr. Lin noted that triterpenoids, the main active components of Antrodia cinnamomea, are small-molecule compounds that are easier to characterize structurally and control for quality than polysaccharides - one of the key reasons ALPS chose Antrodia for botanical drug development. The research team found that Antrodia components inhibit the NLRP3 inflammasome, which is associated with neuroinflammatory diseases; animal studies also detected the major active triterpenoids in the brain (LC-MS/MS), supporting their potential to cross the blood-brain barrier. Dr. Lin emphasized that further research is needed to validate these mechanisms. AC04 has completed preclinical work including cell experiments, 90-day toxicology data, CMC product analysis, and strain and material identification.
ALPS collaborates with Dr. MingChe Kuo of National Taiwan University Cancer Center (NTUCC) on the exploratory clinical study "Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients" (NCT06633003), a double-blinded, two-arm crossover study with the SARA ataxia scale as the primary endpoint and additional measures including the 9-hole peg test and 8-meter walk time. The study was approved by the institutional review board (REC No. 202404011RSA) and is registered on clinicaltrials.gov. As announced at this year's shareholders' meeting, the study has been completed; preliminary analysis of 22 subjects with spinocerebellar ataxia showed statistically significant improvement in selected measures.
Dr. Lin explained that botanical drug developers must first obtain IND approval from regulators before entering formal Phase I-III trials. ALPS is currently discussing a U.S. FDA botanical drug IND application with a CRO, with the goal of entering Phase 2a after approval. As spinocerebellar ataxia is a rare disease, a combined Phase II/III design may accelerate the development timeline in the future.
Both guests emphasized that new drug development is a decade-long endeavor. Spinocerebellar ataxia comprises many genetic subtypes, with types 2 and 3 being more common in Taiwan, and patients are eager for a new drug. ALPS Biotech thanks TSCAA for its long-term support, will continue to deepen collaboration with clinical institutions, and looks forward to more resources and talent entering the rare disease field.
搖擺人生有限公司｜牛樟芝與小腦萎縮症：臨床研究與新藥開發 - 郭明哲醫師 ft. 林秀成理事長 × 林子文博士, TSCAAclub channel, 2026-09-01. https://www.youtube.com/watch?v=scUGQqFQD6g
ALPS Biotech Co., Ltd. focuses on Antrodia cinnamomea botanical drug development alongside biomaterials and medical devices, and was founded by Dr. Shui-Tien Chen. The company is committed to science-based botanical new drugs, rare disease research, and the green circular economy.
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