Chinese Biotech Hoyotek Achieves Major Breakthrough in Alzheimer's 'Diagnostics + New Drug' Strategy as Experimental Antibody 6C3 Matches Lilly's Donanemab in Head-to-Head Preclinical Tests

TIANJIN, China — A Chinese biotech company says its experimental Alzheimer's drug candidate matches the performance of Eli Lilly's recently approved therapy in head-to-head preclinical tests, a milestone that could reshape the competitive landscape for treating a disease affecting more than 10 million people in China alone.

Hoyotek Biomedical Co., Ltd. disclosed that its anti-amyloid-beta monoclonal antibody, known as 6C3, demonstrated plaque-clearing efficacy comparable to donanemab — sold as Kisunla — in tests using a standard Alzheimer's mouse model, without any molecular optimization. The results position 6C3 as one of the most competitive domestic candidates in China's growing pipeline of Alzheimer's therapies.

The data arrive at a critical juncture. Imported treatments such as donanemab and lecanemab carry annual price tags of 200,000 to 300,000 yuan (roughly $28,000 to $42,000) and remain outside China's national medical insurance coverage, placing them out of reach for most patients. A domestically developed equivalent could eventually cost one-third of that amount or less, the company said.

Head-to-Head Results

In preclinical studies using 5×FAD transgenic mice — a widely accepted Alzheimer's model — researchers compared four groups: one treated with 6C3, one with donanemab as a positive control, one with an IgG isotype control, and a wild-type group receiving IgG. The study employed thioflavin S staining and 6E10 immunofluorescence to assess amyloid-beta plaque burden, along with GFAP and Iba1 staining to measure neuroglial activation.

The 6C3 treatment group showed approximately a 40% reduction in amyloid-beta plaque count in the cerebral cortex (p<0.01) and roughly a 50% reduction in plaque area (p<0.01) compared with the IgG control group. The hippocampus exhibited a consistent downward trend. Critically, no statistically significant difference was observed between 6C3 and donanemab in either cortical or hippocampal plaque measures — indicating equivalent plaque-clearing capability.

On neuroinflammation, 6C3 significantly reduced GFAP-positive astrocytes in both the cortex (p<0.01) and hippocampus (p<0.01). Iba1-positive microglia likewise declined significantly in both regions (p<0.01 for each). The company noted that most domestic Alzheimer's antibody programs conduct only basic efficacy studies without benchmarking against an approved reference drug, making 6C3's head-to-head validation against donanemab a notable differentiator.

A Dual-Track Strategy

Beyond its drug pipeline, Hoyotek has built what it calls a uniquely integrated commercial model in China: combining Alzheimer's diagnostics with therapeutic development. The company holds National Medical Products Administration registration certificates for eight core Alzheimer's biomarkers — Aβ1-42, Aβ1-40, P-tau 181, NFL, GFAP, AD7C-NTP, PGP9.5, and S100β — enabling early screening and diagnosis.

On the intellectual-property front, Hoyotek has secured a patent for a P-tau 181 monoclonal antibody and has two invention patents related to Alzheimer's antibody drugs currently under substantive examination. The combination of a commercially available diagnostics platform and a proprietary drug pipeline is rare in China's Alzheimer's sector, where most companies focus on either testing or treatment — but not both.

Market Opportunity

China's Alzheimer's patient population exceeds 10 million, with a far larger group in the earliest stages of the disease. Yet approved therapies remain prohibitively expensive for the vast majority of families. Most domestic antibody candidates are still in Phase Ib or Phase II trials, meaning the competitive window for a new entrant remains open.

Based on global comparables, preclinical-stage Alzheimer's antibody candidates have commanded transaction values in the hundreds of millions of dollars. With equivalent preclinical efficacy data, a differentiated diagnostics-plus-therapeutics model, and potential for next-generation delivery methods — including what the company describes as a potential first-in-class intranasal anti-amyloid-beta formulation leveraging the nasal-brain pathway — 6C3 carries significant research and capital-market value, the company said.

Hoyotek plans to accelerate process optimization, complete preclinical evaluations, and file an Investigational New Drug application for 6C3, while continuing to expand its Alzheimer's diagnostics and therapeutics portfolio. The goal: establish a Chinese benchmark in a disease area where domestic options remain scarce and the clinical need is immense.