Huanzhang Builds on TFA-01 R&D Progress to Advance China Development and Regulatory Planning
Updates in canine osteoarthritis toxicology, injectable nanoformulation development, feline stomatitis research and HPF technology inform China planning for an investigational veterinary anti-inflammatory candidate with potential as an alternative to glucocorticoids.
Canine Osteoarthritis ToxicologyInjectable NanoformulationFeline Stomatitis ResearchHPF Raw-Material TechnologyIn Development · Not Approved for Marketing
On September 29, TFA team members and researchers discussed progress in the Antcin A companion-animal drug development program at NPUST.
Executive summary: As the exclusive entity responsible for the development and commercialization of TFA-01 in China, Huanzhang is reviewing TFA’s stage-specific R&D progress to inform technical assessment, preparation for China-specific studies and regulatory strategy under China’s veterinary drug registration requirements. These developments may inform the China program but do not establish safety, efficacy or regulatory approval.
Xiamen Huanzhang Biopharmaceutical Technology Co., Ltd. (“Huanzhang”), the exclusive China development and commercialization entity for TFA-01, continues to coordinate its China program with stage-specific R&D undertaken by TFA Therapeutics, Inc. (OTCQB: RAJAF; “TFA”). In line with China’s veterinary drug registration requirements, Huanzhang is advancing technical assessment, planning for local studies, regulatory strategy and manufacturing readiness.
On September 29, 2026, a seminar on Antcin A formulation optimization and pharmacology research was held at the Graduate Institute of Animal Vaccine Technology, National Pingtung University of Science and Technology (“NPUST”). Members of the TFA team delivered technical presentations. Topics included ongoing toxicology research in canine osteoarthritis, injectable nanoformulation development, feline stomatitis research, and progress in Hyphal Pairing & Fusion (HPF) technology and production-capacity enhancement.
HUANZHANG DEVELOPMENT FOCUS
TFA-01 is based on Antcin A and is initially being developed for canine osteoarthritis. The program is evaluating TFA-01 as a novel veterinary anti-inflammatory drug candidate with potential as an alternative to glucocorticoid therapy.
01 / Initial indication
Canine Osteoarthritis
Toxicology studies remain ongoing. Safety and efficacy remain to be established in subsequent studies.
02 / Formulation development
Injectable Nanoformulation
Stage-specific technical progress has been reported. Further formulation and process validation remain required.
03 / Pipeline expansion
Feline Stomatitis Research
The research plan and current status were presented. The indication remains under evaluation.
04 / Raw-material foundation
HPF Technology
Hyphal Pairing & Fusion research and production-capacity enhancement continue and may inform future supply-continuity planning.
01 / INITIAL INDICATION
First-Indication Toxicology Continues as Formulation Development Supports Subsequent Studies
Toxicology work related to the initial indication, canine osteoarthritis, remains ongoing. In parallel, TFA is developing an injectable nanoformulation of Antcin A. Once the formulation has completed the necessary validation and meets the requirements for subsequent studies, it is intended for use in relevant target-animal toxicology studies and future clinical evaluation, supporting the development of a sequential evidence package spanning formulation, toxicology and clinical research.
Current nanoformulation work focuses on assessing biological activity, exploring dosing, and evaluating raw-material and process economics. Whether the nanoformulation can improve pharmacological activity, reduce the dose needed to achieve the intended effect, or provide a meaningful cost benefit must be confirmed through subsequent studies, formulation quality and consistency testing, and process scale-up.
01 / Evaluation areaBiological Activity AssessmentEvaluate biological effects at the cellular level and their relevance to further development.
02 / Evaluation areaDose ExplorationExplore a potential dose range for achieving the intended biological effect.
03 / Evaluation areaRaw-Material and Process EconomicsAssess raw-material requirements, formulation processes and scale-up conditions in an integrated manner.
02 / TECHNICAL PRESENTATIONS
Raw-Material Technology and Nanomaterials Research Inform Further Development
TFA Chief Technology Officer Vincent Liu presented “Antcin A: From a Scarce Compound to a Stable Supply,” describing experimental progress in Hyphal Pairing & Fusion (HPF) technology and ongoing efforts to enhance production capacity. Dr. Wei-Yu Chen of NPUST’s Functional Materials and Analytical Technology Laboratory presented research on carbon nanogel design and biomedical applications. He also discussed findings from experimental sepsis studies involving the related nanomaterial platform and related patent work, providing research context for further development of the Antcin A injectable nanoformulation.
Presented progress in Hyphal Pairing & Fusion research and current production-capacity enhancement efforts.
Nanomaterials · Biomedical ResearchDr. Wei-Yu Chen | National Pingtung University of Science and Technology
Presented research on carbon nanogel design and biomedical applications.
03 / PIPELINE EXPANSION
Feline Stomatitis Research Broadens Evaluation of a Second Indication
Professor Hsian-Yu Wang of NPUST’s Graduate Institute of Animal Vaccine Technology presented the research plan and current status for Antcin A in feline stomatitis, the second indication under evaluation. The research will continue to assess Antcin A’s potential application in feline stomatitis and may inform the expansion of TFA-01 beyond canine osteoarthritis into other inflammatory conditions in companion animals.
For Huanzhang, the feline stomatitis research provides an important technical reference for future pipeline planning. Whether this indication enters the China development program—and, if so, its development pathway and timing—will be determined after careful evaluation of study results, market needs and regulatory requirements.
04 / SUPPLY & QUALITY
HPF Technology Supports Quality Development and Continuity of Supply
Reliable preparation, batch-to-batch consistency and continuity of supply for Antcin A are important foundations for subsequent toxicology, clinical, quality and manufacturing scale-up work. Huanzhang will continue to review relevant raw-material, formulation and quality data against China development needs, including the work required for quality standards, technology transfer, manufacturing scale-up and supply-chain development.
HPF technology and injectable nanoformulation development are building capabilities at the raw-material and drug-product levels, respectively. Together, these workstreams may help establish a more integrated product and process foundation for TFA-01 development in China. Their specific technical value remains subject to confirmation through further research and manufacturing validation.
CHINA DEVELOPMENT PATH
China Development Program to Assess Data Applicability and Regulatory Gaps
Research data generated in Taiwan may inform candidate-formulation selection, toxicology study design, quality studies, dose exploration and subsequent clinical planning for the China program. They do not, however, automatically qualify as data acceptable for a Chinese regulatory submission or imply any regulatory outcome.
Huanzhang will assess the applicability of existing data and identify gaps against applicable Chinese veterinary drug regulations and technical requirements. The company will arrange any supplemental China-based studies required by regulators while advancing registration, manufacturing and commercialization preparations in parallel.
01Data Applicability Assessment
02China Registration Gap Analysis
03Required Supplemental Studies in China
04Manufacturing and Commercialization Readiness
The seminar focused on progress in Antcin A formulation optimization and pharmacology research. Huanzhang will further assess the applicability of the related data and the design of subsequent studies in accordance with Chinese regulatory and research requirements.
Development-stage notice:
This news release is provided solely to describe the company’s R&D and business progress. It does not constitute any representation, warranty or commitment regarding product safety, efficacy, marketing authorization, regulatory approval or commercial returns. TFA-01 and its injectable nanoformulation remain under development and have not been approved for marketing in China; the indications discussed have not been approved.
Statements regarding potential as an alternative to glucocorticoids, improved pharmacological activity, dose optimization, cost benefits, indication expansion or other anticipated outcomes remain subject to verification in subsequent studies. Whether research data generated in Taiwan may be used in a Chinese regulatory submission, the extent to which such data may be accepted, and whether supplemental studies in China will be required are subject to applicable Chinese regulatory requirements and the conclusions of formal review by the relevant authorities.
