Advagene Biopharma is a biopharmaceutical company focused on the development of mucosal immunotherapy and committed to providing innovative biotech drugs for prevention and treatment to the world.
Advagene Biopharma Co., Ltd. is a biopharmaceutical company focused on the development of mucosal immunotherapies. We are dedicated to developing innovative biopharmaceuticals for global disease prevention and treatment.
Core Technology & Patents
Our proprietary LTh(αK) immunomodulatory protein technology platform demonstrates immense medical potential. It can be formulated with antigens to develop nasal spray vaccines or utilized independently to develop immunotherapeutic drugs.
Currently, this platform is being applied to three major product categories: intranasal vaccines, asthma immunotherapies, respiratory antiviral immunotherapies.
Our core detoxified LTh(αK) platform is backed by comprehensive patents covering compositions of matter, applications, and manufacturing processes. We have successfully secured patent approvals across multiple key global markets, including Taiwan, China, the United States, Europe, Japan, Russia, Australia, and Canada.
Key Clinical Developments
Nasal Spray Influenza Vaccine (AD07030)
Our "Applications and Platform Technology of Detoxified Enterotoxin LT Adjuvant" was awarded "Innovation of the Year" at the Taiwan Bio-Industry Organization Outstanding Biotechnology Industry Awards in 2014. Notably, our nasal spray influenza vaccine (AD07030) has successfully completed Phase II human clinical trials, proving both safety and efficacy.
Clinical data indicates that the nasal spray not only induces an antiviral IgG response but also generates an antiviral mucosal IgA response, providing frontline protection directly at the mucosal tissues where human infection begins. We are currently planning Phase III clinical trials for AD07030. In the future, this will relieve the general public's fear of injections, offer superior protection for the elderly and healthcare workers, and position us to compete in an influenza vaccine market that exceeds $3 billion in annual turnover.
Respiratory Allergies & Asthma Immunotherapy (AD17002-AI)
Our applications for respiratory allergies and asthma treatments hold major global market patents. By modulating autoimmune cell responses to allergens, these therapies are expected to replace or reduce reliance on steroids, potentially benefiting hundreds of millions of respiratory allergy and asthma patients worldwide. This includes alleviating the need for allergy medications among hay fever patients in the US and dust mite allergy sufferers in Asia. For patients with severe asthma poorly controlled by steroids, we offer a promising alternative to antibody drugs, allowing us to enter the tens of billions of dollars annual asthma treatment market.
Following the successful completion of Phase I/II human clinical trials for AD17002-AI (treating dust mite allergic rhinitis) in 2020, we initiated an investigator-initiated trial for "Eosinophilic Asthma Immunotherapy" in 2023, followed by a Phase II clinical trial in 2025. Full patient enrollment is expected to be completed in 2026.
COVID-19 Immunotherapy (AD17002-SC)
Following the outbreak of the COVID-19 pandemic in 2019, SARS-CoV-2 infection has been known to cause various respiratory symptoms, potentially leading to cytokine storms and severe pneumonia. As our AD17002-SC immunotherapeutic protein drug modulates and induces innate immune mechanisms—including Type I interferons—it is anticipated to establish a first line of defense against viral infections at the mucosal tissues. Pathological analysis from animal challenge studies has also demonstrated that AD17002-SC significantly improves pneumonia conditions in animals infected with COVID-19.
A Phase II clinical trial for the treatment of mild COVID-19, completed in 2023, showed that the treatment can shorten the disease course and accelerate viral clearance. This not only proves the efficacy of AD17002-SC in treating COVID-19 but also highlights the broad potential of this technology and its antiviral mechanisms for treating other respiratory infectious diseases.
Future Outlook
We will continue to systematically enter other therapeutic vaccine sectors. We expect that our robust R&D and technological capabilities will continuously expand the company's product pipeline and value, ultimately delivering beneficial new biopharmaceuticals that improve quality of life and enhance human well-being.
Taiwan Bio Industry Organization awarded “Detoxified LT adjuvant application and platform technology” for “Innovation of the Year”
Taiwan Mask Corporation (TMC) invested ADVAgene in March, 2014, then ADVAgene becomes TMC subsidiary. ADVAgene also received technology transfers from DCB on detoxified LT platforms, and as a result, many products developed from it. A team led by Dr. Hsu, who is the inventor of detoxified LT plateform, has joined ADVAgene for continual development.
Received permission for phase I nasal Flu vaccine from TFDA
Received New Biologics Development Status (or Approval) for LT-Flu and LT/Allergy from Industrial Development Bureau, Ministry of Economic Affairs.
We completed a NT$150 million capital increase including Yuanta Asia Investment and China Investment &Development(CIDC). The main sponsor of the Yuanta Asia Investment is the South Korean government funds, which actively looks for investment targets in Taiwan. ADVAgene is the first company they invested in Taiwan. This indicates immunotherapy platform from ADVAgene has been recognized by the international biotech funds. China Investment & Development has a long story of leading domestic investment company. Its investment funding included Grand Cathay Venture Capital Co.,Ltd、Grand Cathay Venture CapitalⅡCo.,Ltd and Asia Global Venture Capital Co., Ltd.
ADVAgene have completed a NT$200 million capital increase from additional corporations including Mycenax Biotech Inc.、Synmosa Biopharma Corporation、Hua Nan Venture Capital CO., LTD and Waterland Venture Capital CO., LTD. Mycenax Biotech Inc. and Synmosa Biopharma Corporation are renowned biopharma and listed companies in Taiwan with specific focus on biopharmaceutical development and developing quality pharmaceutical products, respectively. Hua Nan Venture Capital CO., LTD and Waterland Venture Capital CO., LTD are all famous venture capital companies with extended experiences on targeting potential biotech for investment. This successful capital increase highlights the potential and recognition of ADVAgene in future biopharmaceutical role.
Phase II of LT-Flu nasal Flu vaccine has received award for A+ Industrial Innovative R&D program from Department of Industrail Technology (DoIT), Ministry of Economic Affairs.
ADVAgene completed a NT$200 million Equity Financing by issuing new shares.And submit for public issuance to be one listed company on TPEx Emerging Stock Board.
LT-Allergy immunotherapy for phase Ib/ IIa was received IND pass from TFDA.
The result of LT-Flu nasal Flu vaccine Phase II Clinical Trial was positive Top-Line Results.
ADVAgene is in the process of entering clinical Phase Ib/ IIa of LT Allergy immunotherapy trials. No.of enrollment will be 48 in 1 site-Taipei Medical University.
The results of the LT-Flu nasal spray influenza vaccine phase 2 clinical trial are published in Vaccine, the authoritative international journal Vaccine.
The LTh (αK) conjugated pneumococcal pneumococcal and Haemobacter B vaccine was patented in the United States.
Yu-Thu LTh (αK) is used in COVID-19 immunotherapy, and was included in the project indicative case by the Medical Corporation's Corporate Drug Testing Center (CDE).
According to the Biotechnology New Drug Industry Development Ordinance, Yu Hou Biotech has been approved by the Ministry of Economy as a biotech new drug company.
YUHU BIOTECH'S “NASAL INFLUENZA VACCINE (106IDX10023)” R&D CASE WAS SELECTED AS A POTENTIAL PRODUCT BY THE TAIFU DEPARTMENT OF PHARMACY (TFDA) AND LISTED AS A CONSULTATION COUNSELING CASE.
Yu Hou Biotechnology collaborates with Taipei Medical University to carry out the research project “LTh (αk) for Asthma and Allergic Rhinitis Immunomodulatory Transition”.
The results of the new drug AD17002 dust mite nasal spray allergy treatment IB/IIa clinical trial showed that AD17002 showed good safety and clinical tolerability in the treatment of allergic rhinitis, without serious adverse reactions, and was observed by physiological examination to alleviate the symptoms of nasal inflammation in patients.
The results of an animal trial of a novel coronavirus treatment drug developed by Yu Hou Biotechnology showed a clear improvement in symptoms of pneumonia.
The company's new drug AD17002-SC for the treatment of COVID-19 (COVID-19) has passed TFDA approval for Phase IIa human clinical trial.
The Company has signed a Memorandum of Cooperation (MOU) to authorize and distribute the Company's novel coronavirus drug AD17002-SC in Pakistan with Macter International Limited.
The Company's new drug AD17002 has passed approval through the Indonesian Food and Drug Administration (BPOM) review for the treatment of COVID-19 in Phase 2/3 human clinical trials for the treatment of mild and moderate patients.
The Company is approved by TFDA to conduct a Phase II clinical trial for the treatment of the new drug AD17002 in patients with severe asthma.
The results of the human clinical trial of our new drug AD17002-SC for the treatment of Coronavirus Phase 2 show statistically significant efficacy and good safety and tolerability.
Michael Hwang serves as the Chairman of Advagene Biopharma.
The Company passed TFDA review approval to conduct a Phase II clinical trial of the new drug AD17002 for the treatment of moderate to severe eosinophilic asthma.
