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Gongwin's Novel Canine Melanoma Drug Clears Key Regulatory Milestone
時報記者郭鴻慧台北報導 referenceLINK
Breakthrough in Pet Cancer Treatment: Gongwin’s Novel Canine Melanoma Drug Clears Key Regulatory Milestone
Gongwin-KY (6617) announced on September 5 that it has received official notification from Taiwan’s Ministry of Agriculture confirming that the technical dossier review for the marketing authorization of its novel targeted tumor ablation drug for the treatment of canine melanoma has been successfully completed.
Gongwin is concurrently initiating pre-launch preparations and clinical education programs. This regulatory milestone represents an important step toward the commercialization of anticancer therapies for companion animals in Taiwan and marks further progress in expanding treatment options in veterinary oncology.
According to statistics cited from the Taiwan Institute of Economic Research, the number of newly registered dogs and cats in Taiwan reached approximately 180,000 in 2022, substantially exceeding the approximately 100,000 births recorded annually. Meanwhile, according to Fortune Business Insights, the global veterinary oncology market reached approximately US$2.9 billion in 2025 and is projected to grow at a compound annual growth rate (CAGR) of 10.7% from 2026, potentially reaching US$7.11 billion by 2034.
As companion animals live longer and pet owners become increasingly willing to invest in advanced medical care, veterinary pharmaceuticals have emerged as an important segment of the global healthcare market. Many of the world’s leading pharmaceutical companies have established dedicated animal health divisions or spun them off as independent companies. For example, Zoetis originated from Pfizer’s animal health business, while Elanco was spun off from Eli Lilly and Company.
Gongwin-KY has currently signed letters of intent for cooperation with more than 100 veterinary hospitals across Taiwan. Following completion of product labeling, supply chain preparations, and hospital onboarding procedures, the company plans to begin supplying the product in accordance with applicable regulatory requirements. Clinical education and training programs will also be introduced to support veterinary professionals in providing additional treatment options under appropriate safety and compliance standards.
Gongwin-KY stated that it will continue to collaborate closely with veterinary hospitals, academic institutions, and professional veterinary communities in Taiwan and internationally. In collaboration with National Pingtung University of Science and Technology (NPUST), the company has completed a clinical study involving 12 horses with superficial tumors, with related findings presented at an international equine veterinary congress in Bangkok earlier this year. The company also plans to expand its equine clinical research program into Australia.
Building on its experience in canine and equine oncology, Gongwin plans to further investigate additional canine tumor indications as well as feline cancers. Through evidence-based clinical research and regulatory compliance, the company aims to translate its technology into accessible clinical solutions that can provide veterinarians, pet owners, and families with additional options when making cancer treatment decisions for companion animals.
Expanding the Global Animal Oncology Strategy
Internationally, Gongwin-KY plans to leverage its regulatory progress in Taiwan as a foundation for further global development. The company has also obtained authorization to proceed with clinical development in the United States and intends to actively evaluate a potential pathway toward conditional approval in the U.S.
Gongwin-KY will continue expanding its animal oncology development strategy into major companion-animal markets, including Australia, Japan, the United States, China, and Hong Kong, as it advances the international development of its targeted tumor ablation technology.
Clinical outcomes of intratumoural PTS treatment in equine melanoma
Publication Article link
Title: Clinical outcomes of intratumoural para‐toluenesulfonamide treatment in equine melanoma - Lo - Equine Veterinary Education - Wiley Online Library
Summary
Equine melanoma is one of the most common cutaneous neoplasms in horses and is particularly prevalent in grey horses. Although these tumours often demonstrate indolent biological behaviour, some progressively develop locally invasive or malignant characteristics over time, making treatment decisions challenging in clinical practice. This case series describes the clinical outcomes of intratumoural para-toluenesulfonamide (p-TLS) treatment in seven horses with cutaneous melanoma managed under field conditions. Seven horses with histopathologically confirmed melanoma were treated with intratumoural p-TLS at approximately weekly intervals, and tumour response was assessed through clinical examination, tumour measurements and serial photographic documentation. Clinical complete response was achieved in six of seven horses, while one horse showed partial response. Local tumour necrosis and sloughing developed in all cases and were followed by progressive wound healing. Mild treatment-related adverse effects, including transient local inflammation and reduced appetite, were observed but were self-limiting. Follow-up duration ranged from 107 to 765 days, with one case of local recurrence. Intratumoural p-TLS appeared to provide effective local tumour control and was generally well tolerated. This minimally invasive approach may represent a practical treatment option for equine melanoma, particularly where surgical management or referral-based treatment is not feasible. However, these findings should be interpreted with caution because of the small sample size, absence of a control group and variable follow-up duration.
Participate 2026 FASAVA on 10/31-11/2
FASAVA to be held in Taipei, Taiwan, from October 31 (Sat.) to November 2 (Mon.), 2026, at the Taipei Nangang Exhibition Center, Hall 2 (7F).
FASAVA (Asian Small Animal Veterinary Association) was born from the collaborative efforts of veterinarians from the Asia-Pacific region. By establishing an international small animal veterinary organization, it fosters a better environment for academic exchange among veterinarians from all regions. Currently, over 14 countries in the Asia-Pacific region participate.
Equine cutaneous tumorsresults published
發表
Intratumoral para-toluenesulfonamide as a tumor-ablative therapy for equine cutaneous tumors: a case series of three horses
Publication link ScienceDirect
Equine clinical trials results published at WEVA 2026
PTS Treatment for Equine Tumors to Be Presented at the World Equine Veterinary Association Congress
The clinical study results of GWA106, an investigational animal targeted tumor-ablating drug based on PTS, for the treatment of equine tumors have been accepted for presentation at the 2026 World Equine Veterinary Association (WEVA) Congress.
The abstract describing the clinical outcomes has successfully passed the WEVA scientific review process and will be presented at the congress. The findings are expected to provide valuable data regarding the safety and efficacy of PTS in the treatment of equine tumors.
The global horse population is estimated to be approximately 60 million, with around 600,000 new cases of equine tumors diagnosed each year, representing a potential therapeutic market valued at approximately USD 180 million.
However, the treatment of tumors in horses presents unique challenges. Conventional therapeutic approaches such as radiotherapy, cryotherapy, and electrochemotherapy may cause adverse effects that can interfere with essential functions including locomotion, feeding, or excretion, thereby significantly affecting the horse’s quality of life.
Surgical excision, particularly when tumors are located in specific anatomical regions, further highlights the complexities of large-animal medicine. These procedures must be performed in specialized surgical facilities designed for large animals and often require industrial-grade lifting systems to move or stabilize the horse during surgery. Such procedures impose substantial demands on infrastructure and cost, while also exposing the horse to considerable risks, including complications associated with general anesthesia and potential secondary injuries during lifting or repositioning.
In contrast, PTS therapy provides a novel and less invasive alternative. Through precise local administration and intratumoral injection, the treatment directly targets the tumor site without the need for extensive surgical intervention. This approach significantly reduces systemic burden, anesthesia-related risks, and reliance on specialized surgical facilities. As a result, PTS therapy has the potential to effectively treat tumors while preserving the horse’s mobility, comfort, and overall quality of life, addressing a critical unmet need in equine oncology.
To date, 12 horses with palpable skin tumors have been treated, including cases of melanoma, sarcoma, and squamous cell carcinoma. The related clinical outcomes will be presented at the WEVA 2026 Congress.
Canine Journal Publication
International Journal of Veterinary Science (IJVS)
Published Efficacy and Safety of Para-Toluenesulfonamide in Treating Various Canine Tumors
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