2026/09/05 Gongwin Pet Biopharm: Pet anti-cancer drug Gwa103 passes MOA technical review for NDA.

1.Date of occurrence of the event:2026/09/04

2.New drug name or code:Oncur Injection (Gwa103)

3.Indication: Gongwin Pet Biopharm Co., Ltd. applied to Taiwan’s Ministry of Agriculture (MOA) for the New Drug Application (NDA) of its pet anti-cancer drug Oncur Injection (Gwa103), indicated for the treatment of canine melanoma. On September 4, 2026, the company received official notification from the MOA that the technical data review for new drug marketing approval has passed. Currently, the primary treatment for canine melanoma remains surgery combined with chemotherapy. Because canine melanoma frequently occurs in the oral cavity and extremities—often involving extensive lesion areas—surgical resection typically requires removing significant amounts of normal tissue. This causes considerable trauma to the pet and imposes a substantial caregiving burden on the pet owner. In contrast, Oncur Injection eradicates cancer cells via the mechanism of Intratumoral Drug Ablation (IDA). This property allows the drug to selectively enter cancer cells, thereby minimizing damage to normal tissues. Furthermore, the necrosis margin formed after cancer cells are eliminated provides a clear visual assessment of tumor necrosis while preserving more healthy tissue, which significantly reduces the subsequent post-treatment caregiving burden for pet owners.

4.Planned development stages:None.

5.Current development stage: (1)Application submission/approval/disapproval/each of clinical trials(include interim analysis): The Company's subsidiary announces that its pet biomedical new drug, Oncur Injection (Gwa103), for the treatment of canine melanoma, has passed the technical data review for new drug marketing approval. (2)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:None. (3)After obtaining official approval or the results of statistically significant sense, the future strategy:The pet biomedical new drug Oncur Injection (Gwa103) has passed the technical data review for new drug marketing approval, and the company will proceed with the subsequent sample testing and inspection procedures accordingly. (4)Accumulated investment expenditure incurred: In consideration of future marketing strategies and to safeguard the interests of the Company and its investors, such information will not be publicly disclosed.

6.Upcoming development plan: (1)Estimated Completion Date:None. (2)Estimated responsibilities:None.

7.Market situation: Amid the demographic trend toward declining birth rates, the humanization of pets has gained significant momentum, establishing the widespread concept of pets as family members. According to statistics from the Taiwan Institute of Economic Research (TIER), as of 2022, the number of newly registered domestic cats and dogs reached 180,000, far exceeding the annual newborn population of approximately 100,000. Furthermore, research by Fortune Business Insights indicates that the global veterinary oncology market reached USD 2.9 billion in 2025 and is projected to expand at a compound annual growth rate (CAGR) of 10.7% starting in 2026, surpassing USD 7.11 billion by 2034. Data indicates that over the past decade, cancer has surged to become the leading cause of death among senior dogs and cats. Currently, standard treatment remains predominantly surgical resection, which typically involves removing substantial amounts of healthy tissue. This inflicts significant trauma on pets and imposes a heavy caregiving burden on their owners, falling short of meeting the compassionate care expected in an era where pets are embraced as family. In contrast, Oncur Injection leverages the therapeutic advantage of Intratumoral Drug Ablation (IDA) to preserve more normal tissue,thereby substantially alleviating the post-treatment caregiving burden for pet owners. By addressing these critical unmet medical needs, Oncur Injection holds tremendous commercial potential for the future.

8.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):None.

9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.