Company Introduction
Gongwin Biopharm Holdings Co., Ltd. is a Taiwan-based biopharmaceutical company focused on developing novel anti-cancer drugs.The proprietary core technology of Gongwin is PTS, an innovative anti-tumor therapy called Minimally Invasive Targeted Tumor Ablation (MITTA) for treating focal malignancies. This therapy is effective, fast, safe and requires minimal time in hospital.
Gongwin is also developing other treatment options for unmet medical needs. Our goal is to provide effective and safe novel treatments with high quality results and minimal side effects.
We hope to become a standard in the future of cancer treatment options.
Brief description of main products or services
Our pipeline includes a collection of investigational treatments designed to target cancerous tumors:PTS302 for the treatment of lung cancer:
A phase III study was completed in China to recruit 90 patients in 17 hospitals. In 2019, the Center for Drug Evaluation (CDE) of National Medical Products Administration of China has completed the clinical evaluation of PTS302. The pharmacy materials, indications and instructions for use, and post-launch risk management plans are currently under review. Once this stage is passed, "GMP on-site verification" can be carried out.
In 2020, the new drug inspection and registration of PTS302 in China has moved forward smoothly.
PTS-02 for the treatment of Adenoid cystic carcinoma (ACC):
As our current data shows promising efficacy in treating this rare disease, the orphan drug designation from the U.S. Food and Drug Administration (FDA) was obtained, and the Phase II clinical trial application to the U.S. FDA will be submitted in the near future.
Gongwin is also exploring uses for PTS in other indications such as MPE and veterinary medicine. The pilot study results reveal that our drug is equally safe and effective for treating cancers in pet animals. A formal pet animal study will initiate soon.