Gongwin-KY’s (6617) American subsidiary, PTS International Inc.’s new drug for adenoid cystic cancer, was granted US FDA orphan drug identification. Gongwin-KY pointed out that obtaining the orphan drug identification this time means that there may be an opportunity to apply to bring the drug to the market through a more flexible review system in the future, accelerating the development of PTS-02 for the treatment of adenoid cystic carcinoma.
Gongwin-KY pointed out that the cell types of lung cancer include squamous cell carcinoma and adenocarcinoma, while tracheal adenoid cystic carcinoma is a malignant tumor that originates from the mucous glands of the trachea and forms a cystic shape. Even though the carcinogenesis of airway adenoid cystic carcinoma is slower than that of lung cancer, the tumor often infiltrates the wall of the tracheal cavity, making it difficult to eradicate through physical therapy and causing subsequent recurrence of the original lesion or lung cancer metastasis.
Gongwin-KY pointed out that as PTS-02 is selective towards cancer cells in the injected lesions and has a spreading and killing effect on infiltrating cancer tissues, this type of cancer can highlight even more of the product’s treatment advantages, providing a development strategy for the orphan drug to enter the market in order to gain competitiveness and foothold in the market.
Gongwin-KY said that this new PTS drug offers the broad-spectrum characteristic. Even though the orphan drug application was submitted for airway adenoid cystic cancer in the U.S., it will not be limited to the treatment of rare diseases in the future. Further development can continue for other cancer indications to increase its market potential in the future.
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