PTS Global Market Development
First Named Patient Application of Tolsulfamide injection Approved in Singapore
With the approval of drug license in China, the global market development for Para-toluenesulfonamide (PTS) is also unfolding. The official approval of the first Named Patient Application (NPA) of PTS by Singapore government marks a significant milestone for Gongwin Biopharm. Collaborated with agencies specializing in medical technology trades, this NPA case which will be held at the Singapore’s leading hospital ranking among the world’s best hospitals, will be the first overseas application of PTS treatment.
NPA is a special condition, through which novel therapeutic drug products or new treatment approaches are granted permission by authorities to be imported into a country before they are officially registered in this country. However, these approaches or products are supposed to exhibit better treatment outcomes and have been at least approved in any one country. On account of the lengthy process of drug licensing, which the patients of advanced cancers or rare diseases cannot afford to wait, this condition enables new technology and treatment approaches to be available for health care practitioners to provide better care and treatment options for their citizens.
PTS is a new chemical entity, that has been approved in China in 2022 for ablating central airway tumors in patients with Non-Small Cell Lung cancers. This new approach of “Minimally Invasive Targeted Chemical Tumor Ablation” – MITTA, ensures targeted tumor ablation and decreases the chances of local recurrence and has significantly less adverse events, compared to the existing therapeutic options.
Through NPA pathway, pre-marketing activities by partnering with distributors are being strategized for Gongwin’s key markets including Malaysia, Japan, Thailand & Australia. Gongwin’s innovative approach provides doctors with a new option for tumor ablations, enhancing the overall outcome of cancer therapy while improving quality of life for cancer patients.