About Gongwin
Gongwin Biopharm Holdings, Co., Ltd. Cayman (Gongwin-KY; ticker: 6617), founded in 2014, is a Taiwan-based biopharmaceutical company focused on developing novel anti-cancer drugs.
In 2017, Gongwin-KY was granted the "Biotech New Drug Company" designation by MOEA in Taiwan, and it became a publicly traded company on the Taipei Emerging Stock Board.
Gongwin-KY utilizes a proprietary technology called MITTA (minimally-invasive targeted tumor ablation) therapy for the treatment of focal malignancies. This innovative tumor ablation technique involves the intratumoral injection of our API, PTS (para-toluene sulfonamide), which is administered using existing diagnostic and minimally-invasive intervention techniques. This approach is unique and distinct in the current market for treating focal malignancies.
Our product, PTS 302, has been newly listed in the pharmacopeia of China and has received marketing approval from NMPA (China) for the treatment of severe malignant airway obstructions in non-small cell lung cancers (NSCLC). We are proud to report that PTS 302 has demonstrated both safety and efficacy in treating tumors causing airway obstructions, and we are confident in our ability to introduce this novel therapeutic approach as a superior treatment for focal malignancies in the airways.
PTS intratumoral injections have high selectivity for cancer cells and have minimum damage to healthy cells. It has shown great results in treating tumors in H & N cancers, liver cancer, breast cancer, and other types. These trials are currently running in Taiwan, China, and the USA.
Gongwin Biopharm is also utilizing its core technology to develop tumor ablation formulas for companion animals in Taiwan. The company has completed a pre-field study to evaluate potential indications to target and has started field trials for treating canine melanomas in 2022. We are one of the few biopharmaceutical companies in the world developing tumor-ablating techniques for both humans and companion animals.
Key Features of PTS - MITTA
【Safety】: PTS causes tumor cell necrosis within 24 hours of the minimally invasive injection with high selectivity of cancer cells over normal ons.
【Efficacy】: As a targeted chemical ablation drug through intratumoral injection, PTS can effectively cause tumor necrosis/apoptosis within a few hours after injection.
【Broad Efficacy】: PTS has proven to be effective against a variety of solid tumors, including head and neck cancer, breast cancer, lung cancer, and liver cancers, and PTS can also be combined with existing cancer treatment methods.
Management Philosophy
【Innovation】: Providing novel local-regional tumor ablation therapy based on Gongwin-KY’s core MITTA (minimally invasive targeted tumor ablation) approach.
【Professionalism】: Maximizing corporate value and company competitiveness under the leadership of a seasoned management team.
【Integrity】: Adhering to the golden rule of honesty and truthfulness and creating a triple-win situation for patients, physicians, and investors.
【Care】: Fulfilling corporate social responsibility and caring for life. After being treated with PTS MITTA, patients can extend their happiness to family and friends.
[ Company Milestone]
🟩 U.S Phase (R&D and Regulatory Initiation)
1994 - Discovered potential of PTS, initiated human trails
2000 - Founded PTS International Inc.
2004 - First FDA IND approval
2017 - Adenoid cystic carcinoma receives orphan drug designation
2022 - Canine melanoma and Neurotendinoma receive MUMS approval
2024 - Canine drug submitted to IND
🟥China Phase (Clinical and Product Launch)
2005 to 2009 - Completed Phase I/II clinical trials (lung cancer, breast cancer, liver cancer, head and neck cancer, superficial tumors)
2011 - Completed Phase III clinical trial for lung cancer
2022 - Para-toluenesulfonamide was incorporated in the Chinese Pharmacopoeia
2023 - Purocenta® officially launched in China
🟧 Taiwan Phase (Operation Center and Animals Medicine)
2014 - Established Gongwin Biopharm Holdings, Co., Ltd. (Taiwan operation center)
2017 - Listed on Taiwan Emerging Stock Market
2020 - GMP R&D center in NewTaipei Industrial Park officially opened
2022 - Canine melanoma field experiment approved (GWA103)
2024 - Our company's Initial Public Offering(IPO) officially launched in June