Company Profile


About Gongwin BioPharm Holdings, Co., Ltd.

 

Gongwin Biopharm Holdings, Co., Ltd. Cayman (Gongwin-KY; ticker: 6617) founded in 2014 is a Taiwan-based clinical-stage biopharmaceutical company focused on developing novel anti-cancer drugs. We adopt an innovative anti-tumor therapy called “minimally-invasive targeted tumor ablation” (MITTA) therapy for the treatment of focal malignancies. In 2017, Gongwin-KY has been granted “Biotech New Drug Company” designation by MOEA, Taiwan and became a public trading company at Taipei Emerging Stock Board.

The proprietary core technology of Gongwin-KY is intratumoral injection of PTS (para-toluenesulfonamide) by combining the active therapeutic agent-PTS and minimally-invasive intervention, which is unique and distinct from traditional anti-tumor therapies. The advantages include targeting specific tumors plus the nature of high selectivity of PTS on tumor cells. Based on a completed Phase III clinical trial conducted in China, PTS MITTA therapy has demonstrated its safety showing minimal damages to adjacent normal cells and efficacy by statistical analysis. Gongwin-KY is confident to provide PTS MITTA as a better novel anti-cancer treatment option.

 

Following are Gongwin-KY’s new drug candidates under development.

  1. PTS302 (for the treatment of lung cancer):
  • In 2018, PTS302 was inspected, registered, and classified by CFDA as Class 1 new drug, currently under special & priority review for approval. 
  • In 2019, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China has completed the clinical evaluation of PTS302. The pharmacy materials, indications and instructions for use, and post-launch risk control 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.
 
   2. PTS100 (for the treatment of liver cancer): 
  • Phase II clinical trial of liver cancer has been carried out at National Taiwan University Hospital, Taipei Veterans General Hospital, and Taipei University  Hospital, with anticipation to accelerate the clinical acceptance as soon as possible by the end of 2021.

   3. PTS-02 (for the treatment of Adenoid cystic carcinoma (ACC)
  • 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 for will be submitted in the near future.

   4. PTS500 (for the treatment of Malignant pleural effusion):

  • The clinical trial application is expected to be submitted in Taiwan, China, Australia, etc.

In addition to the development of anti-cancer drugs, Gongwin-KY has been working on other novel drugs for unmet medical needs. To expand our R&D capacity, Gongwin-KY plans to build a GMP-equivalent pilot laboratory qualified for conducting optimization of drug formulation, animal study, and manufacturing of pilot-scale API. We expect the development timeline of PTS novel drugs will be expedited with this new laboratory to be completed in 2019.

Dr. Wu, the inventor of PTS, and Dr. Shih have been conducting various exploratory studies on PTS since 1980s. In 2000, PTS International Inc., Texas, USA, and Beijing Vision Drugs Development Limited were established in China to conduct multiple pre-clinical studies and clinical trials. Since then, we have accumulated a great deal of clinical data and experience on PTS anti-cancer therapy. In 2011, a Phase III multi-center, non-randomized, single-arm, open-label trial has been completed in China. Afterward, a category 1.1 NDA has been submitted to China FDA and is under priority review now. In order to accommodate the local regulatory affairs and markets in China, Tianjin Chase Sun Jiandakang Pharmaceutical Technology Co., Ltd. was founded by PTS International Inc. and Tianjin Chase Sun Pharmaceutical Co., Ltd. to be responsible for the license registration and manufacturing of PTS for China market.
 
To leverage Taiwan’s research and development capabilities and deploy our global business strategy, PTS International Inc., in 2014, established Gongwin Biopharm Holdings Co., Ltd. Cayman and Gongwin Biopharm Co., Ltd. in Taiwan and completed re-organization in December 2015. Gongwin Biopharm Co., Ltd., the wholly-owned subsidiary of Gongwin Biopharm Holdings Co., Ltd. Cayman, is the global business headquarter responsible for new drug development, clinical study, manufacturing, marketing, business development, and licensing. As a Taiwan public company, Gongwin-KY strongly believes in “Gain a strong foothold in Taiwan, Eye on the world”.


Corporate Philosophy

Gongwin-KY is focusing on the development of PTS MITTA anti-cancer novel drugs and other new drugs for unmet medical needs. Our ultimate goal is to provide effective and safe novel drug with high quality. Gongwin-KY’s corporate culture is based on four core values:

Innovation:
Providing a novel loco-regional tumor ablation therapy based on Gongwin-KY’s MITTA core competency,

Professional:
Maximizing corporate value and company competitiveness under the leadership of seasoned management team

Integrity︰
Bracing the golden rule of being honest and truthful and creating a triple-win situation among patients, physicians and investors

Care:
Fulfilling corporate social responsibility and caring for life. After cured by PTS MITTA, patients can extend his or her happiness to family and friends.