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Company History
- Human Indication Progress
- Veterinary Indication Progress
2025
  • ROAN medical gel got the Medical Device Class I permit.
  • ASCO paper publication
  • ROAN gel Exclusive Distribution Agreement to Taiwanese company
  • PTS on treating MPE in compasionate used Retrospective Study approved by Taipei Veterans General Hospital
  • Signed MOU with Malaysina company
  • PTS on treating Melanoma in canine patent approved.
  • OnCur 
  • Combination Therapy for Treating Cancer patent approved.
  • Speedling medical gel got the Medical Device Calss I permit
2024
  • Passed the review for over-the-counter (OTC) listing in February and officially listed in June, successfully raising 14.17 million new shares and a total of 61.7 million USD.
  • Completed field trials for PTS treatment of canine melanoma in August.
2023
  • Initiated the use of PTS intratumoral injection in Southeast Asia through the Named Patient Application (NPA) in Singapore and Malaysia.
  • The PTS intratumoral injection anticancer drug was launched for sale in China in August.
  • Signed "Market Promotion Service Agreements" with distributors in several regions and provinces across China.
  • The application for Investigational New Animal Drug (INAD) clinical trials submitted to the U.S. FDA has been approved.
  • Collaborated with National PingTung University of Science and Technology on an industry-academia partnership for equine melanoma.
2022
  • The new drug "PTS302 Toluene Sulfonamide Injection" has obtained the drug registration certificate issued by the National Medical Products Administration of China.
  • Obtained the production license for PTS lung cancer treatment in China in August.
  • Received MUMS qualification for fee waivers for clinical trials of new animal drugs (melanoma and neurofibromas) from the FDA.
  • Received NSCLC-MAO market approval in China in November.
  • The PTS animal new drug has received approval from the Council of Agriculture to conduct field trials for canine melanoma (GWA103).
  • Conducted compassionate use of PTS100 for patients with breast cancer, liver cancer, tongue cancer, and adenoid cystic carcinoma (ACC) at several hospitals in Taiwan.
  • Signed a "Distribution and Licensing Agreement" with a regional distributor in Australia in November.
2021
  • Signed a collaboration agreement with TaiRx Biotechnology Corporation for the development of the CVM-1118 product for the lung cancer indication in the Chinese market.
  • Obtained patents for the treatment of adenoid cystic carcinoma (ACC) and malignant plural effusion (MPE) in several countries
2020
  • PTS is listed in the NMPA Chinese Pharmacopoeia.
  • The WuGu R&D Center in the New Taipei Industrial Park has commenced operations.
  • The PTS100 new drug for liver cancer is undergoing Phase II clinical trials at National Taiwan University Hospital, Taipei Veterans General Hospital, and Taipei Medical University Hospital.
2019
  • In July, held a face-to-face consultation with the U.S. FDA regarding the Phase II clinical trial for the rare cancer adenoid cystic carcinoma (ACC).
  • The PTS animal new drug has received approval from the Council of Agriculture (COA) to conduct a preliminary clinical trial for canine cancer (GWA101).
2018
  • Signed a Memorandum of Understanding (MOU) with Best Friend Int'l Ltd. for the development and global sales of GW-1205 in cosmetic products.
  • Phase II clinical trial kickoff meeting for PTS100 liver cancer at National Taiwan University Hospital, officially initiating patient enrollment.
2017
  • PTS-02 for the treatment of adenoid cystic carcinoma (ACC) has received orphan drug designation from the U.S. FDA.
  • Gongxin-KY was publicly issued in Taiwan and listed on the over-the-counter market on February 8.
  • New Drug Application (NDA) for severe airway obstruction in central lung cancer submitted to the CFDA.
2014
  • Established Taiwan Gongwin Biopharma Co., Ltd. as the operational and research headquarters.
2012
  • Founded a subsidiary in China, Holyject Pharmaceutical Technology Co., Ltd., in collaboration with Chase Sun Pharmaceutical and Nanshan Foundation.
2011
  • Completed Phase III clinical trials of PTS302 for patients with severe airway obstruction (sMAO) in NSCLC
2009
  • Completed Phase IIa and IIb clinical trials, including studies on breast cancer, head and neck squamous cell carcinoma, malignant superficial tumors, lung cancer, and liver cancer.
2005
  • Established a subsidiary in China, Beijing Jiankang New Drug Development Co., Ltd., and completed Phase I clinical trials.
2004
  • Submitted for FDA IND approval for Phase I clinical trials in the United States.
2004
~2000
  • Established PTS International Inc. in the United States.
  • Conducted hundreds of exploratory clinical research cases involving human subjects in Guangzhou, China.