History
Year History & Evolution
2020 Taiwan
 

February 
The Council of Agriculture approved additional [canine] field clinical pre-trial institutions (Official Letter Prevention Inspection First No.1081415339); trial institutions: WellcareVet Animal Hospital,
Aurora Animal Hospital, and TZUOO-ANN Animal Hospital.

March
The animal facility in Wugu Gongwin Technology R&D Center officially opened.

Gongwin’s Wugu Technology R&D Center: Chemical and Formulation Laboratory officially opened.
Trial Kick-off Meeting of Taiwan Phase II liver cancer trial held at Taipei Veterans General Hospital.


April 
Trial Kick-off Meeting of Taiwan Phase II liver cancer trial held at Taipei Medical University Hospital

June 
Wugu Technology R&D Center completed.


July
The Council of Agriculture approved kick-off of [cat] safety data collection trial (Official Letter Prevention Inspection First No.1091409941).


October
The Council of Agriculture approved additional [canine] field clinical pre-trial institutions (Official Letter Prevention Inspection First No.1091415141); trial institutions: The National Taiwan University Veterinary Hospital, Master Specialists Animal Hospital.

November
– Gongwin Biopharm signed "IBD98-M Phase II Cooperation Agreement for the Implementation of Clinical Trials in China Area" with Holy Stone Healthcare Co.
Entrusted GMP API plant to manufacture Novel excipients

December
– Entrusted GMP animal drug plant to manufacture new drugs for companion animal field trials.

–The compassionate treatment case for advanced liver cancer was reviewed and approved by Taipei Medical University – Joint Institutional Review Board.
Adenoid Cystic Carcinoma (ACC) Patent-Obtained patent certificate in Taiwan

China
December – Passed NMPA review of PTS302 toxicity/safety portion.

Indonesia

October - Malignant Pleural Effusion (MPE) Patent -Obtained patent certificate in Indonesia

Australia
January - Malignant Pleural Effusion (MPE) Patent-Obtained patent certificate in Au
October - Adenoid Cystic Carcinoma (ACC) Patent-Obtained patent certificate in Australia


New Zealand
March - Malignant Pleural Effusion (MPE) Patent-Obtained patent certificate in New Zealand

Korea

July - Malignant Pleural Effusion (MPE) Patent-Obtained patent certificate in Korea.

2018 Global:

International out-licensing:Signed a MOU with Best Friend Int'l Ltd.: GW-1205 for beauty product development and global sales
Paper Publication: PTS Cancer Drug Action Machine Forwarding Table in Frontiers in Pharmacology
Signed a clinical cooperation agreement with the US Center for Indicator Medicine
Participated in the WCBIP World Lung Bronchoscopic Interventional Research Conference


China:

Paper Published: PTS for the treatment of adenoid cystic carcinoma (Journal of Thoracic Disease)
CFDA inspection registration is classified as a new class 1 drug and is included in the special & priority review approval
Received a notice of on-site verification of the PTS issued by the State Food and Drug Administration of China


Taiwan:

Gongwin-KY is expected to handle a cash increase of RMB 20 million through Tianjin Chase Sun Jiandakang Pharmaceutical Technology Co., Ltd.
Academic meeting - share strategic planning and specific implementation experience in the development of new drugs for respiratory diseases in China.
Purchase of real estate in the WuGU Industrial Park, and it is expected to build a research and development center.
Completed cash increase of NT$297 million.
Ministry of Science and Technology approved the establishment of the second phase of the investment in Hsinchu Science Park.
Initiate PTS Phase II clinical trial on Liver Cancer in Taiwan.
2017 1.1 NDA for Malignant Airway Obstruction submitted to China FDA
Granted “Biotech & New Drug Company Designation” by MOEA, Taiwan
Granted Orphan Drug Designation for ACC by US FDA
IPO and Publicly Listed in Taipei Emerging Exchange (Ticker: 6617)
2016 PTS-02 Orphan Drug Designation application submitted to US FDA
Phase II IND application submitted to Taiwan FDA
2015 Signed a collaboration agreement with NanShan Medical Development Foundation
2014 Gongwin Biopharm Co., Ltd established in Taiwan as the global operation and R&D headquarter
Gongwin Biopharm Holding Co., Ltd. established in Cayman
2012 Tianjin Chase Sun Jiandakang Pharmaceutical Technology Co., Ltd. Established in China
2011 Completed Phase III trial for Malignant Central Airway Obstruction in China
2009 Granted Phase III trial for Malignant Central Airway Obstruction in China
2007 Completed Phase IIb trial for late-stage lung cancer
Completed Phase IIb trial for late-stage liver cancer
Completed Phase IIb trial for malignant superficial solid tumor
2004 Phase I IND granted by US FDA for malignant superficial solid tumor
Phase IIb trial for late-stage lung cancer granted by China FDA
Phase IIb trial for late-stage liver cancer granted by China FDA
Phase IIb trial for malignant superficial solid tumor granted by China FDA
Completed Phase IIa trial for early breast cancer in China
Completed Phase IIa trial for I/II stage head & neck cancer in China
2001 Granted Phase IIa trial for early breast cancer in China
Granted Phase IIa trial for I/II stage head & neck cancer in China
~2000 First invention of PST’s anti-cancer therapeutic effect
PTS International Inc. established in Texas, USA to conduct preclinical studies and exploratory clinical research