History

Year

History & Evolution

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