共信醫藥科技控股股份有限公司 (Gongwin Biopharm Holdings Co., Ltd.) 2025Q2 法說會簡報
Company Overview
Basic Information
- Company Name: 共信醫藥科技控股股份有限公司 (Gongwin Biopharm Co., Ltd.)
- Paid-in Capital: 新台幣 12.7億元 (NTD 1.27 billion)
- Main Product: 甲苯磺醯胺注射液 (PTS) (p-Toluenesulfonamide Injection (PTS))
- Drug Names:
- 普羅先安 (人用) (Proscian (Human Use))
- 思沛康 (犬用) (Sepicon (Canine Use))
- Chemical Information:
- Tolsulfamide
- CAS Number: 70-55-3
- Linear Formula: CH3C6H4SO2NH2
- Molecular Weight: 171.22
- Drug Names:
- Product Manufacturing Location: 台灣 (Taiwan), 中國-天津 (China - Tianjin)
- Application Technology Platform: 微創靶向腫瘤消融 (Minimally Invasive Targeted Tumor Ablation)
- Main Indications: 肺癌-中央氣道阻塞 (Lung Cancer - Central Airway Obstruction), 犬科-黑色素瘤 (Canine - Melanoma)
R&D Center
- Location: 新北市五股產業園區 (Wugu Industrial Park, New Taipei City)
- Capabilities:
- Independent R&D capability from 0 to 100 development
- Chemical Process Development Center
- Animal Center for various tumor models
- BSL1 Cell and Biochemistry & Molecular Biology Laboratories
Organizational Structure
- Gongwin-KY Structure
- 台灣股東 (Taiwan Shareholders) -> 共信-KY (Cayman)
- Branches:
- 共信醫藥 (台灣) 營運總部
- PTS USA
- PTS ASIA (香港)
Company History
- 2000: Laboratory discovered PTS has anti-cancer effects.
- 2011: Established Gongwin Biopharm Holdings in Taiwan.
- 2014: Obtained US orphan drug designation for adenoid cystic carcinoma.
- 2016: Applied for China lung cancer drug license.
- 2020: Obtained marketing approval in mainland China.
- 2024: Listed on OTC market and applied for canine melanoma drug license.
Important Medical Advisory Group
- USA: Michael G. Simoff, MD
- Taiwan: 郭順文 (Kuo Shun-Wen)
- China: 鍾南山 (Zhong Nanshan)
- Malaysia: Dr. Jamalul Azizi
Financial Highlights
(No specific financial highlights were provided in the extracted content)
Business Segments
- Main Business Areas:
- Minimally Invasive Targeted Tumor Ablation
- Veterinary Products
Products & Technologies
PTS Product Overview
- Mechanism of Action:
- Disrupts lipid raft stability and induces cancer cell apoptosis.
- Inhibits cancer cell CA9 and regulates tumor microenvironment.
Product Advantages
- Safety: Selective toxicity towards cancer cells.
- Efficacy: Induces tumor necrosis/apoptosis rapidly post-injection.
- Broad Efficacy: Effective for various solid tumors.
Products Developed and Under Development
| Product | Indication | Status | Key Notes |
|---|---|---|---|
| PTS-302 (Proscian) | Central Lung Cancer Severe Tracheal Obstruction | Sales commenced in China (August 2023) | Phase III results show obstruction relief rate of 70.3%/73.1%. |
| GW046 (Le'an Gel) | Medical Gel | Medical device sales license obtained (February 2025) | Expected launch in September 2025. |
| GWA-103 (Sepicon) | Canine Tumors | Drug license application in December 2024 | U.S. conditional product launch planned for Q1 2026. |
| PTS500 | Malignant Pleural Effusion | Phase II trial application in Taiwan (Q4 2025), Phase II/III in U.S. | Significant market potential. |
Summary of Unique Advantages of PTS Products
- PTS500 for MPE: Reduces pneumothorax risk and maintains quality of life.
- PTS202 for H&N: Preserves more functional tissue during surgery.
- GWA103 for Canine Melanoma: Low equipment requirements and easy administration.
Clients & Markets
Market Analysis
- China Market: Over 200 hospitals, no major fatalities.
- Ex-China Markets: Signed contracts in Taiwan and Malaysia, preparing to develop markets in Hong Kong and Southeast Asia.
ESG / Sustainability
(No specific ESG or sustainability initiatives were provided in the extracted content)
Outlook & Strategy
Future One-Year Outlook Plan
- Grow PTS302 and GWA103 markets in China and Southeast Asia.
- Expand into European and North African markets.
- Establish U.S. subsidiary and prepare for PTS02 and PTS500 clinical developments.
Additional Data
Recent Major News
- Participation in the 2025 APCB Asia Pacific Respiratory Intervention Congress.
Contact Information
- Company: 共信醫藥科技控股股份有限公司 (Gongwin Biopharm Holdings Co., Ltd.)
- Address: 台北市中山區建國北路一段80號3樓 (3F, No. 80, Sec. 1, Jianguo N. Rd., Zhongshan Dist., Taipei City)
- Website: www.gongwinbiopharm.com
- TEL: +886 2 2503-5282
- FAX: +886 2 2503-5281