共信-KY 2025Q3 法人說明會
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法人說明會
共信-KY 2025Q3 法說會簡報重點與營運摘要

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
  • 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

ProductIndicationStatusKey Notes
PTS-302 (Proscian)Central Lung Cancer Severe Tracheal ObstructionSales commenced in China (August 2023)Phase III results show obstruction relief rate of 70.3%/73.1%.
GW046 (Le'an Gel)Medical GelMedical device sales license obtained (February 2025)Expected launch in September 2025.
GWA-103 (Sepicon)Canine TumorsDrug license application in December 2024U.S. conditional product launch planned for Q1 2026.
PTS500Malignant Pleural EffusionPhase 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

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