CANbridge Pharmaceuticals Inc. Expands Gaurunning® (Velaglucerase-beta for Injection) into the North African Market
Hong Kong, July 30, 2026 – CANbridge Pharmaceuticals Inc. (HKEX: 1228) has announced a significant business development: the initiation of registration and launch preparations for its proprietary enzyme replacement therapy, Gaurunning® (velaglucerase-beta for injection), in a key North African market.
Key Highlights from the Announcement
- Market Expansion: The company has begun the formal registration process and commercial readiness work for Gaurunning in North Africa, targeting a region characterized by large unmet clinical needs and sizable market potential for Gaucher disease therapies.
- First Global Expansion Step: This marks Gaurunning’s first move beyond the China market, representing an important milestone for CANbridge’s international growth strategy in the global Gaucher disease market.
- Regulatory Approval in China: Gaurunning received marketing approval from the National Medical Products Administration (NMPA) of China on May 15, 2025. It is the first domestically and independently developed long-term enzyme replacement therapy approved in China for adolescents aged 12 and above and adults with Type I and Type III Gaucher disease.
- Global Rights and Competitive Position: CANbridge holds global proprietary rights for Gaurunning and is positioning the drug as an alternative to imported products, with lower treatment costs expected to improve accessibility and sustainability for patients worldwide.
- Ongoing Clinical Trials: An NMPA-approved registration trial is underway to potentially expand the drug’s label to include patients aged 2 to under 12, further increasing its market reach.
- Revenue Diversification: Expansion into North Africa is expected to diversify CANbridge’s revenue streams, strengthen its profit base, and deliver long-term value to shareholders.
- No Revenue Yet from North Africa: As of this announcement, CANbridge has not yet generated sales revenue from the North African market. Progress depends on successful completion of registration and regulatory approval by local health authorities.
Shareholder Considerations and Potential Price Sensitivity
- International Expansion: The move into North Africa could be a game-changer for CANbridge, signaling the start of its global commercialization efforts for Gaurunning. This could drive investor optimism and influence share price direction, given the size and potential of the Gaucher disease market in new geographies.
- Regulatory Risk: The company cautions shareholders that completion of regulatory procedures, and thus market entry, is subject to approval by the local health authorities. There is no guarantee of success at this stage.
- Long-Term Value: Management emphasizes that this expansion is expected to generate long-term shareholder value, diversify revenues, and strengthen the company’s profit base over time.
Board and Management
The Board is chaired by Dr. James Qun Xue (Executive Director), with Ms. Wei Zhao and Mr. Tingwei Wang as Non-Executive Directors. Independent Non-Executive Directors include Dr. Richard James Gregory, Mr. James Arthur Geraghty, Mr. Peng Kuan Chan, and Dr. Lan Hu.
Investor Guidance
Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares, as the registration and approval processes in North Africa are ongoing and outcomes remain uncertain.
Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors are urged to conduct their own due diligence and consult professional advisors before making investment decisions. The information contained herein is based on public disclosures as of July 30, 2026, and may be subject to change.
康諾橋製藥宣布Gaurunning®（貝拉葡糖苷酶β注射液）擴展至北非市場
香港，2026年7月30日 – 康諾橋製藥有限公司（港交所：1228）宣布一項重大業務發展：正式啟動自家研發的酶替代療法 Gaurunning®（貝拉葡糖苷酶β注射液） 在北非主要市場的註冊及上市準備工作。
公告重點
- 市場擴展： 公司已展開Gaurunning在北非的正式註冊程序及商業準備，針對該區高需求且市場潛力巨大的戈謝病治療領域。
- 全球擴張第一步： 這次行動是Gaurunning首次走出中國，標誌著康諾橋國際化戰略的重要里程碑。
- 中國監管批准： Gaurunning已於2025年5月15日獲中國國家藥監局（NMPA）批准，成為中國首個本土獨立研發、針對12歲及以上青少年及成人（I型及III型戈謝病）的長效酶替代療法。
- 全球權利與競爭優勢： 康諾橋擁有Gaurunning的全球專有權，並定位其為進口產品的替代方案，預期更低的治療成本有助提升全球患者的可及性和治療可持續性。
- 臨床研究進展： 公司正進行NMPA批准的註冊臨床試驗，目標擴展適應症至2歲至12歲患者，進一步擴大市場。
- 收入多元化： 北非市場擴展預計有助多元化康諾橋的收入來源，加強盈利基礎，並為股東帶來中長期價值。
- 北非尚未產生收入： 截至公告日，公司尚未在北非市場產生銷售收入，進展取決於註冊及當地衛生部門的審批。
股東須知及潛在影響股價因素
- 國際擴展： 進軍北非或成為康諾橋全球商業化的轉捩點，對於投資者信心及股價有潛在正面推動作用，特別是在新興地區戈謝病市場潛力巨大。
- 監管風險： 公司提醒股東，有關註冊程序及市場進入需獲當地監管部門批准，現階段仍存在不確定性。
- 長遠價值： 管理層強調，這次擴展預計會為股東帶來長遠價值、收入多元化及盈利基礎強化。
管理層及董事會
董事會由薛群博士（執行董事）擔任主席，趙薇女士及王廷偉先生為非執行董事；獨立非執行董事包括Gregory博士、Geraghty先生、陳鵬寬先生及胡蘭博士。
投資者建議
由於北非市場註冊及審批進展仍在進行中，結果尚未明朗，股東及有意投資者應謹慎處理公司股份買賣。
免責聲明： 本文僅供參考，並不構成任何投資建議。投資者應自行審慎評估，並諮詢專業意見後才作出投資決定。本文內容截至2026年7月30日，如有變動恕不另行通知。
