event-trade登录编辑
🇭🇰 港交所CANBRIDGE-BCodex · 实盘不做把握 7/10
北京时间·🕒 发布 07-30 17:21:00时区推断·⟳ 抓取 07-30 17:23:52·⚡ 决策 07-31 02:13:29 +8h49m·88.7 天前

北海康成启动高瑞宁北非市场注册及商业准备

公告只披露高瑞宁已启动北非某关键市场注册程序和商业化准备,尚未取得当地批准。

📄 原文CANBRIDGE-B↗ 原文
1 Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the c…
不做 北海康成(01228.HK)
只是在北非启动注册及商业准备,未获批、未销售、未披露合作方或收入量级,按审批进展类公告不追。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)

研究档案

🔎 新鲜度:最早出现 2026-07-30 · 扩散 low · price-in 风险 medium ↗

关键理由

  • 公告只披露高瑞宁已启动北非某关键市场注册程序和商业化准备,尚未取得当地批准。
  • 公司明确称北非市场尚无正式销售收入,短期收入、利润和现金流增量无法量化。
  • 该事件更接近国际化进展披露,不是获批、上市销售或订单落地,短线重定价基础不足。

主要风险

  • 若后续获得当地药监批准并披露销售节奏或合作方,需由新事件重新评估。
  • 高雪氏病为罕见病适应症,北非单一区域可触达患者和支付能力未披露,商业化量级不清。

原文全文

展开原文 · 3,812 字
1
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take
no responsibility for the contents of this announcement, make no representation as to its accuracy or
completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in
reliance upon the whole or any part of the contents of this announcement.
CANbridge Pharmaceuticals Inc.
ʮ̡
(Incorporated in the Cayman Islands with limited liability)
(Stock Code: 1228)
VOLUNTARY ANNOUNCEMENT
EXPANSION OF GAURUNNING ® (VELAGLUCERASE-BETA FOR
INJECTION) INTO NORTH AFRICAN MARKET
This announcement is made by CANbridge Pharmaceuticals Inc. (the “ Company ”, together with its
subsidiaries, the “Group”) on a voluntary basis to update the shareholders and potential investors of the
Company on the latest business development of the Group in relation to the expansion of Gaurunning ®
(velaglucerase-beta for injection) (“Gaurunning”) into the North African market.
The board of directors (the “Board”) of the Company is pleased to announce that the Group has fully
initiated the registration procedures and commercial readiness work for Gaurunning to cover a key North
African market, and launch preparations in the region have commenced. The Group’s entry into the
North African market, a region with sizable market potential and unmet clinical needs, marks the first
step for Gaurunning to expand into a growing global Gaucher disease market.
Gaurunning has been granted marketing approval by the National Medical Products Administration (the
“NMPA”) of the People’s Republic of China (the “PRC”) on May 15, 2025 and is the first domestically
independently developed long-term enzyme replacement therapy approved in the PRC for adolescents
aged 12 and above and adults with Type I and Type III Gaucher disease. Gaurunning is the Company’s
first in-house developed enzyme replacement therapy, and the Company holds global proprietary rights
to develop and commercialize Gaurunning. As an innovative biologic drug, Gaurunning is positioned
as an alternative to comparable imported products. The expected lower treatment costs will enhance
treatment accessibility and sustainability for Gaucher disease patients globally. In addition, an NMPA-
approved registration trial is ongoing, aiming to expand Gaurunning’s label to patients aged 2 to under
12.
The Company considers that the expansion of Gaurunning into the North African market represents an
important milestone for the international rollout of Gaurunning into the global Gaucher disease market.
Such expansion is expected to not only enhance treatment accessibility for Gaucher disease patients in
North Africa, but also diversify the Group’s revenue mix, strengthen its profit base and deliver long-
term value to shareholders over the medium to long term.

2
As at the date of this announcement, the Group is progressing with the registration procedures and
commercial readiness work as mentioned above, and no formal sales revenue has yet been derived
from the North African market in respect of Gaurunning. The completion of the applicable registration
procedures with the relevant health authorities remains subject to, among other things, review and
approval by such authorities. Shareholders and potential investors of the Company are advised to
exercise caution when dealing in the shares of the Company.
By Order of the Board
CANbridge Pharmaceuticals Inc.
Dr. James Qun Xue
Chairman
Hong Kong, July 30, 2026
As of the date of this announcement, the Board comprises Dr. James Qun Xue as executive Director;
Ms. Wei Zhao and Mr. Tingwei Wang as non-executive Directors; and Dr. Richard James Gregory,
Mr. James Arthur Geraghty, Mr. Peng Kuan Chan and Dr. Lan Hu as independent non-executive
Directors.

决策记录链 · 只追加

每次领取产生一条记录,重新决策追加一条并以 supersedes 指向被替代的记录(ADR 0014)。

这条决策早于决策账本(2026-10-08 起逐条追加),没有追加记录。