🇭🇰 港交所SSY GROUPCodex · 实盘不做把握 6/10
北京时间·🕒 发布 07-30 16:31:00时区推断·⟳ 抓取 07-30 16:32:01·⚡ 决策 07-31 02:41:29 +10h09m·88.7 天前
石四药集团获西咪替丁注射液及吸入用乙酰半胱氨酸溶液药品生产注册批件
本次NMPA批件确认石四药集团可销售两个仿制药品种，事件方向为正面，但只是产品管线扩容而非订单或集采中选。
📄 原文SSY GROUP↗ 原文
VOLUNTARY ANNOUNCEMENT - UPDATE ON PRODUCT DEVELOPMENT
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
不做 石四药集团（02005.HK）
两项药品获批方向正面但属于高频仿制药注册进展；乙酰半胱氨酸吸入剂虽有超20亿元市场但批文企业已达45家，西咪替丁注射液市场约6430万元，公告未披露中标、订单或销售额，相对02005.HK收入和市值缺少可执行短线edge。
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
消息传播链
- 港交所披露的PDF原件确认公司取得西咪替丁注射液及吸入用乙酰半胱氨酸溶液两个NMPA生产注册批件。市场反应:公告在港股收盘后发布，02005.HK当日收2.44港元、跌0.81%，尚无公告后连续交易反应。
- 2026-07-31 02:37 HK其它行情核查非一手当前仍为港股盘前，未出现公告后可交易价格验证。市场反应:02005.HK近20日上涨9.42%，但没有证据显示本次具体批件已提前交易。
关键理由
- 本次NMPA批件确认石四药集团可销售两个仿制药品种，事件方向为正面，但只是产品管线扩容而非订单或集采中选。
- 吸入用乙酰半胱氨酸溶液市场规模较大，但米内网称该品种已有45家企业拥有生产批文、39家企业按新分类获批，新增一家获批难以形成独占重定价。
- 西咪替丁注射液2024年公立医院销售规模约6430万元，即使取得份额，相对石四药集团2025年约41.65亿港元收入和70.55亿港元市值也偏小。
主要风险
- 若后续披露乙酰半胱氨酸吸入剂快速中选集采或取得大额渠道订单，需要用新增销售额重新评估。
- 仿制药获批后的价格、招标准入和放量节奏不确定，当前公告未给销售额、产能利用或上市时间表。
反向证据
- 做多前查反向 · 来源 kb_search · 影响 weakens
内部KB未命中本次批件的旧闻或可验证的销售占比数据，不能支持重大业绩增量判断。
检索:石四药集团 乙酰半胱氨酸吸入溶液 西咪替丁注射液 获批 销售 收入 占比 - 做多前查反向 · 来源 web · 日期 2026-05-25 · 影响 weakens
市场资料显示该品种规模大但竞争充分，SSY从报产在审转为获批不等于取得确定份额。
检索:吸入用乙酰半胱氨酸溶液 概念股 受益股 原料药 上市公司 原文 ↗ - 做多前查反向 · 来源 web · 日期 2025-07-31 · 影响 weakens
同规格西咪替丁注射液市场规模仅约6430万元且已有多家企业获批，单品弹性不足。
检索:西咪替丁注射液 市场规模 获批 企业 2025 米内网 原文 ↗
工具调用 · 历史记录,结果未知(3 种)
- search_processed_events · 结果未知
- stock_quote · 结果未知
- kb_search · 结果未知
原文全文
展开原文 · 2,190 字
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.
# VOLUNTARY ANNOUNCEMENT UPDATE ON PRODUCT DEVELOPMENT
The board of directors (the “Board”) of SSY Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Group has obtained the approval for drug production and registration for Cimetidine Injection (2ml: 0.2g) from National Medical Products Administration of China (the “NMPA”), being under type 3 chemical drug and regarded as passing the consistency evaluation. Cimetidine Injection is mainly used for the treatment of digestive tract ulcer.
The Board is also pleased to announce that the Group has obtained the approval for drug production and registration for Acetylcysteine Solution for Inhalation (3ml: 0.3g) from the NMPA, being under type 4 chemical drug and regarded as passing the consistency evaluation. Acetylcysteine Solution for Inhalation is mainly used for the treatment of respiratory diseases with excessive thick mucus secretions such as acute bronchitis, chronic bronchitis and its exacerbations, emphysema, viscous obstruction syndrome, and bronchiectasis. This product enhances the Group’s nebulized expectorant product types, enriching their nebulized inhalation treatment options for respiratory diseases.
This announcement is a voluntary announcement made by the Company to keep the shareholders and potential investors informed of the latest business development of the Group.
By order of the Board Chow Hing Yeung Executive Director and Company Secretary Hong Kong, 30 July 2026
As at the date of this announcement, the Board comprises Mr. Qu Jiguang, Mr. Su Xuejun, Mr. Meng Guo, Mr. Chow Hing Yeung and Ms. Qu Wanrong as executive Directors, Mr. Liu Wenjun as non-executive Director, and Mr. Wang Yibing, Mr. Chow Kwok Wai and Mr. Jiang Guangce as independent non-executive Directors.
# VOLUNTARY ANNOUNCEMENT UPDATE ON PRODUCT DEVELOPMENT
The board of directors (the “Board”) of SSY Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Group has obtained the approval for drug production and registration for Cimetidine Injection (2ml: 0.2g) from National Medical Products Administration of China (the “NMPA”), being under type 3 chemical drug and regarded as passing the consistency evaluation. Cimetidine Injection is mainly used for the treatment of digestive tract ulcer.
The Board is also pleased to announce that the Group has obtained the approval for drug production and registration for Acetylcysteine Solution for Inhalation (3ml: 0.3g) from the NMPA, being under type 4 chemical drug and regarded as passing the consistency evaluation. Acetylcysteine Solution for Inhalation is mainly used for the treatment of respiratory diseases with excessive thick mucus secretions such as acute bronchitis, chronic bronchitis and its exacerbations, emphysema, viscous obstruction syndrome, and bronchiectasis. This product enhances the Group’s nebulized expectorant product types, enriching their nebulized inhalation treatment options for respiratory diseases.
This announcement is a voluntary announcement made by the Company to keep the shareholders and potential investors informed of the latest business development of the Group.
By order of the Board Chow Hing Yeung Executive Director and Company Secretary Hong Kong, 30 July 2026
As at the date of this announcement, the Board comprises Mr. Qu Jiguang, Mr. Su Xuejun, Mr. Meng Guo, Mr. Chow Hing Yeung and Ms. Qu Wanrong as executive Directors, Mr. Liu Wenjun as non-executive Director, and Mr. Wang Yibing, Mr. Chow Kwok Wai and Mr. Jiang Guangce as independent non-executive Directors.
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