北海康成製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1228） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因依賴該等內 容而引致的任何損失承擔任何責任。 本公告或其任何副本概不得直接或間接於美國境內或有關刊發或派發屬違法的任何其他司法權區刊 發或派發。本公告僅作參考用途，並不構成收購、購買或認購本公司任何證券之邀請或要約。 本公告並不構成或組成於美國境內或有關發售屬違法的任何其他司法權區出售證券的任何要約或 招攬購買或認購證券的一部分。本公告所述本公司股份並無亦不會根據1933年美國證券法（經修訂） （「美國證券法」）登記，且不得於美國境內提呈發售或出售，惟根據美國證券法登記規定進行登記者 或獲豁免遵守該等登記規定者除外。本公司無意根據美國證券法登記本公告內所指之任何證券，或 在美國境內進行證券公開發售。 CANbridge Pharmaceuticals Inc. (1)完成根據一般授權認購新股份； (2)根據上市規則第14A.60(1)條進行的持續關連交易；及 (3)委任 ...

Group 1 - The biotechnology sector in the Hong Kong stock market experienced a significant decline, with several companies reporting substantial drops in their stock prices [1] - Notable declines include Clover Biopharmaceuticals, which fell by 14.13%, and Beigene, which dropped by 8.33% [2] - Other companies such as Innovent Biologics and WuXi Biologics also saw declines exceeding 5%, indicating a broader trend of negative performance in the sector [1][2] Group 2 - The following companies reported specific percentage declines: Clover Biopharmaceuticals (-14.13%), Beigene (-8.33%), and Innovent Biologics (-6.50%) [2] - Additional companies with notable declines include Kintor Pharmaceutical (-6.38%), CanSino Biologics (-5.98%), and Zai Lab (-5.50%) [2] - The overall trend suggests a challenging environment for biotechnology stocks in the Hong Kong market [1]

此外，2025年，国家医保局首次设立"商保创新药目录"，并于7月11日正式启动申报工作。北海康成的3 款产品戈芮宁（注射用维拉苷酶β）、迈芮倍（氯马昔巴特口服溶液）、海芮思（艾度硫酸酯酶β注射 液）于8月12日通过初审，有望加速市场准入。市场人士称，通过初审名单，对于北海康成意义重大。 假设进入商保创新药目录，药品将获得商业保险的支持，患者用药的经济负担有望减轻，从而提高产品 的可及性。 消息面上，8月13日，北海康成宣布与百洋医药达成股份认购协议，根据协议，百洋医药将斥资1亿港元 认购北海康成股份。与此同时，北海康成与百洋医药双方通过签订独家商业化服务协议，进一步深化战 略协同。根据协议，百洋医药旗下子公司将获得北海康成旗下特定产品在中国内地、香港及澳门地区的 推广权。 北海康成-B(01228)再涨超12%，年内累计涨幅已接近20倍。截至发稿，涨11.69%，报2.77港元，成交额 5007.84万港元。 本文源自：智通财经网 ...

Core Viewpoint - Beihai Kangcheng-B (01228) has seen a significant increase in stock price, rising over 12% recently and nearly 20 times year-to-date, indicating strong market interest and potential growth opportunities for the company [1] Group 1: Stock Performance - As of the latest report, Beihai Kangcheng's stock price is at 2.77 HKD, with a trading volume of 50.08 million HKD [1] - The stock has experienced a year-to-date increase of approximately 1900% [1] Group 2: Strategic Partnerships - On August 13, Beihai Kangcheng announced a share subscription agreement with Baiyang Pharmaceutical, where Baiyang will invest 100 million HKD to acquire shares [1] - The partnership includes an exclusive commercialization service agreement, enhancing strategic collaboration between the two companies [1] Group 3: Market Access and Product Approval - Beihai Kangcheng's three products have passed the initial review for the "Commercial Insurance Innovative Drug Directory" set by the National Medical Insurance Administration, which was officially launched on July 11 [1] - The products include Gerunine (Injectable Vira Glycosidase β), Mai Ruibei (Chloramphenicol Oral Solution), and Hai Ruisi (Aidu Sulfate Esterase β Injection), which are expected to accelerate market access [1] - Inclusion in the directory would allow these drugs to receive commercial insurance support, potentially reducing the economic burden on patients and improving product accessibility [1]

Core Viewpoint - Beihai Kangcheng-B (01228) has seen a significant increase in its stock price, rising over 12% recently and nearly 20 times year-to-date, indicating strong market interest and potential growth opportunities [1] Group 1: Stock Performance - As of the latest update, Beihai Kangcheng's stock price is reported at 2.77 HKD, with a trading volume of 50.08 million HKD [1] - The stock has experienced a year-to-date increase of nearly 2000% [1] Group 2: Strategic Partnerships - On August 13, Beihai Kangcheng announced a share subscription agreement with Baiyang Pharmaceutical, with Baiyang investing 100 million HKD in Beihai Kangcheng [1] - The partnership includes a commercial service agreement, allowing Baiyang's subsidiary to promote specific products from Beihai Kangcheng in mainland China, Hong Kong, and Macau [1] Group 3: Regulatory Developments - In 2025, the National Healthcare Security Administration will introduce a "Commercial Insurance Innovative Drug Directory," with application processes starting on July 11 [1] - Three of Beihai Kangcheng's products have passed the initial review as of August 12, which could expedite their market entry [1] - Inclusion in the Commercial Insurance Innovative Drug Directory would provide commercial insurance support for these drugs, potentially reducing the economic burden on patients and increasing product accessibility [1]

Core Viewpoint - The article highlights the remarkable stock performance of Beihai Kangcheng, a small-cap biotech company, which has seen its share price increase by over 1700% this year, driven by the approval of its first self-developed rare disease drug and strategic investments [3][4]. Company Overview - Beihai Kangcheng's stock price has dramatically rebounded from a low of 0.315 HKD per share, with the highest price reaching 2.5 HKD per share after the approval of its innovative drug, Goryning (注射用维拉苷酶β) [4][5]. - The company was listed on the Hong Kong Stock Exchange on December 10, 2021, but faced significant challenges initially, including a nearly 27% drop on its first trading day [4][6]. Product Development - Goryning is the first self-developed class 1 innovative drug for rare diseases in China and has successfully passed the preliminary review for inclusion in the commercial insurance innovative drug directory [4][5]. - The drug's development timeline was notably short, taking only 6.5 years from project initiation to market approval, breaking the traditional "30 principle" of drug development [9][12]. Market Dynamics - The article discusses the changing landscape for rare disease drugs in China, with increasing recognition of the innovation capabilities of domestic biotech companies and supportive government policies [4][6]. - The company aims to significantly reduce the annual treatment cost for Goryning by at least 50%, making it more accessible to patients [11][12]. Challenges and Opportunities - Despite the recent success, the potential of rare disease drugs remains underestimated in the domestic market, with Beihai Kangcheng's market capitalization hovering around 1 billion HKD, despite having three approved products [13][14]. - The company is exploring international business development opportunities and aims to engage with multinational pharmaceutical companies to expand its market reach [14].

行业估值方面，药品及生物科技行业市盈率（TTM）平均值为-2.48倍，行业中值1.49倍。北海康成-B市 盈率-1.73倍，行业排名第156位；其他精优药业（00858.HK）为1.34倍、金斯瑞生物科技（01548.HK） 为1.64倍、东瑞制药（02348.HK）为3.2倍、吉林长龙药业（08049.HK）为6.04倍、和黄医药 （00013.HK）为6.09倍。 资料显示，北海康成制药有限公司(以下简称'北海康成',股票代码1228.HK)是一家在中国领先并专注罕 见疾病领域的全球化的生物制药公司,致力于创新疗法的研究、开发和商业化。公司目前拥有10个具有 可观市场潜力的药物资产组合,其中包括2种已获批上市产品和8个在研药物。这些产品均针对一些较普 遍的罕见疾病适应症,比如亨特综合征和其他溶酶体贮积症、补体介导的疾病、血友病A、代谢紊乱、罕 见的胆汁淤积性肝病、神经肌肉疾病。 北海康成的新一代基因技术研发中心实验室正在开发针对罕见遗传病,包括庞贝氏症、法布雷病、杜氏 肌肉营养不良症(DMD)和其他神经肌肉疾病的新型及潜在治愈性的基因疗法,并与世界领先的研究人员 和生物技术公司合作。公司的全球合作伙伴包括 ...

Group 1 - Beihai Kangcheng-B (01228) has seen a nearly 17% increase recently, with a year-to-date cumulative increase exceeding 1500% [1] - As of the report, the stock price is at 2.23 HKD, with a trading volume of 41.075 million HKD [1] - Beihai Kangcheng has entered into a share subscription agreement with Baiyang Pharmaceutical (301015), where Baiyang will subscribe for shares worth approximately 100 million HKD at a price of 1.34 HKD per share [1] Group 2 - The two companies have signed an exclusive commercialization service agreement to deepen strategic collaboration, allowing Baiyang's subsidiary to promote specific products of Beihai Kangcheng in mainland China, Hong Kong, and Macau [1] - On August 12, the National Healthcare Security Administration released the preliminary list of innovative drugs for commercial insurance, with three rare disease products from Beihai Kangcheng passing the review [1] - The approved products include: - Gorynin (injectable velaglucerase beta) for long-term enzyme replacement therapy for patients aged 12 and above with Type I and III Gaucher disease - Mairuibai (oral chloramphenicol) for treating ALGS/PFIC cholestatic pruritus - Haierisi (injectable idursulfase beta) for treating Mucopolysaccharidosis Type II [1]

智通财经APP获悉，北海康成-B(01228)再涨近17%，年内累计涨幅已超1500%。截至发稿，涨14.36%， 报2.23港元，成交额4107.5万港元。 此外，国家医保局8月12日公布商保创新药目录初审名单。北海康成三款罕见病产品均通过了商保创新 药目录的形式审查。包括今年5月获批上市的用于12岁及以上青少年和成人I型和Ⅲ型戈谢病患者的长期 酶替代产品戈芮宁（注射用维拉苷酶β）；用于治疗ALGS/PFIC胆汁淤积性瘙痒的迈芮倍（氯马昔巴特 口服液）；用于治疗黏多糖贮积症II型的海芮思（艾度硫酸酯酶β注射液)。 消息面上，北海康成近日公布，与百洋医药达成股份认购协议。百洋医药将以每股1.34港元的价格认购 价值约1亿港元的北海康成股份。与此同时，北海康成与百洋医药双方通过签订独家商业化服务协议， 进一步深化战略协同。根据协议，百洋医药旗下子公司将获得北海康成旗下特定产品在中国内地、香港 及澳门地区的推广权。 ...

Summary of Beihai Kangcheng Conference Call Company Overview - **Company**: Beihai Kangcheng - **Focus**: Rare disease sector, with five products launched including Haier Si, Mai Rui Bei, and Wei La Gan En Zhi Bei Ta, covering mainland China, Taiwan, and Hong Kong-Macau regions [2][5][10] Strategic Partnerships - **Collaboration with Baiyang Pharmaceutical**: - Baiyang's exclusive CFO has joined and acquired nearly 15% equity, indicating a new development phase for the company [2][4] - This partnership is expected to influence future adjustments in medical insurance and commercial insurance directories [2][4][7] Product Development and Market Position - **Haier Si**: - The only enzyme replacement therapy globally for Mucopolysaccharidosis Type II, included in the initial selection list for innovative drug insurance payment [2][10] - Significant market potential with a high incidence rate in East Asian populations [10] - **Ge Rui Ning**: - First domestically developed enzyme replacement therapy for Gaucher disease types I and III, aiming to reduce annual treatment costs by at least 50% [2][12][13] - Plans for large-scale promotion starting in early 2026 and discussions for international market entry [2][17] - **CAN204**: - A gene therapy for Duchenne Muscular Dystrophy (DMD) that has passed animal testing and is in talks for international collaboration [2][21][22] Financial Goals and Projections - **Sales Targets**: - Aiming for sales of 200 million, 500 million, and even 1 billion RMB, with expectations of positive cash flow by 2026 [3][23][25] - **Commercialization Outlook**: - No specific sales forecasts for 2025 and 2026 yet, but significant growth is anticipated if innovative drug insurance payments are implemented [20] Market Trends and Global Strategy - **International Market Entry**: - The trend of Chinese innovative drugs entering global markets is irreversible, with a focus on rare diseases [6][9] - Plans to leverage partnerships for regulatory navigation and market entry [14][17] Research and Development - **R&D Focus**: - Continuous innovation in rare disease treatments, with a strategy to develop products with global market potential [9][21] - Emphasis on patient education, diagnostic technology, and updating treatment guidelines [18][19] Future Plans - **Ecosystem Development**: - Building a rare disease ecosystem in collaboration with CROs and CDMOs, and leveraging genetic testing technologies [24][26] - **Financial Management**: - Aiming for cash flow positivity by 2026, with a focus on balancing funding for new projects and operational sustainability [25][26] Conclusion - Beihai Kangcheng is positioned to capitalize on its strategic partnerships and innovative product pipeline in the rare disease sector, with ambitious sales targets and a clear path towards international market expansion and financial sustainability [2][3][6][17][25]