智通财经APP获悉，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。 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。 ...

Core Viewpoint - North Sea Kangcheng (HK01228) has seen a significant stock price increase following the approval of its first self-developed product, Velaglucerase beta (Goreining), for the treatment of Gaucher disease, raising questions about its potential to reverse the company's financial struggles [2][8]. Company Overview - North Sea Kangcheng's market capitalization is approximately HKD 160 million, with a recent stock price of HKD 0.38 per share, reflecting a 16.92% increase on June 16 [2]. - The company has previously launched two licensed rare disease drugs, but their annual revenue has rarely exceeded HKD 100 million, leading to increased losses projected for 2024 [2][6]. Product Details - Goreining is the first product approved for long-term enzyme replacement therapy for adolescents and adults with Type I and III Gaucher disease, making it the most broadly indicated product among the three approved Gaucher disease treatments in China [3][4]. - The annual treatment cost for imported Gaucher disease drugs ranges from RMB 1.5 million to RMB 2.5 million, and Goreining aims to reduce this cost by at least 50% through segmented production [4]. Financial Situation - The company reported revenues of RMB 78.97 million, RMB 103 million, and RMB 85.10 million for the years 2022 to 2024, with net losses of RMB 483 million, RMB 379 million, and RMB 443 million respectively [6][7]. - As of March 2024, the company's cash and bank balance was only RMB 10.5 million, prompting a reduction in workforce to 50 full-time employees and seeking new financing sources [7]. Market Strategy - The company is exploring innovative payment systems for domestic medical insurance while also expanding its international market presence [2][3]. - There is a focus on leveraging local clinical resources for targeted research and reducing production costs to offer competitive pricing for therapies globally [4]. Regulatory Environment - The company faces challenges in having Goreining included in the national medical insurance directory, but it is preparing for potential inclusion in the newly established Category C drug list, which focuses on highly innovative drugs with significant clinical value [8].