Group 1 - The core viewpoint of the article highlights the significant stock price increase of Beihai Kangcheng-B (01228), which has surged over 12% recently, bringing its year-to-date increase close to 20 times [1] - As of the report, the stock price reached 2.77 HKD with a trading volume of 50.08 million HKD [1] - On August 13, Beihai Kangcheng announced a share subscription agreement with Baiyang Pharmaceutical, where Baiyang will invest 100 million HKD to acquire shares in Beihai Kangcheng [1] Group 2 - The agreement also includes an exclusive commercialization service contract, enhancing strategic collaboration between Beihai Kangcheng and Baiyang Pharmaceutical [1] - Baiyang's subsidiary will gain promotional rights for specific products of Beihai Kangcheng in mainland China, Hong Kong, and Macau [1] - In 2025, the National Healthcare Security Administration will introduce a "Commercial Insurance Innovative Drug Directory," which has begun the application process as of July 11 [1] Group 3 - Beihai Kangcheng's three products, namely Geruneng (Injectable Vira Glycosidase β), Mairuibai (Chloramphenicol Oral Solution), and Hairuisi (Aidu Sulfate Esterase β Injection), passed the preliminary review on August 12, which is expected to accelerate market access [1] - The preliminary review list is considered significant for Beihai Kangcheng, as inclusion in the commercial insurance innovative drug directory would provide insurance support for the drugs, potentially reducing the economic burden on patients and improving product accessibility [1]

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]

Group 1 - On August 13, Beihai Kangcheng's stock price surged by 25.75% after announcing a strategic financing deal and an exclusive commercial service agreement with Baiyang Pharmaceutical [1][2] - Baiyang Pharmaceutical will act as the exclusive contract sales organization (CSO) to promote several of Beihai Kangcheng's products in mainland China, Hong Kong, and Macau [1][2] - Beihai Kangcheng's stock has increased over 1400% this year, highlighting strong market interest in rare disease treatments [1][4] Group 2 - The strategic investment amounts to 100 million HKD, with Baiyang Pharmaceutical acquiring approximately 17.65% of Beihai Kangcheng's existing shares [2] - The funds will be used to advance the commercialization of existing products and improve operational efficiency [2] - Beihai Kangcheng currently has three commercialized products targeting rare diseases, including Hai Ruisi, Mai Ruibei, and Wei La Gan En [2][3] Group 3 - The company faces challenges in market access for rare disease drugs, which are often priced high due to the limited patient population [3][6] - Despite being the leading drug for MPS II, only about 10% of diagnosed patients have used Hai Ruisi [6] - The company is exploring international markets and advocating for a specialized rare disease fund to support drug development [7]

每经记者｜林姿辰 每经编辑｜陈柯名 陈俊杰 8月13日开盘，北海康成股价大涨，截至收盘涨25.75%。 8月13日，百洋医药方面对《每日经济新闻》记者表示，公司非常看好罕见病赛道，公司将与北海康成一起拓展并丰富罕见病药物管线，同时提升罕见病 药物可及性，惠及更多患者。记者注意到，今年以来，北海康成这个"罕见病第一股"股价涨幅已经超过1400%。 作为创新药中最难商业化的品类之一，罕见病用药面临的进院难"坚冰"是否正在融化？ 公司获得1亿元战略投资 百洋医药首次涉足罕见病投资 今日早间，公司宣布了战略融资事项以及与百洋医药的独家商业服务协议，后者的附属公司将作为独家合同销售组织（CSO），在内地、香港及澳门推广 北海康成的若干产品。前一日，公司两款产品一齐出现在国家医保局公示的商保创新药目录初审名单中。 8月13日，北海康成宣布与百洋医药达成股份认购协议，将以每股1.34港元的价格向其发行股份，总发行价款达1亿港元，该等认购股份将约占公司现有已 发行股本的17.65%，及经扩大后股本的14.99%。 就此，公司获得一笔1亿港元的战略投资，而投资方百洋医药是国内头部创新品牌商业化平台，在OTC（非处方药）及大健康 ...

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].