通过这次认购，百洋医药将成为北海康成最大的股东，但并不谋求控股股东地位。 百洋医药属于医药流通企业，主营业务划分为品牌运营、批发配送及零售三个板块，其中品牌运营是公 司的核心业务。北海康成从事罕见病药物研发，目前拥有10个药物资产组合，其中包括3个已获批上市 产品和7个在研药物。这些产品均针对一些较普遍的罕见疾病， 比如亨特综合征（黏多糖贮积症II型） 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。 今年5月份，北海康成旗下注射用维拉苷酶β（商品名：戈芮宁）获批在国内上市，成为国内首个本土 自主研发适用于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治疗药物。 罕见病药物因研发成本高昂，市场容量小，多数定价高昂，相关药物的商业化开展并不容易，而百洋医 药的入股，能否补齐北海康成的商业化短板，是这次交易的看点。 除了入股外，百洋医药与北海康成还达成了一项独家商业服务协议拓展战略合作。根据该协议，百洋医 药的一家子公司将作为北海康成在中国大陆、中国香港及中国澳门特定产品的独家商业服务提供方，百 洋医药的关联公司还可选择作为上述市场的分销商。 根据认购协议条 ...

消息面上，5月15日，国家药品监督管理局通过优先审评审批程序批准北海康成申报的注射用维拉苷酶 β（商品名：戈芮宁）上市，适用于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治疗。 7月3日，戈谢病一类创新药戈芮宁开出首张处方，首位患者已在新华医院接受治疗。 智通财经获悉，北海康成-B(01228)再涨超35%，年内累计涨幅已超13倍。截至发稿，涨26.67%，报1.71 港元，成交额3038.93万港元。 本文源自智通财经网 北海康成创始人、董事长兼首席执行官表示，罕见病不同于常见病，光依靠保基本的国家医保很难解决 患者的支付难题，北海康成正在积极与医保支付部门沟通，希望通过戈芮宁的案例，为新的更加可行的 罕见病支付机制提供支撑，为中国罕见病商业化环境铺路开桥。 ...

Core Viewpoint - Beihai Kangcheng-B (01228) has seen a significant stock price increase of over 35%, with a cumulative rise exceeding 13 times this year, currently trading at 1.71 HKD with a transaction volume of 30.39 million HKD [1] Group 1: Company Developments - On May 15, the National Medical Products Administration approved the injection of Velaglucerase beta (brand name: Gorenin) for long-term enzyme replacement therapy for patients aged 12 and above with Type I and III Gaucher disease [1] - On July 3, Gorenin was prescribed for the first time, with the first patient receiving treatment at Xinhua Hospital [1] - The founder, chairman, and CEO of Beihai Kangcheng stated that rare diseases differ from common diseases, and relying solely on basic national medical insurance is insufficient to address patients' payment challenges [1] Group 2: Industry Context - Beihai Kangcheng is actively communicating with medical insurance payment departments to establish a more feasible payment mechanism for rare diseases, aiming to pave the way for the commercialization environment of rare diseases in China [1]

智通财经APP在《一个月4.6倍涨幅或还不是北海康成-B(01228)的终点？》中指出，随着维拉苷酶β的上 市，国内戈谢病治疗市场将逐渐形成进口药物与国产药物竞争的局面。虽然国内也有其他企业关注戈谢 病治疗药物的研发，但进展相对缓慢。也就是说在此背景下，维拉苷酶β有望凭借国产和先发优势在国 内戈谢病治疗市场站稳脚跟，市场可及性有望出现明显提高，还有望未来出海冲击全球戈谢病治疗体 系，因而存在潜在重磅BD的可能性。 本文源自智通财经网 消息面上，5月15日，国家药品监督管理局通过优先审评审批程序批准北海康成申报的注射用维拉苷酶 β（商品名：戈芮宁）上市，适用于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治疗。 7月3日，时代财经从北海康成获悉，其戈谢病一类创新药戈芮宁开出首张处方，首位患者已在新华医院 接受治疗。 智通财经获悉，北海康成-B(01228)再涨超25%，6月初至今累计涨幅接近900%。截至发稿，涨22.64%， 报1.3港元，成交额1517.64万港元。 ...

Core Viewpoint - The stock price of Beihai Kangcheng-B (01228) has experienced a significant surge, with a maximum increase of 165.63% over three trading days, indicating strong investor optimism regarding its innovative value and potential business development (BD) achievements [1][2][9]. Price Movement and Technical Analysis - After reaching a peak of 0.48 HKD on June 16, the stock showed signs of overbuying and subsequently underwent a technical correction, with a drop to 0.28 HKD by June 27, representing a decline of 41.67% from the high [2][4]. - The decline in stock price from June 18 to June 27 occurred without a corresponding increase in trading volume, indicating a lack of panic selling and a potential for recovery [4][5]. - On June 30, the stock began to recover, with a notable increase in trading volume, suggesting a shift in market sentiment and the potential for a new upward trend [5][6]. Market Sentiment and Trading Activity - The trading activity from July 2 to July 8 showed a consistent increase in volume alongside rising stock prices, indicating a strong buying interest from investors [5][7]. - The top net buyers among brokerage firms included Futu Securities and Yao Cai, reflecting a clear trend of domestic investors accumulating shares [7]. Policy and Market Impact - Recent policy measures from the National Healthcare Security Administration and the National Health Commission aimed at supporting innovative drug development have positively influenced market sentiment towards Beihai Kangcheng [9]. - The launch of the domestically developed enzyme replacement therapy for Gaucher disease, known as Velaglucerase beta (Goreining), marks a significant milestone for the company, potentially disrupting the market dominated by imported drugs [9][10]. Valuation Perspective - Despite the substantial price increases, the company's current price-to-sales (PS) ratio stands at 3.15, significantly lower than the industry average of 7.98, suggesting room for further valuation recovery [11].

Group 1: Company Performance - Since the beginning of this year, the innovative drug sector has become the best-performing segment in the Hong Kong market, with over 30 innovative drug companies doubling their stock prices, and Beihai Kangcheng-B (01228) leading with a 2.5 times increase in just half a month [1] - In June, Beihai Kangcheng's stock price experienced significant increases, with five trading days showing single-day gains exceeding 15%, including a remarkable rise of 58.54% on June 13 [1][3] - The stock price of Beihai Kangcheng reached a maximum monthly increase of 252.94% in June [1] Group 2: Market Dynamics - The surge in Beihai Kangcheng's stock price is attributed to both external and internal positive factors, including revenue growth and reduced losses among domestic innovative drug companies, driven by technological breakthroughs, accelerated internationalization, and policy support [3] - In Q1 2025, domestic License-out transactions reached 41, totaling $36.9 billion, nearing the total for the entire year of 2023, indicating the ongoing release of intrinsic value in domestic innovative drugs [3] Group 3: Product Approval and Market Impact - On May 15, the NMPA approved Beihai Kangcheng's injection of Velaglucerase beta (trade name: Gorening) for long-term enzyme replacement therapy for patients with Type I and III Gaucher disease, marking the first domestically developed enzyme replacement therapy for Gaucher disease in China [3][11] - The approval of Velaglucerase beta breaks the monopoly of imported drugs and fills the gap in domestic R&D, validating Beihai Kangcheng's innovative value [3][11] Group 4: Trading Volume and Investor Sentiment - Since June, Beihai Kangcheng has seen a significant increase in trading volume, with six trading days exceeding 10 million shares traded, and a record high of 58.46 million shares on June 13 [5] - The top net buying brokers include Futu Securities and China Merchants Yonglong Bank, indicating strong buying interest from domestic investors [6] Group 5: Rare Disease Market Context - The global rare disease market affects 260 million to 450 million people, with over 7,000 known rare diseases, but only about 5% have effective treatments available [8] - The high barriers to entry in rare disease drug development highlight the significance of Beihai Kangcheng's approval of Velaglucerase beta, which is based on a randomized, double-blind study demonstrating its efficacy and safety [8][9] Group 6: Competitive Landscape and Future Outlook - Prior to the approval of Velaglucerase beta, the domestic Gaucher disease treatment market relied heavily on imported drugs, which are expensive, costing over one million yuan annually [10] - Beihai Kangcheng's Velaglucerase beta is expected to significantly lower treatment costs by at least 50%, enhancing drug accessibility for patients [11] - The company is well-positioned to establish a foothold in the domestic Gaucher disease treatment market and potentially expand globally, reflecting investor optimism regarding its innovative value and future business development opportunities [11]

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].

Core Viewpoint - The approval of the injection drug Velaglucerase beta (brand name: Gorynin) by the National Medical Products Administration (NMPA) marks a significant milestone as it is the first domestically developed enzyme replacement therapy for Gaucher disease in China, targeting adolescents and adults aged 12 and above with Type I and III Gaucher disease [1][2]. Group 1: Product Approval and Significance - Velaglucerase beta is the only locally developed enzyme replacement therapy for Gaucher disease in China, making it a unique addition to the treatment options available [1]. - The drug is noted for having the broadest range of indications among Gaucher disease treatments currently available [1]. Group 2: Disease Background and Treatment - Gaucher disease is a rare genetic lysosomal storage disorder, with clinical manifestations including hepatosplenomegaly, anemia, bone pain, and neurological complications, potentially leading to life-threatening conditions [2]. - The global prevalence of Gaucher disease is estimated at 0.7 to 1.75 cases per 100,000 people [2]. - Enzyme replacement therapy (ERT) has been the standard treatment for Gaucher disease for 30 years, showing significant efficacy in improving non-neurological symptoms and enhancing the quality of life for patients [2]. Group 3: Development and Technology - The development of Gorynin was facilitated by collaborative efforts with partners like WuXi Biologics, which helped reduce development costs and ensure the drug is safe and effective for patients [2]. - The drug's development utilized second-generation innovative technology, resulting in over a 110-fold increase in production yield and more than a 50% enhancement in enzyme activity, significantly lowering production costs [2]. - WuXi Biologics also developed a cell-based activity assay for quality control, addressing the unique challenges of testing enzyme-based drugs [2].

Core Viewpoint - The approval of domestic enzyme replacement therapy, Gorenin, for Gaucher disease patients in China is expected to significantly reduce treatment costs compared to imported alternatives [1][3][5]. Group 1: Product Overview - Gorenin is the first domestically developed enzyme replacement therapy for type I and III Gaucher disease patients aged 12 and above, fully replacing similar imported products [1][2]. - The drug has been approved for a comprehensive range of indications, covering both type I and III patients, including those who are intolerant or unresponsive to other treatments [2][5]. Group 2: Market Context - The annual treatment costs for imported therapies like imiglucerase can range from $100,000 to $300,000, with domestic adult patients potentially facing costs exceeding 1 million yuan [3][5]. - Approximately 3,000 Gaucher disease patients are reported in China, making it challenging for pharmaceutical companies to justify the investment in research and development for such a small patient population [5][6]. Group 3: Cost Management Strategies - WuXi Biologics, the CRDMO service provider, aims to control the development and production costs of rare disease drugs through innovative technology, allowing for competitive pricing [5][6]. - Gorenin is expected to reduce annual treatment costs for Gaucher disease patients by over 50% compared to imported drugs [3][5]. Group 4: Future Directions - The company plans to push for Gorenin's inclusion in medical insurance systems to ensure broader access for patients [6][7]. - There is a strategic focus on developing international markets for rare disease drugs, leveraging local clinical resources and competitive pricing strategies [7].

Group 1 - The approval of the drug "Gorainin" marks the first domestically developed enzyme replacement therapy for Gaucher disease in China, addressing a significant unmet medical need for patients who previously relied on imported treatments [1][2] - Gaucher disease is a rare genetic lysosomal storage disorder characterized by symptoms such as hepatosplenomegaly, anemia, bone pain, and neurological complications, with severe cases posing life-threatening risks [1] - The drug is specifically indicated for adolescents and adults aged 12 and above with Type I and Type III Gaucher disease, providing a targeted treatment option through intravenous infusion [1] Group 2 - The annual treatment cost for patients using imported drugs ranges from 1.5 million to 2.5 million RMB, making it unaffordable for many, highlighting the need for local production to improve accessibility [2] - The company aims to reduce the annual treatment cost of Gorainin by over 50% compared to imported alternatives, enhancing affordability for patients [2] - The drug's development involved collaboration with WuXi Biologics, utilizing innovative technology to significantly increase production yield and enzyme activity, ensuring better availability for patients [3][5] Group 3 - The drug is part of a pilot project for segmented production of biopharmaceuticals in China, which allows for flexible resource allocation and cost reduction in manufacturing [4][5] - The segmented production model has been successfully implemented for Gorainin, with the active ingredient produced by WuXi Biologics and the formulation handled by its subsidiary, demonstrating a new approach in the industry [5]