北海康成创始人、董事长兼首席执行官薛群日前在接受中国证券报记者专访时表示，罕见病创新药市场 是"蓝海中的蓝海"，国内存在大量未被满足的临床需求。凭借二十余年深耕积累，公司已构建起多元产 品矩阵，未来将以"双核驱动"战略深化全球创新布局，借力政策红利与产业协同，让更多罕见病患者享 受到创新药带来的希望。 逾二十载深耕筑根基 薛群介绍，公司的三款上市产品已精准填补多个临床空白：海芮思和迈芮倍两款产品是公司通过专利买 断引进后在国内上市，填补了黏多糖贮积症Ⅱ型（MPS Ⅱ）、阿拉杰里（ALGS）综合征等领域的临床 空白，还刷新了相关适应症的国家诊疗共识与指南；戈芮宁于2025年5月获批上市，是我国首个本土自 主研发生产的针对戈谢病的酶替代1类创新药。 政策赋能破困局 在罕见病创新药研发的高成本赛道上，政策支持成为破解产业困境的关键力量。薛群直言，公司核心产 品戈芮宁的成功上市，既离不开企业直面研发挑战的坚守，更得益于国家生物制品分段生产试点政策的 精准赋能。 戈芮宁的研发历程曾深陷高成本困境。作为国内首个本土自主研发的戈谢病酶替代治疗药物，其采 用"上海外高桥（600648）基地生产原液+江苏无锡GMP厂房制剂罐装 ...

Core Insights - The company, Beihai Kangcheng, has established itself as a global biopharmaceutical firm focused on rare diseases, with three approved products and seven in development [1][2] - The founder, Xue Qun, emphasizes the unmet clinical needs in the rare disease sector as a significant opportunity for growth and innovation [4] Company Development - Beihai Kangcheng was founded in 2012 after Xue Qun's decade-long experience in the rare disease field, initially focusing on oncology due to funding challenges [1] - A pivotal moment for the company was in 2018 when the Chinese government released a rare disease directory, leading to strategic partnerships and significant funding [1][3] Product Portfolio - The company has three marketed products that address clinical gaps in conditions such as MPS II and ALGS, with the first domestically developed enzyme replacement therapy for Gaucher disease, Gorenin, expected to be approved by May 2025 [2][4] Policy Support - Government policies have played a crucial role in alleviating challenges in rare disease drug development, particularly through the segmented production pilot policy that supports innovative biopharmaceuticals [3][5] - Gorenin's successful development benefited from this policy, allowing for a segmented production model that meets clinical needs while navigating regulatory hurdles [3][5] Market Strategy - The company is entering a 3.0 development phase, implementing a "dual-core drive" strategy to solidify its leadership in the domestic rare disease market while expanding internationally [7] - A strategic partnership with Baiyang Pharmaceutical aims to enhance commercialization efforts and leverage each other's strengths in the rare disease sector [7][8] Future Outlook - The company anticipates a significant market expansion for rare disease drugs, particularly with the inclusion of Gorenin in the first commercial insurance innovation drug directory set to take effect in January 2026 [5][6] - Xue Qun envisions a collaborative ecosystem that integrates diagnostics and patient education to improve awareness and treatment of rare diseases [8]

北海康成创始人、董事长兼首席执行官薛群日前在接受中国证券报记者专访时表示，罕见病创新药市场 是"蓝海中的蓝海"，国内存在大量未被满足的临床需求。凭借二十余年深耕积累，公司已构建起多元产 品矩阵，未来将以"双核驱动"战略深化全球创新布局，借力政策红利与产业协同，让更多罕见病患者享 受到创新药带来的希望。 逾二十载深耕筑根基 作为专注罕见疾病领域的全球化生物制药公司，北海康成如今已拥有3个已获批上市产品和7个在研药 物。 在2012年创建北海康成之前，薛群已在罕见病领域深耕十年，其中有四五年时间以拓荒者的身份在国内 推广，彼时国内罕见病领域尚处启蒙阶段。2011年，他任职的健赞公司被收购，薛群表示，出于对更具 挑战性、更高节奏创业环境的追求，他当时主动选择离开。"在我看来，国内存在大量未被满足的临床 需求，是更有作为的创业沃土。"基于这一判断，北海康成应运而生。 创业初期的道路并不平坦。"受融资难题限制，无法直接布局罕见病赛道。"薛群坦言，当时公司的首要 目标是活下来，因此早期管线均围绕肿瘤领域展开。2018年成为公司发展的关键转折点，行业风口迎来 集中爆发：国家五部门联合发布首批罕见病目录，将121种疾病纳入其 ...

薛群介绍，公司的三款上市产品已精准填补多个临床空白：海芮思和迈芮倍两款产品是公司通过专利买 断引进后在国内上市，填补了黏多糖贮积症Ⅱ型（MPS Ⅱ）、阿拉杰里（ALGS）综合征等领域的临床 空白，还刷新了相关适应症的国家诊疗共识与指南；戈芮宁于2025年5月获批上市，是我国首个本土自 主研发生产的针对戈谢病的酶替代1类创新药。 政策赋能破困局 在罕见病创新药研发的高成本赛道上，政策支持成为破解产业困境的关键力量。薛群直言，公司核心产 品戈芮宁的成功上市，既离不开企业直面研发挑战的坚守，更得益于国家生物制品分段生产试点政策的 精准赋能。 戈芮宁的研发历程曾深陷高成本困境。作为国内首个本土自主研发的戈谢病酶替代治疗药物，其采 用"上海外高桥基地生产原液+江苏无锡GMP厂房制剂罐装"的分段生产模式推进临床试验，该模式虽适 配临床需求，但在原有政策框架下，药品生产全流程需集中于同一厂房才能获得GMP认证，给商业化 推进带来巨大阻碍。更关键的是，一期临床患者接受治疗后，经过六个月剂量爬坡后，患者无法中途停 药的治疗连贯性，促使企业必须推动上海外高桥车间完成GMP认证改造。 ● 本报记者 傅苏颖 北海康成创始人、董事长兼 ...

Group 1 - The stock of Beihai Kangcheng-B (01228) has surged over 9%, with a remarkable year-to-date increase of 16 times, currently trading at 2.4 HKD with a transaction volume of 16.13 million HKD [1] - In the first half of the year, Beihai Kangcheng reported revenues of 22.248 million HKD, a decrease of 50.33% year-on-year, while achieving a profit of 59.238 million HKD, compared to a loss of 247 million HKD in the same period last year [1] - The revenue decline is attributed to the company's strategic focus on rare diseases since 2021, with the termination of the distribution agreement for the product He Li An in Taiwan by the end of 2024, leading to a 170,000 HKD or 6.9% decrease in revenue excluding sales in Taiwan [1] Group 2 - In August, Beihai Kangcheng announced a share subscription agreement with Baiyang Pharmaceutical, where Baiyang will invest 100 million HKD to acquire shares in Beihai Kangcheng [2] - The agreement includes a commercial service contract that grants Baiyang's subsidiary promotional rights for specific products of Beihai Kangcheng in mainland China, Hong Kong, and Macau [2] - Beihai Kangcheng's three rare disease products have passed the preliminary review for the commercial insurance innovative drug directory announced by the National Healthcare Security Administration, including the recently approved long-term enzyme replacement product for Gaucher disease patients [2]

Group 1 - The stock of Beihai Kangcheng-B (01228) has surged over 9%, with a remarkable year-to-date increase of 16 times, currently trading at 2.4 HKD with a transaction volume of 16.13 million HKD [1] - In the first half of the year, Beihai Kangcheng reported revenues of 22.248 million HKD, a decrease of 50.33% year-on-year, while achieving a profit of 59.238 million HKD, compared to a loss of 247 million HKD in the same period last year [1] - The revenue decline is attributed to the company's strategic focus on rare diseases since 2021, with the termination of the distribution agreement for the product He Li An in Taiwan by the end of 2024, leading to a revenue drop of 1.7 million HKD or 6.9% excluding sales in Taiwan [1] Group 2 - In August, Beihai Kangcheng announced a share subscription agreement with Baiyang Pharmaceutical, where Baiyang will invest 100 million HKD to acquire shares in Beihai Kangcheng [2] - The agreement includes a commercial service contract that grants Baiyang's subsidiary promotional rights for specific Beihai Kangcheng products in mainland China, Hong Kong, and Macau [2] - Beihai Kangcheng's three rare disease products were included in the preliminary list of innovative drugs for commercial insurance published by the National Healthcare Security Administration on August 12, including the recently approved long-term enzyme replacement product for Gaucher disease [2]

Core Viewpoint - Beihai Kangcheng-B (01228) reported a significant increase in stock price following its interim results, with a rise of over 12% and a current price of 2.54 HKD, reflecting a trading volume of 10.31 million HKD [1] Financial Performance - The company reported a revenue of 22.248 million HKD for the first half of the year, a decrease of 50.33% year-on-year [1] - The net profit for the period was 59.238 million HKD, a turnaround from a loss of 247 million HKD in the same period last year [1] - Revenue decline was primarily attributed to the strategic focus on rare diseases initiated in 2021, with the termination of the distribution agreement for the product He Li An in Taiwan by the end of 2024 [1] - Excluding the sales of He Li An in Taiwan, the company's revenue decreased by 1.7 million HKD or 6.9% compared to the same period in 2024, mainly due to proactive inventory management and reduced stock of Mai Ruibei in the channels [1] Strategic Developments - In August 2025, Beihai Kangcheng announced a share subscription agreement with Baiyang Pharmaceutical, with Baiyang investing 100 million HKD in the company [1] - The agreement includes an exclusive commercialization service contract, enhancing strategic collaboration between Beihai Kangcheng and Baiyang Pharmaceutical [1] - A subsidiary of Baiyang Pharmaceutical will gain promotional rights for specific products of Beihai Kangcheng in mainland China, Hong Kong, and Macau [1]

Core Viewpoint - Beihai Kangcheng-B (01228) experienced a significant stock price increase of over 12% following the release of its interim results, indicating positive market sentiment despite a decline in revenue [1] Financial Performance - For the first half of the year, the company reported revenue of 22.248 million, a decrease of 50.33% year-on-year [1] - The company achieved a profit of 59.238 million, compared to a loss of 247 million in the same period last year, marking a turnaround to profitability [1] - Revenue decline was primarily attributed to the company's strategic focus on rare diseases initiated in 2021, with the termination of the distribution agreement for the product "He Li An" in Taiwan by the end of 2024 [1] - Excluding the sales of "He Li An" in Taiwan, the company's revenue decreased by 1.7 million or 6.9% compared to the same period in 2024, mainly due to proactive inventory management and reduced stock of "Mai Ru Bei" in the channels [1] Strategic Developments - In August 2025, the company announced a share subscription agreement with Baiyang Pharmaceutical, where Baiyang will invest 100 million Hong Kong dollars to subscribe for shares in Beihai Kangcheng [1] - The agreement includes an exclusive commercialization service contract, enhancing strategic collaboration between the two companies [1] - A subsidiary of Baiyang Pharmaceutical will gain promotional rights for specific products of Beihai Kangcheng in mainland China, Hong Kong, and Macau [1]

Core Viewpoint - Beihai Kangcheng-B (01228) reported a significant decrease in revenue for the six months ending June 30, 2025, with earnings of 22.248 million, a year-on-year decline of 50.33% [1] Financial Performance - The company achieved a profit of 59.238 million, contrasting with a loss of 247 million in the same period last year [1] - Earnings per share stood at 0.14 yuan [1] Revenue Drivers - The revenue decline is primarily attributed to the company's strategic focus on rare diseases initiated in 2021, leading to the cessation of sales of He Li An in Taiwan after the distribution agreement ends in late 2024 [1] - Excluding the sales of He Li An in Taiwan, revenue decreased by 1.7 million or 6.9% compared to the same period in 2024 [1] - The company implemented proactive inventory management in the first half of 2025, resulting in reduced inventory levels of Mai Ru Bei in the distribution channels [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].