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: Key Policies and Measures - Hubei Province's Medical Insurance Bureau and Health Commission launched 18 measures to support the high-quality development of innovative drugs, covering key aspects such as R&D support, inclusion in the medical insurance catalog, clinical application promotion, and strengthening payment systems [1][2][5] - The measures aim to alleviate public concerns regarding medical treatment and medication, while also establishing a solid foundation for the health industry in central China [1][5] Group 2: R&D and Innovation Support - The new measures extend the payment model from the end of the insurance process to the R&D phase, assisting pharmaceutical companies and research institutions in overcoming challenges and accelerating the market entry of effective drugs [2] - The initiative encourages commercial health insurance to invest in long-term capital through funds, alleviating the financial pressure on R&D for companies [2] Group 3: Access and Reimbursement - A dual-channel support system combining medical insurance and commercial insurance is being established to ensure innovative drugs are more accessible to the public [3] - The medical insurance department is committed to including all innovative drugs in the national medical insurance catalog and providing early intervention for eligible local innovative drugs [3] Group 4: Clinical Application and Training - The medical insurance department is optimizing processes to expedite the entry of innovative drugs into hospitals and directly to patients, including a green channel for drug listing and a two-month deadline for medical institutions to discuss new drug entries [4] - Training for healthcare professionals on the clinical use of innovative drugs will be conducted to ensure effective application and outcomes [4] Group 5: Market Expansion and Global Reach - The measures aim to create a multi-layered payment guarantee network, encouraging commercial insurance and mutual aid organizations to include innovative drugs in their coverage [5] - Hubei Province is actively promoting its innovative drugs in global markets, particularly in countries along the Belt and Road Initiative, enhancing the international influence of Hubei's pharmaceutical industry [5] Group 6: Commercial Insurance Directory - The first commercial health insurance innovative drug directory was published, focusing on high-value drugs that exceed the basic medical insurance's scope, including high-priced cancer drugs and gene therapies [6][7] - A total of 121 drug names were reviewed for inclusion, with 19 drugs from 18 innovative pharmaceutical companies successfully added to the directory, indicating a selection rate of approximately 15.7% [6][7] Group 7: CAR-T Therapies and Market Impact - Five CAR-T therapies were included in the first commercial health insurance innovative drug directory, which is expected to significantly reduce patient out-of-pocket expenses and improve accessibility [8][13] - The inclusion of CAR-T products is anticipated to have a positive ripple effect across the entire industry, enhancing market coverage and patient access [8][13]

Core Insights - The newly released "Commercial Health Insurance Innovative Drug Directory (2025)" marks the first of its kind in China, focusing on high-innovation drugs that exceed the basic medical insurance's scope [1][2] Group 1: Overview of the Commercial Health Insurance Innovative Drug Directory - The directory was developed by the National Healthcare Security Administration and includes high-priced innovative drugs, gene therapies, and specific rare disease treatments [1] - A total of 121 drug names were reviewed, with 19 drugs from 18 innovative pharmaceutical companies successfully included, resulting in an acceptance rate of approximately 15.7% [1] Group 2: Focus on Rare Diseases and Cancer Treatments - The directory includes drugs for Alzheimer's disease and rare diseases prevalent in children, such as Gaucher disease and neuroblastoma [2] - North Sea Kangcheng's Gaucher drug, the first domestically developed enzyme replacement therapy, was approved for use in patients aged 12 and older [2] Group 3: Impact on CAR-T Therapy - Five domestic CAR-T products were included in the directory, which is expected to significantly reduce patient out-of-pocket expenses and improve accessibility [3] - The inclusion of CAR-T products is seen as a milestone that will positively impact the entire industry chain, with companies planning to expand domestic supplier partnerships to enhance supply chain efficiency [3]

Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory, set to be implemented nationwide from January 1, 2026 [1][2] Summary by Sections National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 of them being new products launched within the last five years, representing 97.3% of the new additions [2] - Among the new drugs, 50 are classified as Category 1 innovative drugs, with a success rate of 88%, an increase from 76% in 2024 [2] - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2] Company Announcements - Several listed companies, including Heng Rui Medicine, Fosun Pharma, and Hai Si Ke, announced new drug inclusions or renewals in the updated National Medical Insurance Directory [3] - Heng Rui Medicine reported that 20 products/indications were included, with significant coverage across various diseases such as tumors and cardiovascular conditions [3][4] - Hai Si Ke's two Category 1 innovative drugs were included, with one being a new addition and the other a renewal [4] Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Category 1 innovative drugs [7] - Notably, five CAR-T products were included, representing over half of the CAR-T products available in China, which previously faced challenges in entering the insurance market due to high pricing [7][8] - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the complementarity with the basic medical insurance [7][10] Notable Drug Inclusions - The directory includes drugs for significant diseases such as triple-negative breast cancer and pancreatic cancer, as well as treatments for rare diseases like Gaucher disease [5][9] - In the diabetes sector, several domestic drugs were newly included, such as a long-acting GLP-1 receptor agonist [6] - Companies like Bei Hai Kang Cheng and Bai Ji Shen Zhou have also successfully included their innovative drugs in the Commercial Health Insurance Directory [9]

日前，《国家基本医疗保险、生育保险和工伤保险药品目录(2025年)》(以下简称"基本医保目录")及 《商业健康保险创新药品目录(2025年)》(以下简称"商保创新药目录")公布。其中，商保创新药目录是 国内首次发布，受到业内广泛关注。 公开资料显示，商保创新药目录由国家医保局主导制定，聚焦创新程度高、临床价值显著但超出基本医 保"保基本"定位的药品，包括高价肿瘤创新药、基因治疗药物、部分罕见病特效药等。上海市卫生和健 康发展研究中心主任金春林表示，部分疗效确切、创新度高的高价药由此获得纳入保障的新路径。"商 保创新药目录和基本医保目录是互补关系，商保的良性发展既能更好满足患者用药需求，支持创新药产 业发展，也有利于健全多层次医疗保障体系，减轻基本医保负担。" 据国家医保局披露，今年共有121个药品通用名通过商保创新药目录的形式审查，最终18家创新药企业 的19种药品成功纳入，涉及和黄医药(中国)有限公司、绿叶制药集团有限公司、北海康成制药有限公司 (以下简称"北海康成")等上市公司。据此推算，首版商保创新药目录的"海选"入选率仅约15.7%。 国家医保局表示，此次商保创新药目录的"选品"，既体现了支持创新的导 ...

Core Viewpoint - The new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory will be implemented nationwide starting January 1, 2026, providing a dual-track system for basic and innovative drug coverage [1][2]. Group 1: National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 being new products launched within the last five years, representing 97.3% of the new entries [2]. - Among the new additions, 50 are classified as Class 1 innovative drugs, with an overall success rate of 88%, an increase from 76% in 2024 [2]. - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2]. Group 2: Company Announcements - Several listed companies, including Heng Rui Medicine and Fuxing Medicine, announced new drug entries or renewals in the National Medical Insurance Directory [3]. - Heng Rui Medicine reported that 20 products/indications were included in the new directory, with a projected sales revenue of approximately 8.66 billion yuan in 2024 and about 7.55 billion yuan in the first three quarters of 2025 [4]. - Hai Si Ke's two Class 1 innovative drugs were also included, with applications in sedation and pain management [6]. Group 3: Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Class 1 innovative drugs [11]. - Notably, 5 CAR-T products were included, representing over half of the CAR-T products available in China, addressing previous challenges in pricing negotiations [11][12]. - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the coverage provided by basic medical insurance [11][13].

Core Insights - Beihai Kangcheng Pharmaceutical Co., Ltd. has successfully included its innovative drug, Goreni, in China's first "Commercial Insurance Innovative Drug Directory," effective from January 1, 2026 [1][3] - Goreni is the first domestically developed enzyme replacement therapy for patients aged 12 and above with Type I and III Gaucher disease, marking a significant advancement in the treatment of rare diseases in China [3][4] Company Overview - Beihai Kangcheng is a leading global biopharmaceutical company focused on rare diseases, dedicated to the research, development, and commercialization of innovative therapies [1] - The company has formed a strategic partnership with Baiyang Pharmaceutical, which invested in Beihai Kangcheng in August 2025, focusing on the commercialization of rare disease products [1][4] Market Context - In the 2025 National Medical Insurance negotiations, 121 products applied for the Commercial Insurance Innovative Drug Directory, with only 19 drugs from 18 innovative companies successfully included, highlighting the competitive landscape for innovative drugs in China [1] - The Commercial Insurance Innovative Drug Directory targets high-innovation drugs not yet included in the basic medical insurance catalog, providing broader access to effective domestic treatments for patients [4] Future Outlook - The inclusion of Goreni in the directory is expected to enhance the accessibility of this innovative therapy for Gaucher disease patients in China, reflecting the urgent medical needs in the enzyme replacement therapy sector [3][4] - Baiyang Pharmaceutical is actively expanding its portfolio in the innovative drug sector, with investments in various therapeutic areas, indicating a robust strategy for growth and innovation in the pharmaceutical industry [4]