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。 ...

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。 消息面上，8月13日，北海康成宣布与百洋医药（301015）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。 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。 ...

近日，首版商保创新药目录通过初审名单正式公布，121款药品赫然在列，"双目录"时代亦近在咫尺。 《科创板日报》记者注意到，复星医药旗下有多款产品进入首版商保创新药目录初审名单，其中备受关 注的120万元/针 CAR-T 疗法阿基仑赛注射液亦在列。值得一提的是，该产品自2021年在国内上市以 来，已连续四年通过国家医保药品目录的初步形式审查，但最终因国谈中"50万不谈，30万不进"的隐形 门槛均未通过专家评审，无缘医保谈判桌。 此次阿基仑赛注射液仅申报了商保创新药目录，而与该产品一同进入初审名单的，还有另外四款CAR-T 疗法，该五款CAR-T疗法在后续专家评审、价格协商等环节将有如何表现，最终能否顺利纳入商保目 录，并实现市场价值与患者可及性的平衡，成为行业的关注点之一。 启德医药董事长秦刚则对《科创板日报》记者指出："中国商业保险体系纳入创新药，是我们创新药从 业者期盼多年的事。不过同时也存在大量不确定性，如何推动相关政策落地，仍需行业持续观望与深入 思考。" 对于一众创新药企而言，国家医保局首次将商业健康险纳入目录体系，这一举措不仅打破了此前支付端 的单一格局，更通过"基本医保保基本、商业健康险保创新"的 ...

Core Viewpoint - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][2] Summary by Sections Commercial Health Insurance Innovative Drug Directory - The commercial health insurance innovative drug directory is voluntary for pharmaceutical companies and insurance firms, meaning that the success of negotiations remains uncertain [3][4] - The directory aims to include innovative drugs that exceed the basic insurance coverage, focusing on high clinical value and significant patient benefits [5][6] Market Dynamics and Drug Coverage - The directory primarily covers unmet needs in areas such as oncology, rare diseases, and chronic conditions, with several CAR-T therapies included [6][7] - The inclusion of domestic pharmaceutical products has increased, enhancing the controllability of the drug supply chain [6][7] Challenges in Implementation - The process from preliminary review to final inclusion in the directory involves multiple steps, including expert evaluation and price negotiations, which introduces uncertainty [9][11] - Concerns exist regarding the balance between patient accessibility and the sustainability of insurance companies, particularly regarding the definition of coverage limits and risk management [10][11] Impact on Insurance Products - The innovative drug directory is expected to stimulate discussions on product innovation within the insurance industry, encouraging companies to optimize their product strategies based on the directory [13][14] - Insurance companies are advised to design products that cater to different consumer capabilities, enhancing the appeal of high-end medical insurance [14][15] Future Market Potential - The innovative drug market in China is projected to reach 1 trillion yuan by 2035, with commercial health insurance expected to cover a significant portion of this market [16][17] - The NHSA's recent measures aim to establish a multi-layered payment system for innovative drugs, enhancing their accessibility and reducing the financial burden on patients [17][18]

Core Insights - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][3] - The commercial health insurance innovative drug catalog aims to include high-value innovative drugs that are not covered by basic insurance, focusing on areas such as oncology and rare diseases [4][15] - The process for drugs to be included in the commercial health insurance catalog involves multiple steps, including expert review and price negotiations, which introduces uncertainty regarding the final inclusion of these drugs [7][10] Industry Dynamics - The NHSA's new policies are seen as a significant step towards creating a multi-layered payment system for innovative drugs, addressing the historical challenges of insufficient insurance coverage and high out-of-pocket costs for patients [15][16] - The commercial health insurance sector is expected to play a crucial role in expanding access to innovative drugs, with the potential to cover a larger patient base and enhance the financial viability of drug companies [17] - The introduction of the commercial health insurance innovative drug catalog is anticipated to stimulate product innovation within the insurance industry, as companies adapt their offerings to meet the needs of patients seeking coverage for high-cost medications [11][12] Market Opportunities - The innovative drug market in China is projected to reach 1 trillion yuan by 2035, with commercial health insurance expected to cover 44% of this market, translating to approximately 440 billion yuan [14][15] - The inclusion of domestic drug companies in the innovative drug catalog is increasing, which may enhance the stability of the drug supply chain and improve pricing negotiations [4][16] - The potential for specialized insurance products targeting high-net-worth individuals seeking coverage for innovative drugs is growing, as insurers look to differentiate their offerings in a competitive market [12][13]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [5]. Core Insights - The initial review of the commercial insurance innovative drug directory has been approved, indicating a continuous expansion of payment space [2][21]. - The report highlights the importance of focusing on companies with strong R&D capabilities and existing commercialized innovative drug products, such as BeiGene, Hengrui Medicine, Innovent Biologics, and Kangfang Bio [2][25]. Summary by Sections Market Review - Last week, the A-share pharmaceutical and biotechnology index rose by 3.08%, outperforming the CSI 300 index by 0.77 percentage points, but underperforming the ChiNext index by 2.76 percentage points, ranking 10th among 31 sub-industries [1][15]. - The Hong Kong Hang Seng Medical Health Index increased by 7.12%, outperforming the Hang Seng Index by 5.51 percentage points [1][15]. Company R&D Progress - Recent IND applications include Hengrui Medicine's HRS-4729 injection and HRS-7172 tablets, as well as clinical applications for Kangnuo's CM536 injection and Sanofi's SSS50 injection [28]. Key Company Profit Forecasts and Valuation - Hengrui Medicine: EPS forecast for 2024 is 0.99 CNY, with a PE ratio of 64, rated as "Accumulate" [4]. - Yuyue Medical: EPS forecast for 2024 is 1.80 CNY, with a PE ratio of 20, rated as "Buy" [4]. - Mindray Medical: EPS forecast for 2024 is 9.62 CNY, with a PE ratio of 24, rated as "Buy" [4]. - United Imaging Healthcare: EPS forecast for 2024 is 1.53 CNY, with a PE ratio of 84, rated as "Buy" [4]. Payment Perspective Strategy - The report emphasizes the need to select investment opportunities structurally, focusing on the core contradiction between payment willingness and ability [3][25]. - It identifies three key payment channels: hospital payments, out-of-pocket payments, and overseas payments, recommending companies like Hengrui Medicine, Mindray Medical, United Imaging Healthcare, and Yuyue Medical [3][25]. Innovative Drug Directory Insights - A total of 121 drugs passed the initial review for the commercial insurance innovative drug directory, with 79 drugs appearing in both the basic medical insurance and commercial insurance directories, providing a "double insurance" effect [2][22]. - The report notes that targeted therapies, particularly PD-(L)1 monoclonal antibodies, dominate the applications for the commercial insurance directory [2][23].

Investment Rating - The report does not explicitly state an investment rating for the industry, but it indicates a positive trend in the pharmaceutical and biotechnology sector with a weekly increase of 3.08% [3][8]. Core Insights - The pharmaceutical and biotechnology sector outperformed the Wind All A index and the CSI 300 index during the week of August 11 to August 15, with notable gains in medical research outsourcing (7.77%), hospitals (5.59%), and medical consumables (4.47%) [3][8]. - The upcoming launch of the commercial insurance innovative drug directory is expected to activate the domestic high-end payment market for innovative drugs, with 121 drug names passing preliminary review [3][8]. - The World Conference on Lung Cancer (WCLC) will take place from September 6 to 9, showcasing significant research advancements in lung cancer, with domestic research playing an increasingly important role [3][8]. Market Weekly Review - The pharmaceutical and biotechnology sector rose by 3.08%, outperforming the Wind All A index (2.95%) and the CSI 300 index (2.37%) [3][8]. - Medical research outsourcing, hospitals, and medical consumables led the sector's gains, while offline pharmacies, blood products, and medical circulation experienced declines [3][8]. - Notable individual stock performances included Sino Medical (69.1%), Innovation Medical (51.5%), and Guangsheng Tang (40.7%) for gains, while *ST Suwu (-16.8%), ST Sansheng (-15.2%), and Nanhua Biological (-14.2%) faced significant losses [3][11]. Industry News and Key Company Announcements - The National Medical Insurance Administration announced the preliminary review of the 2025 National Basic Medical Insurance drug directory and the commercial insurance innovative drug directory [3][13]. - Novo Nordisk received accelerated FDA approval for its therapy Wegovy for treating non-alcoholic steatohepatitis (NASH) [3][13]. - Yunnan Baiyao approved a full acquisition of An Guo Shi Ju Yao Tang Pharmaceutical Co., Ltd. for 660 million RMB to enhance its traditional Chinese medicine business [3][15]. - Insmed's DPP1 inhibitor Brensocatib received FDA approval for treating non-cystic fibrosis bronchiectasis [3][14].

Core Viewpoint - The article discusses the introduction of the commercial insurance innovative drug directory in China, which supplements the basic medical insurance directory and aims to include high-priced innovative drugs that provide significant clinical value and patient benefits [2][10]. Summary by Sections Introduction of the Commercial Insurance Innovative Drug Directory - The National Healthcare Security Administration announced a list of drugs that passed the initial review for the commercial insurance innovative drug directory, with a total of 121 drugs, over half of which are cancer or rare disease medications [2][5]. - The directory is expected to include high-priced drugs, such as CAR-T therapies costing over 1 million yuan per injection and gene therapies priced around 98,000 yuan per injection [2][4]. Drug Approval and Characteristics - To qualify for the commercial insurance innovative drug directory, drugs must either be newly approved from January 1, 2020, to June 30, 2025, or have indications included in the national rare disease directory by June 30, 2025 [5]. - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer and Johnson & Johnson [5]. Focus on Cancer and Rare Diseases - The majority of drugs that passed the initial review are cancer treatments, with over 40 entries, followed by 35 for rare diseases [5][6]. - The article highlights the potential for the directory to alleviate payment challenges for rare disease medications, with companies actively submitting applications [6]. Pricing and Negotiation Challenges - The pricing negotiation process for drugs in the commercial insurance directory remains uncertain, as it involves collaboration between the National Healthcare Security Administration, commercial insurers, and pharmaceutical companies [12][13]. - The article notes that the commercial insurance directory may serve as a "double insurance" for companies, allowing them to apply for both the basic medical insurance and the commercial insurance directories simultaneously [9]. Future Considerations and Recommendations - The article suggests that the implementation of the commercial insurance innovative drug directory requires further exploration and refinement, with recommendations for pilot programs in specific insurance products [14]. - It emphasizes the need for insurance companies to develop reasonable pricing mechanisms and improve data integration with basic medical insurance to enhance their pricing strategies [13][14].

Core Insights - The National Healthcare Security Administration (NHSA) has released a list of drugs that passed the preliminary review for the commercial insurance innovative drug directory, which is a new supplement to the basic medical insurance directory aimed at covering high-priced drugs [2][3] - A total of 121 drugs have passed the initial review, with over half being cancer or rare disease medications, including several high-cost therapies [2][5] - The final commercial insurance innovative drug directory is expected to be published between October and November 2023, following expert evaluations and price negotiations [2][3] Summary by Category Drug Characteristics - The drugs included in the commercial insurance innovative drug directory are characterized by high innovation, significant clinical value, and substantial patient benefits, exceeding the basic insurance's "basic protection" scope [2] - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer, Johnson & Johnson, and Merck [5] Pricing and Negotiation - The drugs will undergo price negotiations, which may lead to price reductions, but the extent of these reductions remains uncertain [9][10] - The commercial insurance innovative drug directory allows for simultaneous applications to both the basic medical insurance and the commercial insurance directories, providing a "double insurance" for companies [7] Market Dynamics - The directory includes a variety of drugs, including CAR-T therapies priced around 1 million yuan per injection, which have faced challenges in entering the basic medical insurance directory [6][9] - The directory's implementation may alleviate payment difficulties for rare disease medications, with companies actively submitting applications [6][8] Insurance Industry Considerations - The insurance industry faces challenges in pricing and market growth potential due to the voluntary nature of commercial insurance participation [9][11] - There is a need for better data integration between commercial insurance and basic medical insurance to enhance pricing strategies and product development [11]

Core Viewpoint - Kintor Pharmaceutical has shown significant stock performance, with an approximately eightfold increase since its low in September 2024, despite still being in a loss position [1] Financial Performance - For the first half of 2025, Kintor reported revenue of approximately 51 million yuan, a year-on-year increase of about 703.8%, primarily driven by sales of its CAR-T product, SaiKezai [1] - The net loss for the same period was approximately 75.48 million yuan, a reduction of over 78% compared to the previous year [1][2] - Cost control measures, including reduced R&D and administrative expenses, contributed to the narrowing of net losses [2] Product Development and Market Strategy - Kintor's first CAR-T product, SaiKezai, was launched on March 1, 2024, and has secured 111 effective orders from its commercial partner, East China Pharmaceutical [3] - The company is optimistic about the sales growth of SaiKezai due to ongoing marketing efforts and expanded insurance coverage [3] - Kintor is also advancing its CAR-T product, ShuRuiJiAoLunSai, aimed at treating solid tumors, with an NDA submission expected to be approved between Q1 and Q2 of next year [3] Cost and Accessibility Challenges - The high production costs of CAR-T therapies remain a significant barrier to accessibility, with domestic pricing generally around one million yuan [1][4] - Kintor is shifting its strategic focus towards developing universal CAR-T therapies, which are expected to have more significant economies of scale [5] Insurance and Policy Developments - The recent introduction of a dual-track system for insurance coverage, including a commercial insurance innovation drug directory, may improve patient access to CAR-T therapies [6] - SaiKezai is among five CAR-T products included in the initial review list for the commercial insurance innovation drug directory, which could lower patient financial burdens [6] - Kintor is actively collaborating with East China Pharmaceutical to secure policy support related to SaiKezai [6] Industry Context - The establishment of a national commercial insurance directory is expected to address disparities in drug coverage across regions, enhancing the sustainability of insurance support for innovative therapies [7]