Core Viewpoint - AstraZeneca announced the official launch of Ultomiris® (Ravulizumab injection) in China, aimed at improving the quality of life for patients with generalized Myasthenia Gravis (gMG) and reducing relapses in patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) [1] Group 1 - Ultomiris® is a long-acting C5 complement inhibitor that will be used in combination with conventional treatment for adult gMG patients who are positive for anti-acetylcholine receptor (AChR) antibodies [1] - The drug is also indicated for adult NMOSD patients who are positive for anti-aquaporin-4 (AQP4) antibodies [1] - AstraZeneca's Vice President for Rare Diseases in China expressed optimism about the drug's potential to provide innovative treatment solutions for patients suffering from gMG and NMOSD [1]

Core Insights - The article discusses the recent approval of several high-priced innovative drugs for the commercial insurance innovation drug directory, which were previously excluded from the basic medical insurance directory due to high costs [2][5] - Over 60% of the drugs included in the commercial insurance innovation drug directory have also applied for the basic medical insurance directory, indicating a dual strategy by pharmaceutical companies [2][5] - The National Healthcare Security Administration (NHSA) has initiated a new phase of expert reviews for these drugs, which will determine their final inclusion in the insurance directories [10] Group 1: Drug Approval and Market Dynamics - A total of 121 innovative drugs passed the preliminary review for the commercial insurance innovation drug directory, with 141 applications submitted [5] - Approximately 80 drugs applied for both the basic medical insurance and commercial insurance directories, highlighting a trend towards dual applications [5][9] - The article identifies five categories of drugs that were only submitted for the commercial insurance directory, including rare disease treatments and newly approved drugs with limited clinical data [3][4] Group 2: Pricing and Economic Considerations - Some high-priced rare disease treatments have annual costs exceeding 1 million yuan, which have previously failed to meet the basic medical insurance criteria [6] - The NHSA emphasizes that the approval for the basic medical insurance directory does not guarantee inclusion, as drugs must pass rigorous evaluations and negotiations [9] - The article notes that the commercial insurance directory may serve as a transitional option for innovative drugs that exceed the acceptable pricing thresholds for basic medical insurance [5][10] Group 3: Industry Perspectives and Future Implications - Industry experts suggest that the commercial insurance innovation drug directory should focus on new drugs that fill clinical gaps and provide differentiated treatment options [7] - There is a concern among pharmaceutical companies regarding the potential impact of drug inclusion on insurance premiums and patient access [10][11] - The article highlights the need for real-world evidence to support the clinical efficacy of some newly approved drugs, which may influence their acceptance in the basic medical insurance directory in the future [8][9]

Core Viewpoint - The article discusses the recent approval of high-priced innovative drugs for commercial insurance innovation drug directory, highlighting the ongoing negotiations for inclusion in the basic medical insurance directory, which remains the primary goal for most innovative drug companies [3][4][8]. Summary by Sections Approval Process - The National Medical Insurance Administration announced that 121 innovative drugs passed the preliminary formal review for the commercial insurance innovation drug directory, with a significant number also applying for the basic medical insurance directory [3][7]. - The review process assesses whether the drugs meet the criteria for inclusion in the insurance directories and the completeness of their information [7]. Drug Categories - Less than 40% of the drugs approved only for the commercial insurance innovation drug directory fall into five main categories: rare disease medications, newly approved drugs with limited real-world evidence, globally priced drugs that still do not meet basic insurance thresholds, high-priced new drugs for existing treatments, and preventive biological agents restricted by legal regulations [4][5]. Dual Directory Applications - Approximately 80 drugs, or about 60% of those in the commercial insurance innovation drug directory, applied for both directories, indicating a transitional strategy for many innovative drug companies [8]. - Many high-priced innovative drugs that exceed the acceptable value threshold for basic medical insurance are opting for single directory applications [8][10]. Market Dynamics - The competition in the market for cancer drugs and other treatment areas is intensifying, with a focus on "true innovation" and "differentiated innovation" as encouraged by the National Medical Insurance Administration [10]. - The article notes that some innovative drugs are being submitted for commercial insurance first, with the expectation that they may later be evaluated for inclusion in the basic medical insurance directory once sufficient real-world data is available [11]. Insurance Considerations - The decision to include innovative drugs in the commercial insurance directory is influenced by factors such as the drug's appeal to insurance products, potential premium increases, and the risk of excessive claims [14][15]. - The article highlights the differences in coverage and reimbursement capabilities across various regions, which may affect the sales pathways for innovative drugs [15].

今年，曾在历年"国谈"中或因不符合"70万不谈，50万不入"隐形门槛而被基本医保目录谈判拒之门外的 多款高价创新药通过了商保创新药目录初审。 与此同时，超六成纳入商保创新药目录初审名单的药品同时申报并进入基本目录谈判的初审名单，包括 2款阿尔茨海默症治疗药物、3款CAR-T药物等，这些高价"明星药物"能否通过专家评审、进入"谈判 桌"并最终获得医保支付，仍待揭晓。 8月12日，国家医保局发布《关于公示通过2025年国家基本医疗保险、生育保险和工伤保险药品目录及 商保创新药目录调整初步形式审查的药品及相关信息》的公告（下称"形式审查公示"），121款创新药 通过商保创新药目录初步形式审查，第一财经记者梳理得出上述信息。这与记者此前和多家申报企业方 交流情况基本一致，鉴于基本医保目录覆盖人群广、支付和"进院"政策确定性更强，仍是多数创新药企 的首选或最终目的。 此外，根据国家医保局公示的"入围"药品信息，第一财经还发现，在占比不到四成（40余款）的仅申报 并通过商保创新药目录的药品中，主要包含五类：一是适应证人群少但价格高昂的罕见病用药；二是以 海外临床数据或替代终点上市，真实世界证据尚待积累的刚获批新药；三是药 ...

Core Insights - Gastric cancer remains a significant global health issue, ranking fifth in cancer-related deaths according to GLOBOCAN 2022 data from the IARC, with a particularly heavy burden in Asia, Latin America, and parts of Africa [6][7] - Approximately 76% of gastric cancer cases globally are attributed to Helicobacter pylori infection, with higher attribution rates in specific regions, such as 82% in African women and 71% in Asian men [7][8] - The rising incidence of gastric cancer among individuals under 50 years old is concerning, potentially reversing previous trends of declining rates [6][7] - Implementing effective H. pylori screening and treatment strategies could reduce gastric cancer cases by up to 75% globally, highlighting the importance of developing and promoting H. pylori vaccines as a preventive measure [8][9] - The report suggests a positive outlook for innovative drug companies, particularly those with true innovation capabilities, and highlights potential investment opportunities in sectors such as CXO services and AI healthcare [9][10] Industry Overview - The pharmaceutical and biotechnology sector's TTM-PE ratio is currently at 50.25, representing a 106% increase from its historical low of 24.38 [11] - The sector's premium over the CSI 300 index is 278%, significantly higher than the historical average of 241% over the past decade [11] - The healthcare sector has experienced a decline of 0.84% in the past week, ranking last among 27 sub-industries [20][22] - Notable individual stock performances include Hai Chen Pharmaceutical with a 41.29% increase and Qi Zheng Tibetan Medicine with a 16.11% decrease [22][24] Industry Dynamics - Recent approvals in the industry include AstraZeneca's long-acting C5 complement inhibitor and the first biosimilar of dulaglutide for diabetes management [25][28] - The report emphasizes the ongoing trend of innovative drug approvals and the potential for significant market opportunities in the pharmaceutical sector [25][28][29]

Core Viewpoint - AstraZeneca's long-acting C5 complement inhibitor, Relatuzumab, has been approved in China for the treatment of adult patients with anti-AQP4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD) [1][2] Group 1: Product Approval and Impact - Relatuzumab is now officially approved in China for NMOSD, a condition characterized by unpredictable relapses leading to irreversible disability and significantly affecting patients' quality of life [1] - The drug aims to provide a convenient treatment experience with an administration frequency of once every eight weeks, potentially helping patients achieve a "zero relapse" lifestyle [1] Group 2: Disease Overview - NMOSD is a rare central nervous system disease caused by the immune system attacking healthy tissues and cells, with approximately 75% of patients testing positive for anti-AQP4 antibodies [2] - Symptoms of NMOSD can include vision problems, severe pain, loss of bladder or bowel function, sensory abnormalities, and coordination or motor skill impairments [2] Group 3: Mechanism of Action - As a long-acting C5 complement inhibitor, Relatuzumab provides immediate, complete, and sustained complement suppression by inhibiting C5 activation in the immune system's terminal complement cascade [3] - The drug has received approvals in multiple regions, including the US, EU, and Japan, for various indications, including NMOSD [3]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [4] Core Insights - The innovative drug sector has seen a significant increase in institutional interest, with the total heavy positions in Biotech innovative drugs reaching 80.371 billion yuan, a quarter-on-quarter growth of 39% [7][18] - The proportion of heavy positions in Biotech innovative drugs relative to the overall market has increased to 2.39%, up by 0.49 percentage points, indicating sustained enthusiasm from institutions towards the innovative drug sector [19][25] - The heavy positions in Biotech innovative drugs account for 24.93% of the total heavy positions in the pharmaceutical industry, reflecting a rise of 5.49 percentage points [19][25] Summary by Sections Weekly Review of New Drug Market - From July 28 to August 1, 2025, the top five companies in the new drug sector by stock price increase were: Zhongsheng Pharmaceutical (29.53%), WuXi AppTec (17.72%), CSPC Pharmaceutical Group (14.60%), Maiwei Biotech (12.08%), and Haizhi Pharmaceutical (11.76%) [14][15] - The top five companies by stock price decrease were: Kintor Pharmaceutical (-19.09%), Hualing Pharmaceutical (-16.19%), Junsheng Pharmaceutical (-13.24%), Kintor Pharma (-12.70%), and Yunding New Drug (-11.29%) [14][15] Key Analysis of New Drug Industry - The report analyzed the latest heavy positions of all funds in the innovative drug sector as of June 30, 2025, focusing on A-share and Hong Kong Biotech companies [18] - The heavy positions in Biotech innovative drugs accounted for 7.05% of the total market capitalization, an increase of 0.93 percentage points [23][28] New Drug Approval and Acceptance - This week, 13 new drug or new indication applications were approved, including drugs such as Risperidone orally disintegrating film and Nivolumab injection [33][34] - Additionally, 6 new drug or new indication applications were accepted, including drugs like Eptinezumab injection and Edaravone tablets [35][36] Clinical Application Approval and Acceptance - A total of 50 new drug clinical applications were approved this week, while 44 new drug clinical applications were accepted [37]

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