Core Insights - The 2025 National Medical Insurance Negotiation has commenced, expected to last 4-5 days, focusing on both basic medical insurance and commercial health insurance innovative drug pricing [1][2] - This year's negotiation marks the 8th adjustment since the establishment of the National Medical Insurance Bureau and introduces a new commercial health insurance innovative drug directory [2][3] Group 1: Negotiation Details - The negotiation will begin with drugs that have relatively transparent pricing, such as antiviral and chronic disease medications, while more challenging drugs like cancer treatments will be discussed later [3] - Key innovative drugs, including TROP2 ADC and several CAR-T products, are anticipated to participate in this year's negotiations [2][3] Group 2: Directory Adjustments - A total of 535 drug names have passed the formal review for the basic drug directory, with 311 being new entries and 224 existing ones [2] - For the commercial health insurance innovative drug directory, 121 drug names have passed the formal review, with 79 applying for both directories [2][3] Group 3: Policy Framework - The dynamic adjustment mechanism for the national medical insurance directory has evolved into a scientific and fair process over the years [3] - The commercial health insurance innovative drug directory focuses on high-innovation, clinically valuable drugs that cannot be included in the basic directory due to their cost [3]

说明： 湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 证券代码：603998 证券简称：方盛制药 公告编号：2025-090 湖南方盛制药股份有限公司 2025年前三季度经营数据公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 根据《上市公司行业信息披露指引第六号——医药制造》的 相关规定，湖南方盛制药股份有限公司（以下简称"公司"）现 将 2025 年前三季度主要经营数据披露如下（单位：元，人民币）： | | | 主营业务分行业情况 | | | | | | --- | --- | --- | --- | --- | --- | --- | | 分行业 | 营业收入 | 营业成本 | 毛利 率% | 营业收 入比上 | 营业成 本比上 | 毛利率比上年增减 | | | | | | 年增减 | 年增减 | | | 工业小计 | 1,155,172,695.85 | 299,438,278.53 | 74.08 | -6.75% | 2.51% | 减少 2.34 个 ...

Core Viewpoint - The Hong Kong Stock Connect innovative drug sector is showing strong performance, with the Hong Kong Stock Connect Innovative Drug ETF (520880) experiencing significant trading activity and price increases, indicating a bullish sentiment in the market [1][4]. Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (520880) surged by nearly 4% in early trading, surpassing its 5-day moving average, with trading volume exceeding 400 million yuan, surpassing the previous day's total [1]. - The ETF covers 37 innovative drug research companies, with 36 stocks showing gains, including notable increases from companies like BeiGene and China Biologic Products [4]. - The index tracked by the ETF has shown a year-to-date increase of 108.14%, outperforming other innovative drug indices [8]. Group 2: Key Companies and Their Performance - Major companies within the ETF include: - BeiGene (6160) with a weight of 10.46%, current price at 191.60, and a 2.13% increase [2]. - China Biologic Products (1177) with a weight of 10.01%, current price at 7.66, and a 2.00% increase [2]. - Innovent Biologics (1801) with a weight of 9.20%, current price at 88.35, and a 3.21% increase [2]. - Other notable performers include CanSino Biologics and 3SBio, with increases of over 6% and 7% respectively [4]. Group 3: Upcoming Events and Opportunities - The European Society for Medical Oncology (ESMO) annual meeting is scheduled from October 17 to 21 in Berlin, which is expected to be a significant platform for domestic pharmaceutical companies to showcase their achievements and explore new business development opportunities [2]. - Recent business development transactions, such as the $100 million upfront payment by Innovent Biologics, indicate a robust pipeline for potential deals in the coming months, particularly in the traditional peak season for such transactions [3]. Group 4: Policy and Economic Environment - Domestic policy adjustments in the medical insurance directory are expected to support genuine innovation, providing a stable outlook for commercialization [3]. - The resumption of the Federal Reserve's interest rate cut cycle is anticipated to benefit the Hong Kong Stock Connect innovative drug sector through improved valuation and financing conditions [3].

Core Viewpoint - The Hong Kong innovative drug sector continues to rise, with the Hang Seng Innovative Drug Index increasing by 3.2% shortly after market opening, driven by significant gains in constituent stocks such as InnoCare Pharma and 3SBio [1] Group 1: Market Performance - The Hang Seng Innovative Drug Index rose by 3.2% within the first half hour of trading [1] - InnoCare Pharma-B surged over 10%, while 3SBio increased by over 6%, and both CanSino Biologics and BGI Genomics rose by over 5% [1] Group 2: Upcoming Events - The 2025 European Society for Medical Oncology (ESMO) annual meeting is scheduled from October 17 to October 21 in Berlin, Germany, expected to be a significant platform for domestic pharmaceutical companies to showcase their achievements and facilitate new business development (BD) agreements [1] Group 3: Market Trends and Policies - October to November is traditionally a peak season for BD transactions, with notable deals already initiated by companies like Innovent Biologics, indicating potential for continued activity in the sector [1] - The adjustment window for the medical insurance catalog has opened, with clear policy support for genuine innovation, providing stable expectations for commercialization [1] - The Federal Reserve's potential interest rate cuts may benefit the innovative drug sector through improved valuation and financing conditions [1] Group 4: Index Composition and Investment Products - The Hang Seng Innovative Drug Index is the first "pure" innovative drug index with 100% purity, excluding CXO companies, allowing for an accurate reflection of the overall performance of China's innovative drug firms [1] - The Hang Seng Innovative Drug ETF (159316) is currently the only product tracking this index, having attracted over 500 million yuan in the last 10 trading days, facilitating investor access to leading innovative drug companies [1]

Core Viewpoint - WuXi AppTec's CAR-T product, Benodida, along with four other CAR-T therapies, has successfully passed expert review for inclusion in the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory, signaling a positive regulatory shift towards improving access to cutting-edge therapies [1] Group 1: Stock Performance - WuXi AppTec-B (02126) saw a nearly 7% intraday increase, currently up 6.1% at HKD 4.35, with a trading volume of HKD 7.2867 million [1] Group 2: Regulatory Developments - The National Healthcare Security Administration announced the completion of expert review for the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory adjustments [1] - The inclusion of CAR-T therapies in the review indicates a commitment from regulators to enhance the accessibility of advanced treatments [1] Group 3: Market Context - CAR-T therapies have not been included in the basic medical insurance directory due to their high cost, often exceeding one million yuan per injection [1] - Currently, CAR-T therapy payment structures are diversified, relying primarily on commercial health insurance, supplemented by special disease insurance, financial installment plans, and various assistance programs [1] Group 4: Company Response - WuXi AppTec has stated that its CAR-T products will actively participate in the application process for the 2025 medical insurance and commercial insurance innovative drug directories [1] - Over 70 commercial health insurance products have already included WuXi AppTec's Benodida [1]

Core Viewpoint - The National Healthcare Security Administration (NHSA) has completed the expert review for the 2025 National Basic Medical Insurance (BMI) catalog and the commercial insurance innovative drug catalog, marking the eighth adjustment since its establishment and the first inclusion of a commercial insurance innovative drug catalog [1][2]. Group 1: CAR-T Products Approval - Five CAR-T products have successfully passed the expert review and will be included in both the basic medical insurance and commercial insurance innovative drug catalogs, laying the groundwork for future negotiations and access [1][2]. - The approval of these CAR-T products is seen as a positive signal, indicating the regulatory body's commitment to improving access to cutting-edge therapies [1][3]. - The review process emphasized the innovation level, efficacy, and the ability to fill treatment gaps, with CAR-T therapies receiving unanimous approval [2][5]. Group 2: Impact on Patients and Companies - The introduction of the commercial insurance innovative drug catalog is expected to significantly reduce out-of-pocket expenses for patients, making high-cost CAR-T treatments more accessible [3][4]. - Companies view the catalog as a "second channel" for innovative drugs, alleviating pricing pressure during negotiations with basic medical insurance and potentially expanding market share [4][5]. - The collaboration between pharmaceutical companies and insurance providers is anticipated to evolve towards deeper cooperation, exploring mechanisms like outcome-based payments and risk-sharing [4][5]. Group 3: Future Outlook - Companies express cautious optimism regarding the inclusion of CAR-T products in the commercial insurance innovative drug catalog, supported by policy direction, clinical value, and practical experience [5][6]. - The ongoing expansion and optimization of the commercial insurance catalog are expected to further benefit patients in need of CAR-T therapies [6].

Core Insights - The National Healthcare Security Administration (NHSA) announced the completion of expert reviews for the 2025 National Basic Medical Insurance Directory and the Commercial Health Insurance Innovative Drug Directory, marking the 8th adjustment since the NHSA's establishment and the first inclusion of a commercial insurance innovative drug directory [1][2] Group 1: Directory Adjustments - A total of 534 drugs were reviewed for inclusion in the basic medical insurance directory, while 121 drug generic names were reviewed for the commercial health insurance innovative drug directory, including high-priced innovative drugs like CAR-T therapy [1] - The NHSA's announcement indicates that drugs marked for "proposed negotiation," "proposed bidding," and "proposed price consultation" are eligible for negotiation or bidding but do not guarantee inclusion in the directories [1] Group 2: Negotiation and Communication - Following the expert review, the next phase will involve negotiation, bidding, and price consultation, where companies must submit relevant materials for assessment by the NHSA [2] - The NHSA plans to hold a face-to-face communication meeting in Beijing with companies involved in negotiations, bidding, and price consultations to discuss evaluation methods and gather feedback [2] - The timeline for this year's negotiations is tighter compared to previous years, with companies required to submit materials by September 30, 2023, following the announcement on September 20, 2023 [2]

Core Points - The National Healthcare Security Administration (NHSA) announced the adjustment of the national basic medical insurance directory and the commercial health insurance innovative drug directory for 2025, marking the first time a commercial insurance innovative drug directory has been added outside the basic medical insurance directory [1] - A total of 534 drugs were reviewed for inclusion in the basic medical insurance directory, while 121 drug generic names were reviewed for the commercial insurance innovative drug directory, including high-priced innovative drugs like CAR-T [1] - The NHSA will hold a communication meeting in Beijing with companies involved in negotiations, bidding, and price consultations, emphasizing the importance of face-to-face communication with enterprises [2] Summary by Sections Directory Adjustment Process - The adjustment process for the 2025 directory consists of five stages: preparation, application, expert review, negotiation, and result announcement, with the basic directory adjustment and commercial insurance innovative drug directory being developed simultaneously [2] - After the expert review, the process will move into the negotiation/bidding/price consultation phase, where companies must submit relevant materials for assessment by the NHSA [2] Timeline and Comparison - The announcement of the expert review results this year was made on September 20, with companies required to submit materials by September 30, indicating a tighter schedule compared to previous years [2] - The negotiation for the national medical insurance directory is expected to start around October 27, similar to last year, although the addition of the commercial insurance innovative drug directory may slightly delay the timeline [3]

Core Points - The National Healthcare Security Administration (NHSA) has announced the results of the expert review phase for the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory adjustments [1][2] - Companies can check the review results through the NHSA service platform and must submit required documents by specified deadlines [1][2] Group 1 - Companies can log into the NHSA service platform to query the expert review results for the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory adjustments [1] - The expert review results include categories such as "proposed simple renewal," "proposed renegotiation renewal," "proposed negotiation addition," "proposed competitive addition," and "proposed price negotiation" [1][2] - Companies must download the corresponding confirmation letter template and submit it by September 23, 2025, along with the original documents sent to the NHSA [1][2] Group 2 - For drugs confirmed to participate in negotiations, competitive bidding, and price negotiations, companies must download the relevant submission material templates and ensure the completeness and authenticity of the submitted data [2] - The review results indicating "proposed negotiation addition," "proposed competitive addition," and "proposed price negotiation" do not guarantee inclusion in the National Basic Medical Insurance Directory or Commercial Insurance Innovative Drug Directory [2] - A communication meeting for companies involved in negotiations and bidding will be held in Beijing, with details to be announced later [2]

Core Points - The National Healthcare Security Administration (NHSA) has released the interim results of expert reviews for the 2025 National Basic Medical Insurance Directory and the Commercial Insurance Innovative Drug Directory [1] - Companies can access the evaluation results through the National Medical Insurance Service Platform, specifically in the "2025 Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory Adjustment" module [1] - The evaluation results categorize drugs as "proposed for negotiation addition," "proposed for competitive bidding addition," or "proposed for price negotiation," indicating eligibility for negotiation or bidding but not confirmation of inclusion in the directories [1]