Core Viewpoint - The article highlights a significant rise in the stock prices of several innovative pharmaceutical companies following the announcement of the 2025 National Medical Insurance drug list, which includes a substantial number of new innovative drugs [1] Group 1: Stock Performance - WuXi AppTec (02126) saw an increase of 8.77%, trading at HKD 3.35 [1] - Kintor Pharmaceutical (02171) rose by 3.8%, reaching HKD 18.87 [1] - Beihai Kangcheng (01228) increased by 3.38%, priced at HKD 2.45 [1] - Junshi Biosciences (01877) gained 2.29%, with a share price of HKD 24.1 [1] Group 2: Drug List Adjustments - The 2025 National Medical Insurance drug list is the 8th adjustment since the establishment of the National Healthcare Security Administration [1] - A total of 114 new drugs were added to the list, including 50 Class 1 innovative drugs [1] Group 3: Notable Drug Inclusions - Fosun Pharma's (600196) Luwomei Tablets and Beihai Kangcheng's injectable Vilazodone Beta were included in the commercial insurance innovative drug list [1] - The highly anticipated CAR-T cell therapies from various companies, including Fosun Kairui's Acalabrutinib Injection and WuXi AppTec's Regorafenib Injection, were also included in the first batch of commercial insurance innovative drug list [1]

Group 1 - The core viewpoint of the article highlights a significant rise in certain innovative drug concept stocks, driven by the recent adjustment of the national medical insurance drug list in China, which includes 114 new drugs, 50 of which are classified as innovative drugs [1] - WuXi AppTec's stock (02126) increased by 8.77% to HKD 3.35, Kintor Pharmaceutical's stock (02171) rose by 3.8% to HKD 18.87, Beihai Kangcheng's stock (01228) went up by 3.38% to HKD 2.45, and Junshi Biosciences (01877) saw a 2.29% increase to HKD 24.1 [1] - Notably, Fosun Pharma's drug, Luwomei Tablets, has been included in the 2025 medical insurance directory, while Beihai Kangcheng's injectable Viraquinase β has entered the commercial insurance innovative drug directory [1] Group 2 - The article emphasizes the inclusion of several CAR-T cell therapies in the first batch of commercial insurance innovative drug directory, including Fosun Kairui's Acalabrutinib injection, WuXi AppTec's Regorafenib injection, and others from various biotech companies [1] - The adjustment of the medical insurance drug list marks the 8th update since the establishment of the National Medical Insurance Bureau, indicating ongoing efforts to enhance access to innovative treatments [1]

国家医保局等部门印发《国家基本医疗保险、生育保险和工伤保险药品目录》以及《商业健康保险创新 药品目录》，自2026年1月1日起正式执行。 国家医保局成立以来医保药品目录已调整8次，本次医保药品目录调整新增114种药品，其中50种为1类 创新药。首版商保创新药目录共纳入19种药品，既有CAR-T等肿瘤治疗药品，也有社会关注度较高的阿 尔茨海默病治疗药品。 恒生医药ETF（159892）聚焦创新药产业，在港交所18A制度优势下覆盖众多创新标的（百济神州、信 达生物、康方生物等），有望受益于医保目录的更新和美联储降息。 （文章来源：每日经济新闻） 具体来看，复星医药的芦沃美替尼片进入2025年医保目录，北海康成的注射用维拉苷酶β进入商保创新 药目录。同时，5款CAR-T药进入商保创新药目录，分别是复星凯瑞的阿基仑赛注射液、药明巨诺的瑞 基奥仑赛注射液、合源生物的纳基奥仑赛注射液、驯鹿生物的伊基奥仑赛注射液、科济药业的泽沃基奥 仑赛注射液。 从药企角度来看，纳入医保+商保的创新药大多处于放量初期，随着政策红利释放，纳入医保、商保目 录的创新药有望快速放量。商保的逐步推广也有望增加创新药费用的支付来源，促进创新药在支付 ...

Core Viewpoint - The inclusion of five CAR-T cell therapies in the first edition of the "Commercial Health Insurance Innovative Drug Directory" marks a significant breakthrough for these high-cost treatments, which have previously struggled to gain access to national insurance negotiations [2][5]. Group 1: CAR-T Cell Therapies Overview - Five CAR-T cell therapies have been successfully included in the directory: Fosun Kite's Acarbose Injection, WuXi AppTec's Regeneron Injection, Huyuan Biotech's Nacarbose Injection, Reindeer Biotech's Ikcarbose Injection, and Kanjin Pharmaceutical's Zewokarbose Injection [2]. - Among these, Huyuan Biotech's Nacarbose Injection is priced at 999,000 yuan per dose, making it the only CAR-T therapy priced below one million yuan, while WuXi AppTec's Regeneron Injection is the most expensive at 1,290,000 yuan per dose [2]. Group 2: Significance of Inclusion - The entry of these CAR-T therapies into the commercial insurance directory is seen as a major milestone in establishing a multi-tiered, institutionalized payment system for high-value innovative drugs in China [5]. - This development is expected to create a sustainable and predictable market access pathway for high-value drugs, including those considered "sky-high priced," providing a reference directory for all commercial health insurance products [5]. Group 3: Cost and Accessibility - Some CAR-T products have already penetrated the commercial insurance market, particularly through local health insurance projects, with reported price reductions of at least 15% for these therapies compared to local health insurance plans [6]. - The production costs of CAR-T therapies are significantly influenced by the use of expensive lentiviral vectors sourced from foreign suppliers, which has historically limited the pricing of these therapies [4]. Group 4: Implementation Challenges - The successful inclusion of CAR-T therapies in the directory raises questions about how to effectively implement and promote these therapies in hospitals, as the directory's impact ultimately depends on hospital adoption [6]. - Recent policies from the National Healthcare Security Administration and the National Health Commission have alleviated concerns among hospitals and physicians regarding cost assessments, which could facilitate the entry of these innovative drugs into hospitals [7][8].

Core Viewpoint - The preliminary results of CT0596, an allogeneic CAR-T cell therapy targeting BCMA, were reported at the 67th American Society of Hematology (ASH) Annual Meeting, indicating promising safety and efficacy signals in patients with relapsed/refractory multiple myeloma [1][2]. Group 1 - CT0596 is developed based on the company's proprietary THANK-u Plus platform and is currently undergoing investigator-initiated clinical trials for relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (PCL) [2]. - Initial results show good safety and encouraging efficacy signals, with CAR-T cell expansion observed across all predefined dose groups [2]. - The company plans to explore CT0596 in other plasma cell tumors and autoimmune diseases driven by autoreactive plasma cells [2]. Group 2 - The company anticipates submitting an Investigational New Drug (IND) application for CT0596 in the second half of 2025 [2].

Core Viewpoint - The preliminary results of CT0596, an allogeneic CAR-T cell therapy targeting BCMA, were reported at the 67th American Society of Hematology (ASH) Annual Meeting, indicating promising safety and efficacy signals in patients with relapsed/refractory multiple myeloma [1][2]. Group 1 - CT0596 is developed based on the company's proprietary THANK-u Plus™ platform and is currently undergoing investigator-initiated clinical trials for relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (PCL) [2]. - Initial results show good safety and encouraging efficacy signals, with CAR-T cell expansion observed across all predefined dose groups [2]. - The company plans to explore CT0596 in other plasma cell tumors and autoimmune diseases driven by autoreactive plasma cells [2]. Group 2 - The IND application for CT0596 is expected to be submitted in the second half of 2025 [2].

香港交易及結算所有限公司、香港聯合交易所有限公司及香港中央結算有限公司對本公告的內 容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任 何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 CARsgen Therapeutics Holdings Limited 科濟藥業控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2171） 自願公告 於2025年ASH年會上呈列的CT0596的研究成果更新 本公告由科濟藥業控股有限公司（「本公司」，連同其附屬公司及併表聯屬實體統 稱「本集團」或「科濟藥業」）自願作出，以告知本公司股東及潛在投資者本集團最 新業務更新。 本公司董事會（「董事會」）宣佈，CT0596（一種靶向BCMA的同種異體CAR-T細胞 候選產品）的初步結果已在第67屆美國血液學會（「ASH」）年會上進行報告。更多 詳情請參見本公司官網 www.carsgen.com 。 CT0596 IIT初步研究結果已於美國東部時間2025年12月6日下午5:30－下午 7:30，在第67屆ASH年會上進行壁報展示，標題為「CT0596（一種靶向BCMA 的同 ...

Core Insights - The Chinese medical insurance directory will undergo its largest expansion of innovative drugs in history starting January 1, 2026, adding 114 new drugs, including 50 class 1 innovative drugs, while removing 29 drugs that are either unavailable or can be replaced by better alternatives [1][9] - The new directory will increase the total number of drugs to 3,253, significantly enhancing coverage for key areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [1][9] - The inclusion of innovative drugs in the medical insurance directory reflects a strong commitment to support genuine innovation and differentiated innovation in the healthcare sector [1][9] Medical Insurance Directory Expansion - The new medical insurance directory will include 114 new drugs, with nearly 44% being class 1 innovative drugs, indicating a growing emphasis on innovative treatments [1][2] - The directory aims to balance the clinical value of innovative drugs, corporate profits, and the sustainability of the insurance fund, with a new commercial insurance directory established for high-cost innovative drugs [2][15] - The entry of innovative drugs into the medical insurance directory is seen as a critical step in making these treatments accessible to patients, thereby reducing their economic burden [13][23] Market Dynamics and Trends - The inclusion of innovative drugs in the medical insurance directory is expected to accelerate sales growth for these products, reshaping the business models of Chinese innovative drug companies [4][20] - Companies like Hengrui Medicine and Innovent Biologics have successfully included multiple innovative products in the new directory, indicating a trend of increasing market access for innovative therapies [4][5] - The commercial insurance directory, which includes 19 innovative drugs, aims to provide additional support for high-cost treatments, potentially lowering patient treatment costs significantly [15][18] Focus on Key Therapeutic Areas - The new directory emphasizes significant clinical value and urgent patient needs, particularly in oncology, with new drugs targeting various types of cancers being added [10][11] - The inclusion of drugs for rare diseases and conditions like severe asthma highlights a commitment to addressing critical healthcare challenges faced by patients [16][17] - The directory also includes innovative treatments for chronic conditions such as diabetes, further expanding access to essential therapies for a large patient population [8][12] Policy and Regulatory Environment - Recent reforms in drug approval and medical insurance payment systems have created a conducive environment for the development of innovative drugs in China [19][20] - The acceleration of drug review processes and the establishment of a more rigorous value assessment framework are expected to enhance the accessibility of innovative treatments [19][22] - The collaboration between policy and capital markets is crucial for fostering innovation and ensuring the sustainability of the healthcare system [21][22] Future Outlook - The successful implementation of the new medical insurance directory is anticipated to restore investor confidence in the innovative drug market, which has seen a slowdown in investment interest recently [18][21] - The ongoing development of commercial insurance options for innovative drugs is expected to play a significant role in expanding patient access and improving treatment outcomes [18][19] - The transition from merely making innovative drugs available to ensuring they are affordable and effective represents a significant shift in the Chinese healthcare landscape [23][24]

Core Insights - The 2025 National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory were announced, marking a significant development in the pharmaceutical industry [1][3][10] - A total of 114 new drugs were added to the National Medical Insurance Directory, including 50 innovative drugs, which is expected to enhance patient access and support sustainable investment in drug development [1][2][3] National Medical Insurance Directory - The 2025 National Medical Insurance Directory includes 114 new drugs, with 50 classified as innovative drugs, such as Tislelizumab and domestic ADC drugs [1][3] - Companies like Kelun-Biotech and Kangnuo have successfully included their innovative drugs in the directory, reflecting strong government support for domestic innovation [3][4] - The total number of drugs in the National Medical Insurance Directory has increased to 3,253, with significant improvements in coverage for critical areas like oncology and chronic diseases [5][6] Commercial Health Insurance Innovative Drug Directory - The newly introduced Commercial Health Insurance Innovative Drug Directory includes five CAR-T cell therapies and several high-cost drugs for rare diseases, enhancing accessibility for patients [1][6][8] - The directory allows innovative drug companies to explore new payment channels outside of traditional medical insurance, potentially increasing patient access to high-value therapies [11][12] - The pricing for drugs in the Commercial Health Insurance Directory is expected to be more flexible, allowing for negotiations between companies and insurers, which could lead to better affordability for patients [8][12] Industry Impact - The introduction of the Commercial Health Insurance Innovative Drug Directory is seen as a milestone for improving drug accessibility and affordability, particularly for high-cost therapies [7][9][12] - The past decade has witnessed significant growth in China's innovative drug sector, with the new directory marking a pivotal moment in the industry's evolution [10][11] - The dual-track payment framework established by the National Medical Insurance and Commercial Health Insurance is expected to foster a more robust ecosystem for drug research and application in China [12]

Core Insights - The Chinese medical insurance directory will undergo its largest expansion of innovative drugs in history starting January 1, 2026, adding 114 new drugs, including 50 class 1 innovative drugs, while removing 29 drugs that are either unavailable or can be replaced by better alternatives [1][2] - The total number of drugs in the directory will increase to 3,253, significantly enhancing coverage for key areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [1][2] - The inclusion of innovative drugs in the medical insurance directory reflects a strong commitment to support genuine innovation and differentiated innovation in the healthcare sector [1][2] Medical Insurance Directory Expansion - The new directory will include 114 drugs, with nearly 44% being class 1 innovative drugs, indicating a growing emphasis on innovative treatments [1][2] - The directory will enhance the insurance coverage for critical areas, improving access to necessary medications for patients [1][2] Innovative Drug Market Dynamics - The entry of innovative drugs into the medical insurance directory is a key driver for market growth, with those included typically experiencing rapid sales growth within a year [4] - Companies like Heng Rui Medicine and Innovent Biologics have successfully included multiple innovative products in the new directory, indicating a trend towards increased market access for innovative therapies [4][5] Clinical Needs and Treatment Options - The new directory addresses significant clinical needs, particularly in oncology, with new drugs targeting various types of cancers, thereby expanding treatment options for patients [9][10] - The inclusion of targeted therapies for conditions like severe asthma and breast cancer provides patients with more accessible and effective treatment options [6][10] Commercial Insurance Directory - The introduction of a commercial insurance directory for innovative drugs aims to balance clinical value, corporate profits, and the sustainability of insurance funds [2][12] - The commercial insurance directory includes 19 innovative drugs, highlighting a focus on high-value treatments that exceed basic insurance coverage [12][15] Policy and Regulatory Environment - Recent reforms in drug approval and medical insurance payment systems have created a conducive environment for the development of innovative drugs in China [17][18] - The acceleration of drug approvals and the establishment of a more rigorous evaluation system for innovative drugs are reshaping the landscape for pharmaceutical companies [17][18] Future Outlook - The ongoing expansion of the medical insurance directory signifies a shift towards making innovative drugs more accessible and affordable for the general population, enhancing overall healthcare outcomes [20][21] - The collaboration between policy, industry, and capital markets is essential for fostering high-quality development in the innovative drug sector [19][20]