记者丨韩璐 编辑丨陈晓平 一家上海抗癌药公司，管理层正式变更。 12月29日，药明巨诺官宣了新董事名单。田丰出任执行董事、行政总裁；董事刘诚升任为董事会主席。 田丰履新，已在两周多前预告，前任CEO刘敏，本月中旬已辞任，他主管运营才1年半左右。 "CAR-T疗法创新却昂贵，一直不在蓬勃周期。" 投资人陈瑜告诉《21CBR》记者，药明巨诺遇到的困境，在于CAR-T的产业环境，新管理层的任务将相当艰巨。 两度换帅 18个月内，田丰是药明巨诺第3位CEO。 他现年48岁，毕业于上海交大医学院，在生物制药工作超过20年。 在职业生涯早期，田丰多在跨国药企就职，曾是辉瑞制药资深国际产品经理，其后转至上海罗氏制药任市场总监，负责了多款肿瘤产品。 2019年后，他跳槽到恒瑞医药，担纲肿瘤事业部市场和医学事务负责人；三年后，出任上海经久生物科技CEO，负责中国区所有运营及战略规划，开始独 当一面。 田丰的上一份工作，在金赛药业任肿瘤事业部总经理，成功引进美适亚®，以前瞻性的准入策略纳入国家医保。 有知情人士向《21CBR》记者透露，上一轮更替，股东方讨论已久，市场有预期；此轮调整，事先未听到风声，相对突然。 药明巨诺一度是细 ...

今日（12月29日），科济药业宣布已向国家药监局提交通用型BCMA CAR-T产品CT0596的两项新药临床试验申请，拟分别启动针对复发/难治性多发性骨 髓瘤及原发性浆细胞白血病的Ib/Ⅱ期注册临床研究。 这是科济药业在通用型CAR-T细胞治疗研发进程中的又一重要进展。 01 "功能性治愈"突围之路 多发性骨髓瘤（MM）是血液系统第二大常见恶性肿瘤，随着人口老龄化，其发病率持续上升。尽管近年来蛋白酶体抑制剂、免疫调节剂以及抗CD38单 抗等靶向药物的陆续问世，显著延长了初治患者的生存期，推动了MM治疗格局的迭代，但该疾病仍被认为无法根治。绝大多数患者会经历多次复发，且 随着治疗线数后移，缓解期逐渐缩短，治疗选择日益匮乏。 当前，多发性骨髓瘤新药研发的核心目标是推动疾病达到更深层次的缓解，实现深度且持久的疾病缓解，对改善患者长期生存具有重要意义。CAR-T疗 法，因其有望实现更深、更持久的缓解，甚至推动疾病走向"功能性治愈"，被视为更具突破潜力的武器。与传统药物相比，CAR-T不仅能够高效清除肿瘤 细胞，还可能重建长期免疫记忆。 然而，现有自体CAR-T疗法仍存在明显瓶颈，例如，个性化制备周期长达数周甚至更久， ...

Investment Rating - The industry investment rating is maintained at "Overweight" [5] Core Insights - The management change at WuXi AppTec is seen as a strategic move to leverage the expertise of both commercial and technical leaders to navigate the evolving payment landscape for CAR-T therapies. The new CEO, Tian Feng, brings over 20 years of experience in oncology commercialization, while the new chairman, Dr. Liu Cheng, is a leading scientist in the CAR-T field [5][7] - The establishment of the first national commercial health insurance innovation drug directory marks a significant shift in China's multi-tiered payment system, providing new payment channels for high-cost therapies like CAR-T. This policy change indicates a transition in market focus from "technical validation" to "payment capability and market access" [7] - The management aims to capitalize on this policy window by enhancing collaborations with insurance companies and optimizing costs, such as reducing core material costs by over 90% through self-developed lentiviral vectors. This strategic adjustment signals a broader industry shift from research-driven to a dual focus on research and commercialization [7] Summary by Sections Recent Industry Performance - The industry has shown relative returns of -3.06% over the past month, -9.84% over the past three months, and -7.91% over the past year compared to the CSI 300 index. Absolute returns were 0.49% for the last month, -7.88% for the last three months, and 9.5% for the last year [3] Management Changes - WuXi AppTec announced significant changes in its core management team, appointing Tian Feng as the new CEO and Dr. Liu Cheng as the chairman. This change is crucial as the company seeks to enhance its market performance amid evolving industry challenges [5][7] Investment Recommendations - The report suggests focusing on companies within the A-share market that have a strong position in the cell therapy industry, such as WuXi AppTec, Fosun Pharma, and others, due to the anticipated opportunities arising from the breakthrough in CAR-T therapy payment bottlenecks [7]

医药周报 20251221 In Vivo CAR-T 国内外进展大 医药行情回顾&分析&近期判断 > 1) 行情回顾：当周（12.15-12.19）医药生物指数环比-0.14%，跑赢创业板指数和沪深 300 指数, 在所有行业中，当周（12.15-12.19）医药涨跌幅排在第 18 位, V 型走势。周度结构上看, 蚂蚁阿 福、"搞赏经济"主题等相关标的表现较好，周五表现更为强势，CXO、小核酸、部分创新药和 AI 创 新药相对较好。医药成交总额 3898.24 亿元，沪深总成交额为 86901.56 亿元，医药成交额占比沪深 总成交额比例为 4.49%（2013 年以来成交额均值为 7.12%）。 2）原因分析：医药近期暂未有较大的产业催化，板块贝塔效应不明显，但经过一段时间消化，很多 标的进入价值区间，或潜在具备一定的反攻可能，这期间结构性热度会逐步提升。本周蚂蚁阿福带 动相关个股演绎：一类是阿里的持股相关医药公司，一类阿福可能引流的公司（渠道如部分药店、 部分消费端器械、检测服务、药品等 ) ，一类是有数据沉淀未来潜在可能对标公司。全市场 "椅赏经 济"也影射了医药中部分公司，如部分药店。周五医药表现 ...

Core Insights - The 2025 National Medical Insurance Drug List has been officially released, adding 114 new drugs, including 50 innovative Class 1 drugs, with a negotiation success rate of 88%, the highest in seven years [1][3] - The first version of the commercial insurance innovative drug list has been introduced, featuring 5 CAR-T cell therapies and 19 high-priced innovative drugs, marking a significant expansion in coverage [1][5] - The adjustment reflects a strategic upgrade in China's medical insurance from "basic coverage" to "basic + high-end coverage," addressing the demand for accessible and affordable innovative drugs [1][9] Drug Additions and Market Impact - The new drug list includes 114 drugs, with 44% being Class 1 innovative drugs, and a total of 3,253 drugs now covered under the insurance [3] - Notable winners include Heng Rui Pharma, which secured 20 new drug approvals, and Eli Lilly, whose drug Tirzepatide has entered the Chinese market, benefiting 140 million diabetes patients [3][4] - The inclusion of CAR-T therapies in the commercial insurance list allows for reimbursement of high-cost treatments, which were previously inaccessible to many patients [5][7] Innovations in Treatment - The new list includes significant advancements in treatments for Alzheimer's disease, with two new drugs targeting amyloid beta accumulation, providing options for over 10 million patients in China [7] - The addition of 13 rare disease drugs fills coverage gaps in four rare disease areas, expanding the total number of rare disease drugs covered to approximately 100 [8] - The adjustment also emphasizes pediatric medications, with a separate review channel for children's formulations, indicating a positive shift in addressing children's healthcare needs [9] Strategic Implications - The 2025 adjustment signifies a shift towards a dual-track medical payment system in China, combining basic medical insurance with commercial insurance to meet both fundamental and advanced healthcare needs [9] - The rapid inclusion of innovative drugs into the insurance system reflects a decade of progress in China's pharmaceutical landscape, transitioning from rare domestic innovations to a robust pipeline of new therapies [9]

香港交易及結算所有限公司及香港聯合交易所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，概不對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。 Genscript Biotech Corporation （於開曼群島註冊成立的有限公司） （股份代號：1548） 自願性公告 傳奇宣佈於2025年ASH年會上公佈報告 本自願性公告由金斯瑞生物科技股份有限公司（「本公司」）作出。 本公司董事會（「董事會」）欣然宣佈，傳奇生物科技股份有限公司（「傳奇」，為本公司聯 營公司，其股份以美國存託股份形式於美國納斯達克全球精選市場上市）於2025年12月6日（紐 約時間）發佈新聞稿宣佈於2025年美國血液學會（「美國血液學會」）年會上通過一項口頭報 告公佈了CARVYKTI®（西達基奧侖賽，cilta-cel）在復發或難治性多發性骨髓瘤（RRMM）患 者中開展的CARTITUDE-1和CARTITUDE-4研究長期隨訪的臨床及轉化研究數據，以及III期研 究CARTITUDE-4的最新結果，還通過六項壁報展示了CARVYKTI®在不同亞組中的緩解持久性 數據及 ...

- The provided content does not include any quantitative models or factors, nor their construction, evaluation, or backtesting results[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]

Core Viewpoint - The stock of Kaineng Health reached a daily limit increase, closing at 8.48 yuan, driven by strategic moves in the cell therapy sector and strong financial performance [1][3] Group 1: Company Developments - Kaineng Health accelerated its strategic layout in the cell therapy field by establishing a subsidiary with a registered capital of 1 billion yuan, leveraging the policy advantages of Hainan's medical pilot zone to create a second growth curve [1] - The company continues to implement a high cash dividend strategy, with a projected dividend payout ratio of 67%-70% of net profit by mid-2025, enhancing market expectations regarding its cash flow [1] - The company reported steady growth in performance, with a 7.23% year-on-year increase in revenue and a 24.82% increase in net profit excluding non-recurring items for the first half of 2025, indicating improved profitability in its main business [1] Group 2: Market Performance - On November 12, 2025, Kaineng Health's stock saw a net inflow of 173 million yuan from main funds, accounting for 17.48% of total trading volume, while retail investors experienced a net outflow of 79.04 million yuan [1] - The stock is part of a broader trend, with related sectors such as stem cells, CAR-T therapy, and gene sequencing seeing respective increases of 2.96%, 1.72%, and 1.41% on the same day, indicating significant sectoral momentum [3]

Core Insights - The National Medical Insurance Negotiation concluded on November 4, with 120 companies participating, involving 127 off-list drugs and 24 drugs for commercial insurance innovation [1] Group 1: Introduction of Commercial Health Insurance Innovation Drug Directory - The "Commercial Health Insurance Innovation Drug Directory" was introduced for the first time this year, building on the existing medical insurance directory adjustment mechanism [2] - A total of 121 drug names passed the formal review for the commercial health insurance innovation drug directory, with 79 drugs applying for both the basic medical insurance and the commercial health insurance directories [2] Group 2: CAR-T Therapy and Pricing Negotiations - The high-priced CAR-T therapies are highlighted as a significant focus in the commercial health insurance innovation drug directory [4] - Five CAR-T therapies have passed the formal review for the commercial insurance directory, with three also applying for the basic medical insurance directory [5] - The only CAR-T therapy priced below one million yuan is the one from Huyuan Biotechnology, priced at 999,000 yuan per injection, and negotiations for this therapy have reportedly gone smoothly [5][6] Group 3: Market Dynamics and Future Implementation - The introduction of the commercial health insurance innovation drug directory is seen as a key step to break the payment deadlock, potentially lowering patient out-of-pocket expenses and expanding the patient population [6] - The new basic medical insurance drug directory and the first commercial health insurance innovation drug directory are expected to be released in early December, with implementation starting on January 1 of the following year [6]

Core Viewpoint - The introduction of the commercial insurance innovative drug directory marks a historic shift in the accessibility and affordability of CAR-T therapies in China, potentially reducing patient out-of-pocket costs from millions to approximately 40,000 yuan [1][4]. Group 1: CAR-T Therapy Overview - CAR-T therapy represents a significant breakthrough in cell immunotherapy, offering new hope for patients with hematological malignancies [2]. - The production of CAR-T therapies is highly complex and individualized, leading to high costs that are difficult to reduce in the short term [2]. Group 2: Commercial Insurance Innovative Drug Directory - The establishment of the commercial insurance innovative drug directory is a precise institutional innovation by the National Medical Insurance Administration, allowing high-value innovative drugs to be covered outside the basic medical insurance framework [1][4]. - The new directory is set to be released in December and will take effect on January 1, 2025 [1]. Group 3: Price Negotiation and Accessibility - Five CAR-T products have passed the formal review for inclusion in the commercial insurance directory, with expected patient costs significantly reduced [4]. - The price negotiation process has introduced a tripartite mechanism involving the National Medical Insurance Administration, commercial insurance companies, and pharmaceutical companies, enhancing collaboration in pricing discussions [7]. Group 4: Market Impact and Future Directions - The introduction of the commercial insurance directory is expected to open up substantial market opportunities for commercial health insurance, with a projected premium scale of approximately 977.4 billion yuan in 2024 [8]. - Successful local pilot programs, such as Shanghai's "Hu Hui Bao," have demonstrated the potential for effective reimbursement and integration of commercial insurance with medical services [8].