NASDAQ:ANIX March 10, 2026 Forward-Looking Statements Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa Biosciences' current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to iden ...

Core Viewpoint - Gilead Sciences has agreed to acquire Arcellx for $115 per share in cash, with potential additional contingent payments of up to $5 per share, implying a total value of $7.8 billion for the deal, aimed at gaining full control of the BCMA CAR-T therapy anito-cel for multiple myeloma, with an FDA PDUFA date set for December 23, 2026 [1] Summary by Category - **Acquisition Details** - Gilead Sciences will pay $115 in cash per share for Arcellx [1] - There is a potential for additional contingent payments of up to $5 per share [1] - The total implied value of the acquisition is $7.8 billion [1] - **Product Information** - The acquisition includes full control of the BCMA CAR-T therapy anito-cel [1] - The FDA PDUFA date for anito-cel is December 23, 2026 [1]

Core Viewpoint - The announcement indicates that the SYS6055 injection developed by the company has received approval from the National Medical Products Administration (NMPA) of China to conduct clinical trials, marking it as the first domestically approved in vivo CAR-T product for clinical use [1]. Group 1: Product Details - SYS6055 is designed to generate CAR-T cells targeting CD19 directly in vivo using a lentiviral vector, which allows for specific recognition and elimination of target cells [1]. - Compared to traditional CAR-T products, SYS6055 has potential advantages in terms of cost, accessibility, and immediacy [1]. - Preclinical studies have shown that SYS6055 can specifically generate CAR-T cells in vivo, demonstrating significant anti-tumor effects and good safety profiles [1]. Group 2: Clinical Applications - The approved clinical indication for SYS6055 is for the treatment of relapsed/refractory aggressive B-cell lymphoma [1]. - The product also has potential applications for treating other CD19-positive B-cell malignancies and autoimmune diseases, indicating high clinical development value [1].

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has undergone a management change with Tian Feng appointed as the new CEO, following the resignation of Liu Min, who served for only 1.5 years. This change comes as the company faces significant challenges in commercializing its CAR-T therapy product, Benauda, which has seen a decline in market performance despite being a once-promising player in the cell therapy sector [2][5][9]. Management Changes - Tian Feng has been appointed as the new CEO and Executive Director, while Liu Cheng has been promoted to Chairman of the Board. This marks the third CEO change in 18 months for WuXi Biologics [2][5]. - Tian Feng, aged 48, has over 20 years of experience in the biopharmaceutical industry, having previously held senior positions at multinational pharmaceutical companies and successfully introduced products into the national medical insurance system [5][8]. - Liu Cheng, the new Chairman, is a seasoned technical expert with over 300 patents and significant experience in CAR-T technology, although he will not be involved in daily operations [8][9]. Product and Market Challenges - WuXi Biologics' core product, Benauda, has been included in the first batch of commercial insurance innovative drug directories, which may lead to a price reduction from 1 million RMB to around 100,000 RMB per injection [4][9]. - The company has faced substantial losses, with annual losses ranging from 600 million to 800 million RMB since 2021, totaling approximately 3 billion RMB over five years, leading to a significant drop in market capitalization [9][19]. - Benauda, approved in 2021, has only benefited around 600 patients, with total sales exceeding 600 million RMB, but the high costs of research and commercialization have made it difficult for the company to sustain operations [11][19]. Financial and Operational Strategies - The company has implemented cost-cutting measures, reducing its workforce from 534 to 281 employees and decreasing operational expenses by 20-40% in various departments [24][26]. - WuXi Biologics aims to lower production costs by promoting domestic sourcing of raw materials and expanding its research pipeline to explore new opportunities [20][22]. - The company has made progress in the blood cancer field and is advancing research in solid tumors, while also securing multiple technology agreements that could generate significant revenue [22]. Future Outlook - The CAR-T therapy market in China is projected to grow from 200 million RMB in 2021 to 8 billion RMB by 2025, with expectations of reaching 28.9 billion RMB by 2030, although achieving these targets may be challenging [15][19]. - The new management team, led by Tian Feng, is tasked with navigating through the current difficulties and positioning the company for future growth and potential capital injections [26].

Core Insights - Kogei Pharmaceuticals has submitted two new drug clinical trial applications for its universal BCMA CAR-T product CT0596 to the National Medical Products Administration, targeting relapsed/refractory multiple myeloma and primary plasma cell leukemia [1][17][22] - The development of universal CAR-T therapies is seen as a significant advancement in the treatment of multiple myeloma, which remains incurable despite recent therapeutic advancements [2][19] - CT0596 is developed on the THANK-u Plus platform, which enhances the product's durability and safety by gene editing to reduce the risk of graft-versus-host disease and immune rejection [4][21] Group 1: Clinical Development - CT0596 has shown promising preliminary efficacy and safety in early human studies, with 6 out of 8 patients achieving partial response or better, and no severe adverse events reported [4][21] - The submission of clinical trial applications marks the entry of CT0596 into the registration clinical development phase, potentially providing new treatment options for patients with R/R MM and pPCL [5][22] - Kogei plans to explore CT0596's application in other plasma cell tumors and plasma cell-driven autoimmune diseases [5][22] Group 2: Technological Advancements - The THANK-u Plus platform allows for immediate use and mass production of CAR-T cells, significantly reducing treatment costs compared to autologous CAR-T therapies [3][20] - Kogei has developed a robust pipeline of universal CAR-T products targeting various malignancies, including blood cancers and solid tumors, leveraging the advantages of the THANK-u Plus platform [6][23] Group 3: Market Position and Future Directions - Kogei's self-developed CAR-T product, Sazekai (Zewokaiolun), has been approved for use in relapsed or refractory multiple myeloma, with significant market penetration across over 20 provinces in China [29] - The company is actively pursuing partnerships to enhance the development and commercialization of its universal CAR-T products in mainland China [28][29] - The competitive landscape for CAR-T therapies is intensifying, with multiple companies exploring dual-target strategies and innovative delivery methods to improve patient outcomes [14][30]

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]

Group 1: Market Overview - The pharmaceutical and biotechnology index decreased by 0.14% from December 15 to December 19, outperforming the ChiNext and CSI 300 indices [1][23] - The total trading volume in the pharmaceutical sector was 389.82 billion yuan, accounting for 4.49% of the total trading volume in the Shanghai and Shenzhen markets, which is below the average of 7.12% since 2013 [1][38] - The pharmaceutical sector ranked 18th in terms of weekly performance among all industries during the same period [1][25] Group 2: Sector Analysis - The recent lack of significant industrial catalysts has led to a muted beta effect in the sector, but many stocks have entered a value range, indicating potential for a rebound [2][59] - The "reward economy" theme has positively influenced certain pharmaceutical companies, particularly those linked to Ant Group and related retail channels [2][59] - Strong performance was noted in CXO, small nucleic acids, and certain innovative drugs, driven by specific stock factors such as BD expectations and overseas mapping [2][59] Group 3: In Vivo CAR-T Developments - In vivo CAR-T technology is expected to address the accessibility issues of CAR-T therapies, potentially lowering treatment costs and making it available as a shelf product [4][12] - Major pharmaceutical companies are actively investing in in vivo CAR-T, with business development (BD) transactions exceeding 5 billion USD, indicating its strategic importance [4][16] - Clinical data presented at the 2025 ASH meeting showed promising results for in vivo CAR-T therapies, with high rates of minimal residual disease (MRD) negativity in patients [4][19] Group 4: Future Outlook - The company maintains a positive outlook on innovation, international expansion, and turnaround opportunities in the pharmaceutical sector, focusing on BD 2.0, small nucleic acids, and supply chains as key investment areas [3][22] - The upcoming 2026 potential catalysts include the publication of the commercial insurance innovation drug directory and the commercialization of targeted CAR-T therapies [21][22] - Domestic companies are rapidly advancing in the in vivo CAR-T space, with several candidates in early clinical stages, indicating a growing competitive landscape [22][22]

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 ...

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