Core Insights - The emerging autologous CAR-T therapy significantly reduces costs compared to traditional CAR-T therapies, which can exceed hundreds of thousands of yuan, but it faces high technical barriers [1][4]. Industry Developments - AbbVie announced a $2.1 billion acquisition of Capstan Therapeutics to expand its product line in autoimmune disease therapies, marking the highest transaction record in the cell therapy sector for 2025 [1]. - CloudTop New Horizon (01952.HK) reported advancements in its autologous CAR-T projects, which utilize a proprietary targeted LNP (tLNP) system for treating tumors and autoimmune diseases, achieving effective tumor cell clearance in humanized mouse models and validating T cell transfection in non-human primate models [1]. Advantages of Autologous CAR-T Therapy - Compared to traditional CAR-T therapies, autologous CAR-T therapy offers multiple advantages, including large-scale production capabilities, no need for lymphodepleting chemotherapy prior to treatment, predictable pharmacokinetics/pharmacodynamics, adjustable dosing, and better overall quality control [4]. - The mRNA technology in autologous CAR-T therapy allows for a shift from "molecular screening" to "information design," enabling the body to produce its own drugs, thus marking a new era in biopharmaceuticals [4]. Cost Reduction Potential - The core advantage of in vivo CAR-T cell manufacturing lies in significantly simplifying the process and reducing costs, potentially lowering the cost of a single treatment by an order of magnitude compared to currently commercialized CAR-T therapies [4]. Challenges in Autologous CAR-T Therapy - The main challenge for autologous CAR-T therapy is the precise, efficient, and safe delivery of CAR-T constructs to target T cells [5]. - Two primary technical routes have emerged: lentiviral vectors and RNA delivery. Lentiviral vectors can achieve permanent CAR expression but may lack targeting precision, while RNA delivery offers higher safety but only transient CAR protein synthesis [5]. - The high technical barriers in autologous CAR-T technology limit participation to a few companies, requiring proprietary cationic lipids and stringent delivery technology to target spleen and peripheral T cells while avoiding safety risks associated with liver expression [5].

Group 1 - The core viewpoint of the news highlights the recent stock performance of CloudTop New Horizon (01952.HK), which closed at HKD 67.000, a slight decrease of 0.15% from the previous trading day, with an intraday high of HKD 69.800, marking a new high in nearly a year [1] - The company experienced a net outflow of HKD 37.6499 million in capital on the day, with unspecified amounts flowing in and out [1] Group 2 - CloudTop New Horizon Limited is a Hong Kong-listed biopharmaceutical company focused on the research, clinical development, manufacturing, and commercialization of innovative drugs and vaccines, aiming to meet unmet medical needs in Greater China and other Asian markets [2] - The management team possesses extensive expertise and experience in high-quality research and development, clinical development, regulatory affairs, chemical manufacturing and control (CMC), business development, operations, and commercialization within the pharmaceutical industry [2] - The company has established a portfolio of globally first-in-class or best-in-class drugs and vaccines in areas such as nephrology, mRNA platforms, infectious and communicable diseases, and autoimmune diseases [2] - CloudTop New Horizon initiated commercial listing in 2021 and is building a professional and efficient commercialization team to accelerate product commercialization in Greater China and other Asia-Pacific markets [2] - The company is committed to becoming a leading biopharmaceutical company in Asia, focusing on the development and commercialization of innovative drugs and vaccines to meet the growing medical needs in China and globally, with a mission to enhance human health and well-being [2]

Investment Rating - The industry investment rating is "Positive" (maintained) [2] Core Insights - The report highlights the acquisition of Capstan Therapeutics by AbbVie for up to $2.1 billion, focusing on in vivo CAR-T therapy development [6][15] - The report emphasizes the growing interest and investment in in vivo CAR-T technology, with multiple companies actively pursuing diverse delivery systems [7][26] - The pharmaceutical and biotechnology sector saw a weekly increase of 3.64%, outperforming the CSI 300 index by 2.1 percentage points, ranking 4th among 31 sub-industries [8][31] Summary by Sections 1. AbbVie Acquisition of Capstan - AbbVie announced the acquisition of Capstan Therapeutics for a maximum of $2.1 billion, focusing on in vivo CAR-T therapies [6][15] - Capstan's main asset, CPTX2309, is an RNA delivery candidate for anti-CD19 CAR-T therapy, currently in Phase I clinical trials [15][20] 2. MNC's Active Layout in In Vivo CAR-T Technology - MNC has been actively investing in in vivo CAR-T technology through collaborations and acquisitions, focusing on both lentiviral and lipid nanoparticle delivery systems [7][26] - The report notes that over 20 disclosed mRNA technology projects in in vivo CAR-T are primarily concentrated in the lipid nanoparticle direction [22][30] 3. Weekly Performance of the Pharmaceutical Sector - The pharmaceutical sector increased by 3.64% in the first week of July, outperforming the CSI 300 index [31] - Among sub-sectors, other biological products saw the highest increase of 8.28%, while medical equipment experienced the largest decline of 0.21% [35][36] 4. Recommended Stocks - Recommended stocks include major pharmaceutical and biotechnology companies such as Heng Rui Medicine, East China Medicine, and others [9]

Core Viewpoint - The company, Ginkgo Bioworks, is balancing operational sustainability with future growth through a dual strategy of "licensing in + independent research and development" to drive innovation and revenue generation [1][2]. Group 1: Business Strategy - Ginkgo Bioworks has achieved stable cash flow through the introduction of large commercial products while focusing on cutting-edge mRNA therapies, resulting in the development of key products such as EVM14, EVM16, and CAR-T [1][3]. - The company has established a comprehensive technology platform that includes antigen design, mRNA sequence optimization, lipid nanoparticle delivery technology, and industrial production capabilities, making it one of the few companies with end-to-end capabilities in the industry [3][6]. Group 2: Financial Performance - Financial data indicates that Ginkgo Bioworks expects to generate revenue of 707 million yuan in 2024, representing a year-on-year increase of 461%, driven by three commercialized products [3]. - The company aims to achieve sales of 10 billion yuan by 2030, leveraging its existing product portfolio [3]. Group 3: Competitive Advantage - Ginkgo Bioworks possesses a proprietary lipid library of over 500 types, which supports various projects including vaccines and CAR-T therapies [5][6]. - The company has developed an AI algorithm for efficient antigen sequence design, with its algorithm system now in its third generation, and has established a lipid nanoparticle delivery technology platform with patent protections [6]. Group 4: Market Position - Major pharmaceutical companies like AbbVie, Eli Lilly, Johnson & Johnson, and AstraZeneca are investing in mRNA therapies and CAR-T technologies, indicating a competitive landscape [4]. - Ginkgo Bioworks is one of the few domestic companies capable of full-process localized production of mRNA therapy drugs, enhancing its market position [6].

Group 1 - BioNTech's research on mRNA neoantigen vaccines shows potential in treating pancreatic cancer by inducing long-lived CD8+ T cell responses, offering new hope for cancer immunotherapy [1] - The challenge of tumor recurrence and metastasis remains significant in clinical treatment, highlighting the importance of mRNA technology in immune response [1] - Cloud Health's CEO discusses how mRNA technology stimulates T and B cells to create specific immune responses against tumor cells, forming immune memory to reduce recurrence risk [1] Group 2 - mRNA technology shifts drug development from "molecular screening" to "information design," transforming the human body into a smart factory for protein drug production [2] - Despite its advantages, the delivery system poses a major barrier for mRNA technology, as synthesized mRNA is prone to degradation when entering the human body [2] - Cloud Health has made breakthroughs in delivery technology, establishing a proprietary LNP (lipid nanoparticle) delivery platform with patents in ionizable and stealth lipids [2] Group 3 - The third-generation AI algorithm significantly enhances target protein expression levels, enabling Cloud Health to advance mRNA tumor drug development [3] - EVM16 is Cloud Health's first personalized mRNA tumor vaccine entering clinical stages, with the first patient dosing completed in March 2025 [3] - EVM14 is a universal therapeutic vaccine targeting five tumor-related antigens, intended for the treatment of squamous cell carcinoma [3]

Investment Rating - The report assigns a "Buy" rating to the company, with a target price of HKD 72.50, indicating a potential upside of 16.6% from the current closing price of HKD 62.20 [1][27]. Core Insights - The mRNA platform development is progressing steadily, with excellent data on the reversible BTK inhibitor for membranous nephropathy. The target price has been raised to reflect these developments [2][6]. - The company has showcased its fully integrated and localized AI + mRNA platform, highlighting several mRNA tumor drug developments, including personalized and universal therapeutic vaccines [6]. - The reversible BTK inhibitor EVER001 has shown promising results in clinical trials for treating membranous nephropathy, with significant reductions in anti-PLA2R antibody levels and urinary protein levels [6]. Financial Overview - Revenue projections for the company are as follows: - 2023: RMB 126 million - 2024: RMB 707 million - 2025E: RMB 1,660 million - 2026E: RMB 2,552 million - 2027E: RMB 3,752 million - Year-on-year growth rates are projected at 884.5% for 2023, 461.2% for 2024, and 134.9% for 2025 [5][28]. - The net profit (loss) is expected to improve from a loss of RMB 844 million in 2023 to a profit of RMB 743 million by 2027 [5][28]. - The company’s market capitalization is approximately HKD 20.2 billion, with an average daily trading volume of 13.36 million shares [3]. Valuation Metrics - The report indicates a peak sales estimate for EVER001 exceeding RMB 1.5 billion, with a target valuation of HKD 72.50 corresponding to a market cap of HKD 237 billion and a price-to-sales ratio of 1.8 times at peak revenue [6][24]. - The company’s financial forecasts have been adjusted, reflecting a more cautious outlook on product revenue ramp-up, with slight downward revisions in revenue estimates for 2025-2027 [6][23].

Core Viewpoint - CICC maintains the profit forecast for CloudTop New Horizon (01952) for 2025 and 2026, adjusting the target price by 14.3% to HKD 80.0, indicating a potential upside of 28.6% from the current stock price [1] Company Status - On June 27, CloudTop New Horizon held an mRNA innovation technology platform R&D day, showcasing three core product lines: the universal on-demand therapeutic vaccine EVM14, the personalized therapeutic vaccine EVM16, and the autologous CAR-T project. The company has established extensive contacts with global top 20 pharmaceutical companies, focusing on leveraging international partnerships to promote the global layout of innovative drugs [2] Complete mRNA R&D and Production Platform - The company has successfully built a comprehensive mRNA platform covering antigen design, algorithm optimization, LNP delivery systems, CMC process development, and GMP industrial production. Key patents include: 1) self-developed third-generation AI algorithm optimization, significantly enhancing target protein expression; 2) proprietary LNP delivery platform with over 500 internal lipid types, capable of liver and extrahepatic delivery, supporting both "passive" and "active" targeting strategies; 3) two major bases in Zhangjiang and Jiashan ensuring process development and industrial production [3] Project Progress - EVM16: Utilizes the company's self-developed EVER-NEO-01 "MiaoSuan" AI algorithm system to identify patient-specific tumor cell mutations and design mRNA vaccines encoding dozens of new tumor antigens. Preclinical data indicates good safety and strong immunogenicity, with IIT research completing the first patient dosing in March this year [4] - EVM14: A universal on-demand therapeutic bivalent vaccine targeting five tumor-related antigens, intended for squamous cell carcinoma, including non-small cell lung cancer and head and neck cancer. Preclinical data shows EVM14 can induce a strong immune response and can be combined with IO drugs to enhance anti-tumor activity, with FDA approval for clinical trials obtained in March [4] - Autologous CAR-T: Developed based on the proprietary LNP (tLNP) system, demonstrating efficient T cell transfection, CAR expression, and B cell clearance effects in monkey models [4]

Core Insights - The National Healthcare Security Administration and the National Health Commission issued measures to support the high-quality development of innovative drugs, focusing on the entire chain from research and development to payment systems [1] - The inclusion of innovative drug directories in commercial health insurance is expected to enhance the multi-tiered medical security system and provide economic support for the development of innovative drugs [1][2] - The stock market reacted positively, with significant gains in innovative drug concept stocks and ETFs, indicating strong investor interest and liquidity in this sector [1][2] Industry Developments - The establishment of a commercial insurance innovative drug directory marks a significant step in enhancing the role of commercial insurance in the multi-tiered medical security system, providing payment support for high-priced innovative drugs and medical devices [2] - The "18A" policy has catalyzed a wave of medical companies listing in Hong Kong, focusing on cutting-edge medical industry directions, which has attracted market attention and investment [2] Market Performance - The Hong Kong innovative drug ETF (513120) saw a rise of over 2%, with a trading volume of 4.1 billion yuan, leading the market in the pharmaceutical ETF category [1] - The latest scale of the Hong Kong innovative drug ETF reached 13.4 billion yuan, indicating its leading position in the market [1] - The innovative drug ETF (515120) also performed well, with a trading volume of 145 million yuan and a net inflow of nearly 200 million yuan over five consecutive days [1]

Core Viewpoint - CloudTop New Horizon (HK01952) has seen a significant stock price increase of 28.6% over the past seven trading days, driven by the presentation of its mRNA technology platform and three products targeting autoimmune diseases at a recent R&D event [1][2]. Company Developments - The company showcased its mRNA technology platform, including the universal tumor therapeutic vaccine EVM14, personalized tumor therapeutic vaccine EVM16, and autologous CAR-T project [1][3]. - EVM14 is set to begin a global multi-center Phase I clinical trial (EVM14 C101), with the first patient expected to be enrolled by Q3 2025 [1][3]. - EVM16 has shown efficacy in mouse melanoma models and is the company's first personalized mRNA tumor vaccine to enter clinical stages, with initial patient dosing expected to be completed by March 2025 [3][4]. Business Strategy - The CEO emphasized a selective business development strategy, focusing on leveraging international partnerships to enhance the global footprint of innovative drugs [1][4]. - The company aims to utilize its mRNA technology platform for developing both preventive and therapeutic mRNA products, with a focus on therapeutic vaccines [2][4]. Market Position - CloudTop New Horizon's mRNA platform has become a focal point for international pharmaceutical companies, potentially accelerating the commercialization of its products [4][7]. - The company has established a comprehensive industry chain platform that includes antigen design, sequence optimization, delivery systems, and large-scale production capabilities [7][8]. Industry Context - The global mRNA tumor vaccine market is projected to reach $21 billion by 2035, with the domestic market expected to reach 10 billion RMB [7]. - Compared to international leaders like BioNTech and Moderna, which have advanced their mRNA tumor vaccine pipelines to Phase II and III clinical trials, CloudTop New Horizon is still in the early stages of development [5][6]. Technical Challenges - Efficient delivery systems remain a significant bottleneck for mRNA vaccines, with limited suppliers for lipid nanoparticles (LNP) and ongoing patent disputes hindering development [8]. - CloudTop New Horizon has developed its proprietary LNP delivery technology, with a rich internal lipid library exceeding 500 types to meet the needs of various projects [8].

Core Viewpoint - The article highlights the rapid growth of China's innovative pharmaceutical companies, particularly in the context of supportive government policies and the increasing commercialization of their products, exemplified by the strategic shift of CloudTop New Horizon towards self-developed mRNA technology and its potential for global expansion [1][12]. Group 1: Policy Support and Market Dynamics - Recent government policies, including the State Council's approval of the "Full Chain Support for Innovative Drug Development Implementation Plan," have significantly boosted the innovative drug sector in China [1]. - In Q1 2025, the "License-out" transaction amount for Chinese innovative drugs reached $36.929 billion, indicating a surge in outbound transactions [1]. Group 2: CloudTop New Horizon's Strategic Shift - CloudTop New Horizon is transitioning from a "License-in" model to a self-developed innovative drug company, marking a significant strategic transformation [1][12]. - The company will hold its first mRNA technology platform R&D day on June 27, showcasing its self-research capabilities and signaling a potential value release [1]. Group 3: Commercialization and Revenue Projections - CloudTop New Horizon has successfully commercialized several key products, including Nefukang® and Yijia®, with projected sales reaching 10 billion yuan by 2030 [2][3]. - Nefukang® has seen a significant increase in sales following its inclusion in the medical insurance system, with expectations for revenue to double in the second half of the year [3][4]. Group 4: Product Pipeline and Market Potential - The company anticipates that Nefukang® could achieve peak sales of 5 billion yuan, while Yijia® is expected to reach similar sales figures due to its potential in the ulcerative colitis market [4][5][6]. - CloudTop New Horizon's product matrix, including Nefukang®, Yijia®, and the pipeline product Cefepime-Tazobactam, is projected to exceed 10 billion yuan in sales by 2030 [6]. Group 5: mRNA Platform Development - The mRNA platform is gaining attention from multinational pharmaceutical companies, with potential business development (BD) collaborations on the horizon [7][12]. - The company has developed a diverse pipeline within its mRNA platform, including personalized tumor therapeutic vaccines and CAR-T therapies, which are expected to attract further investment and partnerships [8][9]. Group 6: EVER001 Clinical Data and Global Expansion - EVER001, a new generation covalent reversible BTK inhibitor, has shown promising clinical data, with plans for global development and potential overseas licensing agreements [10][12]. - The positive clinical results for EVER001 in treating primary membranous nephropathy have garnered interest from multiple multinational pharmaceutical companies, indicating a strong market potential [11][12].