思路迪医药股份(01244)发布公告，思路迪医药于2025年8月20日与楷拓生物订立战略合作框架协议。 思路迪医药目前已建立起拥有全球自主知识产权的mRNA技术平台及LNP递送系统平台。该mRNA技术 平台是基于目前先进的AI技术构建的多模块肿瘤疫苗分析平台(3D-PreciseAg)，可支持海量抗原多组学 分析以及优选肿瘤抗原。同时拥有自主知识产权的AI加强型LNP递送技术平台，可通过AI智能算法对数 千种化合物进行筛选，最终合成多种可覆盖不同递送场景的LNP产品，提升mRNA肿瘤疫苗、in vivo CAR-T/NK免疫细胞治疗等药物的递送效率和靶向性，同时显著降低毒性。 根据该协议，双方将基于思路迪医药的自研具有自有知识产权的AI+mRNA研发平台和脂质体递送系统 (3D-LNP)，与楷拓生物的mRNA规模化生产优势和经验，深化靶向LNP递送(tLNP)、肿瘤疫苗、in vivo CAR-T/NK等领域的合作。具体实施将依据后续正式协议落实。此次合作标志着思路迪医药正不断加速 布局mRNA领域研究，为基于mRNA-LNP技术的创新疗法产品后续临床开发以及未来商业化提供坚实的 产能保障。 ...

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。 3D Medicines Inc. 思路迪医药股份有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1244） 本公司欣然宣布，思路迪醫藥於2025年8月20日與楷拓生物訂立戰略合作框架協 議（「該協議」）。 根據該協議，雙方將基於思路迪醫藥的自研具有自有知識產權的AI+mRNA研發 平台和脂質體遞送系統(3D-LNP)，與楷拓生物的mRNA規模化生產優勢和經驗， 深化靶向LNP遞送(tLNP)、腫瘤疫苗、in vivo CAR-T/NK等領域的合作。具體實 施將依據後續正式協議落實。此次合作標誌着思路迪醫藥正不斷加速布局mRNA 領域研究，為基於mRNA-LNP技術的創新療法產品後續臨床開發以及未來商業化 提供堅實的產能保障。 思路迪醫藥目前已建立起擁有全球自主知識產權的mRNA技術平台及LNP遞送系 統平台。該mRNA技術平台是基於目前先進的AI技術構建的多模塊腫瘤疫苗分析 平台(3D-Pre ...

Core Viewpoint - CloudTop New Horizon (01952) has seen a stock increase of over 3%, currently trading at 72.05 HKD with a transaction volume of 231 million HKD, following its strategic investment in Tianjing Bio [1] Group 1: Strategic Investment - CloudTop New Horizon has participated in Tianjing Bio's capital increase, acquiring new shares at a price of 1.95 USD per ADS, totaling approximately 30.9 million USD, making it the largest single shareholder [1] - This strategic investment allows CloudTop New Horizon to leverage Tianjing's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical translation capabilities, creating synergies with its existing mRNA tumor vaccine portfolio [1] Group 2: Tianjing Bio's Pipeline - Tianjing Bio possesses a differentiated pipeline of tumor-targeted/immunotherapies, including Givastomig (Claudin18.2/4-1BB dual antibody) and Ragistomig (PD-L1/4-1BB dual antibody) [1] - Givastomig is currently being explored in first-line gastric cancer treatment in combination with O drug and chemotherapy, showing superior data compared to current standard therapies in the U.S. Phase Ib study [1] - Ragistomig features a unique molecular design that selectively binds to PD-L1 in the tumor microenvironment and activates 4-1BB, with Phase I data indicating better overall response rate (ORR) and disease control rate (DCR) compared to competing products targeting the same pathway [1]

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]

Core Insights - The mRNA industry is transitioning from a pandemic-driven boom to a critical transformation phase, with significant potential in cancer immunotherapy and personalized medicine [1][6][7] - Major players like BioNTech and Moderna are adjusting their strategies in response to declining revenues from COVID-19 vaccines, focusing on expanding their cancer treatment pipelines [6][7] Industry Developments - mRNA technology has shown promise in various applications beyond vaccines, including therapeutic vaccines, cancer immunotherapy, and regenerative medicine [4][5] - The market potential for mRNA cancer vaccines is projected to reach hundreds of billions of dollars, driven by their accessibility and personalization capabilities [1][4] Company Strategies - BioNTech has made strategic acquisitions to enhance its capabilities in mRNA cancer immunotherapy, including a $1.25 billion acquisition of CureVac [1] - Moderna is facing financial challenges, with a projected revenue drop of 33% in 2025, leading to workforce reductions [6][7] Market Dynamics - The Chinese mRNA sector is experiencing a bifurcation, with some companies like Simao Biotechnology facing financial difficulties, while others are making significant advancements [8][9] - Chinese companies are gaining international recognition, with successful FDA approvals for innovative mRNA cancer vaccines [9] Future Outlook - The mRNA industry is expected to evolve towards a model where drug development is based on "coding nucleic acid sequences," potentially revolutionizing treatment for various diseases [5][10] - The success of Chinese mRNA companies in the competitive landscape will depend on their ability to leverage business development opportunities for rapid monetization [10]

Core Insights - The pharmaceutical industry in China is undergoing a significant transformation from a focus on generic drugs to innovation-driven development, particularly in mRNA technology and other advanced therapies [1][4][10] - The traditional model of "using generics to support innovation" is becoming unsustainable as over 60% of generic drug companies have seen profit margins fall below critical levels [1][4] - Major players like Heng Rui and others are adapting by streamlining operations and focusing on innovative drug development to maintain competitiveness in a rapidly evolving market [5][10] Company-Specific Developments - Heng Rui Pharmaceutical is investing in mRNA production lines to support clinical trials for cancer vaccines, indicating a strategic shift towards cutting-edge technology [1] - The company has seen its market capitalization drop from over 610 billion RMB in 2020 to approximately 355.2 billion RMB in 2025, reflecting the challenges posed by national drug procurement policies [3] - Heng Rui has reduced its sales team from 17,138 in 2020 to 8,910 by 2024, a decrease of about 48%, as part of its restructuring efforts [5] Industry Trends - The implementation of national drug procurement policies has significantly impacted profit margins for traditional pharmaceutical companies, forcing them to innovate or face decline [4][10] - The market is witnessing a shift where innovative drug companies are gaining market share, with companies like Innovent Biologics and others achieving substantial valuations [8][9] - The total value of out-licensing deals for innovative drugs in China reached approximately 36.9 billion USD in early 2025, indicating a robust market for innovative therapies [8] Future Outlook - The industry is expected to see increased consolidation, with a focus on high-value innovative drugs while low-margin generic drugs may be phased out [10][12] - Companies are encouraged to adopt a "dual-platform strategy," maintaining generics for cash flow while developing innovative drug platforms to attract investment [10][11] - The integration of AI technology in drug development is anticipated to accelerate the process and reduce costs, further enhancing the competitive landscape [15][16]

Group 1 - The core viewpoint of the article emphasizes the significant potential of China's innovative drug industry, particularly highlighted by the recent large-scale licensing deal involving innovative drugs [1] - The innovative drug sector is characterized by a "bet first, collapse later" nature, making it suitable to view through a "cycle" perspective, where the most attractive aspect is the value escalation cycle of a technology or product transitioning from obscurity to a major market player [1][2] - The value escalation cycle for PD1/CTLA4 and PD1/VEGF dual antibodies began around 2020/2021, with expectations that this cycle will continue at least until 2027/2028, barring any major setbacks [2] Group 2 - The comparison between Sanofi's 707 and Ivosidenib indicates that while there may be some local improvements, it does not significantly differentiate itself enough to disrupt the value escalation cycle of Ivosidenib [4] - The introduction of Sanofi's 707 may have short-term negative impacts on the original drug companies in Hong Kong, as it reduces the potential acquisition interest from partners like SUMMIT, but long-term effects may be limited [5][6] Group 3 - The original drug companies in Hong Kong are expected to see value escalation primarily through three phases, with the current phase being the second stage that has been active for 4-5 years and is projected to continue for another 2-3 years [7][8] - The market's perception of the potential value of Ivosidenib in various cancers appears to be underappreciated, with estimates suggesting that its overseas licensing could support a market value of approximately 320-480 billion HKD for the licensing party [8][9] Group 4 - The future value expansion for companies hinges on their ability to ignite the "third stage rocket," which involves developing universally applicable therapies that can enhance the efficacy of PD1 dual antibodies [10][11] - Companies are already pursuing clinical trials for TROP2*NECTIN4 dual antibody ADCs and mRNA tumor vaccines, indicating a proactive approach to maintaining value escalation in the face of potential market shifts [11][13]