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 ...

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $47.4 million, down from $69.4 million in Q2 2024. Excluding high volume Clean Cap, base revenue increased by 5% year-over-year [19][20] - GAAP net loss before non-controlling interests was $69.8 million for Q2 2025, compared to a loss of $18.4 million in Q2 2024 [20] - Adjusted EBITDA was negative $10.4 million for Q2 2025, down from a positive $13 million in Q2 2024 [21] - Basic and diluted EPS for Q2 2025 was a loss of $0.27 per share, compared to a loss of $0.07 per share in Q2 2024 [21] Business Line Data and Key Metrics Changes - Nucleic Acid Production (NAP) segment revenue was $31.1 million in Q2 2025, with base NAP business excluding high volume Clean Cap up 3% year-over-year [23] - Biologics Safety Testing (BST) segment revenue was $16.3 million in Q2 2025, reflecting a 10% year-over-year increase [24] - Adjusted EBITDA for BST was $10.9 million, resulting in an adjusted EBITDA margin of 67% [24] Market Data and Key Metrics Changes - Revenue by customer type in Q2 2025: 28% biopharma, 30% life sciences and diagnostics, 8% academia, 7% CRO, CMO, CDMO, and 27% to distributors [19] - Revenue by geography: 65% North America, 18% EMEA, 12% Asia Pacific (excluding China), and 5% in China [19] Company Strategy and Development Direction - The company is committed to improving operational excellence and execution through a restructuring plan aimed at reducing annualized expenses by over $15 million [6][7] - Focus on revenue diversification and growth across business segments, particularly in BST and NAP, with investments in new analytical products [10][11] - The company aims to return to sustainable positive adjusted EBITDA and free cash flow by 2026 [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the need for a stronger culture of accountability and operational discipline to drive results [5] - The CEO expressed optimism about the company's future, emphasizing the potential for growth and profitability despite current challenges [15] - The leadership team is focused on stabilizing the organization and exploring further growth opportunities post-restructuring [111] Other Important Information - The company has initiated a comprehensive business review and has withdrawn prior guidance for 2025, planning to reinstate guidance after completing the review [27] - Anticipated restructuring charges of approximately $8 million to $9 million in 2025, primarily for employee severance and related expenses [26] Q&A Session Summary Question: Guidance philosophy and visibility for 2026 targets - Management is focused on controlling costs and gaining confidence in the numbers shared, with no specific red flags indicating incorrect guidance [36][40] Question: Durability of BST improvement and pull forward dynamics - BST showed strong growth, with no significant pull forward dynamics from China or Asia impacting Q2 results [41][43] Question: Growth potential in China - Management expects China to become a growth driver as relations between the U.S. and China improve [47] Question: Impact of tariffs on CDMO business - Currently, there has been little movement regarding tariffs, but potential opportunities exist if tariffs lead to U.S. production shifts [51] Question: Positive surprises and challenges in the business review - Management was surprised by the extent of expenditures and the loyalty of customers in the preclinical to phase three segments [56][58] Question: E-commerce revenue potential - E-commerce currently represents a small percentage of revenue, but management sees significant potential for growth in this area [75][78] Question: Long-term margin potential - Management aims to restore profitability and free cash flow before addressing long-term margin targets [92][94]

Core Insights - The high cost of advanced cell therapy drugs, reaching hundreds of thousands to millions per injection, can potentially be reduced through mRNA and advanced delivery technologies, transforming highly personalized therapies into more universal drugs [1] - The development of in vivo CAR-T therapy pipelines by Chinese biopharmaceutical companies aims to address the long development cycles and high treatment costs associated with traditional CAR-T therapies [1] Company Developments - DeepXing Biotechnology, led by Dr. Linxian Li, has innovated a delivery technology platform using lipid nanoparticles (LNP), enabling "instant modification and treatment," which could significantly lower costs and expand the range of applicable conditions for advanced immunotherapy [2] - The company has rapidly grown into an international team of over 150 people and has secured over 1 billion in financing since its establishment in late 2019 [2] Government Support - Shenzhen has initiated the 2023 second batch of special funds for strategic emerging industries, with DeepXing's LNP delivery technology platform project successfully receiving government investment [3] - The company has also received funding approval for its "R&D Investment Support Plan for Technology-based Enterprises" from the Shenzhen government [3] - DeepXing has four mRNA rare disease therapies that have received pediatric rare disease designation and orphan drug designation from the FDA [3]

Group 1: Domestic News - The State Council announced that from the autumn semester of 2025, public kindergarten tuition fees for large classes will be waived, benefiting approximately 12 million children and reducing family burdens by 20 billion yuan [2] - China's total import and export value of goods reached 25.7 trillion yuan in the first seven months of this year, a year-on-year increase of 3.5%, marking a historical high for the same period [2] - The Ministry of Commerce extended the investigation period for import beef safeguard measures until November 26, 2025, urging related enterprises to monitor developments closely [2] Group 2: Financial Markets - Childcare concept stocks surged, with Chuangyuan Co. rising by 15.34% and others like BeiYinMei and WeiSi Medical increasing over 5%, reflecting strong investor interest in the maternal and infant consumption chain [3] - The Hong Kong Stock Exchange reported a significant year-on-year increase in market capitalization, reaching 44.9 trillion HKD, a 44% rise, with operating income and net profit growing by 16.05% and 5.74% respectively [3] - U.S. stock markets closed higher, with the Dow Jones up 0.19%, Nasdaq up 1.21%, and S&P 500 up 0.73%, driven by a 5.09% jump in Apple’s stock [3] Group 3: Corporate Dynamics - OpenAI launched the revolutionary GPT-5 model, claiming a significant step towards AGI, with a record coding accuracy of 74.9% and a low misinformation rate of 1.6% in health-related areas [4] - Tesla's sales in Europe declined significantly in July, losing its top sales position to Volkswagen, although it saw growth in Spain and Norway [4] - The U.S. government canceled a $500 million mRNA vaccine development project, withdrawing 22 related contracts, which faced criticism from infectious disease experts [4]

Core Viewpoint - The U.S. government has decided to cancel approximately $500 million in funding for mRNA vaccine development, marking a significant shift away from mRNA technology in public health strategy [2][3]. Group 1: Decision Details - U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced the cancellation of the mRNA vaccine development project, which includes the termination of 22 contracts related to mRNA technology by the Biomedical Advanced Research and Development Authority (BARDA) [2][3]. - The decision is influenced by consultations with top experts from the National Institutes of Health (NIH) and the FDA, concluding that the risks of mRNA technology outweigh its benefits for respiratory viruses like COVID-19 and influenza [3][4]. - The U.S. Department of Health and Human Services plans to redirect the canceled funds to "safer and broader vaccine platforms" that remain effective even with viral mutations [3]. Group 2: Expert Opinions - Many experts argue that mRNA vaccines have a significant advantage in rapid development and adaptability, which is crucial for responding to emerging viruses and variants [6]. - Dr. Peter Hotez criticized the decision as undermining national biosecurity and promoting a "pseudo-scientific agenda" [6]. - Dr. Paul Offit expressed concern that the decision was made without scientific evidence, potentially exposing the nation to unnecessary risks [6]. Group 3: Industry Impact - The cancellation of contracts with companies like Moderna and others indicates a broader shift in the U.S. government's approach to vaccine development, which may affect future innovations in the biomedical field [5][6]. - The U.S. Department of Health and Human Services is also terminating contracts with Emory University and Tiba Biotech, which were working on mRNA-based antiviral platforms [6].

Summary of Key Points from the Conference Call Company Overview - **Company**: 云顶医药 (Cloudtop Pharmaceuticals) - **Industry**: Biopharmaceuticals, specifically focusing on anti-infective and renal disease treatments Core Insights and Arguments - **Market Demand**: The demand for the drug 依拉环素 (Ilaris) is strong, with projected sales reaching 1 billion yuan in 2025, indicating a growing hospital market [2][3] - **Product Pipeline**: The company is expanding its product line with new anti-infective products such as 坦尼彭巴坦 (Tanecomartin) and F206, further solidifying its position in the anti-infective sector [2][3] - **Self-developed Products**: BDK ever 001 has shown impressive results in clinical trials, being recognized as a best-in-class product. The mRNA tumor vaccine platform has entered patient enrollment, with encouraging preliminary data [2][4][5] - **Financial Performance**: The drug 耐福康 (Nafamostat) is expected to achieve sales of 1 billion yuan in 2025, with a potential peak sales target of 4 to 5 billion yuan in the long term [2][18] - **Clinical Data**: For the drug Alpha 001, used in treating membranous nephropathy, the complete remission rates were 76.9% for the low-dose group and 81.8% for the high-dose group, indicating leading efficacy in its class [2][21] Management and Structure - **Stable Shareholding**: The company is controlled by CBC, with the introduction of long-term international investors, ensuring a stable shareholding structure [2][6] - **Experienced Management**: The management team, led by CEO 罗总 and CFO 何总, has extensive experience in large multinational companies, which aids in effective commercialization and strategic planning [2][7] Future Development Goals - **Revenue Target**: The company aims to achieve a revenue target of 10 billion yuan by 2030 through expanding existing product sales and developing new indications for I8-001 and the mRNA platform [2][8] - **Market Positioning**: The company seeks to consolidate its market position and expand its business scale in the coming years [2][9] Additional Important Insights - **IgA Nephropathy Treatment**: The drug 耐赋康 has shown strong performance in treating IgA nephropathy, with a significant market opportunity given the prevalence of the disease in China [2][14][18] - **Competitive Landscape**: Other drugs for IgA nephropathy are in development, but 云顶医药 is expected to maintain a leading position for the next two to three years [2][19] - **mRNA and CAR-T Developments**: The company is advancing its mRNA technology platform and in vivo CAR-T therapy, with significant investments in these areas indicating strong future potential [2][22][23] Conclusion - **Investment Opportunities**: The company presents multiple investment opportunities through its robust product pipeline, strong market demand, and experienced management team, making it a noteworthy player in the biopharmaceutical industry [2][25]

Financial Data and Key Metrics Changes - In Q2 2025, the company reported revenues of $100 million and a net loss of $800 million, reflecting the seasonal nature of its respiratory vaccine business [6] - Cash and investments at the end of the quarter stood at $7.5 billion, down from $8.4 billion at the end of Q1 2025 [15] - The company achieved a 35% reduction in combined cost of sales, R&D, and SG&A compared to 2024, with cash operating expenses reduced by $581 million year-over-year, representing a 40% reduction [7][10] Business Line Data and Key Metrics Changes - Net product sales for the quarter were $114 million, primarily driven by COVID vaccine sales, with a 38% decline compared to 2024 [12] - R&D expenses were $700 million, down 43% year-over-year, attributed to the wind down of respiratory trials and lower clinical manufacturing costs [13] - SG&A expenses were $230 million, reflecting a 14% year-over-year decrease due to broad-based cost reductions [14] Market Data and Key Metrics Changes - The U.S. accounted for approximately 80% of total sales, with international markets contributing the remainder [12] - The company updated its 2025 projected revenue range to $1.5 billion to $2.2 billion, reflecting a $300 million reduction at the high end due to a timing shift of UK COVID shipments [16][17] Company Strategy and Development Direction - The company is focused on three strategic priorities: driving use of commercial products, advancing its pipeline, and executing with financial discipline [9][41] - The company aims to secure up to 10 product approvals targeting an addressable market exceeding $30 billion [41] - A workforce reduction of approximately 10% was announced to align the cost structure with current business conditions while sustaining investments in the mRNA pipeline [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash breakeven by 2028, supported by ongoing cost reduction initiatives [28][43] - The company is optimistic about the upcoming approvals for seasonal flu and flu plus COVID combination vaccines, as well as the readout of CMV Phase III efficacy data later this year [45][46] Other Important Information - The UK Court of Appeal upheld the validity of Moderna's EP949 patent, which is infringed by Pfizer and BioNTech, reinforcing the company's commitment to enforce its patent rights globally [11] - The company is leveraging AI tools to enhance operational efficiency, with 100% of knowledge workers actively using ChatGPT [43] Q&A Session Summary Question: Context for CMV changes and data cadence for neoantigen therapy - Management explained the rationale for adding secondary endpoints to the CMV study to enhance the analysis and protect the study's integrity, with results expected in the fall [50][51][87] - The cadence of results for the individualized neoantigen therapy is anticipated to be consistent over the next year, with several studies expected to read out [54] Question: Pricing expectations for COVID vaccine - Management indicated that pricing discussions are complete, with a revenue range of $1 billion to $1.5 billion for U.S. product sales, factoring in competitive pressures and vaccination rates [57][60] Question: Balancing R&D investments and cost-cutting - Management emphasized the importance of investing in the late-stage pipeline while also reducing costs, with a focus on diversifying the product portfolio beyond seasonal products [79][83] Question: Employee headcount reduction context - The company clarified that the headcount reduction is part of a broader strategy to enhance efficiency while continuing to invest in key areas [90]

Core Insights - The mRNA sector shows signs of recovery since 2025, with significant acquisitions and advancements in technology by companies like AbbVie and BioNTech [1] - Domestic companies, while still in early stages, are beginning to emerge, with YunTing New Medicine showcasing three products based on its self-developed mRNA technology platform [1][2] Company Developments - YunTing New Medicine has developed three products: a universal therapeutic vaccine EVM14, a personalized therapeutic vaccine EVM16, and an autologous CAR-T project [1][2] - The company has integrated self-developed AI algorithms with a lipid nanoparticle (LNP) delivery system, completing three generations of AI algorithm upgrades to enhance protein expression levels [1][2] Clinical Progress - EVM14 has completed dual submissions in China and the U.S., with a global multi-center Phase I clinical trial expected to enroll its first patient in Q3 this year, targeting three major cancer types [2] - EVM16 has shown promising preliminary data, demonstrating good immunogenicity even at low starting doses in advanced cancer patients [2] Industry Trends - In the past two years, business development (BD) has become a key performance indicator for domestic innovative pharmaceutical companies, with Chinese assets contributing nearly 50% of upfront payments in global oncology licensing deals this year [2][3] - The mRNA technology platform offers advantages in drug development across various difficult-to-treat diseases, transforming the process from "molecular screening" to "information design" [2] Strategic Considerations - YunTing New Medicine is not rushing into BD but is focused on making the right strategic decisions, with a cash reserve of 1.6 billion yuan by the end of 2024, allowing for continued development without external capital [3] - The timing and structure of BD are critical, as having clinical data can significantly increase the value of licensing agreements compared to preclinical stages [3][4]

Core Viewpoint - The recent announcement of long-term safety data for VELSIPITY® (Iqumod) in treating moderate to severe active ulcerative colitis (UC) has generated positive market sentiment towards Cloudtop New Horizon (1952.HK), with expectations of significant commercial potential and a peak sales forecast of 5 billion yuan [1][2][5]. Group 1: Clinical Data and Research Findings - The long-term safety study included over 1,000 patients and demonstrated good tolerability and safety for Iqumod, with an adverse event exposure rate of only 1.63 per patient-year over four years [3]. - In a large-scale Phase III clinical trial in Asia, Iqumod achieved a mucosal healing rate of 52% and complete mucosal normalization of 46% after 52 weeks of treatment, providing strong evidence for its application in UC patients [2][4]. - The drug has been recognized in clinical guidelines as a first-line treatment for UC, further validating its clinical value [6]. Group 2: Market Performance and Investor Sentiment - Cloudtop New Horizon's stock has surged over 60% since June, reaching a four-year high, reflecting investor confidence in the company's product pipeline and strategic positioning [2][7]. - CICC has maintained a "outperform" rating for Cloudtop New Horizon and raised its target price to 80 HKD, driven by positive expectations for Iqumod's commercialization potential [2]. Group 3: Regulatory and Commercialization Progress - Iqumod's new drug application (NDA) in mainland China is under review, with expectations for approval by late 2025 to early 2026, which would benefit domestic patients [1][6]. - The drug has already been approved in several Asian regions, including Singapore and Hong Kong, and is set to enhance accessibility for patients in the Greater Bay Area [6]. Group 4: Industry Context and Future Outlook - The increasing prevalence of UC in China, projected to rise from 800,000 patients in 2024 to 1 million by 2030, highlights the significant unmet medical needs and the relevance of Iqumod's clinical research [4]. - The theme of the AOCC 2025 conference emphasizes collaboration in treating inflammatory bowel disease (IBD), with Iqumod's research contributing important clinical evidence towards this goal [5].

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].