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].

Market Overview - The Hang Seng Index fell by 0.59% to close at 23,892.56, while the Hang Seng Tech Index experienced the largest decline of 1.72% to 5,239.71 [1][2] - The geopolitical tensions in the Middle East have heightened risk aversion, contributing to the overall market downturn [1] Sector Performance - The innovative drug sector saw a significant pullback, with CloudTop falling over 12%, and other biotech stocks also declining [2][6] - Automotive stocks continued to decline, with Xpeng Motors dropping over 5% and other major players like NIO and BYD also experiencing losses [5][6] - Airline stocks were negatively impacted by a recent Boeing 787 crash, with China Southern Airlines falling nearly 3% [8] - Gold and oil prices surged due to geopolitical tensions, leading to gains in gold and oil stocks, with Chifeng Gold rising over 10% [11][12] Individual Stock Movements - Alibaba fell by over 2%, while Meituan and JD.com dropped more than 1% [3][4] - Xpeng Motors saw a decline of 5.17%, while NIO and other automotive stocks followed suit [5] - In the gold sector, Chifeng Gold rose by 10.55%, reflecting the increase in gold prices [12] - Shandong Molong surged over 75% in the oil and gas equipment sector, indicating strong market interest [10] Company News - Chow Tai Fook reported a revenue of HKD 89.656 billion for the fiscal year ending March 31, 2025, a decrease of 17.53% year-on-year, with a net profit of HKD 5.916 billion, down 8.97% [18] - The company announced a final dividend of HKD 0.32 per share, with a payout ratio of 87.8% [18] - Morgan Stanley raised its target price for Chow Tai Fook from HKD 13 to HKD 14, maintaining an "overweight" rating [18] Investment Sentiment - The market sentiment remains cautious due to ongoing geopolitical tensions and potential trade tariff increases, which may hinder foreign capital inflow into the Chinese market [20]

Core Viewpoint - Company executives have not sold or reduced their shares, indicating confidence in the company's operational status and future development [1] Group 1: Management and Shareholder Actions - The CEO and CFO of the company have not engaged in any share sales, reflecting a positive outlook on the company's performance [1] - The sale of shares by Kangqiao Capital to global long-only and healthcare specialist investors is seen as a strategic move to enhance the investor base without directly impacting the market price [1] - After the transaction, Kangqiao Capital retains over 25% ownership, maintaining its position as the controlling shareholder [1] Group 2: Future Growth Potential - The company anticipates significant value enhancement by 2025, driven by the successful integration of its product, Naisufang, into the medical insurance system, resulting in over 20,000 new patients [1] - The preliminary data for EVER001 (BTK inhibitor) presented at the ERA conference has attracted interest from multinational companies, paving the way for potential global partnerships [1] - The mRNA platform is entering a harvest phase, with EVM16 personalized cancer vaccines expected to complete initial human immunogenicity data collection this year, and EVM14 receiving IND approval in the U.S. [1] - The company is also progressing with its CAR-T project, which is nearing completion of large animal preclinical validation, attracting interest from several multinational pharmaceutical companies for collaboration opportunities [1]

Core Insights - There are currently no approved drugs for the treatment of primary membranous nephropathy globally [1] - The emergence of small molecule targeted BTK inhibitors is leading to a shift towards "chemotherapy-free" treatment options in hematological malignancies [1] - Cloudbreak New Horizon (01952.HK) presented preliminary results of its novel covalent reversible BTK inhibitor EVER001 at the 62nd European Renal Association Congress, showing efficacy and good tolerability in patients with primary membranous nephropathy [1][3] Group 1: Clinical Study Results - The 1b/2a study of EVER001 involved 31 patients with confirmed anti-PLA2R antibody-positive primary membranous nephropathy, divided into low-dose and high-dose groups, treated for 36 weeks [3] - At the 24-week mark, both low-dose and high-dose groups showed a 93% reduction in anti-PLA2R antibodies, with complete immunological remission rates of 76.9% and 81.8% respectively [3] - Proteinuria levels decreased by 78.0% in the low-dose group at 36 weeks (maintained to 52 weeks) and by 70.1% in the high-dose group at 24 weeks, with 80% of patients achieving clinical remission [3] Group 2: Market Context and Future Plans - Currently, five BTK inhibitors have been approved in China, with three imported and two domestic, primarily focusing on the hematological malignancy market, which is becoming increasingly competitive [4] - The company plans to accelerate the global clinical development of EVER001 and explore indications for IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis, and lupus nephritis [4] - There are potential plans for global market expansion and licensing collaborations for EVER001 in the future [4]

Group 1 - The Hong Kong stock market experienced a decline, with the Hang Seng Index down by 0.31% and the Hang Seng Tech Index down by 0.75%, while the pharmaceutical and biotechnology sector underwent a correction [1] - The Hong Kong Innovative Drug ETF (159567) fell by 0.43%, with a turnover rate exceeding 6% and trading volume quickly surpassing 100 million yuan, indicating active trading [1] - The number of license-out transactions by Chinese pharmaceutical companies reached 33 in Q1 2025, totaling 36.633 billion USD, representing a year-on-year increase of approximately 258%, indicating a shift towards international innovation and research [1] Group 2 - Longcheng Securities suggests that favorable policies for the pharmaceutical sector are emerging, with expectations for steady recovery in industry sentiment, particularly in the hospital market affected by previous anti-corruption and centralized procurement measures [2] - Oriental Securities highlights significant breakthroughs for foreign innovative drugs at the recent ASCO conference, while also noting the strong competitive edge of domestic innovative drugs, recommending attention to companies with international competitive advantages [2]

Core Viewpoint - The latest research presented at the ERA 2025 conference demonstrates that NefECON (budesonide delayed-release capsules) provides significant clinical benefits when used early in the treatment of IgA nephropathy, supporting a new management strategy focused on early and targeted treatment [1][2][3] Group 1: Research Findings - Eight oral presentations and one electronic poster were showcased, with two studies confirming the clinical benefits of early treatment with NefECON for IgA nephropathy [1] - A sub-analysis of the NefIgArd study indicated that budesonide significantly reduces proteinuria and protects kidney function across different diagnosis times, with more pronounced benefits in patients diagnosed within 0.6 years [2][3] - A prospective study showed that early use of budesonide not only reduces pathogenic IgA production but also may help control inflammatory responses, thereby slowing disease progression [2] Group 2: Clinical Implications - The findings emphasize the importance of early intervention in IgA nephropathy treatment, providing strong evidence for clinical practice [2] - The 2025 version of the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis" in China recommends budesonide as the first choice for reducing pathogenic IgA [2] - NefECON has been included in both the KDIGO and Chinese clinical practice guidelines, highlighting its significance as a treatment option [12] Group 3: Company Positioning - NefECON is the first and only drug for targeted treatment of IgA nephropathy approved in China, the US, and Europe, marking a shift in treatment standards [2][12] - The drug has shown the potential to delay kidney function decline by 66% in the Chinese population and extend the time to dialysis or kidney transplant by 12.8 years [13] - The company has secured full approval for NefECON in China, removing previous restrictions related to proteinuria levels [2]