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 就 因 本 公 告 的全部或任何部份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。 LUYE PHARMA GROUP LTD. 綠葉製藥集團有限公司 （於 百 慕 達 註 冊 成 立 之 有 限 公 司） （股 份 代 號：02186） 自願性公告 若欣林®治療廣泛性焦慮障礙的 中國Ⅲ期臨床試驗完成所有患者入組 綠葉製藥集團 有限公司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）董事會（「董 事 會」）宣 佈，本 集 團 自 主 研 發 的1類創新藥若欣林® （鹽 酸 托 魯 地 文 拉 法 辛 緩 釋 片）用 於 治 療 廣 泛 性 焦 慮 障 礙 的 Ⅲ 期 臨 床 試 驗 已 完 成 所 有 患 者 入 組。 該 項 Ⅲ 期 臨 床 試 驗 為 一 項 多 中 心、隨 機、雙 盲、安 慰 劑 對 照 的 研 究，以 評 估 若 欣 林®治 療 廣 泛 性 焦 慮 障 礙 的 安 全 性 和 有 效 性。試 ...

Group 1 - The company has received a "Notice of Acceptance" from the National Medical Products Administration regarding its clinical trial application for HSK39297 tablets, which are intended for the treatment of age-related macular degeneration (AMD) and generalized myasthenia gravis (gMG) [1][2] - AMD is a degenerative disease affecting the macula, with a global prevalence of approximately 8.7%, and it is estimated that nearly 300 million people will be affected by 2040 [2] - HSK39297 is a novel small molecule drug with independent intellectual property rights, showing clear targets, confirmed efficacy, and good safety, indicating a high benefit/risk ratio for clinical application [3] Group 2 - The drug has previously submitted IND applications for complement-mediated primary or secondary glomerular diseases and complement-mediated hemolytic diseases, with ongoing clinical studies for IgA nephropathy and paroxysmal nocturnal hemoglobinuria [3] - The current acceptance pertains specifically to clinical trials for AMD and gMG, addressing the clinical drug shortage faced by patients [3][4]

Core Viewpoint - The surge of pharmaceutical companies listing on the Hong Kong Stock Exchange (HKEX) reflects a growing interest in the biotech sector, driven by innovative drug development and supportive regulatory frameworks [1][2][3]. Group 1: Market Activity - In 2023, 14 biopharmaceutical and medical device companies have listed on HKEX, raising a total of 182.25 billion HKD, with 36 more companies in the pipeline [2]. - The rapid development of innovative drugs is closely linked to the increase in listings, with 43 innovative drugs approved in the first half of the year, a 59% year-on-year increase [2]. - The Hang Seng Biotechnology Index has doubled in value this year, indicating strong market performance in the biotech sector [2]. Group 2: Regulatory and Capital Support - The introduction of the "Science and Technology Enterprises Special Line" and the 18A listing rule has facilitated early and customized listing guidance for innovative drug companies [3]. - Since the implementation of the 18A rule, 77 biotech companies have gone public, demonstrating the positive impact of regulatory reforms on the industry [3]. - Increased liquidity and capital inflow, particularly from foreign investments, have significantly improved the valuation and liquidity of the biotech sector [3]. Group 3: Company Performance and Evaluation Criteria - Companies with strong clinical data and rapid pipeline advancement, particularly in oncology, autoimmune diseases, and metabolic disorders, are attracting high valuations [6]. - The focus of investors is shifting from the quantity of drug pipelines to the quality and clinical value of the research outcomes [5][6]. - Successful recent listings, such as Zhonghui Biotech-B and Weilizhibo-B, highlight the market's preference for companies with innovative therapies and strong clinical trial results [6].

Investment Rating - The report maintains a "Buy" rating for the company, with expected earnings per share (EPS) of 1.80, 2.05, and 2.31 RMB for the years 2025 to 2027, respectively [4]. Core Insights - The company's revenue for the first half of 2025 reached 14.81 billion RMB, a year-on-year increase of 5%, while the net profit attributable to shareholders decreased by 24% to 1.82 billion RMB [2]. - The CHC (Consumer Health Care) business faced short-term pressure, with a revenue decline of 18.4% to approximately 6.08 billion RMB, attributed to lower incidence rates of respiratory diseases and adjustments in retail channels [2]. - The prescription drug business continued to grow, achieving a revenue increase of 15.2% to approximately 2.78 billion RMB, with market share steadily improving due to opportunities from national procurement [2][3]. Summary by Sections Performance Review - In 1H25, the company reported a revenue of 14.81 billion RMB, up 5% year-on-year, but a net profit of 1.82 billion RMB, down 24% year-on-year [2]. - For Q2 2025, revenue was 7.96 billion RMB, a 17% increase year-on-year, while net profit fell 47% to 0.55 billion RMB [2]. Business Analysis - The CHC business is under short-term pressure, with a revenue drop of 18.4% to about 6.08 billion RMB, influenced by lower respiratory disease rates and retail channel adjustments [2]. - The prescription drug segment saw a revenue increase of 15.2% to approximately 2.78 billion RMB, benefiting from national procurement opportunities [2]. Innovation and Development - The company is expanding its product pipeline through commercial partnerships and product introductions, including a joint development agreement for a weight loss and diabetes treatment drug [3]. - The company is also conducting Phase I clinical trials for a brain tumor treatment drug, which has received accelerated approval from the FDA [3]. Profit Forecast and Valuation - The profit forecasts for 2025 to 2027 have been adjusted to 3.01 billion, 3.42 billion, and 3.85 billion RMB, reflecting a year-on-year change of -10.62%, +13%, and +12.83%, respectively [4]. - The current price corresponds to a price-to-earnings (P/E) ratio of 17, 15, and 14 for the years 2025 to 2027 [4].

Core Viewpoint - The company, Haisco (002653.SZ), has received a "Notice of Acceptance" from the National Medical Products Administration for its drug HSK39297 tablets, targeting age-related macular degeneration (AMD) and generalized myasthenia gravis (gMG) [1] Group 1: Drug Development Potential - HSK39297 is identified as a small molecule drug with clear targets, confirmed efficacy, and good safety profile, indicating significant development potential [1] - The drug is expected to have a high benefit/risk ratio in clinical applications, suggesting a promising future in the market [1] Group 2: Clinical Application Prospects - The drug addresses the current shortage of effective treatments for AMD and gMG, highlighting its potential to fill a critical gap in clinical medication [1] - The broad clinical application prospects of HSK39297 position it as a potentially effective treatment option for these conditions [1]

Company Updates - The company announced on August 13 that its self-developed innovative drug, Taitasip, a global first BLyS/APRIL dual-target fusion protein, has achieved the primary endpoint in the Phase III clinical trial for treating primary Sjögren's syndrome (pSS) and will soon submit a marketing application to the National Medical Products Administration (NMPA) [1] - Taitasip has shown significant clinical efficacy, with Phase II clinical data indicating a reduction of 4.3 points in the ESSDAI score after 24 weeks of treatment with 160mg, outperforming the placebo [1] - The drug has received multiple authoritative guideline recommendations in China and has been granted Fast Track designation by the FDA for its pSS indication, allowing for a global multi-center Phase III clinical trial [1] Product Development - The company’s novel bispecific antibody, RC148, has received FDA approval for clinical trials in the U.S. for various advanced malignant solid tumors, marking its entry into global clinical development [2] - RC148 is expected to enhance tumor-killing responses through immune checkpoint blockade and tumor angiogenesis inhibition, indicating its international clinical value and potential for global expansion [2] - In China, RC148 is progressing smoothly in clinical research for single-agent and combination therapies for advanced solid tumors, with promising efficacy and safety observed in early trials [2] Financial Forecast and Valuation - The company maintains its net profit loss forecast for 2025 and 2026 at 915 million yuan and 333 million yuan, respectively [2] - Positive Phase III clinical results for Taitasip are expected to enhance its future value, while the FDA approval for RC148's Phase II trial is anticipated to boost its global value [2] - Based on a DCF model, the company has raised its target price by 24.8% to HKD 95.34, indicating a potential upside of 23.1% from the current stock price [2]

Core Insights - China's innovative drug development is transitioning from imitation to independent innovation, with significant achievements in international markets [1][5][7] - The number of new drugs under research in China is projected to rank second globally by 2024, indicating a growing industry scale [3][6] - The domestic innovative drug market has seen over 110 new drugs approved since the 14th Five-Year Plan, with a market size reaching 100 billion yuan [6][12] R&D Advancements - Domestic innovative drugs now account for over half of the clinical trials at Beijing University Cancer Hospital, showcasing rapid development in this sector [1][3] - Multiple innovative drugs have been approved in the first half of this year, including treatments for rare diseases and other conditions, marking breakthroughs in previously unmet clinical needs [5][6] International Expansion - Chinese pharmaceutical companies are increasingly engaging in overseas licensing agreements, with over 90 transactions completed in 2024, totaling more than 50 billion USD [7][9] - Notable licensing deals include a 60 billion USD agreement between 3SBio and Pfizer, and a 125 billion USD deal between Hengrui Medicine and GlaxoSmithKline [9][10] Policy Support - The Chinese government is implementing policies to support the entire lifecycle of innovative drugs, including expedited approval processes and financial investments [11][14] - Recent measures include a 30-day approval timeline for innovative drugs and the establishment of funds to support research and development in the pharmaceutical sector [12][15] Market Dynamics - The innovative drug market is experiencing a surge in both quantity and quality, with a notable increase in the approval of new drugs that cater to both domestic and international patients [7][8] - The market is evolving to include a diverse range of biopharmaceuticals, including monoclonal antibodies and CAR-T cell therapies, reflecting a shift towards cutting-edge technologies [10][11]

Core Viewpoint - Fujian Haixi New Drug Creation Co., Ltd. is seeking to list on the Hong Kong Stock Exchange, heavily relying on its generic drug business, which accounted for over 90% of its revenue from 2022 to 2024, driven by national procurement policies [1][2] Financial Performance - The company experienced significant growth, with a compound annual growth rate (CAGR) of 48.4% in revenue from 2022 to 2024, increasing from 212.5 million RMB to 466.7 million RMB, and net profit doubling from 69 million RMB to 136 million RMB [1][3][8] - Major contributors to revenue include four generic drugs, which accounted for over 90% of total income, with the core product, Haihuaitong, achieving a market share of 59.3% in 2024 [3][4] Market Dynamics - The "volume-based procurement" model has led to a significant increase in sales volume, with the price of the drug Anbili dropping by 60% but sales increasing by 320%, contributing 146 million RMB in revenue in 2024 [4] - The average gross margin for the domestic generic drug sector is around 50%, while Haixi New Drug maintains a gross margin above 80% through a light-asset model [4][5] Innovation Pipeline - The company has only four innovative drugs in early clinical stages, indicating a lack of robust innovation pipeline, which contrasts sharply with its strong generic drug performance [6][7] - R&D spending in 2024 was only 14.5% of revenue, significantly lower than leading companies in the industry, raising concerns about the company's ability to fund its innovation efforts [7] IPO and Future Outlook - The IPO aims to raise funds primarily for innovative drug development, but the market is cautious about companies heavily reliant on generic drugs, with average valuations for generic firms significantly lower than those for innovative drug companies [10] - The company faces pressure to demonstrate the clinical value of its innovative pipeline to avoid valuation discounts during the IPO process [10]

最新公告显示，公司股东盟科香港计划减持不超过3%的公司股份。这一减持计划可能对市场情绪产生 一定影响。从资金流向来看，当日主力资金净流出1767.84万元，近五日累计净流出2882.71万元。 盟科药业-U股价报7.93元，较前一交易日下跌0.03元，跌幅0.38%。盘中最高触及7.96元，最低下探至 7.50元，成交量为201474手，成交金额达1.57亿元。 该公司属于生物制品行业，专注于创新药研发。作为上海板块上市公司，盟科药业-U目前总市值为 51.99亿元，流通市值为41.67亿元。 风险提示：股市有风险，投资需谨慎。本文不构成任何投资建议，投资者应自主决策并承担相应风险。 ...

Core Viewpoint - The report highlights the financial performance of Tibet Rhodiola Pharmaceutical Holding Co., Ltd. for the first half of 2025, indicating a slight increase in revenue but a decline in net profit, primarily due to reduced government subsidies [1][2]. Financial Performance - The company's operating revenue for the first half of 2025 was approximately 1.65 billion RMB, representing a 2.23% increase compared to the same period last year [2][6]. - The total profit for the period was approximately 637.32 million RMB, which is an 8.41% decrease from the previous year [2][6]. - The net profit attributable to shareholders was approximately 567.32 million RMB, reflecting an 8.96% decline year-on-year [2][6]. - The net cash flow from operating activities was approximately 600.22 million RMB, showing a slight increase of 0.93% compared to the previous year [2][12]. Key Financial Indicators - Basic earnings per share decreased to 1.76 RMB, down 8.81% from 1.93 RMB in the previous year [2][6]. - The weighted average return on equity dropped to 14.01%, a decrease of 3.31 percentage points from the previous year [2][6]. - The company's net assets increased by 6.21% to approximately 4.16 billion RMB compared to the end of the previous year [2][6]. Business Overview - The company operates in the pharmaceutical manufacturing industry, producing various forms of medication including capsules, biological agents, and granules, with a focus on cardiovascular, liver, and pain relief treatments [3][4]. - Key products include Xinhuasuan (新活素), Yimuduo (依姆多), and Nuodikan (诺迪康), which target various health conditions [3][4]. Industry Context - The pharmaceutical industry is significantly influenced by national policies, with recent reforms aimed at enhancing innovation and market expansion [4][5]. - The company is recognized as the first high-tech pharmaceutical listed enterprise in Tibet and has established itself as a modern pharmaceutical entity with multiple production bases [4][5]. Strategic Initiatives - The company is focusing on enhancing its product promotion, particularly for core products like Nuodikan and Xueshan Jinluohan pain relief plaster, through academic marketing and expanding hospital coverage [4][8]. - There is an ongoing effort to improve research and development capabilities, with increased investment in R&D by 78.36% compared to the previous year [2][11]. Market Position - The company has been awarded multiple honors, including recognition as a key agricultural industrialization enterprise and ranking in the top lists for innovation in pharmaceuticals [5][6]. - The company is actively pursuing international market opportunities and enhancing its digital management capabilities to improve operational efficiency [8][9].