股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 绿叶制药集团有限公司 FF301 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02186 | 說明 | 普通股 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 3,994,515,953 | | 0 | | 3,994,515,953 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 3,994,515,953 | | 0 | | 3,994,515,953 | 呈交日期: 2025年11月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通 ...

Core Viewpoint - The article discusses the ongoing price negotiation process for innovative drugs under the 2025 National Medical Insurance (NMI) negotiations, highlighting the participation of various pharmaceutical companies and the significance of the commercial insurance innovative drug directory [2][12]. Group 1: Price Negotiation Process - On November 2, 2025, a total of 10 companies participated in the price negotiation for 11 drug products, including 2 products from BeiGene [2][4]. - The negotiation process is divided into two groups, with each group negotiating separately with representatives from the National Medical Insurance Administration and commercial insurance companies [4][6]. - The first company completed its negotiation in 45 minutes, indicating a generally positive atmosphere among participants [6][7]. Group 2: CAR-T Drugs - CAR-T drugs, known for their high prices, are receiving attention in the commercial insurance innovative drug directory, with one product priced at 999,000 yuan per dose, making it the lowest-priced CAR-T drug in China [7][11]. - Multiple CAR-T drugs received unanimous approval during the expert review phase prior to the negotiations, indicating strong interest from the commercial insurance sector [11]. Group 3: Expectations and Concerns - Companies are primarily focused on the potential patient access to drugs rather than just price reductions, expressing uncertainty about how the innovative drug directory will facilitate market access [12][13]. - A representative mentioned that the National Medical Insurance Administration suggested a price reduction expectation of 15% during pre-negotiation discussions [12]. - There is a notable interest in the innovative drug directory as it allows companies to recover substantial R&D costs without necessitating significant price cuts [13].

Core Insights - The 2025 National Medical Insurance Negotiation has entered its fourth day, focusing on the price negotiation for innovative drugs, with 121 drugs passing the initial review and 24 entering the price negotiation phase [1][2] Group 1: Price Negotiation Process - A total of 10 companies participated in the price negotiation for 11 drugs, including major players like BeiGene and Huyuan Bio [1] - The negotiation process is divided into two groups, with each group negotiating separately with representatives from the National Medical Insurance Administration and insurance companies [3] Group 2: CAR-T Drug Negotiations - CAR-T drugs, known for their high prices, are receiving attention in the innovative drug directory negotiations, with several companies reporting positive experiences during negotiations [4][5] - The price of Huyuan Bio's CAR-T drug, previously set at 999,000 yuan per dose, is expected to be a focal point in the negotiations [5][6] Group 3: Expectations and Concerns - Companies are primarily concerned about the potential patient access to drugs through the innovative drug directory, rather than just price reductions [8][9] - There is uncertainty regarding the implementation and market access of the innovative drug directory, as companies are still exploring the commercial insurance payment mechanisms [8][9]

Core Points - The 2025 National Medical Insurance Directory negotiations have officially commenced, highlighting the importance of pharmaceutical innovation and patient access to medications [1] - The atmosphere at the negotiations is characterized by a cautious and low-key approach from pharmaceutical representatives, with an increased emphasis on confidentiality [3][4] - A total of 535 drugs are under review, with 311 outside the directory and 224 within it, alongside 121 high-value drugs reviewed under the commercial insurance innovation drug directory [9][10] Group 1: Negotiation Atmosphere - The entry process for pharmaceutical representatives was notably quieter and more orderly compared to previous years, reflecting a more subdued approach [3][4] - Representatives from both domestic and multinational pharmaceutical companies, including notable names like 恒瑞医药 and 阿斯利康, participated in the negotiations [4][9] Group 2: Key Drug Categories - Antibacterial drugs are expected to be a significant focus in the afternoon session of the negotiations, with specific products like 万古霉素 being highlighted [9][10] - Innovative drugs, including CAR-T products and new lipid-lowering medications, are also under consideration, with 恒瑞医药 presenting multiple products for initial review [10][12] Group 3: Market Insights - The PCSK9 inhibitor 瑞卡西单抗 has gained attention for its long-acting properties, with a market size of 1.32 billion yuan in 2023, representing 7.8% of the national lipid-lowering drug market [10][11] - The long-acting 阿立哌唑微球 from 丽珠集团 is another product of interest, potentially replacing oral formulations and capturing market share if included in the insurance directory [12]

Group 1 - A-shares and Hong Kong stocks in the innovative pharmaceutical sector have rebounded, with significant gains in related stocks and ETFs [1][3][5] - The largest medical ETF in A-shares (512170) saw a trading volume of 589 million yuan, recovering 1.34% on the day [1] - The innovative drug sector is experiencing a collective rise, with notable stocks like Huahai Pharmaceutical increasing by 7.59% [3] Group 2 - The Hong Kong innovative drug ETF (520880) rose by 2.12%, with 35 out of 37 constituent stocks gaining, led by Green Leaf Pharmaceutical with an 8.31% increase [5][7] - Recent funding trends indicate a significant inflow into the innovative drug sector, with over 1.29 billion yuan added in the last three days [7] - Upcoming catalysts include the European Society for Medical Oncology (ESMO) annual meeting, which may showcase significant research results from Chinese innovative drugs [7] Group 3 - Investment strategies suggest focusing on innovative drugs, with specific ETFs like the Hong Kong innovative drug ETF (520880) and the A-share drug ETF (562050) highlighted for their potential [8] - The medical ETF (512170) is noted for its inclusion of CXO companies, which account for 26.77% of its weight [8] - The medical ETF is the largest in the market, with a scale of 26.4 billion yuan, while the drug ETF is the only one tracking the China Pharmaceutical Index [9]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 绿叶制药集团有限公司 呈交日期: 2025年10月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02186 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 10,000,000,000 | USD | | 0.02 | USD | | 200,000,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 10,000,000,000 | USD | | 0.02 | USD | | 200,000,000 | 本 ...

Core Insights - Shandong Green Leaf Pharmaceutical Co., Ltd. has been recognized as a leading innovative enterprise in the pharmaceutical sector of Yantai, highlighting its commitment to innovation and industrial development [1][3]. Company Performance - Over the past five years, the company has launched 8 innovative drugs, with 5 more in clinical stages, demonstrating a continuous stream of innovation [3]. - The projected revenue for 2024 is 1.79 billion, with a compound annual growth rate (CAGR) of 21.56% over three years, representing an 80% increase compared to 2021 [3]. - For the first eight months of this year, the company achieved a revenue of 1.372 billion, reflecting a growth of 23.59% [3]. Innovation and Technology - The company focuses on CNS and oncology treatment areas, leveraging advanced drug delivery systems and technologies to establish a strong competitive edge [4]. - Green Leaf Pharmaceutical has developed a globally leading continuous production technology platform, overcoming significant production challenges in microsphere formulations [4]. Market Strategy - The company aims to enhance production capacity for existing products, deepen market penetration, and expand clinical applications to secure a larger market share [4]. - Green Leaf Pharmaceutical is committed to optimizing operational efficiency and advancing lean production and smart manufacturing to improve competitiveness [5]. Future Vision - The company aspires to become a respected global leader in pharmaceuticals, particularly in the treatment of mental health and oncology, while promoting the "Yantai Manufacturing" brand on the international stage [5].

Financial Performance - Revenue increased by RMB 106.5 million or 3.5% to RMB 3,181.1 million for the six months ended June 30, 2025[13] - Gross profit rose by RMB 79.0 million or 3.8% to RMB 2,157.6 million, with a gross margin of 67.8%[13] - Net profit attributable to shareholders decreased by RMB 74.9 million or 19.3% to RMB 312.9 million[13] - EBITDA increased by RMB 48.1 million or 4.2% to RMB 1,204.2 million[13] - The company recorded a revenue increase of 3.5% to RMB 3,181.1 million for the six months ending June 30, 2025[16] - Revenue from the oncology treatment segment increased by 13.5% to RMB 1,295.2 million, while revenue from the central nervous system treatment segment rose by 5.4% to RMB 867.5 million[18] - The cardiovascular treatment segment saw a revenue decrease of 9.2% to RMB 693.0 million, and the metabolic treatment segment's revenue decreased by 7.9% to RMB 180.2 million[18] - The net profit attributable to the company was approximately RMB 357.4 million, a decrease of RMB 80.8 million or 18.4% compared to RMB 438.2 million in the previous year[78] - Total comprehensive income for the period was RMB 425,791 thousand, slightly down from RMB 440,312 thousand in 2024[120] Research and Development - The company has a total of 31 products under development in China, including 13 oncology products and 12 CNS products[6] - The R&D team consists of 611 employees, including 59 PhDs and 299 Master's degree holders[6] - The company has achieved significant R&D milestones for several candidate products during the reporting period[40] - The company continues to invest in four strategic therapeutic areas: oncology, central nervous system, cardiovascular, and metabolism, with 31 products in various stages of development in China as of June 30, 2025, including 13 oncology products, 12 CNS products, and 6 others[39] - The global first weekly-administered transdermal patch for donepezil (LY30410) received approval in China in October 2023 for treating mild to moderate Alzheimer's disease symptoms, and is expected to launch in Japan by March 2025[41] - The next-generation VMAT2 inhibitor LY03015 has shown good safety and tolerability in Phase I trials, with Phase II trials for tardive dyskinesia patients ongoing in China[45] - The company is developing LY03017, a novel compound for treating Parkinson's disease psychosis and Alzheimer's disease psychosis, with promising preclinical results indicating superior efficacy and safety[47] - LY03020, a new generation antipsychotic, has demonstrated significant improvements in schizophrenia symptoms and is expected to meet clinical needs better than existing treatments[48] - LY03021, an innovative compound for treating depression, has shown rapid onset and sustained efficacy in preclinical studies, with Phase I trials ongoing in China[49][51] Market and Competitive Position - The company has established a strong competitive advantage in 18 major products within high-prevalence disease areas, with market share expected to grow or maintain current levels[19] - The company has developed a global supply chain with 8 production bases and adheres to international GMP quality management standards[15] - The product "Lipopson" is the only marketed paclitaxel liposome formulation globally and has been included in the 2024 National Medical Insurance Drug List in China[20] - "Bevacizumab" (博優諾) has received approval for multiple cancer treatments and is currently under review for market authorization in Brazil[21] - "Goserelin" (百拓維) is the only long-acting microsphere formulation of its kind and has been included in the 2023 National Medical Insurance Drug List for prostate cancer treatment[22] - "Zanbiga" (贊必佳) has received priority review approval in China and is the only new chemical entity approved by the FDA for treating recurrent small cell lung cancer in nearly 28 years[23] - "Mimixin" (米美欣) is a novel oral formulation approved for severe pain management, incorporating abuse-deterrent technology to prevent misuse[25] - The company has launched Rykindo, a long-acting injectable for schizophrenia, which was included in the national medical insurance catalog in December 2023, maintaining the original reimbursement standards[29] - Erzofri, a long-acting injectable for schizophrenia, received FDA approval in July 2024, marking it as the first product developed by a Chinese company with independent intellectual property rights in the U.S.[30] Financial Position and Assets - The total assets increased to RMB 32,031.5 million as of June 30, 2025, compared to RMB 27,198.5 million at the end of 2024[10] - As of June 30, 2025, the group's net current assets amounted to approximately RMB 3,748.2 million, an increase from RMB 2,539.0 million as of December 31, 2024[79] - The current ratio increased from approximately 1.24 as of December 31, 2024, to approximately 1.31 as of June 30, 2025, primarily due to a slight increase in current assets[79] - Total borrowings increased from approximately RMB 8,294.4 million as of December 31, 2024, to approximately RMB 9,770.9 million as of June 30, 2025[80] - The debt-to-equity ratio rose from 52.7% as of December 31, 2024, to 59.1% as of June 30, 2025, mainly due to the increase in total borrowings during the reporting period[81] - Non-current assets totaled RMB 16,344,287 thousand as of June 30, 2025, compared to RMB 16,304,093 thousand at the end of 2024[121] - Current assets increased to RMB 15,687,178 thousand from RMB 13,308,107 thousand, indicating a growth of 17.9%[121] - Current liabilities rose to RMB 11,939,025 thousand from RMB 10,769,142 thousand, reflecting an increase of 10.9%[122] - Total equity as of June 30, 2025, was RMB 16,542,615 thousand, up from RMB 15,753,670 thousand at the end of 2024[122] Shareholder and Governance Information - Major shareholders include Green Leaf Pharmaceutical Investment Limited with a 33.13% stake and Hillhouse Fund V, LP with a 14.68% stake[107] - The company has adhered to corporate governance standards, except for a deviation regarding the separation of the roles of Chairman and CEO[100] - The company has adopted a code of conduct for securities trading by directors and employees, ensuring compliance with regulations[101] - The audit committee has reviewed the unaudited interim financial statements for the six months ending June 30, 2025, and recommended their adoption to the board[103] - There were no changes in director information that required disclosure under the listing rules as of the reporting date[105] Cash Flow and Financing Activities - The company’s cash flow from operating activities generated RMB 1,784,352,000, a significant improvement compared to a cash outflow of RMB 394,400,000 in the previous year[126] - The company reported a net cash inflow from financing activities of RMB 583,809 thousand for the six months ended June 30, 2025, compared to RMB 980,399 thousand in the same period of 2024[127] - The company’s total cash flow from investment activities was a net outflow of RMB 267,365 thousand for the six months ended June 30, 2025, an improvement from a net outflow of RMB 505,313 thousand in the same period of 2024[127] - The company has secured bank loans with interest rates ranging from 2.27% to 4.50% for guaranteed bank loans maturing between 2025 and 2026, totaling RMB 3,149,496,000[159] - The company reported a provision for arbitration claims amounting to approximately RMB 273,482,000, including arbitration fees and related interest[161] Risks and Contingencies - The company identified potential risks related to pillar two income tax regulations primarily in Switzerland and mainland China, but these do not pose significant impacts on overall tax risks[142] - As of June 30, 2025, the company had no significant contingent liabilities[82] - There were no major acquisitions or disposals of subsidiaries, associates, or joint ventures during the six months ended June 30, 2025[86]

Group 1 - Tianfeng Securities has revised down the revenue forecasts for Green Leaf Pharmaceutical for 2025 and 2026 from 8.529 billion and 10.279 billion to 6.638 billion and 7.447 billion respectively, with an expected revenue of 8.162 billion in 2027 [1] - The net profit estimates have also been reduced from 1.373 billion and 1.678 billion to 672 million and 831 million for 2025 and 2026, with an expected net profit of 916 million in 2027 [1] - In the first half of 2025, the company reported a revenue of 3.181 billion, a year-on-year increase of 3.5%, while the net profit attributable to the parent company was 313 million, a year-on-year decrease of 19.3% [1] Group 2 - The company focuses on two major therapeutic areas: CNS and oncology, with multiple new products beginning commercialization and the sales proportion of new products increasing by 32% year-on-year [1] - In the oncology treatment sector, revenue reached 1.295 billion, a year-on-year increase of 13.5%, while CNS treatment revenue was 868 million, up 5.4%. Cardiovascular treatment revenue was 693 million, down 9.2%, and metabolic treatment revenue was 180 million, down 7.9% [1] Group 3 - The company has successfully commercialized two major products in the CNS field, with Ruxinlin being the first domestically developed antidepressant included in the 2024 medical insurance catalog, achieving over fourfold sales growth in the first half of 2025 [2] - ERZOFRI, a treatment for schizophrenia, was commercialized in the U.S. in April 2025, marking it as the first drug of its kind developed by a Chinese company with independent intellectual property rights [2] - The company has a rich pipeline of innovative drugs in development, including LY03017 for treating Parkinson's disease psychosis and Alzheimer's disease psychosis, with expected completion of Phase I trials in China by the end of 2025 [3]

Core Viewpoint - Tianfeng Securities has revised down the revenue and net profit forecasts for Green Leaf Pharmaceutical for 2025 to 2026 due to intense market competition and centralized procurement impacts, while maintaining a "Buy" rating [1] Group 1: Financial Performance - The revenue forecast for Green Leaf Pharmaceutical has been adjusted from 85.29 billion and 102.79 billion to 66.38 billion and 74.47 billion for 2025 and 2026 respectively, with an expected revenue of 81.62 billion for 2027 [1] - The net profit forecast has been revised down from 13.73 billion and 16.78 billion to 6.72 billion and 8.31 billion for 2025 and 2026 respectively, with an expected net profit of 9.16 billion for 2027 [1] - In the first half of 2025, the company reported revenue of 31.81 billion, a year-on-year increase of 3.5%, while the net profit attributable to the parent company was 3.13 billion, a year-on-year decrease of 19.3% [1] Group 2: Business Focus and Product Development - The company is focusing on two major areas: CNS (Central Nervous System) and oncology, with multiple new products beginning commercialization and an increasing sales proportion of new products (up 32% year-on-year) [1] - In the oncology treatment sector, revenue reached 12.95 billion, a year-on-year increase of 13.5%, while CNS treatment revenue was 8.68 billion, up 5.4%. Cardiovascular treatment revenue was 6.93 billion, down 9.2%, and metabolic treatment revenue was 1.80 billion, down 7.9% [1] Group 3: New Product Commercialization - The company has successfully commercialized two major products in the CNS field, with Ruxinlin being the first domestically developed antidepressant included in the 2024 medical insurance directory, showing over 4 times year-on-year sales growth [2] - ERZOFRI, a product for treating schizophrenia, entered the U.S. market in April 2025, being the first of its kind developed by a Chinese company with independent intellectual property rights [2] - ERZOFRI has a long patent period until 2039 and is currently in a favorable competitive landscape with only two companies in the market [2] Group 4: Innovation Pipeline - The company has a rich pipeline of innovative drugs in development, actively seeking business development collaborations with multinational corporations [3] - LY03017, aimed at treating Parkinson's disease psychosis and Alzheimer's disease psychosis, is expected to complete Phase I clinical trials in China by the end of 2025, with IND approval anticipated in Q3 2025 [3] - Other innovative drugs, including LY03015 for tardive dyskinesia and Huntington's disease, are in Phase II clinical trials, with data expected in the first half of 2026 [3]