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: 遠大醫藥集團有限公司 呈交日期: 2025年11月3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) | 00512 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | | 增加 / 減少 (-) | | | | | | HKD | | | | 本月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | 本月底法定/註冊股本總額： HK ...

Core Viewpoint - The Hong Kong Stock Connect Innovative Drug ETF (Southern, 159297) has shown significant market activity, with a recent increase of 3.38% and a trading volume of 170 million yuan, indicating strong investor interest in the innovative drug sector [1] Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (Southern, 159297) reached a new high in both scale and shares since its inception as of October 31 [1] - The ETF has experienced net inflows for 4 out of the last 5 trading days, totaling 18.9 million yuan [1] - The index it tracks, the National Certificate Hong Kong Stock Connect Innovative Drug Index, rose by 3.67%, with notable increases in component stocks such as Senhwa Biosciences (up 10.11%) and Kanglongda (up 8.80%) [1] Group 2: Policy and Industry Insights - The ongoing negotiations for the National Medical Insurance drug list are complemented by a new commercial health insurance innovative drug directory, aimed at providing new payment channels for high-value innovative drugs [1] - The CAR-T cell drug, Rukiyou Lunsai injection from WuXi AppTec, is making progress in negotiations to be included in the commercial health insurance innovative drug directory, with a listed price of 1.29 million yuan per injection [1] - Open Source Securities notes that the current innovative drugs included in both medical insurance and commercial insurance are in the early stages of volume growth, with potential for rapid revenue increases as policies continue to support innovative drugs [2] Group 3: Institutional Investment Trends - According to Guotou Securities, the proportion of all funds heavily invested in Biotech innovative drug companies has increased to 27.53%, reflecting a 2.61 percentage point rise, indicating growing institutional interest in the innovative drug sector [2] - The increasing allocation of funds to the innovative drug sector suggests a strong market recognition of its long-term development potential [2]

每经AI快讯，远大医药(00512.HK)午前涨超6%，截至发稿，涨6.42%，报8.79港元，成交额1.01亿港 元。 ...

远大医药(00512)午前涨超6%，截至发稿，涨6.42%，报8.79港元，成交额1.01亿港元。 值得注意的是，今年7月，酒石酸伐尼克兰鼻喷雾剂(OC-01)落地中国大陆，通过鼻喷方式革新中国干眼 患者治疗体验。近日，远大医药以第十一届全球干眼学术会议中的"关爱干眼患者，启迎原生泪液时代 ——2025干眼诊疗新进展与眼表健康生态构建大会"为契机，成功举行了OC-01的全国上市会，正式宣 告了干眼症治疗从"外部替代"到"内在唤醒"治疗新纪元的到来。 消息面上，远大医药近日公告称，公司用于延缓儿童近视进展的全球创新眼科药物GPN00884在中国开 展的IIa期临床研究已完成头例患者入组给药。这意味着，GPN00884将进入探索药物剂量、评估初步疗 效的重要阶段。一旦成功兑现药物有效性预期，临床或将迎来全新的缓解儿童近视进展方案。 ...

Group 1 - The Hong Kong Stock Connect innovative drug sector experienced a significant rebound on November 3, with the innovative drug ETF (520880) showing a volatility of over 4.4% and a trading volume exceeding 500 million yuan, indicating strong bullish sentiment [1] - Key stocks such as Kangfang Biotech, Xiansheng Pharmaceutical, and Kangnuo Ya-B saw increases of nearly 6%, while other companies like Yuanda Pharmaceutical and Rongchang Biotech also experienced substantial gains [1] - The National Medical Insurance negotiation, which began on October 30, is expected to conclude with results announced in early December, introducing a new "commercial insurance innovative drug catalog" mechanism for the first time [1] Group 2 - Fund manager Feng Chen indicated that the innovative drug market could see a resurgence, suggesting that now may be a high-probability period for medium to long-term investments in innovative drugs [2] - The recent meeting between US and Chinese leaders has alleviated previous risks that suppressed the sector's performance, potentially allowing previously withdrawn funds to re-enter the market [2] - The current earnings season has shown strong performance from companies like Innovent Biologics and Hengrui Medicine, boosting confidence in the sector [2] Group 3 - The Hong Kong Stock Connect innovative drug ETF (520880) passively tracks the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which focuses entirely on innovative drug R&D companies, with over 70% of its holdings in large-cap innovative drug leaders [3] - As of the end of September, the index has seen a year-to-date increase of 108.14%, outperforming other innovative drug indices [3] - The ETF has a fund size of 1.806 billion yuan and an average daily trading volume of 493 million yuan, making it the largest and most liquid ETF tracking this index [3]

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]

港股上市公司远大医药旗下产品酒石酸伐尼克兰鼻喷雾剂（OC-01）近日在国内上市，其特点在于通过 鼻喷给药，直接"唤醒"泪腺，从"被动补水"迈向"主动生水"促进泪液分泌，使干眼症治疗进入"原生泪 液"时代。 随着电子产品的普及，干眼症发病率上升，药物市场需求居高不下。公开数据显示，国内干眼症药物市 场规模在2030年有望达到180亿元。远大医药新药被认为有可能颠覆当前以局部滴注为主的干眼症药物 格局，与此同时欧康维视、恒瑞医药等多家企业亦在布局干眼症药物市场。 远大医药携新品入局 随着电子产品的普及以及不良用眼习惯等因素，眼科疾病的发病率也随之增加，发病年龄也呈现出年轻 化的趋势，据《2024国民眼健康年度报告》，18-35岁人群干眼症发病率达63%，比10年前上升了 400%。 发病率的增加，直接促进了药物市场规模的扩大。据弗若斯特沙利文测算，2025年中国眼科药物市场将 达440亿元，并将于2030年攀升至1084亿元。干眼症药物市场这一细分赛道也迎来增长，在2024年达到 47.9亿元，2020年-2024年复合增长率达16.17%。弗若斯特沙利文预计，国内干眼症药物市场将在2030 年达到180亿元。 ...

Core Viewpoint - The launch of OC-01, a novel nasal spray for treating dry eye syndrome, marks a significant advancement in the treatment landscape for dry eye patients in China, transitioning from external substitutes to internal stimulation of tear production [1][6]. Group 1: Product Launch and Market Impact - OC-01 was officially launched in mainland China during the 11th Global Dry Eye Academic Conference, indicating a new era in dry eye treatment [1]. - The product is expected to capture a significant share of the dry eye medication market, which is projected to reach 180 billion yuan, providing effective and convenient treatment for millions of dry eye patients [7]. Group 2: Clinical and Market Validation - OC-01 has shown promising results in the U.S. market, with over 97,000 prescriptions written within a year of its approval and approximately $42 million in sales revenue in 2023 [6]. - The product's innovative mechanism, which stimulates natural tear production through nasal administration, addresses the limitations of traditional eye drops, enhancing patient compliance and treatment efficacy [6][5]. Group 3: Industry Context and Future Prospects - The dry eye syndrome is a prevalent condition, affecting 21.0%-52.4% of the population in China, with a notable increase in younger patients, particularly those aged 18-35, whose incidence has risen by 400% over the past decade [5]. - The broader ophthalmic market in China is expected to grow significantly, with projections estimating the eye care drug market to reach 440 billion yuan by 2025 and 1,084 billion yuan by 2030 [9]. Group 4: Company Pipeline and Innovation Strategy - The company has developed a comprehensive pipeline of innovative ophthalmic products, including treatments for dry eye syndrome, meibomian gland dysfunction, and other eye conditions, enhancing its market position [9][12]. - Recent approvals and clinical advancements in the company's pipeline indicate a strong commitment to innovation and market expansion, with multiple products expected to be launched in the coming years [13].

Core Insights - The increasing prevalence of dry eye patients in China highlights a gap in public understanding, which remains focused on temporary relief through eye drops rather than addressing underlying issues [2] - The launch of the innovative drug, the tobramycin nasal spray, represents a shift towards a "repair-type" strategy for treating dry eye, aiming to restore tear gland function and enhance natural tear production [2][4] - The conference held on October 25 showcased the new nasal spray and brought together leading experts to discuss advancements in dry eye treatment and the establishment of a healthy ocular ecosystem [4] Group 1: Medical Insights - Experts from Xiamen University and Huazhong University of Science and Technology discussed typical symptoms and high-risk groups for dry eye, emphasizing the need for new treatment methods that actively stimulate tear production [1] - Clinical evidence presented by Zhejiang University highlighted the long-term benefits of the nasal spray in promoting secretion and providing rapid anti-inflammatory effects [1] - The transition from "supplementing water" to "producing water" in dry eye treatment was analyzed, focusing on the innovative mechanism of the nasal spray that activates tear secretion through neural stimulation [1] Group 2: Industry Developments - The traditional approach of using artificial tears is criticized for its limitations, including dependency and potential suppression of natural tear production, which can worsen the condition over time [2] - The launch of the nasal spray aligns with the strategic vision of the company to enhance its portfolio in ophthalmology, with plans for multiple new drug approvals in the next three years targeting various eye conditions [2]