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之內容概不負責，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。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 自願性公告 全球創新產品萊特靈®(Ryaltris®)複方鼻噴劑在中國獲批上市 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 董事會欣然公告，由 Glenmark Specialty S.A. (「Glenmark」)研發的全球創新藥 Ryaltris® 複方鼻噴劑(「GSP 301 NS」或「萊特靈® 」)近日獲得中華人民共和國國家藥品監督管 理局(「藥監局」)頒發的藥品註冊證書，用於治療成人和兒童的過敏性鼻炎(「AR」)， 且在藥品審評過程中未收到補充資料通知，實現「零發補」獲批上市，這是本集團在呼 吸及危重症領域的又一項重大研發進展。本集團於二零一九年二月與 Glenmark 訂立了 ...

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]

Group 1 - The core point of the article is that Yuan Da Pharmaceutical (00512.HK) experienced a significant stock price increase of over 6%, reaching a price of 8.79 HKD with a trading volume of 101 million HKD [1]

Core Viewpoint - The recent announcement by the company regarding the completion of patient enrollment for the GPN00884 clinical trial marks a significant step in the development of a new treatment for childhood myopia, potentially transforming the management of this condition in the future [1] Group 1: Company Developments - The company's stock price increased by 6.42%, reaching HKD 8.79, with a trading volume of HKD 101 million [1] - The GPN00884 drug, aimed at delaying the progression of myopia in children, has entered a critical phase of clinical research in China, focusing on dosage exploration and preliminary efficacy assessment [1] - The successful launch of the OC-01 nasal spray in mainland China represents a significant innovation in the treatment of dry eye disease, transitioning from external substitutes to internal awakening therapies [1] Group 2: Industry Impact - The completion of the GPN00884 trial's first patient enrollment is expected to pave the way for new treatment options for childhood myopia, which could have a substantial impact on pediatric ophthalmology [1] - The OC-01 launch at the national conference highlights a shift in the treatment paradigm for dry eye patients, emphasizing advancements in therapeutic approaches within the ophthalmic industry [1]

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]

Core Viewpoint - The launch of the OC-01 nasal spray by Yuan Da Pharmaceutical marks a significant advancement in the treatment of dry eye syndrome, transitioning from passive hydration to active tear production, which is expected to disrupt the current market dominated by eye drops [1][2][5]. Group 1: Product Overview - The OC-01 nasal spray is the only approved product in China designed to increase tear secretion for dry eye patients, utilizing a method that activates the trigeminal nerve pathway to stimulate the lacrimal glands [2][3]. - This product aims to promote the production of natural tears, which contain various nutrients and protective factors, rather than merely replacing moisture [2][5]. Group 2: Market Potential - The dry eye syndrome market in China is projected to reach 18 billion yuan by 2030, driven by the increasing prevalence of the condition due to the widespread use of electronic devices [1][4]. - The overall ophthalmic drug market in China is expected to grow to 44 billion yuan by 2025 and reach 108.4 billion yuan by 2030, with the dry eye drug segment anticipated to grow at a compound annual growth rate (CAGR) of 16.17% from 2020 to 2024 [4]. Group 3: Competitive Landscape - Other companies, including Xingqi Eye Medicine and Heng Rui Pharmaceutical, are also entering the dry eye market, with various products in development, particularly in the cyclosporine eye drop segment [6][7]. - The competition is intensifying with the approval of several new products, including sodium hyaluronate eye drops by Kanghong Pharmaceutical and Huaxi Biological, indicating a rapidly evolving market [7].

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].