Core Viewpoint - The approval of the recombinant anti-human beta-amyloid monoclonal antibody injection, Lunakanai, by the National Medical Products Administration of China marks a significant milestone for the company as it becomes the first biosimilar of Lunakanai to receive clinical trial permission in China [1] Company Summary - The product is a biosimilar to Leqembi, classified under Category 3.3 of therapeutic biological products, and is intended for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] - The development of the product adheres to the relevant research guidelines for biosimilars, ensuring that it meets the necessary standards for quality, safety, and efficacy [1] - Pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug, supporting the initiation of subsequent clinical studies [1]

（股份代號：1093） （於香港註冊成立之有限公司） 自願公告 侖卡奈單抗注射液在中國獲臨床試驗批准 石 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 」）欣 然 宣 佈，本集團開發的侖卡奈單抗注射液（「該產品」）已獲中華人民共和國國家藥品監督管理局 批 准 ， 可 在 中 國 開 展 臨 床 試 驗 ， 為 國 內 首 個 獲 得 臨 床 許 可 的 侖 卡 奈 單 抗 注 射 液 生 物 類 似 藥。 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。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 該產品是一種重組抗人b澱粉樣蛋白單克隆抗體，為樂意保®的生物類似藥，按照治療用生 物製品3.3類申報，適用於治療由阿爾茨海默病引起的輕度認知障礙和阿爾茨海默病輕度痴 呆。 該產品的研發遵循生物類似藥相關研究指南。藥學及非 ...

Group 1 - The top three stocks with net inflow of southbound funds are Yingfu Fund (02800) with 2.924 billion, Alibaba-W (09988) with 2.610 billion, and Hang Seng China Enterprises (02828) with 1.595 billion [1][2] - The top three stocks with net outflow of southbound funds are Meituan-W (03690) with -0.388 billion, Innovent Biologics (01801) with -0.292 billion, and CSPC Pharmaceutical Group (01093) with -0.261 billion [1][2] - In terms of net inflow ratio, Datang Renewable (01798) leads with 69.20%, followed by Gushengtang (02273) with 58.06%, and Anhui Wanshan Expressway (00995) with 55.69% [1][3] Group 2 - The top ten stocks with the highest net inflow include China Mobile (00941) with 0.481 billion and FIT HON TENG (06088) with 0.450 billion [2] - The top ten stocks with the highest net outflow include China Life (02628) with -0.196 billion and China Construction Bank (00939) with -0.174 billion [2] - The net outflow ratios for the top three stocks are led by Kangji Medical (09997) at -54.12%, followed by Liaogang Co. (02880) at -49.57%, and Zhenjiu Lidu (06979) at -48.65% [3]

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 1.50% on September 22, with a trading volume of 1.263 billion yuan [1] - The fund was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1] - As of September 19, 2024, the fund's latest share count was 8.17 billion shares, with a total size of 7.676 billion yuan, reflecting a year-to-date increase of 1966.38% in shares and 1931.78% in size compared to December 31, 2023 [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 87.92% during the management period [2] - The top holdings of the fund include Innovent Biologics (9.52%), WuXi Biologics (9.47%), BeiGene (8.73%), and others, with their respective market values and share counts detailed [2] - The cumulative trading amount over the last 20 trading days reached 37.235 billion yuan, with an average daily trading amount of 1.862 billion yuan [1][2]

Core Insights - The article discusses the competitive landscape of the drug Diphenylhydantoin, primarily dominated by CSPC Pharmaceutical Group, and highlights the recent failed market entry attempt by a subsidiary of Fosun Pharma, Jinzhou Aohong Pharmaceutical, with their modified new drug SBK010 [1][11]. Market Overview - Diphenylhydantoin, marketed as Enbip, is a Class 1 new drug in China, providing new hope for patients with ischemic stroke. The soft capsule form was launched in 2004, and the injection form was approved in 2009, making it the third Class 1 new drug with independent intellectual property rights in China after artemisinin and bifendate [3]. - The market for Diphenylhydantoin is substantial, with projected total sales exceeding 6 billion yuan in 2024, and sales nearing 3 billion yuan by mid-2025, accounting for nearly 30% of CSPC's revenue [3][5]. Competitive Challenges - Despite the attractive market prospects, many companies have attempted to enter the Diphenylhydantoin market through generic or modified versions but have ultimately failed [5]. - The primary obstacles for generic versions include the lack of inclusion in the reference preparation directory, which has delayed the approval process for many companies that have completed bioequivalence (BE) trials [8][14]. Clinical Trial Insights - The failure of Fosun's SBK010 is attributed to the absence of Phase III clinical trials, which CSPC has rigorously conducted, establishing a robust clinical trial system that ensures the safety and efficacy of Diphenylhydantoin [11][14]. - Currently, only Hebei Saipuruisi Pharmaceutical Technology Co., Ltd. is advancing a Phase III clinical trial for a modified version of Diphenylhydantoin, which could potentially break the current deadlock in the market [14]. Patent Landscape - Although the compound patent for Diphenylhydantoin has expired, CSPC has successfully extended the composition and preparation method patents until 2032, complicating the entry of other companies into the market [14][15]. - The combination of unresolved reference preparation status, unclear clinical pathways, and stringent patent restrictions creates significant barriers for competitors seeking to develop their own versions of Diphenylhydantoin [14]. Innovation and Future Outlook - CSPC continues to innovate, having launched several new drugs in 2024, including Enlansumab and Omab, while also achieving breakthrough therapy designations for multiple projects, reinforcing its leadership in the pharmaceutical market [15].

Core Viewpoint - The report from Open Source Securities highlights that CSPC Pharmaceutical Group (01093) is intensifying its focus on innovation, establishing eight major technology platforms, and has over 130 projects in its pipeline, indicating a period of concentrated value realization for its innovations [1] Financial Projections - The firm forecasts the net profit attributable to the parent company for 2025-2027 to be 4.915 billion, 5.272 billion, and 5.714 billion yuan respectively, with EPS projected at 0.4, 0.5, and 0.5 yuan, corresponding to PE ratios of 21.4, 20.0, and 18.4 times [1] Innovation and Collaborations - CSPC has achieved multiple external licensing agreements for several innovative products in recent years, including Lp(a), MAT2A, ROR1ADC, and irinotecan liposome, with expected revenue recognition from these licenses in 2025 [1] - The company is currently in discussions with international pharmaceutical firms regarding various innovative drug projects, including a collaboration with AstraZeneca in June to co-develop a new oral small molecule candidate using an AI-driven drug discovery platform [1] - In July, CSPC announced the global licensing of its small molecule GLP-1 receptor agonist SYH2086 to Madrigal Pharmaceuticals, which includes a $120 million upfront payment [1] R&D Platform and Growth Potential - The company's R&D platform is entering a realization phase, and the achievement of multiple licensing agreements is expected to become its second growth curve [1]

Core Viewpoint - The report from Kaiyuan Securities highlights that CSPC Pharmaceutical Group (01093) is intensifying its focus on innovation, establishing eight major technology platforms, and has over 130 projects in its pipeline, indicating that the value of its innovations is entering a concentrated realization phase [1] Financial Projections - The company is expected to achieve net profit attributable to shareholders of 4.915 billion, 5.272 billion, and 5.714 billion yuan for the years 2025 to 2027, respectively [1] - Earnings per share (EPS) are projected to be 0.4, 0.5, and 0.5 yuan for the same years, with corresponding price-to-earnings (PE) ratios of 21.4, 20.0, and 18.4 times [1] Innovation and Collaborations - CSPC has recently entered into multiple external licensing agreements for several innovative products, including Lp(a), MAT2A, ROR1 ADC, and irinotecan liposome, with expected revenue recognition from these licenses in 2025 [1] - The company is actively negotiating licensing agreements for various innovative drug projects with international pharmaceutical companies, including a collaboration with AstraZeneca in June to develop a new oral small molecule candidate driven by AI [1] - In July, CSPC announced the global licensing of its small molecule GLP-1 receptor agonist SYH2086 to Madrigal Pharmaceuticals, which includes a $120 million upfront payment [1] - The realization of revenue from multiple pipelines is anticipated to become a second growth curve for the company [1]

Key Points - The article highlights the net inflow and outflow of funds for various companies in the Hong Kong market, with Alibaba-W leading the inflow [1][2] - It provides detailed statistics on the top companies with the highest net inflows and outflows, indicating market trends [2][3] Group 1: Net Inflows - Alibaba-W (09988) recorded a net inflow of 5.042 billion, representing a 20.09% increase in its closing price to 161.600 [2] - Meituan-W (03690) saw a net inflow of 2.098 billion, with a 14.37% increase in its closing price to 105.200 [2] - Changfei Optical Fiber (06869) had a net inflow of 0.989 billion, with an 18.51% increase in its closing price to 54.150 [2] Group 2: Net Outflows - Xiaomi Group-W (01810) experienced the highest net outflow of -0.644 billion, with a -6.48% change in its closing price to 57.850 [2] - China Mobile (00941) had a net outflow of -0.514 billion, reflecting a -25.37% decrease in its closing price to 86.600 [2] - Stone Pharmaceutical Group (01093) faced a net outflow of -0.415 billion, with an -18.51% change in its closing price to 10.010 [2] Group 3: Net Inflow Ratios - The top net inflow ratio was recorded by Standard Chartered Hong Kong 100 (02825) at 100.00%, with a net inflow of 0.0187 million [3] - Datang New Energy (01798) had a net inflow ratio of 53.77%, with a net inflow of 0.03897 million [3] - Jiangsu Ninghu Highway (00177) reported a net inflow ratio of 53.56%, with a net inflow of 0.02301 million [3] Group 4: Net Outflow Ratios - China National Heavy Duty Truck Group (03808) had the highest net outflow ratio at -66.74%, with a net outflow of -0.06031 billion [3] - Q Technology (01478) recorded a net outflow ratio of -51.13%, with a net outflow of -0.03931 billion [3] - China State Construction International (03311) faced a net outflow ratio of -44.37%, with a net outflow of -0.05668 billion [3]

Core Viewpoint - The Hong Kong Innovative Drug ETF (159567) has shown significant growth in both share volume and fund size since its inception, indicating strong investor interest in the innovative drug sector [1][2]. Fund Performance - As of September 18, 2024, the fund's share volume reached 8.17 billion shares, with a total size of 7.839 billion yuan, reflecting an increase of 1966.38% in share volume and 1974.81% in size compared to its initial figures on December 31, 2023 [1]. - The fund manager, Ma Jun, has achieved a return of 90.14% since taking over management on January 3, 2024 [2]. Trading Activity - The ETF recorded a trading volume of 12.58 billion yuan on September 19, 2024, with an average daily trading amount of 18.71 billion yuan over the last 20 trading days [1]. - Year-to-date, the ETF has accumulated a total trading amount of 206.404 billion yuan over 176 trading days, averaging 11.73 billion yuan per day [1]. Top Holdings - The ETF's major holdings include: - Innovent Biologics (9.52% holding, 263 million yuan market value) - WuXi Biologics (9.47% holding, 258 million yuan market value) - BeiGene (8.73% holding, 238 million yuan market value) - CanSino Biologics (7.62% holding, 208 million yuan market value) - China National Pharmaceutical Group (7.17% holding, 196 million yuan market value) [2].

Core Viewpoint - The company, 石药集团 (Stone Group), announced the grant of 9 million restricted shares to an employee under its restricted share award plan, pending acceptance by the recipient [1] Group 1 - The grant involves a total of 9 million restricted shares [1] - The recipient of the shares is an employee who is not a director, CEO, or a major shareholder, nor connected to any of these individuals [1] - The grant will only be effective upon acceptance by the recipient [1]