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: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 | 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) | 02561 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 頁 共 10 頁 v 1.2.0 FF301 II. 已發 ...

Core Viewpoint - The approval of Weisheng Pharmaceutical's core product, Longpei Growth Hormone Injection, marks the company's first commercialized innovative product, but it faces significant competition in the long-acting growth hormone market [3][4]. Market Overview - The Chinese growth hormone market has seen explosive growth, increasing from 4 billion yuan in 2018 to 11.6 billion yuan in 2023, with a compound annual growth rate (CAGR) of 23.9%, and is expected to reach 28.6 billion yuan by 2030 [3]. - The market is characterized by a shift in dosage forms, with long-acting growth hormones gaining traction due to better patient compliance compared to short-acting formulations [3][4]. Competitive Landscape - The competition in the long-acting growth hormone market is intensifying, with existing players including Changchun High-tech, Teva Biopharma, and Novo Nordisk, all of which have products already included in the national medical insurance directory [4][5]. - The entry of long-acting growth hormones into the insurance directory has led to significant price reductions, with some products seeing price drops of over 50%, thereby reducing the financial burden on patients and expanding market share [5]. Company Strategy - As a new entrant, Weisheng Pharmaceutical aims to differentiate itself by emphasizing that Longpei Growth Hormone is the only long-acting growth hormone proven to be superior to daily injections in Phase III studies, providing clear prescription guidance for doctors [6]. - The company recognizes that most growth hormone users are still self-paying, and it plans to collaborate with high-end private clinics to better reach target customers [6]. - The current penetration rate of growth hormones among children in China remains low, indicating a need for increased product awareness and education among potential users [6].

Core Insights - The competition in the long-acting growth hormone market is intensifying, with Weisheng Pharmaceutical's (02561.HK) core product, Longpei growth hormone injection, recently approved for treating children's growth hormone deficiency, marking it as the fourth long-acting growth hormone approved in China [1][2] Industry Overview - The Chinese growth hormone market has seen significant growth, expanding from 4 billion yuan in 2018 to 11.6 billion yuan in 2023, with a compound annual growth rate (CAGR) of 23.9%, and is projected to reach 28.6 billion yuan by 2030 [3] - The market is experiencing a shift in dosage forms, with increasing attention from parents due to "height anxiety" regarding their children's growth, leading to heightened demand for growth hormone treatments [3] Competitive Landscape - Existing competitors in the long-acting growth hormone market include Changchun High-tech (000661.SZ) with Jinsai Pharmaceutical, Teva Biologicals (688278.SH), and Novo Nordisk, with some products already included in the national medical insurance directory, resulting in significant price reductions [3] - The entry of long-acting growth hormones into the insurance directory has led to price drops of over 50%, alleviating the financial burden on patients and potentially expanding market share [3] Company Strategy - As a new market entrant, Weisheng Pharmaceutical aims to differentiate itself by promoting Longpei growth hormone as the only long-acting option proven superior to daily injections in Phase III studies, providing clear prescription guidance for doctors [4] - The majority of growth hormone users are still self-paying, and despite some long-acting products being covered by insurance, this trend is expected to continue, with a focus on partnerships with private clinics to reach target customers [4] - The current penetration rate of growth hormones among children in China remains low, indicating a need for increased product awareness and education among potential users [4]

Core Insights - The long-acting growth hormone market in China is experiencing rapid growth, with market share increasing from less than 10% in 2018 to over 35% in 2023, driven by demands for efficacy and treatment experience [1][2]. Product Breakthrough - The core product of Weisheng Pharmaceutical, Lonapegsomatropin, has received approval from the National Medical Products Administration, marking it as the first product in China with both long-acting and natural structure advantages, addressing unmet clinical needs [2][3]. - Lonapegsomatropin is the only long-acting growth hormone (LAGH) clinically proven to outperform daily growth hormone formulations, showcasing its Best-in-Class (BIC) attributes [3][4]. Clinical Validation - Weisheng has completed critical Phase III trials for Lonapegsomatropin in treating pediatric growth hormone deficiency (PGHD), demonstrating its efficacy and safety compared to daily injections [4][5]. - Multiple key Phase III trials globally support the product's use in initial treatment, conversion therapy, and long-term medication, providing solid evidence for its market introduction [5]. Commercialization Strategy - The approval of Lonapegsomatropin represents a pivotal moment for Weisheng, which has established a comprehensive commercialization system to facilitate product launch and market penetration [6][7]. - A strategic partnership with Anke Bio will enhance the promotion of Lonapegsomatropin in China, leveraging Anke's extensive experience and market presence in the growth hormone sector [7]. Market Potential - The global market for Lonapegsomatropin has already seen success, with sales in the U.S. projected to grow from €179 million in 2023 to €206 million by 2025, indicating strong market acceptance [8]. - In China, there is a significant supply-demand gap in PGHD treatment, with an estimated 3.4 million patients and a treatment rate of only 5.3%, suggesting substantial growth potential for long-acting growth hormones [8]. Pipeline and Future Growth - Weisheng's pipeline includes promising candidates for other endocrine disorders, reinforcing its long-term growth strategy and market presence [9]. - The commercialization of Lonapegsomatropin is expected to generate continuous cash flow and support the development of future products, marking a new phase of accelerated growth for the company [9]. Market Positioning - The Hong Kong innovative pharmaceutical sector is transitioning from a research-driven valuation to a profit realization phase, with Weisheng positioned as a rare entity with an approved long-acting growth hormone product [10]. - The competitive landscape for long-acting growth hormones in China is becoming clearer, with Lonapegsomatropin expected to steadily increase its market share over the next 3-5 years, positively impacting the company's valuation [10].

每经AI快讯，维昇药业-B(02561.HK)涨超7%，截至发稿涨7.52%，报42.9港元，成交额156.35万港元。 （文章来源：每日经济新闻） ...

Core Viewpoint - Viesheng Pharmaceutical-B (02561) has seen a stock increase of over 7% following the approval of its core product, lonapegsomatropin, by the National Medical Products Administration of China for treating growth hormone deficiency in children aged 3 and above [1] Group 1: Product Approval - Lonapegsomatropin, marketed as维臻高, has received official approval for use in treating growth hormone deficiency in children and adolescents [1] - The product is developed using Ascendis Pharma's innovative TransCon technology and is the first growth hormone regimen approved for children in the United States [1] Group 2: Commercialization Plans - Following the BLA approval, the company has initiated a comprehensive commercialization plan to ensure supply and expand market coverage [1] - A commercialization supply agreement has been established with Ascendis Pharma to secure the product's market launch [1] - The company is enhancing its commercialization capabilities by building a dedicated team and implementing tailored strategies for commercialization, physician awareness, and market access [1]

Core Insights - The long-acting growth hormone market in China has seen a significant increase, with its market share rising from less than 10% in 2018 to over 35% in 2023, driven by the dual demand for "treatment efficacy certainty" and "treatment experience" [1] - The approval of Weisheng Pharmaceutical's long-acting growth hormone, Lonapegsomatropin, marks a critical milestone for the company, positioning it as a potential "best-in-class" product in the market [2] - The product addresses key issues in pediatric growth hormone deficiency treatment, particularly the challenges of treatment adherence and efficacy stability, with a unique weekly dosing regimen [3][4] Product Breakthrough - Lonapegsomatropin is the first long-acting growth hormone in China that combines a weekly administration schedule with a natural hormone structure, providing a targeted solution to existing treatment challenges [3] - The product has demonstrated superior efficacy compared to daily injection formulations in clinical trials, establishing its best-in-class status [4] - The innovative TransCon prodrug technology allows for a safer and more effective release of growth hormone, reducing the incidence of adverse reactions [4] Commercialization Strategy - Weisheng Pharmaceutical has established a comprehensive commercialization framework to support the product's market entry, including partnerships to enhance distribution and reach [6][7] - The company has signed a strategic cooperation agreement with Anke Bio, leveraging its extensive experience and market presence to accelerate the promotion of Lonapegsomatropin [7] - The product has already achieved commercial validation in global markets, with significant sales growth projected in the coming years [7] Market Potential - There is a substantial unmet need in the pediatric growth hormone deficiency treatment market in China, with an estimated 3.4 million patients and a treatment rate of only 5.3% [8] - The long-acting growth hormone market is expected to capture approximately 80% of the overall growth hormone market by 2030, with Weisheng aiming for a 15%-20% market share [8] - The company’s pipeline includes additional promising products, enhancing its long-term growth prospects and market positioning [8] Industry Context - The Hong Kong innovative pharmaceutical sector is transitioning from a "research-driven valuation" to a "profit realization valuation" phase, with Weisheng's product launch aligning with this trend [10] - The competitive landscape for long-acting growth hormones in China is becoming clearer, with Lonapegsomatropin expected to steadily increase its market share over the next 3-5 years [10] - The successful commercialization of Lonapegsomatropin is anticipated to significantly enhance the company's valuation and performance, reflecting its industrial development capabilities [10]

Core Viewpoint - The approval of the long-acting growth hormone, Rongpei (SKYTROFA), by the National Medical Products Administration marks a significant advancement in the treatment of growth hormone deficiency in children aged 3 and above in China [1]. Group 1: Product Approval - Weisheng Pharmaceutical has received approval for the marketing authorization of Rongpei growth hormone in China [1]. - The product is specifically indicated for treating growth retardation due to growth hormone deficiency in children and adolescents [1]. Group 2: Product Characteristics - Rongpei is a weekly administered growth hormone replacement therapy, distinguishing itself as the only long-acting growth hormone that has demonstrated superior efficacy and equivalent safety compared to short-acting daily injections in positive parallel-controlled trials [1]. - The drug has successfully completed Phase III pivotal trials in China [1].

Company News - China Power (02380.HK) expects a total consolidated electricity sales volume of 10.73105 million MWh by December 2025, a decrease of 2.31% year-on-year; the total annual electricity sales volume is approximately 126 million MWh, down 1.27% year-on-year [2] - Harbin Electric (01133.HK) anticipates a net profit attributable to shareholders of approximately RMB 2.65 billion for the fiscal year 2025, compared to RMB 1.686 billion in the previous year, mainly due to increased operating revenue and improved product profitability [2] - Singularity Guofeng (01280.HK) has entered into a GPU distribution cooperation agreement with Muxi Co., aiming to enter the domestic AI computing power market [2] - Dongyang Sunshine Pharmaceutical (06887.HK) has signed a strategic cooperation agreement with Shenzhen Jingtai to establish a joint venture for building an AI-driven drug research and development platform [2] - Weisheng Pharmaceutical-B (02561.HK) has received approval from the National Medical Products Administration for the marketing authorization application of injectable Long Pei growth hormone [2] - Kintor Pharmaceutical-B (02171.HK) issued a profit warning, expecting a net loss for 2025 to be reduced to no more than approximately RMB 120 million [2] - Zhaoke Ophthalmology-B (06622.HK) is advancing the commercialization process of BRIMOCHOL PF for treating presbyopia in Singapore and Vietnam through partnerships with AFT and Qianshou [2] Additional Company Developments - Heng Rui Medicine (01276.HK) has received a clinical trial approval notice for SHR-1049 injection [3] - Baolong Real Estate (01238.HK) has had its bond restructuring plan approved by the relevant bondholders' meeting [3] Strategic Partnerships - Yabo Technology Holdings (08279.HK) has entered into a technical service agreement with Hong Kong Gold Exchange Limited [4] - Future Data Group (08229.HK) has signed a strategic cooperation framework agreement with Linghe Culture [4] - Howey Group (00501.HK) plans to invest up to USD 50 million to subscribe for shares in Aixin Yuanzhi's initial public offering [4] Buyback Activities - Xiaomi Group-W (01810.HK) repurchased 3.9872 million shares for HKD 140 million, with a repurchase price ranging from HKD 35.04 to HKD 35.22 [5] - China Metallurgical Group (01618.HK) repurchased 9.011 million shares for HKD 16.9299 million, with a repurchase price of HKD 1.87 to HKD 1.88 [5] - Geely Automobile (00175.HK) repurchased 4.401 million shares for HKD 72.952 million, with a repurchase price ranging from HKD 16.43 to HKD 16.65 [6] - Reshape Energy (02570.HK) completed the placement of a total of 4.536 million placement shares, raising approximately HKD 258 million [6] - Kintor Pharmaceutical-B (09939.HK) saw an increase of 4.7 million shares by Chairman Tong Youzhi [6]

Core Insights - Long-acting growth hormone, Longpei, developed by Weisheng Pharmaceutical, has shown strong commercial growth since its approval in Europe and the U.S. [1] - Longpei is the only long-acting growth hormone that continuously releases unmodified human growth hormone in the body between weekly doses, utilizing TransCon technology [1] - The product offers a convenient weekly dosing regimen, reducing injection frequency by 86% compared to daily formulations, and has demonstrated superior efficacy in clinical trials [1] - The approval of Longpei marks it as the third long-acting growth hormone approved in China for treating pediatric growth hormone deficiency (PGHD) [2] Company Insights - Weisheng Pharmaceutical is expected to enhance its commercialization framework based on the substantial progress of its innovative pipeline, positively impacting its growth prospects [1] - The introduction of Longpei fills a technological gap in the domestic market, which is primarily dominated by daily formulations, providing new treatment options for patients [1]