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]

Core Viewpoint - The approval of the long-acting growth hormone, Lonapegsomatropin (SKYTROFA), by the National Medical Products Administration of China marks a significant advancement in the treatment of pediatric growth hormone deficiency (PGHD) in children aged 3 years and older [1][2]. Group 1: Product Overview - Lonapegsomatropin is a weekly administered growth hormone replacement therapy for children with PGHD, demonstrating superior efficacy and equivalent safety compared to daily injections of short-acting growth hormone [2][3]. - The drug features a novel molecular design that allows for sustained release of unmodified human growth hormone, matching the structure and mechanism of endogenous growth hormone produced by the pituitary gland [2]. Group 2: Clinical Trial Results - The pivotal Phase 3 trial for Lonapegsomatropin involved children aged 3 to 17 years, showing an annualized height velocity of 10.66 cm/year compared to 9.75 cm/year for the short-acting group, with a statistically significant difference of 0.91 cm/year (95% CI: 0.37-1.45, P=0.0010) [3]. - At 52 weeks, the height standard deviation score (SDS) increased by 1.01 in the Lonapegsomatropin group versus 0.83 in the short-acting group, with a p-value of 0.0015, indicating significant improvement from week 13 onwards [3]. Group 3: Commercialization Strategy - Following the BLA approval, the company has initiated a comprehensive commercialization plan to ensure supply and expand market coverage, including a supply agreement with Ascendis Pharma [4]. - The company is enhancing its commercialization capabilities through a dedicated team and tailored strategies for market access and physician awareness, alongside strategic partnerships with companies like Shanghai Pharmaceuticals, United Family Healthcare, and Anke Bio [4].

Core Viewpoint - The approval of Lonapegsomatropin (SKYTROFA) by the National Medical Products Administration of China marks a significant advancement in the treatment of pediatric growth hormone deficiency, providing a long-acting alternative to daily injections [1][2]. Group 1: Product Approval and Efficacy - Lonapegsomatropin has received a Biologics License Application (BLA) approval for treating growth hormone deficiency in children aged 3 years and older in China [1]. - The drug has demonstrated superior efficacy in a Phase 3 trial, showing an annualized height velocity of 10.66 cm/year compared to 9.75 cm/year for daily injections, with a statistically significant difference of 0.91 cm/year (P=0.0010) [2]. - The height standard deviation score (SDS) increased by 1.01 in the Lonapegsomatropin group versus 0.83 in the daily injection group, with a p-value of 0.0015, indicating significant improvement from week 13 of treatment [2]. Group 2: Commercialization Strategy - Following the BLA approval, the company has initiated a comprehensive commercialization plan to ensure supply and expand market coverage [3]. - A commercial supply agreement has been established with Ascendis Pharma to secure the availability of Lonapegsomatropin upon market launch [3]. - The company is enhancing its commercialization capabilities through a dedicated team and tailored strategies for market access and physician awareness, alongside strategic partnerships with Shanghai Pharmaceuticals, United Family Healthcare, and Anke Bioengineering for distribution and promotion [3].

Core Viewpoint - The approval of the long-acting growth hormone, Lonapegsomatropin (SKYTROFA®), by the National Medical Products Administration of China marks a significant advancement in the treatment of pediatric growth hormone deficiency (PGHD) in children aged 3 and above, providing a more convenient weekly dosing option compared to daily injections [1][2]. Group 1: Product Approval and Efficacy - Lonapegsomatropin is the first long-acting growth hormone that has demonstrated superior efficacy and equivalent safety compared to short-acting daily injections in a positive parallel-controlled trial [2][3]. - In a pivotal Phase 3 trial involving children aged 3 to 17 with PGHD, Lonapegsomatropin showed an annualized height velocity of 10.66 cm/year, compared to 9.75 cm/year for short-acting growth hormone, with a statistically significant difference of 0.91 cm/year (P=0.0010) [3]. - The height standard deviation score (SDS) for the Lonapegsomatropin group increased by 1.01, while the short-acting group saw an increase of 0.83, with a p-value of 0.0015, indicating significant improvement from week 13 onwards [3]. Group 2: Commercialization Strategy - Following the BLA approval, the company has initiated a comprehensive commercialization plan to ensure supply and expand market coverage for Lonapegsomatropin [4]. - The company has established a commercialization supply agreement with Ascendis Pharma to secure market launch supplies [4]. - Strategic partnerships have been formed with Shanghai Pharmaceuticals, United Family Healthcare, and Anke Bioengineering to enhance distribution and promotional activities for Lonapegsomatropin [4].

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，並明確表示不會就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 VISEN Pharmaceuticals 維昇藥業 （於開曼群島註冊成立的有限公司） 注射用隆培生長激素（中國境內商品名稱：維臻高， 英文商品名稱：SKYTROFA）的 生物製品上市許可申請獲國家藥監局批准 本公告乃由維昇藥業（「本公司」，連同其附屬公司統稱「本集團」）根據《香港聯合 交易所有限公司證券上市規則》（「《上市規則》」）第13.09條及香港法例第571章《證 券及期貨條例》第XIVA部項下的內幕消息條文（定義見《上市規則》）而作出。 （股份代號：2561） 內幕消息公告 本公司董事（「董事」）會（「董事會」）欣然宣佈，中國國家藥品監督管理局（「國家 藥監局」）已批准注射用隆培生長激素（中國境內商品名稱：維臻高®，英文商品名 稱：SKYTROFA®）的生物製品上市許可申請（「BLA」），用於在中國治療3歲及以 上兒童及青少年的生長激素缺乏症所致的生長緩慢。 承董事會命 維昇藥業 執行董事兼首席 ...

Core Viewpoint - Viesheng Pharmaceutical-B (02561) has seen a significant stock price increase, with a rise of over 9% during trading, currently up 7.13% at HKD 37.24, driven by the anticipated approval of its core product, Lonapegsomatropin, expected on January 12, 2026 [1] Company Summary - Lonapegsomatropin is a long-acting growth hormone prodrug developed by Viesheng Pharmaceutical-B, licensed from Ascendis Pharma, utilizing TransCon technology for the treatment of Growth Hormone Deficiency (GHD) in children [1] - The product is designed for once-weekly subcutaneous injection, releasing unmodified natural growth hormone, and has already received approval in Europe and the United States [1] Industry Summary - The domestic growth hormone market primarily consists of daily formulations, and the introduction of a weekly formulation is expected to significantly enhance patient compliance [1] - The anticipated launch of Lonapegsomatropin is likely to reshape the competitive landscape and address unmet clinical needs in the market [1]

消息面上，据Insight数据库显示，维昇药业-B核心产品隆培促生长素已于2026年1月12日离开补充资料 任务，预计即将获批。 据公开资料显示，隆培促生长素是维昇药业-B从Ascendis Pharma引进的长效生长激素前药，基于 TransCon暂时连接技术研发，用于治疗儿童生长激素缺乏症(GHD)，每周皮下注射一次，可释放未经修 饰的天然人生长激素，欧美此前已获批。国内生长激素市场以日制剂为主，周制剂可大幅提升患者依从 性，上市后有望重塑竞争格局，满足未被充分满足的临床需求。 智通财经APP获悉，维昇药业-B(02561)盘中涨超9%，截至发稿，涨7.13%，报37.24港元。 ...

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) | 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 第 1 頁 共 10 頁 v 1.1.1 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12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 ...

Core Viewpoint - The "Annual Excellence Brand Power IPO" awards recognize new listed companies with strong brand innovation capabilities and high penetration rates in the capital market, based on a comprehensive evaluation of brand awareness, recognition, and reputation over the past year [4]. Group 1 - The "Annual Excellence Brand Power IPO" award was presented to five companies: Bruker (00325.HK), Green Tea Group (06831.HK), Mixue Group (02097.HK), Weisheng Pharmaceutical-B (02561.HK), and Meet Xiaomian (02408.HK) [1]. - The evaluation process involved quantitative data analysis and a panel of experts to determine the final results [4]. - The awards aim to create a reference for the most valuable listed companies and unicorns in the investment community, covering all listed companies on major exchanges including the Hong Kong Stock Exchange, Shanghai Stock Exchange, Shenzhen Stock Exchange, New York Stock Exchange, and NASDAQ [4].

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11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: 維昇藥業 (於開曼群島註冊成立的有限公司) 呈交日期: 2025年12月4日 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) | 02561 | 說明 | | | | | | | | | 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 | | | 113,926,864 | | 0 | | 113,926,864 | | 增加 / 減少 (-) | | | | | | | | | 本月底結存 | | | 113,926,864 | | 0 | | 113,926,864 | 第 2 頁 共 10 頁 v 1.1.1 I. 法定/註冊股本變動 | 1. 股份分類 ...