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维昇药业-B(02561):注射用隆培生长激素的生物制品上市许可申请获国家药监局批准
智通财经网· 2026-01-26 10:49
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].
维升药业(02561) - 内幕消息公告 注射用隆培生长激素的生物製品上市许可申请获国家药监局批准
2026-01-26 10:40
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 ...
维昇药业-B盘中涨超9% 核心产品隆培促生长素预计即将获批
Zhi Tong Cai Jing· 2026-01-23 04:02
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]
港股异动 | 维昇药业-B(02561)盘中涨超9% 核心产品隆培促生长素预计即将获批
智通财经网· 2026-01-23 04:01
Core Viewpoint - Viesheng Pharmaceutical-B (02561) has seen a significant stock price increase, with a rise of over 9% during trading, currently at 37.24 HKD, 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 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, while weekly formulations like Lonapegsomatropin are expected to significantly enhance patient compliance [1] - The introduction of Lonapegsomatropin is anticipated to reshape the competitive landscape and address unmet clinical needs in the market [1]
维升药业(02561) - 截至二零二五年十二月三十一日止月份之股份发行人的证券变动月报表
2026-01-06 08:30
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 ...
格隆汇“科技赋能·资本破局”线上分享会暨“金格奖”——“年度卓越品牌力IPO”奖项揭晓:布鲁可(00325.HK)、绿茶集团(06831.HK)、蜜雪集团(02097.HK)等5家企业上榜
Ge Long Hui· 2025-12-22 10:59
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].
维升药业(02561) - 截至二零二五年十一月三十日止月份之股份发行人的证券变动月报表
2025-12-04 08:38
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 ...
港股异动 维昇药业-B(02561)再涨超12% 隆培促生长素即将获批 公司近期与东富龙达成战略合作
Jin Rong Jie· 2025-12-02 04:06
Group 1 - The core viewpoint of the article highlights the significant stock price increase of Vison Pharmaceutical-B (02561), which rose over 12% and is currently trading at 35.26 HKD with a transaction volume of 1.9082 million HKD [1] - Anke Bio recently disclosed progress in its collaboration with Vison Pharmaceutical, indicating that the growth-promoting factor, Longpei, is about to receive approval [1] - On November 6, during the 8th China International Import Expo, Vison Pharmaceutical established a strategic cooperation on dual-chamber freeze-drying technology with Dongfulong, a leading domestic pharmaceutical equipment company, and signed an industrial collaboration agreement with the Lingang New Area Management Committee and Lingang Group's trade platform, further implementing its strategy of "Global Innovation, China Acceleration" [1]
维昇药业-B(02561.HK)涨超12%
Mei Ri Jing Ji Xin Wen· 2025-12-02 03:20
Group 1 - The core point of the article is that Vison Pharmaceutical-B (02561.HK) has seen a significant increase in its stock price, rising over 12% and currently trading at 35.26 HKD with a trading volume of 1.9082 million HKD [1]
港股异动 | 维昇药业-B(02561)再涨超12% 隆培促生长素即将获批 公司近期与东富龙达成战略合作
智通财经网· 2025-12-02 03:09
Core Viewpoint - Vison Pharmaceutical-B (02561) has seen a significant stock increase of over 12%, currently trading at 35.26 HKD with a transaction volume of 1.9082 million HKD, driven by recent collaboration announcements and strategic partnerships [1] Group 1: Company Developments - Anke Bio recently disclosed progress in its collaboration with Vison Pharmaceutical, indicating that the growth-promoting agent Longpei is nearing approval [1] - On November 6, during the 8th China International Import Expo, Vison Pharmaceutical established a strategic cooperation on dual-chamber freeze-drying technology with leading domestic pharmaceutical equipment company Dongfulong [1] - Vison Pharmaceutical signed an industrial collaboration agreement with the Lingang New Area Management Committee and Lingang Group's trade platform, further advancing its strategy of "Global Innovation, China Acceleration" [1]