注射用隆培生长激素
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维昇药业:注射用隆培生长激素获批
Zhong Zheng Wang· 2026-01-27 06:13
Group 1 - The National Medical Products Administration has approved the marketing authorization application for Longpei Growth Hormone, which is intended for the treatment of growth hormone deficiency in children aged 3 and above in China [1][2] - Longpei Growth Hormone is a weekly growth hormone replacement therapy that has completed Phase III trials in China and is the only long-acting growth hormone (LAGH) proven to be more effective and equally safe compared to shorter-acting daily injections in positive parallel-controlled trials [1] - The approval marks the first commercialized innovative product for the company, achieving a significant milestone from research and development to commercialization [1] Group 2 - The approval of Longpei Growth Hormone represents a deep implementation of the company's "global innovation, China acceleration" strategy and signifies a critical transition from R&D-driven to market value realization [2] - As the company's products continue to penetrate the market, it is expected to reshape the competitive landscape of the growth hormone industry and drive the industry from "scale expansion" to "value competition" [2] - The company aims to leverage cutting-edge global technology for local transformation, allowing Chinese patients to benefit from global innovations while establishing a foundation for more high-quality innovative drugs to reach the Chinese market [2]
港股异动 | 维昇药业-B(02561)涨超7% 核心产品隆培生长激素国内获批上市
Zhi Tong Cai Jing· 2026-01-27 01:49
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]
港股开盘:恒指涨0.36%、科指涨0.16%,芯片股走高,汽车股活跃,核电及脑机接口板块疲软
Jin Rong Jie· 2026-01-27 01:33
Market Overview - The Hong Kong stock index opened slightly higher on January 27, with the Hang Seng Index rising by 0.36% to 26,863.15 points, the Hang Seng Tech Index increasing by 0.16% to 5,734.9 points, and the National Enterprises Index up by 0.28% to 9,173.2 points [1] - Major tech stocks mostly rose, with Alibaba up by 0.97%, Tencent Holdings up by 0.08%, and JD.com down by 0.17% [1] - Automotive stocks were active, with BYD rising by over 1%, while gold stocks saw some increases, with Zijin Mining up by over 4% [1] Company News - China Power (02380.HK) reported a total consolidated electricity sales volume of 10.73105 million MWh for December 2025, a decrease of 2.31% year-on-year, with an annual cumulative total of approximately 126 million MWh, down by 1.27% year-on-year [2] - Harbin Electric (01133.HK) expects 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 [2] - Singularity National Peak (01280.HK) has entered into a GPU distribution cooperation agreement with Muxi Co., aiming to enter the domestic AI computing power market [3] - East Sunshine Pharmaceutical (06887.HK) has signed a strategic cooperation agreement with Shenzhen Jingtai to establish a joint venture for an AI-driven drug research and development platform [4] - 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 [5] - Kexin 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 [6] - Zhenghong Pharmaceutical (01276.HK) has received a clinical trial approval notice for SHR-1049 injection [7] - Baolong Real Estate (01238.HK) has had its bond restructuring plan approved by the relevant bondholders' meeting [8] - Aobo Technology Holdings (08279.HK) has entered into a technical service agreement with Hong Kong Gold Trading Co., Ltd. [9] - Future Data Group (08229.HK) has signed a strategic cooperation framework agreement with Linghe Culture [10] - Haowei Group (00501.HK) plans to invest up to USD 50 million to subscribe for shares in Aixin Yuan Zhi's initial public offering [11] Institutional Insights - Huatai Securities noted that foreign and southbound capital continues to flow in, with public fund positions in Hong Kong stocks dropping to 23% in Q4, significantly reducing potential selling pressure [12] - Goldman Sachs has raised its year-end gold price forecast from USD 4,900 to USD 5,400 per ounce due to increasing demand from private investors and central banks [12] - CITIC Securities recommends focusing on cloud computing service providers and continuing to recommend AI computing power sectors and AI applications, highlighting the ongoing AI industrial revolution [12]
维昇药业注射用隆培生长激素获批
Bei Jing Shang Bao· 2026-01-26 13:23
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].
哈尔滨电气上一财年净赚超26亿元 中国电力2025年总售电量同比下滑
Xin Lang Cai Jing· 2026-01-26 12:48
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]
维昇药业-B: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
Zhi Tong Cai Jing· 2026-01-26 10:54
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].
维昇药业-B(02561.HK):注射用隆培生长激素(中国境内商品名称:维臻高,英文商品名称:SKYTROFA)的生物制品上市许可申请获国家药监局批准
Ge Long Hui· 2026-01-26 10:53
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].
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].