2026年2月2日，维昇药业于上海举办维臻高®（注射用隆培生长激素）获批上市投资者交流会。 该产品已于1 月26日获得国家药品监督管理局批准上市。公司在会上表示，维臻高®被定位为具备里程碑意义的创新产品 ——不仅是首个在欧美获批用于儿童的长效生长激素，也是目前临床研究中唯一被证实在疗效上优于日制剂的 长效生长激素产品。 在生长激素赛道中，随着多款产品陆续纳入医保、价格体系快速下探，市场竞争格局正在发生变化。维 昇药业以临床价值和技术壁垒为核心，打造差异化的高端产品路径。本次交流会由公司管理层系统介绍 了产品研发逻辑、临床数据及当前阶段商业化策略的核心思路。 本次会议邀请了多位合作伙伴与行业嘉宾出席，包括国妇婴主任医师余文教授、安科生物高级副总裁姚 建平先生、副总裁鲍学科先生、上药控股副总经理宋潞潞女士、上海和睦家医院长宁院区执行院长刘晓 龙先生等到场支持。同时，公司长期股东代表——碧沃投资合伙人柳丹先生亦出席交流，体现了核心股 东对公司商业化路径与长期价值的持续认可。中信证券、东吴证券、天风证券和国海证券等多家大型券 商及投资机构亦参与本次会议。 一、产品内核：技术壁垒构建差异化护城河 1.1 "暂时连接"技 ...

尽管隆培生长激素的官方定价尚未公布，但市场对其讨论热度居高不下。参考全球定价，该产品在美国 的年治疗成本高达50万至60万元，而国内市场普遍预判，其本土年治疗费用将大幅低于这一水平。这种 兼顾品质与性价比的潜在优势，进一步放大了市场期待。 一旦这条路径走通，不仅能帮助维昇药业抢占高端市场先机，更有望推动整个生长激素赛道的发展逻辑 重构，这将是一个不同于以往的里程碑式转折。 近日，维昇药业核心产品隆培生长激素注射液（维臻高，Skytrofa）获批上市，用于治疗儿童生长激素 缺乏症（PGHD），是全球唯一优效于日制剂的长效生长激素。 自此，国内长效生长激素阵营已扩容至4款产品，呈现出鲜明的分化特征。其中，唯有隆培生长激素采 用天然分子结构，与人体自身分泌的生长激素氨基酸序列完全一致，而其余产品均为重组分子结构。 可以说，隆培生长激素的登场，既是维昇药业瞄准市场痛点的一次差异化布局，更是长效生长激素赛道 的一次突破性"社会实验"。 2月2日，维昇药业召开投资人交流会，与投资者展开深度交流，围绕这款产品的临床价值与未来商业化 路径，主动、清晰且坦诚地向市场传递公司的判断与战略思考。 唯一实现迭代性突破的产品，拥有独特 ...

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].

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 Weisheng Pharmaceutical's long-acting growth hormone injection marks a significant advancement in the domestic growth hormone market, addressing compliance issues associated with daily injections for children with growth hormone deficiency [1][2]. Industry Overview - The Chinese growth hormone market has surged 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 [1]. - The long-acting growth hormone market is expected to surpass short-acting products within two years and capture 80% of the total market by 2030 [1]. Competitive Landscape - Existing competitors in the long-acting growth hormone space include Changchun High-tech's Jinsai Pharmaceutical, Teva Biopharma, and Novo Nordisk, with Jinsai and Teva's products already included in the national medical insurance directory for 2025 [2]. - Weisheng's long-acting growth hormone is the only one clinically proven to outperform daily formulations, offering both long-lasting effects and maintaining the natural structure of growth hormone molecules [2]. Product Advantages - Weisheng's long-acting growth hormone can be stored at room temperature below 30 degrees Celsius for up to six months, enhancing convenience for patients compared to other products that require refrigeration [2]. - The pricing strategy for Weisheng's product is anticipated to be higher than currently insured long-acting growth hormones, which have seen significant price reductions due to insurance coverage [3]. Commercial Strategy - Weisheng has partnered with Anke Bio to leverage its extensive commercial experience in the growth hormone sector, focusing on coastal provinces while Anke manages other regions [3]. - The company aims to target private clinics, where a significant portion of growth hormone treatments occur, to reach potential patients effectively [4]. Future Developments - There is potential for the introduction of even longer-acting monthly formulations, with ongoing clinical trials for a novel ultra-long-acting growth hormone [4].

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 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].

Group 1 - The core product of Weisheng Pharmaceutical-B, Longpei Growth Hormone, is expected to be approved soon, having completed its supplementary data task on January 12, 2026 [1] - Longpei Growth Hormone is the first long-acting growth hormone prodrug approved for use in children with Growth Hormone Deficiency (GHD) in the US and Europe, which could significantly enhance patient compliance compared to daily formulations [1][2] - The stock of Weisheng Pharmaceutical-B has risen over 16% this year, outperforming the Hang Seng Index, which has increased by over 4% during the same period [1] Group 2 - Longpei Growth Hormone, introduced by Weisheng Pharmaceutical from Ascendis Pharma, utilizes TransCon technology for long-acting delivery, showing superior efficacy and equivalent safety compared to short-acting growth hormones [2] - The drug has completed critical Phase III trials in China, demonstrating its effectiveness in comparison to short-acting growth hormones [2]

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]

Core Viewpoint - The approval of Yipeisheng (益佩生), a long-acting growth hormone injection by Tebao Biopharma, marks a significant shift in the long-acting growth hormone market, breaking the decade-long monopoly held by Jinsai Pharmaceutical [2][4]. Company Summary - Tebao Biopharma's Yipeisheng is designed for weekly administration, targeting growth hormone deficiency in children aged three and above, enhancing patient compliance and reducing treatment burden [2][3]. - The company reported a revenue of 2.817 billion yuan in 2024, a year-on-year increase of 34.13%, and a net profit of 828 million yuan, up 49% year-on-year [6]. - The company has five existing products, with Paigebin being the main revenue driver, generating 2.447 billion yuan, accounting for over 80% of total revenue [6]. Industry Summary - The long-acting growth hormone market has been dominated by Jinsai Pharmaceutical for over ten years, with its product "Jinsai Zeng" being the first globally approved long-acting growth hormone [3][4]. - The market for growth hormone treatment in China is significant, with approximately 6.4 million children affected by growth hormone deficiency, indicating a substantial unmet medical need [3]. - The entry of Yipeisheng is expected to intensify competition in the long-acting growth hormone sector, potentially leading to expanded indications and increased market share for long-acting products [4].