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]

国海证券曾发研报指，基于TransCon技术的长效生长激素隆培预计上市在即，其相比于短效人生长激素显示出优效性及同等安全性。隆培生长激素为维昇药 业于2018年11月自Ascendis Pharma授权引入，凭借TransCon"暂时连接技术"长效路径，隆培生长激素是唯一一款于每周给药之间在体内持续释放未经修饰的 人生长激素的长效生长激素，经已完成的中国Ⅲ期关键性试验所验证，隆培生长激素是唯一一款在与短效人生长激素的阳性药物对照及平行组试验比较中显 示出优效性及同等安全性的长效生长激素。(格隆汇) 消息面上，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。据悉，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，是全球首个在美国及欧洲获批用于儿童生长激素缺乏症(GHD)的长效周制剂。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。 维昇药业-B(2561.HK)今日高开高走，盘中一度大涨9.9%至38.2港元，股价创去年12月19日以来逾一个月新高。 ...

Core Viewpoint - Guohai Securities reports that the long-acting growth hormone, Lonpei, based on TransCon technology, is expected to be launched soon, demonstrating superior efficacy and equivalent safety compared to short-acting growth hormones [1] Company Summary - Lonpei growth hormone was introduced by Weisheng Pharmaceutical in November 2018 through a licensing agreement with Ascendis Pharma [1] - The growth hormone utilizes TransCon (transient conjugation technology) for long-acting delivery, making it the only long-acting growth hormone that continuously releases unmodified human growth hormone between weekly doses [1] - Completed Phase III pivotal trials in China have validated that Lonpei is the only long-acting growth hormone showing superior efficacy and equivalent safety in comparison to short-acting growth hormones in positive drug control and parallel group trials [1] - Weisheng Pharmaceutical anticipates that Lonpei will receive domestic approval for marketing in the fourth quarter of 2025, suggesting that investors should closely monitor the company in the near term [1]

Financial Data and Key Metrics Changes - Total product revenue for Q2 2025 was €153,700,000, with a negative foreign currency exchange impact of €7,600,000 [27] - Skytrofa revenue for the quarter was €50,700,000, including a €1,800,000 negative currency impact [27] - Eurvipath revenue more than doubled to €103,000,000, up from €44,700,000 in Q1 2025, despite a negative currency headwind of €5,800,000 [27] - R&D costs decreased to €72,000,000 from €83,500,000 year-over-year, while SG&A expenses increased to €107,600,000 from €74,300,000 [29] - The company ended Q2 2025 with cash and cash equivalents totaling €494,000,000, down from €518,000,000 as of March 31 [30] Business Line Data and Key Metrics Changes - Revenues for Europad in Q2 reached €103,000,000, more than double that of Q1 [10] - Skytrofa revenues were €51,000,000, with growth driven by new patient starts and recent label expansion for adult growth hormone deficiency [24] - The company expects continued revenue growth driven by the strength of the global launch of Europad [30] Market Data and Key Metrics Changes - In the U.S., over 1,500 prescribers wrote prescriptions for around 3,100 unique patients for Europad, reflecting strong demand [11] - The company has recognized revenue from more than 30 countries and has commercial agreements covering over 75 countries [15] - The U.S. launch of Europad is progressing well, with expectations for additional commercial launches in Europe and Japan [16][32] Company Strategy and Development Direction - The company aims to achieve blockbuster status for multiple products and expand its innovation engine [8] - Focus on building long-term leadership in the treatment of hypoparathyroidism and growth disorders through differentiation, demand, and access [13] - The company is preparing for future growth opportunities and ongoing collaborations with Novo Nordisk for TransCon-based products in metabolic and cardiovascular diseases [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued strong demand for Europad and the potential for it to become a blockbuster product [10] - The company anticipates becoming cash flow positive on a quarterly basis this year [29] - Management highlighted the importance of payer approvals and the ongoing efforts to improve the patient experience and access to treatment [34] Other Important Information - TransCon Growth Hormone is now approved in the U.S. for adults with growth hormone deficiency, and the company plans further label expansions [5] - The FDA granted priority review for TransCon CNP, recognizing its potential to improve treatment for achondroplasia [9] - The company is advancing new clinical data and preparing for additional key label expansions [25] Q&A Session Summary Question: Continuation of enrollment trends - Management confirmed that the number of unique patients enrolled grew to 3,100 by the end of Q2, indicating steady state growth [36][38] Question: Improving conversion from enrollment to treatment - Management acknowledged ongoing efforts to improve the time from enrollment to treatment, with expectations for better results in the second half of the year [45][49] Question: Patient demographics and severity - Management clarified that there is no medical definition for severity in hyperparathyroidism, and they are focusing on addressing physicians who see a high number of patients [53][55] Question: Future revenue expectations - Management indicated that they expect continued strong revenue growth in the U.S. and Europe, with a focus on expanding commercial launches [61][62] Question: Compliance and patient retention - Management reported low discontinuation rates in Europe, indicating strong patient retention and satisfaction with the therapy [72][73] Question: Reporting enrollment forms - Management confirmed that they will continue to report necessary KPIs related to enrollment and treatment until a steady state is achieved [69][70] Question: Titration period and costs - Management noted that the titration period is successful, but they are still assessing real-world data on costs post-titration [98][101]