TransCon技术
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研报掘金丨国海证券:隆培素上市在即,期待TransCon技术长效生长激素商业化空间,建议近期重点关注维昇药业
Ge Long Hui A P P· 2025-12-09 02:23
格隆汇12月9日|国海证券发表研究报告指,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。根据维昇药业公告,预计隆培生长激素于2025年四季度在国内获批上市,建议近期 重点关注维昇药业。 ...
Ascendis Pharma(ASND) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
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]