创新药周报20250713： 证券研究报告 证券分析师刘浩 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com 联系人段江瑶 邮箱：duanjiangyao@hcyjs.com @2021 华创版权所有 第一部分 本周创新药重点关注 国内创新药回顾 02 全球首个口服HAE急性发作按需治疗药物获批上市 本报告由华创证券有限责任公司编制 卖的出价或询价。本报告所载信息均为个人观点，并不构成对所涉及证券的个人投资建议。 请仔细阅读PPT后部分的分析师声明及免责声明。 2025-07-13 全球新药速递 03 01 遗传性血管性水肿（HAE） 证券研究报告 致。 ┃ HAE诊断流程 ┃ HAE分型及特征 | HAE 分型 | 发病机制 | C1-INH 浓度 | CI-INH 功能 | | --- | --- | --- | --- | | HAE-C1-INH 1 型 | C1-INH 基因突变 | 降低 | 降低 | | HAE-C1-INH2 型 | C1-INH 基因突变 | 正常或增高 | 障低 | | HAE-nC1-INH | FXII、 ANGPTI、PLG 基因突变 | ...

医药生物行业跟踪周报 CXO 及科研服务景气度回暖，建议关注药 明康德、奥浦迈等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 2025 年 07 月 13 日 证券研究报告·行业跟踪周报·医药生物 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 证券分析师 冉胜男 执业证书：S0600522090008 ranshn@dwzq.com.cn 证券分析师 刘若彤 执业证书：S0600525040006 liurt@dwzq.com.cn 行业走势 -9% -5% -1% 3% 7% 11% 15% 19% 23% 27% 2024/7/15 2024/11/12 2025/3/12 2025/7/10 医药生物 沪深300 相关研究 《PD1/VEGF 双抗引领新一代 IO，建 议关注康方生物、神州细胞等》 2025-07-06 《2025ADA 重磅数据披露，关注减脂 增肌、Amylin 及口服赛道》 2025-06-29 东吴证券研究所 1 / 29 请务必阅读正文之后的免责声明部分 ◼ 本周、年初至今 A 股医药指数涨幅分 ...

Core Insights - KalVista Pharmaceuticals, Inc. received FDA approval for its oral on-demand Hereditary Angioedema plasma kallikrein inhibitor drug EKTERLY (sebetralstat) on July 7, 2025, marking a significant milestone for the company [2]. Company Overview - KalVista Pharmaceuticals is focused on developing treatments for hereditary angioedema, a rare genetic condition that causes severe swelling [2]. Market Context - The approval of EKTERLY positions KalVista favorably within the biotech sector, particularly in the niche market of hereditary angioedema treatments, which may enhance its competitive edge [2].

Sebetralstat Overview - Sebetralstat, if approved, is poised to be the first oral on-demand treatment for Hereditary Angioedema (HAE), potentially transforming the global treatment landscape[20, 22] - Clinical data shows the safety profile of Sebetralstat is no different from placebo, with robust efficacy demonstrated across all attack types, severities, and locations[18, 129] - The median time to beginning of symptom relief was 161 hours for 300 mg and 179 hours for 600 mg of sebetralstat, compared to 672 hours for placebo in Phase III trials[67] - In an open-label extension study, the median time to treatment was 10 minutes overall, 20 minutes for abdominal attacks, and 115 minutes for laryngeal attacks[72] Market Opportunity - The current global HAE market is valued at $13 billion, with a $3 billion global on-demand opportunity[23] - The on-demand market is projected to increase by 70%, driving the global sales to over $4 billion by 2030[89] - In the U S, approximately 84,000 on-demand doses are utilized, with 70% of attacks treated with Firazyr or icatibant[98, 99] Commercialization Strategy - KalVista plans to launch Sebetralstat in the US by June 2025, followed by Germany in 2H 2025, and the UK and Japan in 1H 2026[20, 123] - The company anticipates broad payor access, primarily through commercial coverage, with pricing comparable to existing branded therapies, ranging from $11,000 to $16,000 per attack[17, 110] - KalVista is targeting the top 1,000 HCPs and is focusing on patients currently using Firazyr and icatibant to drive early demand and accelerate adoption[126]

Group 1 - KalVista (NASDAQ: KALV) is nearing commercialization of its lead asset, sebetralstat, which targets the hereditary angioedema treatment market [1] - A significant FDA decision date is approaching, indicating potential regulatory approval for sebetralstat [1] - Successful de-risking events in the pediatric program and the development of strategic partnerships are underway, enhancing the company's growth prospects [1] Group 2 - The company operates in a sector that is expected to experience exponential expansion, aligning with high-growth investment strategies [1] - The focus on disruptive technologies and innovative enterprises is central to the company's investment approach [1]