以下文章来源于和谐汇一资产管理 ，作者和谐汇一 和谐汇一资产管理 . 和谐汇一是一家专注于权益类二级市场投资的私募基金管理公司，由林鹏先生发起创立。旨在为投资者、为所投资 公司及社会发展发现持久价值，做中国最优秀企业的长期陪伴者。 创新药，可以是资本市场一时的热点，但资本市场的聚光灯总是追逐着最耀眼的那一刻，而往往会忽视了那些 引发股价飙升的"热点时刻"，其实是漫长创新征途中最后结出的果实。在每一款划时代新药背后，是数十年冷 板凳上的靶点探索，也是临床研究中的折戟与不折不挠的反复迭代。 所以，研究与跟踪新药研发，需要非常前置的研究投入。 今年初，和谐汇一的医药研究员陈倩慧就把她的目光放到了高血压领域。作为全球最常见的疾病之一，高血压 影响着约10亿人的生活，核心治疗靶点的创新已经沉寂了40多年。尽管现有的降压药物在许多情况下有效，但 仍有部分患者（尤其是顽固性高血压患者）难以有效控制血压，或因药物副作用（如高钾血症或低血压）而无 法耐受。 随着3月10日，Mineralys宣布Advance-HTN和Launch-HTN III期成功，降压药领域似乎迎来了新的可能。这 背后究竟会带来什么样的变化？我们又该如何 ...

5月17日是"世界高血压日"，作为全球最常见的慢性病之一，高血压已经成为威胁我们身体健康的严重隐患。 在我们的身边经常遇到这种状况：有不少人吃降压药一段时间后，发现血压"恢复正常了"，就觉得是不是病好了，不吃也行了。还有些人会偷偷试探："我 这几天没吃药，血压也还好，是不是可以停了？" 其实，血压正常，并不是病好了，而是药物在起作用。一旦停药，血压迅速反弹，很可能不是"控制得好"，而是"危险正要开始"。 擅自停药 身体会发生什么？ 许多高血压患者看到血压正常后，常常会萌生停药的念头。然而，这种"见好就收"的做法隐藏着风险，突然停药不仅可能会让之前的治疗前功尽弃，还可能 引发更严重的健康危机。 一项较早发表于《研究生医学》的医学综述指出，突然停用降压药最直接的后果就是血压反弹，甚至"反弹得比原来还高"，医学上称为"反跳性高血压"。这 种情况在突然停用中枢性降压药（如可乐定、甲基多巴）或β受体阻滞剂（如普萘洛尔、美托洛尔）后尤其常见，体现在停药后24—48小时内，血压迅速升 高，有时超过治疗前水平。 更糟糕的是，血压反弹往往伴随着交感神经过度兴奋的症状，包括烦躁、失眠、面部潮红、心悸、出汗、头痛甚至恶心。如果患者 ...

Financial Data and Key Metrics Changes - The company ended Q1 2025 with $257.9 million in cash and cash equivalents and marketable securities, indicating a robust balance sheet [22] - Recognized revenue for the quarter was $9.9 million, which included $6.6 million in cost reimbursements from collaboration with Chiesi [22] - R&D expenses increased to $38 million from $32.4 million in the same period of 2024, while G&A expenses decreased to $8.7 million from $9.6 million [23] - The net loss for Q1 2025 was $36.6 million, or $0.16 per share, compared to a net loss of $41.9 million, or $0.19 per share, in Q1 2024 [23] Business Line Data and Key Metrics Changes - The company reported significant progress in the enrollment of the PROCERA study for saralutinib, with 343 patients already enrolled and more in screening [7][8] - The baseline characteristics of enrolled patients indicate a mean six-minute walk distance of approximately 376 meters, which is lower than previous studies, suggesting a more severe patient population [10] - The mean NT proBNP level in the PROCERA study is 96 ng/L, indicating a more severe population compared to previous studies [11] Market Data and Key Metrics Changes - The company highlighted the substantial unmet need in the PAH and PHILD markets, with only one approved treatment for PHILD in the US and limited options globally [17] - The PROCERA study has a global footprint, with significant patient enrollment expected from regions like Latin America and Asia Pacific, which may yield a larger treatment effect [38] Company Strategy and Development Direction - The company aims to position saralutinib as a first-in-class treatment for PAH and PHILD, with a focus on achieving comprehensive and differentiated outcomes in both phase three trials [27] - The partnership with Chiesi Group is crucial for the global registrational phase three study in PHILD, emphasizing the commitment to innovation and patient care [18] - The company is exploring the potential for saralutinib to address both pulmonary hypertension and underlying interstitial lung disease, which could differentiate it from existing therapies [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the likelihood of achieving positive results in the PROCERA study, citing the successful enrollment of the targeted patient population [6][9] - The company is committed to maintaining high standards to ensure long-term clinical and commercial success for saralutinib, aiming to become a backbone therapy in PAH [27] - Management noted the growing demand for new therapies in PAH and PHILD, highlighting the potential for saralutinib to capture significant market share [26] Other Important Information - The company anticipates completing the blinded portion of the PROCERA study by Q4 2025, with top-line results expected in February 2026 [8] - The SERENADA study for PHILD is set to begin site activations in Q4 2025, with a focus on addressing the unmet needs in this patient population [20] Q&A Session Summary Question: Consideration of stopping enrollment in PROCERA - Management decided to continue enrollment due to high demand and commitment to patients and physicians, ensuring quality and appropriate patient selection [30][32] Question: Influence of global recruitment on results - The broader global footprint in PROCERA is expected to yield a more favorable patient population, potentially leading to a larger treatment effect [35][38] Question: Changes in powering assumptions and enrollment criteria - Stringent enrollment criteria contributed to longer enrollment times, but the study maintains over 90% power based on sample size and expected treatment effect [47] Question: Safety profile of saralutinib - The safety profile remains clean, and the design of the molecule is intended to minimize off-target effects, positioning it as a competitive advantage [49] Question: Baseline measures and future updates - The company does not expect significant changes to baseline data and will provide updates as enrollment completes [57] Question: Clinical impact of open-label extension data - Positive feedback from the KOL community regarding open-label extension data has increased interest in PROCERA enrollment, indicating strong commercial potential [92][94] Question: Regulatory expectations for six-minute walk improvement - The FDA has agreed to the powering and magnitude of effect being targeted, with a focus on clinically meaningful improvements [83]

Mineralys Therapeutics (MLYS) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Company Participants Dan Ferry - Managing DirectorJon Congleton - CEODavid Rodman - Chief Medical OfficerAdam Levy - CFOMichael Difiore - Managing DirectorSeamus Fernandez - Senior Managing DirectorAlice Nettleton - VP - US Pharmaceutical & Biotechnology Equity ResearchJayed Momin - Biopharma Equity Research AssociateSadia Rahman - Vice President, Biopharma Equity Research Conference Call Participants Richard Law - AnalystRami Katk ...