Core Viewpoint - The stock of Baixinan-B (02185) experienced significant volatility, with a rise of over 50% recently, driven by updates in hypertension management guidelines and potential insurance coverage for renal denervation (RDN) procedures [1]. Group 1: Stock Performance - Baixinan-B's stock rose over 15% at one point and closed up more than 50% yesterday, currently trading at 10.36 HKD with a trading volume of 42.644 million HKD [1]. Group 2: Industry Guidelines - The American Heart Association (AHA) and the American College of Cardiology (ACC) released updated guidelines for the prevention, detection, assessment, and management of adult hypertension, marking significant revisions from the 2017 guidelines [1]. - The new guidelines include updates on the diagnosis, risk assessment, and treatment of hypertension, aiming to provide more precise clinical guidance to reduce cardiovascular disease (CVD) risk [1]. Group 3: Insurance Coverage Proposal - The Centers for Medicare & Medicaid Services (CMS) proposed new insurance coverage for RDN, suggesting it be included for patients with uncontrolled hypertension [1]. - The proposal has entered a 30-day public comment period, with a final decision expected to be announced by October 8, 2025 [1].

Core Viewpoint - The release of the 2025 ACC/AHA hypertension clinical guidelines indicates a new direction for hypertension prevention and treatment, highlighting the need for innovative solutions like renal denervation (RDN) to address the global challenge of uncontrolled hypertension [1]. Group 1: Differences Between US and China Guidelines - The US guidelines emphasize early intervention and precise stratification, setting the hypertension threshold at 130/80 mmHg to promote proactive management [2]. - The control targets in the US guidelines recommend a universal goal of <130/80 mmHg, with further specifications for high cardiovascular risk patients to lower systolic pressure to <130 mmHg, ideally <120 mmHg [3]. - In contrast, the Chinese guidelines set the hypertension threshold at 140/90 mmHg, aligning with local epidemiological characteristics and focusing on practical clinical management [4][5]. Group 2: RDN Clinical Application Under Guidelines - The 2025 US hypertension guidelines outline a comprehensive process for RDN application, emphasizing "precise selection, collaborative decision-making, and long-term management" [6]. - RDN is primarily indicated for patients with resistant hypertension, specifically those requiring three or more antihypertensive medications without achieving control [7]. - A multidisciplinary team (MDT) is essential for evaluating patients for RDN, ensuring thorough screening for secondary hypertension and contraindications [9]. Group 3: RDN as a New Treatment Option - RDN is recognized as a valuable adjunct treatment for resistant hypertension, with a recommendation level of 2b, B-R in the 2025 guidelines, indicating its use under specific conditions [11]. - The Iberis RDN system demonstrates significant efficacy, with a study showing a 13 mmHg reduction in 24-hour ambulatory systolic blood pressure and a 21 mmHg reduction in office systolic blood pressure at six months post-treatment [13]. - RDN offers a continuous blood pressure-lowering effect, providing a promising solution for patients with difficult-to-treat hypertension [13][14].

根据新指南，生活方式调整应包括保持或达到健康体重、遵循有益心脏健康的饮食方式、减少钠摄 入量、管理压力、进行适度的体育活动以及进行力量训练等抗阻运动、减少或戒掉酒精摄入等。 在饮酒方面，2017年版指南建议，如果选择喝酒，则女性每天最多喝一杯，男性每天最多喝两杯。 新指南建议尽量减少酒精摄入，理想的选择是戒酒。在饮食方面，新指南的建议没有变化，要多吃水 果、蔬菜、全谷物和低脂乳制品等，减少摄入的饱和脂肪及脂肪总量。钠的摄入量应少于每天2300毫 克，理想摄入量是每天1500毫克。对于超重或肥胖的人，新指南建议至少减掉体重的5%。对于严重肥 胖的人，新指南建议采用经临床证实的干预措施如饮食调整、运动以及减肥药等。 新指南已发表在《美国心脏病学会杂志》上。 新华社洛杉矶8月15日电 美国心脏协会和美国心脏病学会等机构日前发布一份新的高血压临床实践 指南，这是美国自2017年以来首次更新高血压指南。新指南建议针对临界高血压应尽早干预和治疗。 长期以来，心血管疾病是全球首要死因。控制血压有助于降低心血管疾病的发病和死亡风险，还可 以降低罹患肾病、2型糖尿病和阿尔茨海默病等疾病的发病率。 美国近一半的成年人血压高于正常 ...

大多数早期高血压患者没有明显症状，随着病情进展，才有可能会出现头痛、头晕、耳鸣、颈背部肌肉酸痛等症状。即使没有症状，持续的高血压也会对 心、脑、肾等靶器官造成严重损害，因此，一旦诊断为高血压，就应积极干预治疗。 误区1：没症状不用吃药 误区2：血压正常就停药 高血压是慢性病，大多数患者通常需要长期甚至终身服药来控制血压，难以根治。研究表明，停药后极易造成血压反弹，血压波动幅度过大会增加心肌梗 死、脑梗死等并发症的发生风险。所以，抗高血压药的作用不仅是降压，还可维持血压平稳，避免更多脏器损伤。 误区3：抗高血压药有依赖性 抗高血压药非抗菌药，不会出现耐药情况。目前，临床公认高血压患者治疗的"好药"是指长效抗高血压药，即口服一次，降压作用持续24小时，可平稳降压 的药物。短效抗高血压药通常只用于突发性血压增高，作用时间短，长期用药易引起血压波动。因此，应根据患者的具体情况，选择合适的抗高血压药，哪 个适合自己，就选哪个。 误区5：血压高要快速降至正常 一般情况下，血压是缓慢升高的，所以降压过程也要平稳。除了高血压急症外，不可快速大幅度降压，以免引起脑灌注不足等意外情况发生。一般来说，降 压的原则是缓慢、平稳、持久 ...

Core Insights - The innovative drug Rulitan® (generic name: Aliskiren Indapamide Sustained-release Tablets) has been launched on JD Health, marking a significant advancement in hypertension treatment in China [1][2] - Rulitan® is the first ARNI + thiazide-like diuretic fixed-dose combination antihypertensive drug developed exclusively by the company, utilizing a triple mechanism for blood pressure reduction [1] - The prevalence of hypertension among adults in China is approximately 27.5%, highlighting a substantial market opportunity for effective treatment options [1] Company Strategy - The company plans to strategically cover various segments of hypertension patients with Rulitan®, complementing its existing products such as Xintan® (Aliskiren Tablets), Xinchao® (Sacubitril Aliskiren Calcium Tablets), and Rulitan® (Aliskiren Amlodipine Tablets) [2] - The collaboration with JD Health aims to enhance the accessibility of innovative drugs, addressing clinical needs and benefiting a larger patient population [2] Market Context - Hypertension is a systemic disease that can lead to severe complications such as stroke, coronary heart disease, heart failure, and renal failure, emphasizing the importance of effective treatment options [1] - The drug is particularly suitable for patients with salt-sensitive hypertension, elderly patients, and those with comorbidities such as diabetes and metabolic syndrome [1]

近日，西班牙知名报纸 《La Razón》 在 2025年7 月27日健康版专题报道了高血压治疗领域的重要进展—— 铂睿时Iberis RDN（经皮去肾神经术）系统在马德里托雷洪大学医院（Hospital Universitario de Torrejón de Ardoz）成功开展临床应用 ，进一步扩大了铂睿时Iberis产品的全球化版图，同时也再次印证了其在不受控 制的高血压治疗中的学术价值与临床潜力。 此次铂睿时Iberis RDN技术获西班牙媒体专题报道，一方面是对 其安全性与有效性的认可 ；另一方面，正如 报道提及， RDN对心律失常存在一定改善作用 ，这也为该技术在更广泛人群中应用，提供了学术层面的有力 支撑。 # 为什么西班牙知名的全国性日报会关注这项技术？ 传统RDN术通常采用股动脉介入方式开展，不仅创伤大、出血风险高，且术后往往需要长时间卧床恢复。而 托雷洪大学医院采用的铂睿时Iberis RDN 系统，实现了一个关键突破： 消融导管通过手腕处的桡动脉作为进 入通路，无需在腹股沟穿刺 。 # 技术原理与创新突破：重新定义微创介入标准 RDN治疗未控高血压的原理是基于血压调节机制，通过对肾动脉 ...

Core Viewpoint - The article emphasizes the long-term journey of innovation in the pharmaceutical industry, particularly in the hypertension treatment sector, highlighting the recent advancements and unmet needs in this area [3][4]. Group 1: Hypertension Overview - Hypertension affects approximately 1 billion people globally and has seen no significant breakthroughs in core treatment targets for over 40 years [4][5]. - It is a leading cause of cardiovascular diseases and overall mortality, with 10.8 million deaths attributed to high systolic blood pressure in 2019, accounting for about 20% of total deaths [6]. - The prevalence of hypertension is approximately 1.4 billion globally, with 80 million in the U.S. and 90 million in the EU, representing 31% and 24% of the adult population, respectively [6]. Group 2: Treatment Landscape - Current hypertension treatments include lifestyle changes, antihypertensive medications, and some devices [21]. - The article outlines the classification of hypertension into controlled and uncontrolled categories based on blood pressure readings and medication regimens [14]. - The recommended initial medications for hypertension treatment include ACE inhibitors, ARBs, thiazide diuretics, and calcium channel blockers [23]. Group 3: Recent Developments - The recent success of Mineralys in advancing hypertension treatment through innovative drug mechanisms has opened new possibilities in the field [4][5]. - The article discusses the concept of "aldosterone escape," where patients experience a rebound increase in aldosterone levels despite treatment, leading to resistant hypertension [36][39]. - Aldosterone synthase inhibitors (ASI) are highlighted as a promising new class of drugs that can directly inhibit aldosterone production, addressing both RAAS and non-RAAS pathways [40][42]. Group 4: Mechanisms of Hypertension - The pathophysiology of hypertension involves multiple systems, including renal, vascular, neural, and the RAAS system, with obesity also playing a significant role [26][27]. - The article explains the mechanisms by which aldosterone contributes to hypertension, including both direct and indirect pathways [29][36]. Group 5: Clinical Implications - The article emphasizes the importance of accurate blood pressure measurement techniques to avoid misdiagnosis of hypertension, such as white coat hypertension and masked hypertension [18][20]. - It also discusses the need for personalized treatment goals based on individual patient circumstances, particularly for older adults or those with multiple comorbidities [20].

Core Viewpoint - High blood pressure is a common chronic disease that poses serious health risks, and patients often mistakenly believe they can stop medication once their blood pressure appears normal, which can lead to dangerous health consequences [1][4][17] Group 1: Risks of Stopping Medication - Patients who abruptly stop taking antihypertensive medication may experience a rebound effect, leading to blood pressure spikes that can exceed pre-treatment levels, known as "rebound hypertension" [4][5] - Symptoms associated with rebound hypertension include anxiety, insomnia, facial flushing, palpitations, sweating, headaches, and nausea, which can be particularly dangerous for those with pre-existing cardiovascular conditions [4][5] - A clinical study indicated that even under professional monitoring, 14% of patients experienced discomfort during short-term medication cessation, with about 4% requiring emergency care [5] Group 2: Irregular Medication Use - Irregular medication adherence, such as taking medication sporadically, can lead to significant blood pressure fluctuations, increasing the risk of cardiovascular events [8][9] - Research shows that for every 2 mmHg increase in short-term blood pressure variability, the risk of death rises by 28%, and the risk of cardiovascular events increases by 24% [8][9] - Young adults are particularly prone to irregular medication use, often believing they can manage their condition without consistent treatment, which can lead to a significant increase in blood pressure within six months [9][15] Group 3: Conditions for Medication Reduction - Not all patients are required to remain on medication indefinitely; specific conditions must be met for potential medication reduction, including stable blood pressure over several months and low body mass index [12][15] - A study showed that older patients on multiple antihypertensive medications could safely reduce their regimen under medical supervision, with over 85% maintaining target blood pressure levels [14][15] - The decision to reduce or stop medication should be a collaborative process between the patient and healthcare provider, involving careful monitoring and assessment of risks [15][16]

Financial Data and Key Metrics Changes - The company ended the first quarter of 2025 with cash, cash equivalents, and investments of $343 million, compared to $198.2 million as of December 31, 2024, indicating a significant increase in liquidity [23] - R&D expenses for the quarter were $37.9 million, up from $30.8 million in the same quarter of 2024, primarily due to increased preclinical and clinical costs [24] - The net loss for the quarter was $42.2 million, compared to $31.5 million for the same period in 2024, reflecting higher expenses [25] Business Line Data and Key Metrics Changes - The pivotal trials for lorundrostat, including LAUNCH HTN and ADVANCE HTN, achieved statistically significant results in reducing systolic blood pressure in patients with uncontrolled and resistant hypertension [6][9] - The LAUNCH HTN trial demonstrated a placebo-adjusted reduction in systolic blood pressure of 9.1 mmHg at week six and maintained a reduction of 11.7 mmHg at week twelve [14] - The ADVANCE HTN trial showed a placebo-adjusted reduction of 7.9 mmHg in systolic blood pressure, confirming the efficacy of lorundrostat in a high-risk population [17] Market Data and Key Metrics Changes - A survey indicated that 95% of physicians are likely to prescribe lorundrostat if approved, particularly for third and fourth-line treatment of hypertension [9] - The company is targeting approximately 47,000 physicians who account for a significant portion of prescriptions for uncontrolled and resistant hypertension [49] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) for lorundrostat, incorporating data from multiple pivotal trials, including the ongoing EXPLORER CKD trial [9][35] - The appointment of Eric Warren as Chief Commercial Officer is part of the strategy to prepare for potential FDA approval and to enhance commercial efforts [11] - The company is exploring the use of lorundrostat in treating comorbid conditions such as obstructive sleep apnea and hypertensive nephropathy, indicating a broader strategic focus [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical profile of lorundrostat and its potential to address significant unmet medical needs in hypertension [9][93] - The company plans to engage with the FDA in a pre-NDA meeting in Q4 2025 to discuss the path forward for lorundrostat's approval [9] - Management highlighted the importance of the benefit-risk profile of lorundrostat, especially in populations with advanced kidney disease [28] Other Important Information - The company completed a public equity financing that raised approximately $201.2 million, strengthening its balance sheet [12] - The EXPLORER CKD trial is designed to evaluate the safety and efficacy of lorundrostat in patients with chronic kidney disease, which is a critical area of focus for the company [19] Q&A Session Summary Question: What would be the max level of grade two hyperkalemia that would be acceptable if lorundestat yields a high single-digit placebo-adjusted SBP reduction? - Management indicated that specialists are more comfortable with higher potassium levels if there is a significant benefit in blood pressure and kidney function [28] Question: Do you expect similar efficacy and safety with lorundestat as seen with other treatments? - Management anticipates clinically meaningful reductions in blood pressure based on previous studies, but specifics are too early to determine [30] Question: How does the EXPLORER CKD study fit into the strategy for regulatory submission? - The EXPLORER CKD study will be part of the NDA submission, providing clinical support for patients with lower eGFR [35] Question: What are the gating factors to finalizing and filing the NDA? - Key factors include the completion of the open-label extension study and the collection of sufficient data to support the NDA submission [53] Question: Can you discuss any early discussions with potential partners? - Management has not provided updates on partnering discussions but believes that partnerships will be part of the company's strategy moving forward [60] Question: What are the primary objectives for the EXPLORER CKD study? - The primary focus is on safety and clinically meaningful reductions in blood pressure in the CKD population [70] Question: What is the expected timeline for hypertension guidelines to include data from the LAUNCH and ADVANCE HTN studies? - Management noted that it is too early to predict when guidelines will be updated but emphasized the importance of the data for informing treatment paradigms [68]