格隆汇12月8日丨信立泰(002294.SZ)公布，收到国家药品监督管理局核准签发的《临床试验批准通知 书》，同意公司自主研发的创新小分子药物SAL0140片（项目代码：SAL0140）开展治疗原发性醛固酮 增多症的临床试验。SAL0140是公司具有自主知识产权的醛固酮合酶抑制剂，拟开发适应症包括未控制 高血压（包括难治性高血压）、原发性醛固酮增多症、慢性肾脏病（CKD）等。醛固酮是人体最重要 的盐皮质激素，通过激活盐皮质激素受体（MR）来维持体液和电解质的平衡，同时直接参与多种心血 管和肾脏疾病的靶器官损伤。醛固酮合酶抑制剂有望通过直接抑制醛固酮的合成，降低原醛症患者的醛 固酮水平，进而降低血压及器官损伤，具有一定开发潜力。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 二〇二五年十二月四日 （详见2025年2月14日、2025年4月29日、2025年8月29日、2025年9月30日登载于信息披露媒体《中国证 券报》、《证券时报》、巨潮资讯网www.cninfo.com.cn的《关于SAL0140药品临床试验申请获得受理的 公告》、《关于SAL0140获得临床试验批准通知书的公告》） SAL0140若能研发成功并获批上市，将有望为更多细分领域的患者有针对性地提供新的用药选择，满足 未被满足的临床需求，并进一步丰富公司慢病领域的创新产品管线。 公司将按国家药品注册的相关规定和要求开展临床试验，待临床试验成功后按程序注册申报。根据普遍 的行业特点，药品研发周期长、风险较高，从临床到上市受到多方面因素影响，存在不确定性，短期内 对公司业绩不会产生实际影响。公司将按规定对有关后续进展情况及时履行信息披露义务，敬请广大投 资者理性投资，注意风险。 特此公告 深圳信立泰药业股份有限公司 董事会 近日，深圳信立泰药业股份有限公司（下称"公司"） ...

Core Viewpoint - The company, Xinlitai (002294.SZ), has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140, aimed at treating chronic kidney disease (CKD) [1] Group 1: Drug Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company, targeting conditions such as uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1] - The drug is expected to mitigate end-organ damage through the inhibition of aldosterone synthesis, potentially improving the progression of chronic kidney disease [1] Group 2: Mechanism of Action - Aldosterone is a crucial mineralocorticoid hormone that maintains fluid and electrolyte balance by activating mineralocorticoid receptors (MR), and it is directly involved in various cardiovascular and renal diseases [1] - Aldosterone synthase inhibitors may offer therapeutic benefits by reducing both genomic and non-genomic effects associated with end-organ damage [1]

Core Viewpoint - The company, Xinlitai (002294.SZ), has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140, aimed at treating chronic kidney disease (CKD) [1] Group 1: Drug Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company, targeting indications such as uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1] - The drug aims to inhibit the synthesis of aldosterone, which is crucial for maintaining fluid and electrolyte balance, and is involved in various cardiovascular and renal diseases [1] Group 2: Mechanism of Action - Aldosterone is the most important mineralocorticoid hormone in the human body, activating mineralocorticoid receptors (MR) to regulate fluid and electrolyte balance [1] - Aldosterone synthase inhibitors are expected to mitigate end-organ damage caused by both genomic and non-genomic effects, potentially improving the progression of chronic kidney disease [1]

Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Product**: Lorundrostat, an aldosterone synthase inhibitor targeting hypertension, particularly in patients with hyperaldosteronism-driven, uncontrolled, and resistant hypertension Key Points and Arguments 1. **Clinical Success**: Mineralys has achieved successful clinical outcomes in its pivotal program for lorundrostat, with an upcoming FDA filing and preparations for commercial launch expected soon [1][3] 2. **Target Population**: Approximately 30% of hypertension patients exhibit elevated or dysregulated aldosterone, confirming the need for aldosterone-targeted treatments [4] 3. **Market Approach**: The initial market strategy is to target fourth-line treatment for resistant hypertension, with plans to expand into third-line treatment over time [6][9] 4. **Guideline Inclusion**: The company is working closely with key opinion leaders to include lorundrostat in treatment guidelines, which is expected to be achievable based on rigorous trial data [7][8] 5. **Patient Population**: There are about 10 million potential patients with resistant hypertension in the U.S., with an additional 10 million in the third-line category [9][10] 6. **Safety and Efficacy Data**: The company does not anticipate additional incidences of hyperkalemia over time and plans to share comprehensive data with the FDA during the NDA submission [10][11] 7. **Competitive Landscape**: Recent phase three data on Baqsrostat showed comparable results to lorundrostat, but lorundrostat's profile is viewed favorably due to its efficacy and specificity [12][13] 8. **Partnership Opportunities**: Mineralys is open to partnerships to maximize the commercial potential of lorundrostat, especially given the focused nature of the prescribing physician base [18][19] 9. **Independent Launch Considerations**: While an independent launch is feasible, the company believes partnering would enhance market access and efficiency [20][21] 10. **Additional Indications**: Ongoing trials for chronic kidney disease (CKD) and obstructive sleep apnea (OSA) are aimed at establishing a broader treatment profile for lorundrostat [22][24] 11. **Future Development**: Heart failure is identified as a potential area for future research with aldosterone synthase inhibitors [25] 12. **Impact of Weight Loss Treatments**: The rise of GLP-1s and other weight loss treatments may affect the hypertension market, but there remains a significant opportunity for lorundrostat due to the prevalence of elevated aldosterone [26] Additional Important Insights - The company is focused on ensuring that lorundrostat is recognized as a viable treatment option for patients with comorbidities such as CKD and OSA [22][24] - The competitive landscape is evolving, and the company is prepared to address potential counter-detailing from competitors regarding treatment profiles [17] - The overall market for hypertension treatments remains robust, with a significant number of patients requiring effective management strategies [26]