炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ （来源：医学界） 转自：医学界 从新药到疫苗，这些突破正在走向临床！ 整理丨医学界报道组 审核专家丨马志毅教授 高血压作为心血管疾病的"头号危险因素"，其防治领域的每一步突破都牵动着临床医师与亿万患者的心。近日，医学界"年度盘点"栏目——砥砺前"心"特 别邀请到四位高血压领域的顶尖专家，共话2025年度高血压诊疗的核心进展与未来航向。 本次会议由北京大学人民医院孙宁玲教授全程主持，中国医学科学院阜外医院张宇清教授、上海瑞金医院许建忠教授、北京清华长庚医院马志毅教授分别 从不同维度展开深度解析。其中，马志毅教授围绕"难治性高血压的药物治疗最新策略与循证解析"进行了重点分享，结合2025年最新临床研究数据，为大 家带来了一场干货满满的学术盛宴。 核心前提：从"难治性"到"未控制"，治疗关口前移 近年来，高血压新药研发的关注人群已从传统的"难治性高血压"患者逐渐扩展至"未控制高血压"患者。这意味着，当患者在使用两种降压药后血压仍控制 不佳时，即可被纳入相关研究范围，这实现了治疗干预的"关口前移"。 为何新药研发常以这两类患者为切入点？马教授指 ...

Core Insights - Evaluate's latest report indicates that ten innovative therapies are expected to receive FDA approval in 2026, covering various fields such as metabolic diseases, oncology, and autoimmune conditions, signaling a shift in treatment paradigms for the coming years [1] Metabolic Diseases - The competition between Novo Nordisk and Eli Lilly in the obesity treatment market is intensifying with the upcoming submissions of CagriSema and Orforglipron, which may reshape the treatment landscape for obesity [5] - CagriSema is a fixed-dose combination therapy of cagrilintide and semaglutide, designed for weekly subcutaneous injection, aiming to effectively regulate metabolism and achieve weight loss through multiple mechanisms [5][6] - Orforglipron is an oral GLP-1 receptor agonist that can be taken at any time of the day, enhancing patient compliance due to its convenient dosing regimen [6] - Clinical trials show that CagriSema achieved a weight loss of 20.4% at week 68 compared to 3.0% in the placebo group, while Orforglipron also demonstrated significant weight loss and improvements in metabolic risk factors [7][8] - Both drugs represent trends in obesity treatment: combination therapy and oral GLP-1 agonists, potentially leading to a more competitive market and increased R&D investments in metabolic disease therapies [9] Cell Therapy - Anitocabtagene autoleucel (anito-cel), a CAR-T therapy targeting BCMA, is expected to provide breakthroughs in treating multiple myeloma, addressing challenges in expanding CAR-T therapy to solid tumors [10] - The innovative D-Domain design of anito-cel improves CAR expression stability and reduces immune-related adverse effects, enhancing its therapeutic efficacy [11] - Clinical data shows a total response rate of 96% and a 24-month overall survival rate of 83% for patients treated with anito-cel, indicating its potential as a durable treatment option [12] Autoimmune Diseases - Brepocitinib and Icotrokinra are poised to optimize precision treatment strategies in autoimmune diseases, moving from broad-spectrum immunosuppression to targeted mechanisms [14] - Brepocitinib is a selective TYK2/JAK1 inhibitor that effectively blocks pathogenic signaling pathways without broadly suppressing normal immune function, showing significant clinical improvement in dermatomyositis patients [15] - Icotrokinra is a first-in-class oral therapy targeting IL-23R, demonstrating significant efficacy in treating moderate to severe plaque psoriasis [16][17] - Both therapies utilize oral administration, enhancing patient compliance and potentially transforming treatment paradigms in autoimmune diseases [19] Breast Cancer Treatment - Gedatolisib, a multi-target PAM inhibitor, aims to address resistance issues in HR+/HER2- advanced breast cancer by fully blocking the PAM pathway [20] - Clinical trials indicate that gedatolisib significantly improves progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast cancer [21][22] - Camizestrant, a new oral selective estrogen receptor degrader (SERD), shows promise in treating patients with ESR1 mutations, enhancing treatment efficacy [23][24] - The combination of gedatolisib and camizestrant represents a shift towards multi-pathway combination therapies, providing new treatment avenues for resistant breast cancer patients [26][27] Rare Diseases - Baxdrostat, Ulixacaltamide, and Atacicept are innovative therapies targeting unmet needs in hypertension, essential tremor, and IgA nephropathy, respectively, showcasing the industry's focus on rare diseases [28][35] - Baxdrostat is a selective oral aldosterone synthase inhibitor that has shown significant efficacy in treating resistant hypertension [29][30] - Ulixacaltamide is a selective T-type calcium channel inhibitor that has demonstrated efficacy in treating essential tremor [31][32] - Atacicept targets B-cell activation factors, showing promise in reducing proteinuria in IgA nephropathy patients [33][34] Conclusion - The ten therapies highlighted reflect a shift towards precision medicine, optimized delivery strategies, and improved clinical response rates, marking a transition in biopharmaceutical development towards patient-centered and data-driven decision-making [36]

Investment Rating - The report maintains an "Outperform" rating for the industry [1] Core Insights - The report emphasizes the importance of systematically researching next-generation innovative drugs for resistant hypertension (rHTN), highlighting that multiple new mechanism antihypertensive drugs will read out data and/or achieve clinical progress by 2025 [2] - Key catalysts include upcoming Phase 3 clinical studies focusing on cardiovascular and renal endpoints, which are expected to provide significant data in the coming years [2] - The report suggests paying attention to domestic companies involved in relevant target areas [2] Summary by Sections 01 Current Status and Unmet Needs in Hypertension Treatment - Hypertension is a prevalent cardiovascular disease, with approximately 90%-95% of patients suffering from primary hypertension, driven by factors such as salt sensitivity and obesity [3] - In the US, the prevalence of hypertension is around 48%, corresponding to approximately 120 million people, with about 60 million receiving antihypertensive treatment [3] - In China, the prevalence among adults aged 18 and older was 27.5% in 2018, with awareness, treatment, and control rates at 51.6%, 45.8%, and 16.8%, respectively [3] 02 Next-Generation Drug Focus on AGT and ASI - The report discusses the focus on AGT (Angiotensinogen) and ASI (Angiotensin II receptor blockers) in the development of next-generation antihypertensive drugs [3] - AGT-targeting drugs, particularly siRNA and ASO therapies, are highlighted as promising avenues for reducing blood pressure effectively [27] 03 Investment Recommendations - The report suggests that the market for resistant hypertension treatments is highly structured, with a focus on balancing efficacy and safety in drug development [16] - It emphasizes the need for drugs that can manage long-term adherence and safety, particularly for patients with comorbidities such as CKD and HF [19]

Investment Rating - The industry investment rating is "Outperform the Market," indicating that the industry index is expected to perform better than the market by more than 5% over the next six months [36]. Core Insights - The 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List, along with the first version of the Commercial Health Insurance Innovative Drug List, was released on December 7, 2025. This adjustment includes 114 new drugs, of which 50 are classified as Class 1 innovative drugs [3]. - The newly launched Chinese Drug Price Registration System aims to facilitate the global pricing system for innovative drugs and attract high-quality foreign drugs to the Chinese market, benefiting patients [4][5]. - The innovative drug sector is expected to continue its rise, with recommendations to focus on companies with rich pipeline layouts, high-potential innovative drugs, and leading technology platforms [11]. Summary by Sections Industry Developments - The 2025 drug list adjustment marks the eighth update since the establishment of the National Medical Insurance Bureau, reflecting ongoing efforts to enhance drug accessibility and innovation in China [3]. - The Chinese Drug Price Registration System, launched on December 2, 2025, allows pharmaceutical companies to independently declare drug prices, promoting a more transparent and globalized pricing structure [4][5]. Company Highlights - Yino Pharmaceutical has rapidly emerged in the metabolic disease treatment field since its establishment in 2014, with its core product, Isupreglutide α, receiving approval as a Class 1 innovative drug and entering commercialization [7]. Investment Strategy - The report suggests focusing on companies with diverse pipelines, such as Heng Rui Medicine, BeiGene, and China National Pharmaceutical Group, as well as those with high-potential innovative drugs like Sanofi and Kaiyin Technology [11]. - It also highlights the importance of companies with leading technology platforms, such as Dongcheng Pharmaceutical and WuXi AppTec, as well as upstream companies benefiting from overseas expansion [11]. Market Performance - The pharmaceutical sector experienced a decline of 0.74% last week, ranking 19th among 28 industries, while the Shanghai and Shenzhen 300 Index rose by 1.28% [14][24]. - As of December 5, 2025, the pharmaceutical sector's valuation stands at 29.30 times (TTM), with a premium of 17.46% over the overall A-share market [27].

Investment Rating - The report maintains a rating of "Buy" for the pharmaceutical and biotechnology industry, specifically recommending companies such as Heng Rui Medicine and BeiGene for investment [1]. Core Insights - The report emphasizes optimism regarding the international expansion of innovative drugs, highlighting Heng Rui Medicine's comprehensive layout in drug development and its strong performance in both domestic and international markets [1][4]. - The A-share pharmaceutical index has shown a year-to-date increase of 15.86%, although it has underperformed compared to the CSI 300 index by 0.65% [4][9]. - The report identifies a ranking of preferred sub-industries, with innovative drugs at the top, followed by research services, CXO, traditional Chinese medicine, medical devices, and pharmacies [10][12]. Summary by Sections Industry Trends - The report notes that various sectors within the pharmaceutical industry have experienced mixed performance, with pharmaceutical commerce and traditional Chinese medicine showing slight increases, while raw materials, chemical pharmaceuticals, medical devices, and biological products have seen declines [4][9]. Company Focus: Heng Rui Medicine - Heng Rui Medicine has established itself as a leader in innovative drug commercialization, with the highest number of approved innovative drugs in China and a strong pipeline for future approvals [4][12]. - The company has engaged in significant business development (BD) activities, totaling nearly $28 billion over the past three years, which is expected to provide ongoing revenue streams [4][12]. Recommended Stocks - The report suggests specific stocks to watch within various segments: - For innovative drugs: Focus on companies like XinDa Biologics, BeiGene, and Heng Rui Medicine [12]. - For CXO and research services: Consider WuXi AppTec and other related firms [12]. - For medical devices: Look at companies such as Yuyue Medical and others [12]. - For AI drug development: Keep an eye on JingTai Holdings [12]. - For GLP-1 related products: Monitor companies like LianBang Pharmaceutical and others [12].

Core Insights - The healthcare innovation sector is showing positive momentum, with the China Securities Medicine and Medical Device Innovation Index (931484) rising by 0.31% as of November 14, 2025, and several key stocks, including Sanofi and Ganli Pharmaceutical, experiencing significant gains [1] Group 1: Market Performance - The China Securities Medicine and Medical Device Innovation Index has seen a 0.31% increase, with notable stock performances: Sanofi up 4.64%, Ganli Pharmaceutical up 3.28%, and Jiutian Pharmaceutical up 1.83% [1] - The Medical Innovation ETF (516820) has also risen by 0.26%, marking its third consecutive increase [1] Group 2: Clinical Developments - AstraZeneca announced successful Phase III clinical trials for Baxdrostat, which significantly reduced 24-hour average systolic blood pressure in patients with resistant hypertension over 12 weeks, indicating a new treatment pathway for hypertension [1] Group 3: Industry Trends - According to Dongfang Caifu Securities, the pharmaceutical industry showed improvement in Q3 2025, with the medical device sector experiencing a turning point, achieving positive year-on-year revenue growth and a notable narrowing of net profit declines [1] - The CXO sector performed exceptionally well in the first three quarters of 2025, with medical R&D outsourcing revenue increasing by 12.2% and net profit rising by 56.8%, particularly in ADC CDMO and peptide CDMO fields [2] - The index reflects the performance of 30 profitable and growth-oriented companies in the pharmaceutical and medical device sectors, with the top ten stocks accounting for 64.12% of the index [2]

Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS: MLYS) - **Focus**: Development of aldosterone synthase inhibitors (ASI) targeting cardiorenal metabolic disorders, primarily hypertension [1][2] Industry Context - **Market Opportunity**: Approximately 20 million patients in the U.S. suffer from resistant and uncontrolled hypertension, with 10 million specifically identified as resistant hypertension patients [4][5] - **Competitive Landscape**: The ASI class is emerging as a new treatment option for hypertension, with recent data from competitors like AstraZeneca's Baxdrostat [2][3] Key Clinical Data - **Clinical Trials**: Successful outcomes from pivotal studies LAUNCH HTN and ADVANCE HTN, with significant blood pressure reductions observed [1][2] - **Efficacy**: Lorundrostat demonstrated a 15-19 mmHg reduction in blood pressure compared to the typical 5 mmHg improvement seen with existing treatments [5][6] - **Patient Demographics**: Strong representation of Black or African American patients in trials, addressing a high-risk population for hypertension [9][10] Drug Profile - **Selectivity**: Lorundrostat shows a selectivity ratio of 374:1 for aldosterone over cortisol, compared to Baxdrostat's 101:1, indicating a better safety profile [11][12] - **Half-Life**: Lorundrostat has a half-life of 10-12 hours, aligning with the diurnal pattern of aldosterone secretion, which may enhance safety [12][13] - **Safety Signals**: Lower incidence of hyperkalemia compared to Baxdrostat, with 8% incidence above 5.5 mEq/L for lorundrostat versus 11% for Baxdrostat [15][16] Market Strategy - **Target Population**: Initial focus on resistant hypertension, with plans to expand into uncontrolled hypertension as prescriber comfort increases [27][30] - **Commercialization Approach**: Open to partnerships but emphasizes the importance of selecting the right partner to maximize the drug's potential [45][46] - **Market Size**: Targeting a broad market of 120 million people with hypertension, with a focus on the top 60,000 prescribers [46][47] Future Developments - **NDA Filing**: Anticipated NDA filing by the end of 2025, with ongoing collection of safety and efficacy data beyond the initial 12-week trials [37][38] - **Additional Studies**: Ongoing studies in chronic kidney disease (CKD) and obstructive sleep apnea (OSA) to explore additional benefits and potential label expansions [42][43] Conclusion - **Investment Potential**: Mineralys Therapeutics is positioned with a best-in-class molecule in a growing market, with strong clinical data supporting its efficacy and safety, making it a compelling investment opportunity in the pharmaceutical sector [19][50]

Policy Developments - Jiangxi Province is promoting the development of brain-computer interface medical devices, emphasizing the need for regulatory compliance and collaboration among industry players to seize opportunities in emerging technologies [1] - The market for brain-computer interface medical devices is noted to have significant potential, with a strong development momentum in Jiangxi Province [1] Medical Device Approvals - In October, the National Medical Products Administration approved 204 medical device products, including 173 domestic Class III devices, 10 imported Class III devices, and 21 imported Class II devices [2] Pharmaceutical Logistics - The Shanghai Municipal Drug Administration encourages the development of modern pharmaceutical logistics, advocating for improved storage and management systems to enhance operational efficiency and reduce costs [3] Drug Approvals - Fangsheng Pharmaceutical announced that its Indobufen tablets received a drug registration certificate from the National Medical Products Administration, allowing for production [4] - Saito Bio's application for the chemical raw material drug Mometasone Furoate has been approved, indicating its use in treating asthma and skin conditions [5] - Tianyao Pharmaceutical received a drug registration certificate for Metoclopramide injection, which is used for treating nausea and vomiting [6] Capital Market Activities - Yingsi Intelligent submitted a listing application to the Hong Kong Stock Exchange, aiming to raise funds for its AI-driven drug development initiatives [7][8] - Rejuve Bio plans to repurchase shares worth between 100 million and 200 million yuan to support employee stock ownership plans [9] Industry Developments - AstraZeneca's Baxdrostat demonstrated significant reductions in 24-hour average systolic blood pressure in treatment-resistant hypertension patients during the Bax24 Phase III trial, achieving a reduction of 14.0 mmHg compared to placebo [10][11] - The drug showed good overall tolerability and consistent safety profiles, with a notable percentage of patients achieving target blood pressure levels [11] - Maiwei Bio's IL-11 monoclonal antibody 9MW3811 received approval for Phase II clinical trials targeting pathological scars, marking it as the first IL-11 targeted drug to enter clinical trials for this indication [12] - Aiwei Technology's subsidiary obtained a medical institution practice license, enabling it to provide third-party medical testing services [13] - Anke Bio signed an exclusive agency framework agreement with Boshengji for the PA3-17 injection product, aimed at enhancing its product portfolio in the innovative drug market [14][15]

Core Viewpoint - AstraZeneca's drug Baxdrostat successfully met the primary endpoint in a late-stage study for patients with treatment-resistant hypertension [1] Group 1 - The study focused on patients suffering from high blood pressure that is resistant to standard treatments [1] - The successful outcome of the study may enhance AstraZeneca's position in the hypertension treatment market [1]

Core Viewpoint - AstraZeneca's stock rose over 2% to $81.99 following positive results from the Baxdrostat clinical trial presented at the 2025 European Society of Cardiology (ESC) annual meeting, indicating significant sales potential in the hypertension treatment market [1] Group 1: Clinical Trial Results - Baxdrostat demonstrated strong efficacy in treating hypertension during the Phase III BaxHTN clinical trial, which could lead to billions in sales opportunities for AstraZeneca [1] - The drug is a highly selective aldosterone synthase inhibitor (ASI) targeting hormones that elevate blood pressure and increase cardiovascular and renal risks [1] Group 2: Market Potential and Approval Timeline - Over 20,000 patients have been enrolled in global clinical trials for Baxdrostat, which includes studies for hypertension, primary aldosteronism, and chronic kidney disease [1] - Baxdrostat is expected to receive regulatory approval in the first half of 2026 in the US and Europe, potentially becoming the first ASI antihypertensive drug on the market [1] Group 3: Analyst Ratings and Price Target - Goldman Sachs has assigned a "Buy" rating to AstraZeneca with a 12-month price target of $99, representing approximately a 23% upside from the stock's closing price of $80.19 [1]