智通财经APP获悉，中金发布研报称，维持亚盛医药-B(06855)"跑赢行业"评级与目标价89港元，公司近 期研发进展积极。耐立克(奥雷巴替尼)一线治疗Ph+ ALL的全球III期研究(POLARIS-1)已获欧美药监机 构批准开展，并公布亮眼初步数据；利生妥(APG-2575)针对高危基线人群亦显示出良好疗效与安全性， 整体研发管线持续兑现，国际化稳步推进。 中金主要观点如下： 公司近况 1)耐立克(奥雷巴替尼)1L治疗Ph+ ALL的全球注册III期研究POLARIS-1获得美国FDA和欧洲EMA批准开 展;2)公司在12月召开的2025 美国血液学会(ASH)年会上读出3个品种的多个数据，包括利生妥(APG- 2575)的国内II期注册临床数据口头报告，以及耐立克POLARIS-1数据的首次读出等。 风险提示 研发失败，商业化不及预期，竞争格局恶化，对外合作进展不及预期。 本次ASH披露的POLARIS-1数据表明，截至2025年7月18日，耐立克联合低强度化疗在53例1L Ph+ ALL 患者中，94.3%在3个月内实现了CR/CRi，最佳MRD阴性率和MRD阴性CR率分别为66.0%和64.2%。该 ...

点评：分娩"无自付"若落地，将有望改善全国生育预期并利好妇幼医疗与镇痛相关产业链。 丨2025年12月15日星期一丨 NO.1 国家医保局：力争全国2026年基本实现政策范围内分娩个人"无自付" 12月13日，国家医保局党组书记、局长章轲在全国医疗保障工作会议上表示，2026年将根据医保基金可 承受能力，合理提升产前检查医疗费用保障水平，探索制定包括产前检查项目在内的基本服务包，减轻 参保人生育医疗费用负担，力争全国基本实现政策范围内分娩个人"无自付"。所有省份均要将适宜的分 娩镇痛项目按程序纳入基金支付范围，落实完善辅助生殖技术项目医保支付管理。 NO.4 佐力药业：拟购买西藏未来及其两家全资子公司的"多种微量元素注射液资产组" 12月14日，佐力药业发布公告称，根据公司战略布局和经营发展需要，为了进一步优化产品结构，巩固 和提升公司的综合竞争力及可持续发展能力，公司拟购买西藏未来及其两家全资子公司许昌未来和合肥 未来的"多种微量元素注射液资产组"，并签署《多种微量元素注射液资产组收购协议书》。根据天源资 产评估有限公司出具的资产评估报告，并经各方友好协商，资产组的转让总价（含税）为人民币3.56亿 元。 ...

Core Viewpoint - Dyne Therapeutics reported significant progress with its investigational drug zeleciment rostudirsen for Duchenne muscular dystrophy (DMD), achieving primary and secondary endpoints in a clinical trial, leading to a notable increase in share price [1][2][4]. Group 1: Clinical Trial Results - The drug zeleciment rostudirsen met its primary endpoint in a phase 1/2 clinical trial involving 86 patients [2]. - It also achieved secondary endpoints, demonstrating a statistically significant increase in dystrophin production, a crucial protein for muscle protection [4]. Group 2: Regulatory Outlook - Dyne Therapeutics plans to submit zeleciment rostudirsen for accelerated approval by the U.S. Food and Drug Administration (FDA) in the second quarter of next year [4]. Group 3: Market Performance - Following the announcement, Dyne's shares increased by 9.57%, with the current price at $22.22 and a market capitalization of $3 billion [5][6]. - The stock's 52-week range is between $6.36 and $29.71, indicating significant volatility [5].

Financial Data and Key Metrics Changes - The company is currently trading at close to multi-year highs, indicating a positive market sentiment and performance [18] - The Navigate trial's top-line results were presented, showing a lower rate of new varices with the two-milligram dose of belapectin compared to placebo after 18 months, although not statistically significant in the overall population [24] Business Line Data and Key Metrics Changes - The focus has been on analyzing biomarker data from the Navigate trial to support the efficacy of belapectin in treating MASH cirrhosis and portal hypertension [21][25] - Significant findings include a lower rate of new varices in patients treated with belapectin compared to placebo, particularly in those with advanced fibrosis [26] Market Data and Key Metrics Changes - The company has engaged with key opinion leaders (KOLs) and presented findings at major hepatology conferences, enhancing its visibility and credibility in the market [22] - The Navigate trial enrolled one of the most advanced compensated MASH cirrhosis populations studied to date, which may influence market perception and potential partnerships [29] Company Strategy and Development Direction - The company aims to maximize the value of its program and is exploring strategic opportunities to advance belapectin, which has the potential to change the treatment landscape for patients with no FDA-approved therapies [23] - Continued engagement with clinicians and KOLs is planned to further validate and communicate the clinical findings of belapectin [22] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the company's current position and the extensive data available to support its programs [18] - The company anticipates feedback from the FDA regarding its submitted package and is optimistic about the future of its treatment options [23] Other Important Information - The company has maintained a clean safety profile for belapectin, with no drug-related serious adverse events reported during the Navigate trial [29] - The results from the Navigate trial are expected to lead to further discussions with potential partners committed to advancing belapectin [29] Q&A Session Summary Question: What are the key findings from the Navigate trial? - The two-milligram dose of belapectin showed a lower rate of new varices compared to placebo, particularly in the completer population [24] - Biomarker analyses indicated that belapectin may stabilize MASH cirrhosis over time and reduce key inflammatory pathways [26][27] Question: What are the next steps for the company? - The company is finalizing remaining analyses and looks forward to working with the FDA to determine next steps for the belapectin program [29] - Active discussions with potential partners are ongoing to advance the treatment for patients with no approved options [29]

Core Insights - The company is experiencing significant developments, particularly following a successful readout for essential tremor studies, with a filing anticipated early in the year [1] - Progress is being made on several epilepsy assets, including the DEE program with relutrigine, targeting rare indications SCN2A and 8A [1] - An interim analysis for the ongoing study is currently being conducted in Q4, with expectations for positive results leading to an NDA filing for the indication [1] Company Developments - The company is pleased with its progress but maintains a humble outlook despite recent successes [1] - Recruitment for the larger study, referred to as EMERALD, is ongoing and is expected to yield results next year [1] - The company is optimistic about the interim analysis and its implications for future regulatory filings [1]

Financial Performance - Novartis reported a 7% increase in net sales and core operating income for Q3 2025, with a core margin of 39.3% [5][27] - Core EPS rose by 10% to $2.25, and free cash flow totaled $6.2 billion for the quarter [28][27] - For the first nine months, net sales grew by 11%, core operating income by 18%, and core EPS increased by 21% to $6.94 [28][29] Business Line Performance - Key brands showed strong growth: Kisqali grew 68%, Pluvicto 45%, Leqvio 54%, and Scemblix 95% in constant currency [6][10][14][16] - Kisqali's U.S. growth was particularly strong at 91%, with a market-leading position in both metastatic and early breast cancer [7][9] - Pluvicto's growth was driven by new patient starts, with U.S. sales up 53% [11][12] - Leqvio is on track for over $1 billion in sales, with significant growth in both the U.S. and international markets [14][15] - Scemblix is expected to become the most prescribed TKI in the U.S. [16] Market Performance - The U.S. experienced negative growth due to net true-ups related to Medicare Part D redesign, but underlying growth would have been 9% without these adjustments [27][28] - Outside the U.S., Kisqali saw 37% growth in constant currency, and Pluvicto is expanding in Europe, Canada, and Brazil [7][12] - The renal portfolio, particularly IGAN, grew 98% in the U.S., significantly outpacing market growth [20][21] Company Strategy and Industry Competition - Novartis is focused on driving growth through its priority brands and pipeline advancements, despite facing generic erosion from products like Entresto [5][28] - The company is pursuing strategic acquisitions, including Avidity Biosciences, to enhance its growth trajectory [35][36] - Novartis aims to maintain a core margin of around 40% despite expected short-term dilution from new product launches [35][36] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in mid to long-term growth, reaffirming guidance for high single-digit growth in net sales and low teens growth in core operating income for the full year [31][38] - The company anticipates challenges in the first half of 2026 due to generic competition but expects a stronger second half [33][34] - Management highlighted the importance of addressing pricing and reimbursement issues with the administration to support innovation [41][42] Other Important Information - Novartis is preparing for regulatory submissions for several products, including remibrutinib and ianalumab, with expectations for rapid uptake in the market [22][24] - The company is focused on enhancing its R&D capabilities and expanding its manufacturing base in the U.S. [43] Q&A Session Summary Question: Impact of Medicaid and tariffs on the industry - Management indicated that while some companies have reached agreements with the administration, Novartis is in ongoing discussions to find suitable solutions [41][42] Question: CapEx and cash flow modeling - Management clarified that the majority of the $23 billion commitment over five years is for R&D OpEx, with CapEx expected to remain stable at 2.5%-3% of sales [42][43] Question: Market reaction to ATR abstract - Management expressed confidence that detailed data presentation would improve market perception and emphasized the importance of patient benefits over statistical measures [46][47] Question: Pluvicto launch curve and peak sales ambition - Management stated that Pluvicto is on a strong growth trajectory, expecting to reach peak sales of $5 billion with ongoing efforts to tackle commercialization challenges [55][56][58] Question: Remibrutinib ramp-up and European adoption - Management highlighted the focus on payer negotiations and the potential for rapid uptake in the U.S. and Europe, emphasizing the innovative profile of remibrutinib [62][64] Question: Ianalumab study results and secondary endpoints - Management explained the statistical significance achieved in primary endpoints and the importance of patient-relevant outcomes for future discussions with physicians [68][71] Question: Cosentyx market share and new formulation - Management noted that there has been no significant impact from competitor launches and emphasized ongoing efforts to maintain market share in a growing market [74]

Core Insights - Praxis Precision Medicines, Inc. (PRAX) shares experienced a significant rally of 183.7%, closing at $162.71, attributed to higher trading volume compared to typical sessions [1] - The stock has gained 30.3% over the past four weeks, indicating strong investor interest [1] Study Results - Positive topline results from two phase III studies of ulixacaltamide for treating essential tremor (ET) were announced, with Study 1 showing a 4.3-point mean improvement in daily functioning at Week 8 compared to placebo, meeting the primary endpoint [2] - Study 2 revealed that 55% of ulixacaltamide-treated patients maintained response compared to 33% on placebo, confirming sustained benefit and meeting the primary endpoint [2] - The drug was well tolerated, with no serious drug-related adverse events reported, positioning ulixacaltamide as a potential first-in-class treatment for ET, which affects around 7 million Americans [2] Regulatory Outlook - Praxis has submitted a pre-NDA meeting request to the FDA, indicating a path toward commercialization, with plans to submit a regulatory application for ulixacaltamide in early 2026 [2] Financial Expectations - The company is expected to report a quarterly loss of $3.45 per share, reflecting a year-over-year change of -25.5%, while revenues are anticipated to be $0.33 million, up 10.7% from the previous year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, suggesting that stock price movements may not continue without trends in earnings estimate revisions [4] Industry Context - Praxis Precision Medicines is part of the Zacks Medical - Biomedical and Genetics industry, where Royalty Pharma (RPRX) also operates, finishing the last trading session 0.4% higher at $36.34 [4] - Royalty Pharma's consensus EPS estimate for the upcoming report has changed by +0.8% over the past month to $1.11, representing a year-over-year change of +6.7% [5]

Core Insights - Praxis Precision Medicines (PRAX.US) shares surged 240% to a three-year high of $194.90 following the announcement of positive results for their essential tremor drug Ulixacaltamide in two pivotal Phase III studies [1] Group 1: Study Results - Study 1 demonstrated a 4.3-point improvement in the Modified ADL-11 score at week 8 with a p-value of <0.0001, and all key secondary endpoints showed statistical significance [1] - Study 2 indicated significant maintenance of effect with a p-value of 0.0369, and the first key secondary endpoint also showed statistical significance with a p-value of 0.0042 [1] Group 2: Safety and Regulatory Progress - Ulixacaltamide exhibited good safety data, with no drug-related serious adverse events reported in both studies, and tolerability consistent with previous trials [1] - The company has submitted a pre-NDA meeting request to the FDA to advance the drug approval process [1]

Core Viewpoint - Praxis Precision Medicines (PRAX.US) shares surged 240% to a three-year high of $194.90 following the announcement that their drug Ulixacaltamide for essential tremor met primary endpoints in two key Phase III studies [1] Group 1: Study Results - Study 1 demonstrated a 4.3-point improvement in the Modified ADL-11 score at week 8 with a p-value of <0.0001, and all key secondary endpoints showed statistical significance [1] - Study 2 indicated significant maintenance effects with a p-value of 0.0369, and the first key secondary endpoint also showed statistical significance with a p-value of 0.0042 [1] Group 2: Safety and Regulatory Progress - Ulixacaltamide exhibited good safety data, with no drug-related serious adverse events reported in both studies, and tolerability consistent with previous trials [1] - The company has submitted a pre-NDA meeting request to the FDA to advance the drug approval process [1]

Group 1 - The core viewpoint of the news is the significant stock price surge of药捷安康 (Yaojie Ankang), which rose over 124% in intraday trading on September 15, closing at 415 HKD per share, leading to a market capitalization of 164.71 billion HKD [2] -药捷安康 was established in 2014 and went public on June 23, 2025, with an initial share price of 13.15 HKD. The stock has seen a remarkable increase of 3055.89% within less than three months of its listing [2] - The stock price increase is attributed to the announcement of progress regarding its core product, Tinengotinib, which received clinical approval for treating specific breast cancer patients [3][4] Group 2 - Tinengotinib is a multi-target kinase (MTK) inhibitor that targets key pathways including FGFR/VEGFR, JAK, and Aurora, and is the first registered clinical-stage drug for treating recurrent or refractory cholangiocarcinoma (CCA) patients [3] - Clinical trial results for Tinengotinib show a 30% objective response rate (ORR) and a 93% disease control rate (DCR) among previously treated CCA patients in the U.S. [4] - The global CCA drug market is projected to reach 2 billion USD by 2024, with a compound annual growth rate (CAGR) of 16.2% from 2019 to 2024, and expected to grow to 4.6 billion USD by 2030 [4] Group 3 - In addition to Tinengotinib, the company has five other candidates in clinical stages and one in preclinical stage, but it has not yet commercialized any products and is currently operating at a loss [5] - The company reported losses of 343 million CNY in 2023, 275 million CNY in 2024, and 123 million CNY in the first half of 2025 [5] - Other billion-dollar market cap pharmaceutical companies in Hong Kong have established commercial products, raising questions about the sustainability of药捷安康's market cap without commercialized products [6]