信达证券（601059）发布研报称，首次覆盖，给予康哲药业(00867)"买入"评级，该行预计2025-2027年 公司营业收入分别为82.16亿元、98.59亿元、120.28亿元，同比增速分别为10%、20%、22%;归母净利 润分别为16.15亿元、18.50亿元、22.38亿元，同比增速分别为0%、15%、21%。该行看好公司中长期成 长性。 国内商业化能力卓越，海外东南亚市场研产销布局完备 公司通过合作开发及自主研发，高效布局了近40款创新管线，并已进入成果密集兑现阶段。目前已有6 款创新药成功上市实现商业化，处于NDA阶段的重磅创新产品包括：1)注射用Y-3，用于急性缺血性脑 卒中治疗，兼具预防卒中后抑郁焦虑，2025年12月NDA受理;2)德昔度司他片，用于非透析的成人慢性 肾脏病患者贫血治疗，2024年4月NDA受理;3)斯乐韦米单抗注射液，用于成人疑似狂犬病病毒暴露后的 被动免疫，2025年1月NDA受理;4)唯康度塔单抗注射液，用于破伤风的被动免疫，2025年5月NDA受 理;5)ZUNVEYL，用于治疗阿尔茨海默病，2025年7月NDA受理;6)MG-K10(IL-4Rα单抗)，特应性皮 ...

智通财经APP获悉，信达证券发布研报称，首次覆盖，给予康哲药业(00867)"买入"评级，该行预计 2025-2027年公司营业收入分别为82.16亿元、98.59亿元、120.28亿元，同比增速分别为10%、20%、 22%;归母净利润分别为16.15亿元、18.50亿元、22.38亿元，同比增速分别为0%、15%、21%。该行看好 公司中长期成长性。 信达证券主要观点如下： 国内商业化能力卓越，海外东南亚市场研产销布局完备 公司具备卓越的、覆盖全链路的商业化能力，拥有约4700人的专业学术推广团队，网络深度覆盖中国超 5万家医院及医疗机构、约30万家零售药店及主流电商平台，能够高效驱动产品放量。国际化战略方 面，公司前瞻性地在东南亚市场构建了完整的研发+注册与商业化+生产一体化布局，为公司打开了长 期、可持续的第二增长曲线。 公司通过合作开发及自主研发，高效布局了近40款创新管线，并已进入成果密集兑现阶段。目前已有6 款创新药成功上市实现商业化，处于NDA阶段的重磅创新产品包括：1)注射用Y-3，用于急性缺血性脑 卒中治疗，兼具预防卒中后抑郁焦虑，2025年12月NDA受理;2)德昔度司他片，用于非透析的 ...

国内专科商业化领军企业，创新转型开启新一轮成长周期康哲药业创立于1992 年，是国内领先的开放 式医药平台企业，以药品代理业务起步，历经三十余年发展，成功转型为创新型综合性医药企业。自国 家集采政策实施以来，公司原成熟产品如黛力新、波依定、优思弗一度承压，2023-2024 年收入下滑， 集采负面影响在2025 年上半年基本消化，公司营收与归母净利润增速均由负转正，心脑血管、消化等 基石业务企稳，皮肤健康、眼科等新兴业务快速增长。 机构：信达证券 研究员：唐爱金 报告内容摘要: 盈利预测与投资评级：我们预计2025-2027 年公司营业收入分别为82.16亿元、98.59 亿元、120.28 亿 元，同比增速分别为10%、20%、22%；归母净利润分别为16.15 亿元、18.50 亿元、22.38 亿元，同比增 速分别为0%、15%、21%。我们看好公司中长期成长性，首次覆盖给予"买入"评级。 风险提示：药品集中采购政策风险；创新产品研发与上市不及预期风险；创新产品商业化风险；国际化 经营风险。 国内商业化能力卓越，海外东南亚市场研产销布局完备公司具备卓越的、覆盖全链路的商业化能力，拥 有约4700 人的专 ...

Group 1 - The core point of the news is that Kangzheng Pharmaceutical has received acceptance for the New Drug Application (NDA) of its innovative drug Y-3 for the treatment of acute ischemic stroke by the National Medical Products Administration (NMPA) in China [1] - Y-3 is the world's first brain cell protector developed based on key pathological targets PSD95-nNOS and MPO, which acts on multiple critical pathological processes of ischemic stroke [1] - The Phase III clinical study of Y-3 in China has achieved its primary efficacy endpoint, showing significant clinical benefits for patients and good overall safety [1] Group 2 - In China, approximately 3.94 million new stroke cases occur annually, accounting for one-third of global new cases, with ischemic stroke making up about 72% of these cases [2] - The burden of stroke-related disabilities has been increasing over the past thirty years, compounded by an aging population, leading to greater challenges for stroke prevention and control [2] - Post-stroke depression and anxiety are common complications, with incidence rates of about 30% and 25%, respectively, which can affect neurological recovery and increase mortality risk [2] Group 3 - Kangzheng Pharmaceutical has established a deep product layout in the central nervous system field, which is one of its core strengths [2] - If Y-3 is approved, it will synergize with existing innovative drugs such as Vitoqu (for cluster epilepsy) and the original brand drug Dailixin (for anxiety and depression), as well as the modified new drug ZUNVEYL (for Alzheimer's disease) under NDA review [2] - The company aims to leverage its excellent commercialization experience and efficient operational system to accelerate the availability of innovative therapies for more patients [2][3]

Core Insights - 康哲药业's innovative drug Y-3 for treating acute ischemic stroke has received acceptance for its New Drug Application (NDA) by the NMPA in China [1] - Y-3 is the world's first brain cell protector targeting critical pathological processes in stroke, showing significant clinical benefits and good safety in Phase III trials [1][2] - The market potential for Y-3 is substantial, given the high incidence of stroke in China and the associated complications like post-stroke depression and anxiety [2] Company Developments - 康哲药业 has established a strong product portfolio in the central nervous system area, enhancing its market foundation [2] - The company has signed a permanent exclusive promotion agreement for Y-3 with Nanjing Ningdan New Drug Technology Co., expanding its market reach in mainland China and Hong Kong [3] Industry Context - China accounts for approximately one-third of global new stroke cases, with ischemic strokes making up about 72% of these cases [2] - The burden of stroke-related disabilities has been increasing over the past 30 years, compounded by an aging population, which poses significant challenges for stroke prevention and management [2] - Post-stroke depression and anxiety affect around 30% and 25% of stroke patients, respectively, impacting recovery and increasing mortality risk [2]

Summary of Alpha Cognition Fireside Chat - December 02, 2025 Company Overview - **Company**: Alpha Cognition (NasdaqCM: ACOG) - **Product**: ZUNVEYL, targeting the long-term care market for Alzheimer's patients - **Market Size**: Approximately $2.2 billion for long-term care related to Alzheimer's disease [5][6] Key Performance Metrics - **Sales**: Reported $2.3 million in sales for Q3 2025 [5] - **Key Performance Indicators (KPIs)**: - Physician prescribing and repeat orders - Nursing home orders and repeat orders - Adherence rates between 5 mg and 10 mg doses - Payer metrics, including plans covered and lives covered without restriction [5] Market Penetration and Adoption - **Target Market**: Approximately 5,000 specialized nursing homes in the U.S. [6] - **Current Adoption**: - 600 nursing homes have written prescriptions; 550 homes wrote orders in Q3 [6] - 60% refill or reorder rate in homes contacted [6] - 576 healthcare providers (HCP) writers in Q3, approaching 700 since launch [6] - **Payer Contracts**: Currently one contract covering 15% of lives; a second contract anticipated soon [10] Product Utilization - **Dosage Distribution**: 50% of patients on 5 mg and 50% on 10 mg; expected to shift to 75% on 10 mg at steady state [11] - **Pricing**: Flat pricing of $820 WAC per month for all doses; gross-to-net expected to stabilize at $500 in three years [13][15] Stakeholder Engagement - **Key Stakeholders**: - Medical directors (primary customers) - Psychiatrists (treat behavioral symptoms) - Directors of nursing (first to observe symptoms) - Consultant pharmacists (make treatment recommendations) [20][21] - **Messaging**: Focus on lower GI incidents and no insomnia with ZUNVEYL compared to competitors [22][24] Clinical Development - **Ongoing Trials**: - **Converge Trial**: Retrospective analysis of ZUNVEYL in long-term care; results expected in Q3 2026 [42][45] - **Beacon Trial**: Real-world evidence study assessing cognition and behavior in 200 patients; completion expected by end of 2026 [49] - **Resolve Trial**: Phase four observational trial in outpatient settings; expected to provide label-enabling data [64][68] International Strategy - **China Market**: Approximately 10 million patients; submission accepted in July 2025, with potential approval by late 2026 [95][96] - **Economic Model**: Milestone payments and high single-digit royalties from Asian markets; no marketing costs for Alpha Cognition [98] Financial Guidance - **Operating Profitability**: Expected in 2027, excluding non-cash items like depreciation [101] - **R&D Spending**: Anticipated to be $50 million-$55 million in 2026, with a decrease expected in 2027 due to fewer ongoing clinical studies [105][108] Additional Insights - **Sublingual Formulation**: Development underway to address patient difficulties in swallowing; estimated market opportunity of $200 million [69][70] - **Department of Defense Study**: Completed a bomb blast study showing positive cognitive effects; potential for IND submission for cognitive impairment in mild traumatic brain injury [88][89] This summary encapsulates the key points discussed during the fireside chat, highlighting Alpha Cognition's market strategy, product performance, clinical development, and financial outlook.

Core Viewpoint - Alpha Cognition Inc. is actively engaging in commercialization efforts and research initiatives to enhance the adoption of its therapies for neurodegenerative diseases, particularly through participation in a virtual fireside chat hosted by Titan Partners [1][2]. Company Overview - Alpha Cognition Inc. is a commercial-stage biopharmaceutical company focused on developing treatments for neurodegenerative diseases, including Alzheimer's disease and cognitive impairment associated with mild traumatic brain injury (mTBI) [2][9]. - The company is dedicated to addressing the unmet medical needs in these areas, where currently no approved treatment options exist [2]. Product Information - ALPHA-1062, marketed as ZUNVEYL, is an FDA-approved new generation acetylcholinesterase inhibitor designed for the treatment of Alzheimer's disease, with minimal gastrointestinal side effects expected [3]. - ZUNVEYL's active metabolite uniquely binds to neuronal nicotinic receptors, particularly the alpha-7 subtype, which is associated with cognitive enhancement [3]. - The product is also being developed in combination with memantine for moderate to severe Alzheimer's dementia and as a sublingual formulation for cognitive impairment with mTBI [3]. Upcoming Events - Alpha Cognition will participate in a virtual fireside chat on December 2, 2025, featuring CEO Michael McFadden, focusing on commercialization strategies and research initiatives [2]. - The company is set to report its third quarter 2025 financial results and provide a business update on November 13, 2025, after market close [9].

Core Insights - Alpha Cognition Inc. (NASDAQ: ACOG) has shown significant growth in the commercialization of its product ZUNVEYL® during Q3 2025, particularly in the U.S. long-term care (LTC) sector [1][7] - The company reported a 102% sequential increase in pharmacy orders, with over 600 nursing homes now covered and a prescriber base exceeding 500 clinicians [1][7] - Revenue for the quarter reached $2.8 million, driven by $2.3 million in net product sales from ZUNVEYL and $0.5 million in licensing revenue, indicating strong sequential growth [7] Company Performance - ZUNVEYL's launch momentum is accelerating, supported by a differentiated cognitive and behavioral profile and favorable tolerability signals observed in real-world use [1] - The LTC-focused field team is actively reinforcing the product's benefits, contributing to evidence of durable adoption and repeat ordering behavior in high-volume facilities [1] - Pro forma cash stands at approximately $73.2 million following an equity raise in October, providing about two years of operational runway at planned spending levels, bolstered by a $75 million ATM facility [7]

Financial Data and Key Metrics Changes - For Q3 2025, the company generated total revenue of $2.8 million, with $2.3 million from net product sales of ZUNVEYL and $507,000 from licensing revenue [11] - Total operating expenses were $8.2 million, including $633,000 in cost of goods sold, reflecting an increase from $2.5 million in operating expenses in Q3 2024 [11] - The net loss was reported at $1.3 million, or $0.08 basic loss per share, an improvement from a net loss of $1.9 million, or $0.31 per share, in the previous year [12] Business Line Data and Key Metrics Changes - ZUNVEYL sales showed significant growth, with ex-factory purchases rising 44% from Q2 to Q3, and demand sales bottles dispensed growing 102% [15] - The company engaged with 2,038 homes in Q3, with 605 homes ordering ZUNVEYL, and 70% of those homes placing repeat orders [16] Market Data and Key Metrics Changes - The company anticipates continued sequential growth in ZUNVEYL's sales as awareness and payer access expand through 2026 [13] - The average of 16 years of industry experience among sales representatives is driving clinical education and adoption across the long-term care market [18] Company Strategy and Development Direction - The company plans to invest in sales, marketing, and research for ZUNVEYL, particularly focusing on behavioral symptoms associated with Alzheimer's [5] - The company is also advancing its sublingual formulation and anticipates running a comparative PK study in Q1 2026 [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in ZUNVEYL's potential, highlighting the drug's clinically meaningful benefits across cognitive and behavioral symptoms [10] - The company remains focused on executing its commercial strategy and maintaining financial discipline to create long-term value for shareholders [14] Other Important Information - The company raised approximately $38 million in net proceeds through an equity offering in October, strengthening its balance sheet [12] - The company expects to initiate two studies in long-term care settings in Q4 2025 and Q1 2026 to assess ZUNVEYL's cognitive benefits and tolerability [9] Q&A Session Summary Question: Current status of contracting discussions and GPO agreements for ZUNVEYL - The company has one contract with a major PBM and is close to finalizing another by the end of the quarter, targeting four key Medicare plans [23][24] Question: Coverage without restrictions - Currently, about 15% of the signed plan has adopted ZUNVEYL without restrictions, with more visibility expected in the coming quarters [25] Question: Breakdown of unique prescribers and repeat orders - In Q3, 576 prescribers wrote orders, with 62% writing multiple orders, and 70% of homes placing repeat orders [27][28] Question: Key marketing messages resonating with prescribers - The most impactful messages include ZUNVEYL's effect on behaviors and its lack of impact on sleep, which is a significant concern for prescribers [31][32] Question: Sales cycle and prescriber interactions - The sales cycle remains initially slow, but once prescribers gain confidence, they tend to increase their patient base more rapidly [41]

Core Viewpoint - The company is preparing for a public offering and has outlined the potential risks and uncertainties associated with its forward-looking statements regarding the commercialization of ZUNVEYL [1] Group 1: Public Offering Details - The company is proposing a public offering, including the timing and size, along with an option for the underwriter to purchase additional securities [1] - The completion of the offering is subject to customary closing conditions [1] Group 2: Forward-Looking Statements - Forward-looking statements reflect the company's current views about future events and are subject to various risks and uncertainties [1] - The company cannot assure that actual results will align with these forward-looking statements [1] Group 3: Risks Associated with ZUNVEYL - Risks include the ability to raise sufficient capital for ZUNVEYL's commercialization, efficacy and tolerability concerns, and ongoing regulatory oversight [1] - Market adoption, intellectual property issues, and commercial manufacturing risks are also highlighted [1]