国元国际发布研报称，康哲药业(00867)已在全球布局40款以FIC、BIC为主的创新管线，5款已获批创新 药加速释放商业化价值，7项NDA审评中，10余项临床试验推进。口服JAK1抑制剂Povorcitinib获突破性 治疗认定。给予"买入"评级，目标价17.68港元/股。 国元国际主要观点如下： 投资建议 公司业绩见底回升，随着创新药不断上市，公司的产品结构大幅优化，以创新药为主。预计2025-27年 收入分别为人民币78.6亿、89.5亿、100.2亿元，净利润分别为人民币16.67亿、19.41亿、23.08亿，目标 价17.68港元，对应2027年PE为16.9倍。给予买入评级，较现价有32%的升幅。 风险提示 1)新产品研发进度可能低于预期；2)产品商业化进展不达预期；3)国际形势复杂度超预期，创新药国际 化进度低于预期。 创新药管线丰富，1类新药注射用Y-3的上市许可申请获得受理 公司已在全球布局40款以FIC、BIC为主的创新管线，5款已获批创新药加速释放商业化价值；7项NDA 处于审评中，另有10余项注册性临床试验有序进行中。公司的1类新药注射用Y-3的新药上市许可申请于 25年12月11日 ...

智通财经APP获悉，国元国际发布研报称，康哲药业(00867)已在全球布局40款以FIC、BIC为主的创新 管线，5款已获批创新药加速释放商业化价值，7项NDA审评中，10余项临床试验推进。口服JAK1抑制 剂Povorcitinib获突破性治疗认定。给予"买入"评级，目标价17.68港元/股。 风险提示 1）新产品研发进度可能低于预期；2）产品商业化进展不达预期；3）国际形势复杂度超预期，创新药 国际化进度低于预期。 业绩同比上升，创新药开始放量 2025年上半年，公司实现营收（全按药品销售收入计算）46.7亿元，同比增长8.9%；实现净利润9.3亿 元，同比增长3.1%。皮肤健康线实现收入498.0百万元，同比增长104.3%，占集团药品销售收入的 10.7%。德镁医药计划通过介绍上市及实物分派方式在联交所主板独立上市，进一步释放其高成长性， 依托集团强大的商业化能力推动销售增长。公司品牌产品及创新产品全按药品销售收入合计人民币29亿 元，同比增长20.6%，占营业额的62.1%。波依定、黛力新、优思弗等集采产品对业绩的影响已经消 化。 投资建议 公司业绩见底回升，随着创新药不断上市，公司的产品结构大幅优 ...

Core Viewpoint - 康哲药业's subsidiary 德镁医药 has received approval from the NMPA for its innovative oral JAK1 inhibitor povorcitinib, aimed at treating non-segmental vitiligo in adults, which is expected to accelerate the product's development and review process in China [1][2] Group 1 - The product povorcitinib has been included in the list of breakthrough therapeutic drugs, which is anticipated to expedite its research and review process in mainland China [2] - If approved for sale in China, povorcitinib is expected to synergize with 德镁医药's existing innovative drugs, enhancing clinical and commercial value for skin disease patients [2] - The product will provide differentiated and comprehensive treatment options for vitiligo patients alongside the topical formulation of phosphoric acid alfacalcidol [2] Group 2 - On March 31, 2024, the company entered into a collaboration and licensing agreement with Incyte for povorcitinib, securing exclusive rights for research, development, registration, and commercialization in mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries [2] - The subsidiary has sublicensed rights for povorcitinib in regions outside mainland China back to the company, excluding 德镁医药 and its subsidiaries [2]

本次该产品获纳入突破性治疗药物品种名单，有望加速其在中国大陆的研发与审评进程。若于中国获批 上市，该产品将有望与德镁医药在售创新药益路取(替瑞奇珠单抗注射液)、在售独家药喜辽妥(多磺酸粘 多糖乳膏)及正处于新药上市申请(NDA)阶段的创新药磷酸芦可替尼乳膏形成协同，推动产品快速实现 临床和商业价值，惠及更多皮肤疾病患者。此外，该产品还将与外用磷酸芦可替尼乳膏共同为白癜风患 者提供差异化、全面的治疗选择。 本集团于2024年3月31日，通过德镁医药的附属公司与Incyte就povorcitinib订立合作和许可协议，获得在 中国大陆、香港特别行政区、澳门特别行政区、臺湾地区及东南亚十一国(区域)研究、开发、注册及商 业化产品的独家许可权利，以及在区域内生产产品的非独家许可权利。德镁医药的附属公司已将 povorcitinib除中国大陆外的其他区域的相关权利再许可予本集团(不包括德镁医药及其附属公司)。 智通财经APP讯，康哲药业(00867)发布公告，集团旗下德镁医药有限公司(德镁医药，专业聚焦皮肤健 康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市)拥有相关许可权利的创新口服 JAK1抑制剂po ...

格隆汇12月15日丨康哲药业(00867.HK)宣布，旗下德镁医药有限公司(「德镁医药」，专业聚焦皮肤健 康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市，详见公司日期为2025年4月22 日发布的公告)拥有相关许可权利的创新口服JAK1抑制剂povorcitinib(拟定中文通用名：磷酸泊沃昔替尼 片)(「povorcitinib」或「产品」)已获中国国家药品监督管理局(「NMPA」)药品评审中心批准纳入突破 性治疗品种名单，拟定适应症为成人患者非节段型白癜风。此次认定有望加快该产品的研发与审评进 程。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 二零二五年八月，德鎂醫藥獲NMPA簽發的藥物臨床試驗批准通知書，同意開展 povorcitinib用於治療非節段型白癜風等適應症的臨床試驗。德鎂醫藥已啓動產品在中國 的臨床開發工作，並考慮擇機在中國推動其治療HS和結節性癢疹等皮膚相關疾病的臨 *僅供識別 1 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （香港股份代號：867） （新加坡股份代號：8A8） 自願性及業務進展公告 創新藥口服小分子JAK1抑制劑Povorcitinib 納入突破性治療品種名單 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，旗下德鎂醫藥有限公司（「德鎂醫藥」，專業聚焦皮膚健康的創新型醫藥企 業，正申請於香港聯合交易所有限公司主板獨立上市，詳見本公司日期為二零二 ...

Core Viewpoint - Kangzheng Pharmaceutical's new drug application for Y-3 has been officially accepted by the National Medical Products Administration, targeting acute ischemic stroke treatment and potentially preventing post-stroke depression and anxiety symptoms [1][2] Group 1: Product Development - Y-3 is the world's first multi-target neuroprotective agent aimed at PSD95-nNOS and MPO, showing promising efficacy in treating ischemic stroke [1] - The company has established a strong presence in the central nervous system field, with a product portfolio that includes the marketed innovative drug Vituco and the original brand drug Dailixin, along with the NDA-reviewed modified new drug ZUNVEYL [1] Group 2: Clinical Research and Impact - The burden of stroke-related disabilities has increased over the past thirty years, with post-stroke depression and anxiety affecting approximately 30% and 25% of patients, respectively [2] - Y-3 has reached its primary efficacy endpoint in Phase III clinical trials in China, demonstrating significant clinical benefits and good overall safety [2] - The main research results for Y-3 are planned to be presented at international academic conferences, with the overall study set to be published in international academic journals [2]

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]

本文源自：金融界AI电报 康哲药业(00867.HK)发布公告，1类新药注射用Y-3(拟定中文通用名：注射用洛贝米柳)(注射用Y-3或"产 品")新药上市许可申请(NDA)已于2025年12月11日获得中国国家药品监督管理局(NMPA)受理。产品为 一种拟用于急性缺血性卒中的脑细胞保护剂。 ...

注射用Y-3是全球首个基于脑卒中病理过程重要靶点PSD95-nNOS和MPO开发的脑细胞保护剂，作用于 缺血性脑卒中缺血级联反应多个关键病理过程，通过多靶点高选择性协同，更有利于发挥脑细胞保护作 用。产品具有优异的治疗缺血性脑卒中和潜在的预防卒中后抑郁焦虑症状的作用。注射用Y-3的中国Ⅲ 期临床研究达到主要疗效终点，患者临床获益明显，整体安全性良好。主要研究结果未来计划在国际学 术会议上公布，整体研究将在国际学术期刊上发表。 康哲药业表示，中枢神经系统是其核心优势领域之一，已逐步形成深度产品布局，夯实市场基础。注射 用Y-3如获批上市，将与在售创新药维图可(丛集性癫痫)、原研品牌药黛力新(焦虑、抑郁)以及处于NDA 审评中的改良型新药ZUNVEYL(阿尔茨海默症)在专家网络与市场资源上产生高效协同。凭借康哲药业 卓越的商业化经验与合规高效的运营体系，加速推动创新疗法惠及更多患者，为中国缺血性脑卒中患者 带来疗效优异、作用更全面的新一代脑细胞保护剂。 智通财经APP获悉，2025年12月11日，康哲药业(00867)宣布，用于治疗急性缺血性卒中的1类创新药注 射用Y-3(拟定中文通用名：注射用洛贝米柳)的新药上 ...