Dexmedetomidine Hydrochloride

DoW-funded Phase 2a trial led by University of North Carolina at Chapel Hill (UNC) Institute for Trauma Recovery Positive outcomes from trial can potentially impact Veteran Affairs/Department of War Clinical Practice Guidelines for management of acute stress reactions (ASR) NEW HAVEN, Conn., April 08, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced the enrollment of the first patients in a U.S. Department of War (DoW)-funded Phase 2a clinical trial evaluating BXCL501 (sublingual dexmedetomidine) for the treatment of acute stress reactions (ASR), also known as acute stress disorder (ASD). The trial is being led by the University of North Carolina at Chapel Hill (UNC) Institute of Trauma Recovery and marks a significant milestone in the collaboration between BioXcel Therapeutics and UNC. The double-blind, placebo-controlled trial ( NCT06943404 ) is designed to enroll 100 patients experiencing ASRs following motor vehicle collisions and will evaluate the potential of BXCL501 to reduce ASR symptom severity, improve neurocognitive function, and prevent the progression to chronic posttraumatic neuropsychiatric symptoms. BioXcel Therapeutics is supplying BXCL501 for the trial. ASR symptoms occur in the days and weeks after trauma, and include anxiety, sleep disturbance, concentration difficulty, pain, and somatic symptoms such as dizziness and lightheadedness. Chronic adverse posttraumatic neuropsychiatric symptoms occur when acute stress reactions do not resolve, and include persistent pain, posttraumatic stress, and depressive symptoms. ASRs are common among service men and women, police and other first responders, and survivors of shootings and natural disasters. ASRs affect more than 40 million Americans who seek emergency department care annually after traumatic stress exposure (e.g., motor vehicle collision). 1,2 “Supporting service men and women resilience and effectively treating ASRs is an urgent military priority,” said Samuel McLean, M.D., MPH, Professor of Psychiatry and Emergency Medicine and Director of the Institute for Trauma Recovery at the UNC School of Medicine, and Principal Investigator of the study. “We are excited to evaluate BXCL501 as a potential treatment to address this critical unmet need of service men and women and civilians experiencing ASRs.” “We look forward to supporting Dr. McLean and his team at UNC on this important study evaluating BXCL501 for the treatment of ASRs,” Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics, added. “The results from this study could have clinical benefit for this patient population and support BXCL501’s potential as a pipeline-in-a-product.” The 2023 VA/DoW Clinical Practice Guidelines for management of PTSD and ASR recommend trauma-focused psychotherapy, specifically cognitive-behavioral therapy (CBT), as the primary treatment to reduce ASR symptoms and prevent PTSD. Pharmacotherapy is generally not recommended for treating ASR, and benzodiazepines are contraindicated. A positive outcome from this trial could contribute to a reassessment of those guidelines and establish a pharmacological treatment pathway for patients suffering from ASR and have an immediate and critical need for treatment. 3 The ASR research is supported by the DoW under award number HT9425-24-1-1108. The content presented in this release is solely the responsibility of the authors and does not necessarily represent the official views of the DoW. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com . About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI ® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: potential future development of BXCL501 in ASR; BXCL501’s potential as a “pipeline within a product”; the potential for updates to the VA/DoW Clinical Practice Guidelines for management of PTSD and ASR recommend trauma-focused psychotherapy; and a potential reassessment of those guidelines and establish a pharmacological treatment pathway for patients suffering from ASR. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI ® , BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI ®  or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI ® ; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025 , as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at and the Investors section of the Company’s website at. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information: Corporate/Investors Russo Partners Nic Johnson nic.johnson@russopartnersllc.com 1.303.482.6405 Media Russo Partners David Schull david.schull@russopartnersllc.com 1.858.717.2310 Source: BioXcel Therapeutics, Inc. References 1 Adler, Amy B., et al. “Post-traumatic stress disorder risk and witnessing team members in acute psychological stress during combat.” BJPsych Open, vol. 6, no. 5, Sept. 2020, . 2 Lewis, Gemma C., et al. “Incidence and predictors of acute psychological distress and dissociation after motor vehicle collision: A cross-sectional study.” Journal of Trauma & Dissociation, vol. 15, no. 5, 30 Sept. 2014, pp. 527–547, . 3 “Va.Gov: Veterans Affairs.” Management of Posttraumatic Stress Disorder and Acute Stress Disorder 2023, 3 June 2009, .

磷酸芦可替尼乳膏（商品名：百卢妥®，原研Opzelura®），是全球/国内首款、唯一获批用于非节段型白癜风复色的外用JAK1/JAK2选择性抑制剂，由美国 Incyte研发，康哲药业（德镁医药）引进中国，2026年1月30日获NMPA批准上市，适应症为12岁及以上伴面部受累的非节段型白癜风。 基本信息 作用机制：精准抑制JAK1/JAK2信号通路，阻断IFN-γ、IL-15等炎症因子介导的免疫攻击，减少对黑素细胞的破坏，促进黑素细胞再生与复色，实现局部靶向免疫调节、全身暴露极低。 适应症 国内获批：12岁及以上儿童、成人，伴面部受累的非节段型白癜风局部治疗。 国际获批（FDA/EMA） 非节段型白癜风：12岁及以上局部复色治疗。 特应性皮炎：2岁及以上轻中度，外用控制不佳/不适合时，短期/非持续慢性治疗。 使用限制 仅限皮肤外用，禁用于眼、口、阴道、破损/感染皮肤。 不建议与生物制剂、其他JAK抑制剂、强效免疫抑制剂（硫唑嘌呤、环孢素）联用。 用法用量 用法：每日2次，薄涂于脱色皮损，两次间隔≥8小时；用药后2小时内不清洗、不覆盖敷料；手非患处则用药后洗手。 用量限制： 白癜风：涂抹面积≤10%体表面积（BSA）。 每周≤60g、每2周≤100g、每月≤200g。 疗程：通常24 周可见明显复色；52 周复色＜25% 建议停药；复色满意可停药，复发可重启，无需逐渐减量。 不良反应： 白癜风（发生率≥1%）； 应用部位：痤疮（6%）、瘙痒（5%）、红斑（2%）； 全身：鼻咽炎（4%）、头痛（4%）、尿路感染（2%）、发热（1%）； 特应性皮炎（≥1%）； 鼻咽炎、腹泻、支气管炎、耳部感染、嗜酸性粒细胞升高、荨麻疹、毛囊炎、扁桃体炎、流涕。 禁忌：对芦可替尼或乳膏任一成分过敏者禁用。 特殊人群： 妊娠/哺乳期：不建议使用。 儿童：国内仅限≥12岁；FDA≥2岁（特应性皮炎）、≥12岁（白癜风）。 老年人：无需调整剂量。 肝肾功能不全：无需调整（外用全身吸收极少）。 上市情况 磷酸芦可替尼乳膏（Opzelura/百卢妥）是全球唯一白癜风外用JAK靶向药。 FDA（美国）： 2021-09-21：获批2岁及以上轻中度特应性皮炎（外用JAK抑制剂首药）。 2022-07-18：获批12岁及以上非节段型白癜风（全球首个白癜风外用靶向药）。 EMA（欧盟）：2023-04-26，同步获批白癜风（12岁+）、特应性皮炎（2岁+）。 其他：日本、澳大利亚、加拿大等多国 / 地区已获批上市 规格与剂型：1.5%芦可替尼乳膏（15mg/g） 包装：30g、60g、100g / 支（铝管） 中国上市（商品名：百卢妥®，康哲/德镁医药） 磷酸芦可替尼乳膏于2026-01-30获NMPA正式获批。获批适应症为12岁及以上伴面部受累的非节段型白癜风（国内首款、唯一获批白癜风外用JAK抑制剂）。 注册与受理情况 参比制剂 临床试验情况 专利情况 磷酸芦可替尼乳膏（国内商品名百卢妥®，原研Opzelura®）的专利由Incyte主导布局，形成多层级保护体系，国内暂无仿制药上市，核心壁垒持续至2031年。 1. 核心化合物/组合物专利 专利号：ZL201310058988.2（CN103214483B） 2008-12-12申请；2026-12-12（20年保护期）到期。保护芦可替尼游离碱、磷酸芦可替尼（盐）、药物组合物（口服+外用）、制备方法，覆盖乳膏核心活性成分。 2. 盐型/晶型/用途专利 核心专利1：ZL200880102903.3（CN101932582B） 2008-06-12申请，2028-06-12到期。保护磷酸芦可替尼晶型I、盐型JAK抑制用途、白癜风/特应性皮炎治疗用途。 核心专利2：ZL201310367212.9（CN104558115B） 2028-06-12到期，保护特定晶型、稳定性、外用制剂适配性。 3. 外用乳膏制剂/处方专利 核心专利 1：ZL201180035301.2（CN103002875B） 2011-05-20申请日，2031-05-20到期。保护1.5%乳膏完整处方（丙二醇、硬脂醇、鲸蜡醇、聚二甲基硅氧烷等16种辅料配比）、制备工艺、透皮吸收优化、皮肤耐受性。 核心专利 2：CN105853356B 2031-05-20到期，保护乳膏pH、粘度、乳化体系、长期稳定性工艺。 4. 适应症/用途专利 中国ZL201310367212.9覆盖外用JAK抑制剂治疗非节段型白癜风、特应性皮炎，保护至2028年。 美国US11602536（外用JAK治白癜风），2041-05-05到期。US10758543（外用制剂）至2031年，叠加儿科独占6个月，美国独占至 2041+。 专利壁垒 核心化合物专利2026年底到期，是仿制药上市的关键前提； 晶型、制剂、用途等外围专利持续至2028–2031年，覆盖生产与配方核心技术，形成长期保护； 美国等地区存在适应症专属保护（如白癜风用途专利至2041年），进一步延长独占期。 其他药品分享链接如下，欢迎点击查看： Ormeloxifene OTF慢性体重管理的新型药物-Tirzepatide新型的非阿片类小分子镇痛药-Suzetrigine奥麦利昔芬口腔薄膜立项调研报告纳米技术双氯芬酸乳胶剂药学研究2025年9月药品批准信息快讯（八）——利斯的明透皮贴剂分享2025年9月药品批准信息快讯（九）——米托坦片分享CDE-《化学仿制药参比制剂目录（第一百批）》（征求意见稿）[附: 药品分享——阿达苏(洛沙平吸入剂)]药品分享-塞来昔布盐酸曲马多片药品分享——伐莫洛龙口服混悬液【药品分享】盐酸菲优拉生片【药品分享】拉坦噻吗滴眼液【药品分享】Baxdrostat 片【药品分享】Omecamtiv Mecarbil缓释片【药品分享】曲地匹坦（Rolapitant）【药品分享】Zasocitinib 胶囊【药品分享】甲磺酸阿帕替尼片【药品分享】巴氯芬口服溶液【药品分享】奥德昔巴特胶囊【药品分享】扎维吉泮鼻喷雾剂【药品分享】左羟丙哌嗪糖浆【药品分享】利丙双卡因凝胶贴膏【药品分享】司来吉兰改良型新药（缓释片）【药品分享】复方甘菊利多卡因凝胶【药品分享】盐酸索安非托片【药品分享】地塞米松口溶膜【药品分享】盐酸来罗西利片【药品分享】马来酸噻吗洛尔凝胶【药品分享】褪黑素颗粒【药品分享】罗氟司特乳膏【药品分享】盐酸芬戈莫德胶囊【药品分享】示踪用盐酸米托蒽醌注射液【药品分享】美洛昔康纳米晶注射液【药品分享】Clascoterone 5%外用溶液【药品分享】马来酸依那普利口服溶液【药品分享】注射用双氯芬酸钠利多卡因【药品分享】马来酸依那普利叶酸片—复方降压药【药品分享】依曲帕米鼻喷雾剂—用于治疗成人阵发性室上性心动过速的可自行给药鼻喷雾剂【药品分享】奥卡西平口服混悬液—一款可用于儿童的钠通道调节类抗癫痫药【药品分享】泊沙康唑口服混悬液——一种常用的抗真菌药物【药品分享】舒沃替尼片【药品分享】依伏卡塞片——第二代口服拟钙剂【药品分享】西诺氨酯片——第三代抗癫痫发作药物【药品分享】匹妥布替尼片——非共价可逆 BTK 抑制剂（用于复发 / 难治套细胞淋巴瘤（MCL））【药品分享】贝美前列素【产品分享】达普司他片 【药品分享】水合氯醛糖浆——镇静催眠药 【产品分享】苏沃雷生（Suvorexant）——全球首个食欲素受体拮抗剂类催眠药 【药品分享】贝沙罗汀 【药品分享】地夫可特干混悬剂——一种糖皮质激素类药物 【药品分享】伊卢多啉片——治疗成人腹泻型肠易激综合征（IBS‑D）的首创口服阿片受体调节剂 【药品分享】卢美哌隆胶囊——一种新型的非典型抗精神病药物 【药品分享】奥氟格列隆片——口服非肽类小分子 GLP-1 受体激动剂 【药品分享】苯磺酸克利加巴林胶囊——一种新型的治疗神经病理性疼痛的药物 【药品分享】苯磺酸美洛加巴林片——治疗周围神经病理性疼痛（PNP）的第三代钙离子通道调节剂 【药品分享】Iberdomide胶囊——一款新一代cereblon（CRBN）E3连接酶调节剂（CELMoD）化合物 【药品分享】酒石酸伐尼克兰鼻喷雾剂——一种用于治疗干眼症的西药 【药品分享】赛沃替尼片——中国首个获批的高选择性 MET 酪氨酸激酶抑制剂 【药品分享】盐酸阿夫唑嗪缓释片——一种用于治疗良性前列腺增生（BPH） 的 α1 - 受体阻滞剂 【药品分享】索格列净片——全球首个获批的SGLT1/SGLT2 双重抑制剂 【药品分享】奥吡卡朋胶囊——新一代的儿茶酚-氧位-甲基转移酶抑制剂（COMT） 【药品分享】奎扎替尼片——一种口服高选择性 FLT3 抑制剂 【药品分享】硫酸拉罗替尼胶囊 / 口服溶液——全球首个高选择性口服 TRK 抑制剂 【药品分享】司帕生坦片——成人IgA肾病领域首个非免疫抑制疗法 【药品分享】黄体酮阴道栓剂/阴道缓释凝胶剂——主要用于辅助生殖技术（ART）中的黄体支持 【药品分享】替戈拉生片——首款国产钾离子竞争性酸阻滞剂类药物（P-CAB） 【药品分享】拉坦前列烯酯滴眼剂——一种新型眼科用药 【药品分享】布比卡因脂质体注射液——一种长效局部麻醉药 【药品分享】甲磺酸加诺沙星片——一种喹诺酮类抗菌药 【药品分享】磷酸芦可替尼乳膏——中国首款且唯一获批的白癜风治疗靶向药 【药品分享】甲磺酸洛美他派胶囊——全球唯一口服MTP抑制剂 【药品分享】依达拉奉口服混悬液——肌萎缩侧索硬化症（ALS，渐冻人症）新药 【药品分享】依达拉奉右莰醇舌下片——全球卒中领域首个获FDA突破性疗法认定的舌下脑保护剂 【药品分享】马来酸氟诺替尼片——JAK2/FLT3/CDK6 三靶点抑制剂 【药品分享】普拉替尼胶囊——国内首个获批的高选择性 RET（转染重排）酪氨酸激酶抑制剂 【药品分享】右美托咪定舌下膜——新型 α₂肾上腺素受体激动剂舌下膜剂 【药品分享】卡匹色替片——全球首个获批上市的AKT抑制剂 【药品分享】库莫西利胶囊——全球首个CDK2/4/6抑制剂 【药品分享】赛贝曲司他片——全球首个HAE急性发作口服疗法 【药品分享】KYGEVVI（Doxecitine/Doxribtimine）——全球首款且唯一获批的TK2d针对性治疗药物 【药品分享】Forzinity（Elamipretide）注射剂——全球首个用于治疗Barth综合征的药物 【药品分享】Brinsupri（Brensocatib, 布伦索卡替布）片——全球首个获批上市的二肽基肽酶1（DPP-1）抑制剂 【药品分享】维立西呱片——全球首个心衰适应症的可溶性鸟苷酸环化酶（sGC）刺激剂 【药品分享】盐酸哌罗匹隆片——非典型抗精神病药 【药品分享】盐酸托泊替康胶囊/注射用盐酸托泊替康——经典的拓扑异构酶Ⅰ抑制剂类抗肿瘤药 【药品分享】阿普昔腾坦片——全球首个获批用于难治性高血压的口服双重内皮素受体拮抗剂（ERA） 【药品分享】注射用盐酸依拉环素——全球首个氟环素类抗生素 【药品分享】奥洛格列净胶囊——国内首款抑制SGLT1与SGLT2的1类创新药 【药品分享】盐酸匹米替尼胶囊——国内首个、全球首个获批的腱鞘巨细胞瘤（TGCT）系统性靶向药，高选择性CSF-1R抑制剂 【药品分享】布地奈德肠溶胶囊——全球首个、中国唯一获批用于原发性IgA肾病对因治疗的靶向药物 【药品分享】艾拉莫德片——中国原研、全球首个上市的小分子抗风湿药（csDMARD） 【药品分享】索托克拉片——新一代BCL2抑制剂 【药品分享】利奈昔巴特片——口服、选择性、可逆性回肠胆汁酸转运体（IBAT/ASBT）抑制剂 【药品分享】多替诺雷片——高选择性URAT1抑制剂 【药品分享】瑞普泊肽片——口服GLP‑1/GIP双靶点激动剂 【药品分享】硫酸索西美雷塞片——口服、强效的KRAS G12C共价抑制剂 【药品分享】罗伐昔替尼片——全球首创JAK/ROCK双靶点口服小分子抑制剂 【药品分享】埃诺格鲁肽注射液——全球首个获批上市的cAMP偏向型长效GLP-1受体激动剂 【药品分享】维培那肽注射液——长效GLP-1受体激动剂 【药品分享】普乐司兰钠注射液——全球首个靶向APOC3 mRNA的siRNA降脂药 【药品分享】玛仕度肽注射液——全球首个GCG/GLP-1双激动剂 【药品分享】瑞米布替尼片——全球首个获批用于CSU的口服靶向药 【药品分享】溴莫尼定噻吗洛尔滴眼液——α₂受体激动剂与非选择性 β 受体阻滞剂组成的复方降眼压药 【药品分享】吡洛西利片——国内首个CDK2/4/6多靶点抑制剂 【药品分享】奥氟格列隆片（Orforglipron） ——中国首个、全球首批上市的口服小分子 GLP-1受体激动剂 【药品分享】Copper Histidine注射液（Zycubo）——全球首个、唯一用于治疗儿童门克斯病（Menkes disease）的铜替代注射剂 【药品分享】依来格列隆片（Elecoglipron）——口服小分子非肽类GLP-1受体激动剂 【药品分享】阿利奈普仑（Aleniglipron）——口服小分子、非肽类、偏向性GLP-1受体激动剂 【药品分享】甲磺酸阿美替尼片——中国首个原研三代EGFR酪氨酸激酶抑制剂（TKI） 【药品分享】甲磺酸达麦利替尼片——口服高选择性c-MET酪氨酸激酶抑制剂 【药品分享】盐酸Acoramidis片——转甲状腺素蛋白（TTR）稳定剂 【药品分享】阿莫西林伏诺拉生胃漂浮片——3D打印胃漂浮片 【药品分享】盐酸伊可白滞素片——全球首创口服IL‑23受体拮抗剂 【药品分享】马来酸吡咯替尼片——中国首个自研的HER1/HER2/HER4不可逆酪氨酸激酶抑制剂（TKI） 【药品分享】本维莫德乳膏——全球首创芳香烃受体（AhR）调节剂（TAMA）类皮肤病外用药 【药品分享】盐酸莫托咪酯注射液——化药1类静脉麻醉新药 【药品分享】注射用罗哌卡因微晶——长效缓释局部麻醉药 【药品分享】盐酸伊立替康脂质体注射液——一款针对吉西他滨治疗失败的转移性胰腺癌的二线标准脂质体化疗药 【药品分享】甲磺酸氟马替尼片——Bcr-Abl酪氨酸激酶选择性抑制剂 【药品分享】注射用阿加糖酶β——国内获批的首个用于治疗法布雷病的药物 【药品分享】甲苯磺酸尼拉帕利胶囊——高选择性PARP1/2抑制剂 【药品分享】帕米帕利胶囊——强效、选择性PARP1/2抑制剂 【药品分享】苯环喹溴铵鼻喷雾剂——选择性M胆碱能受体拮抗剂 【药品分享】注射用拉罗尼酶浓溶液——MPS Ⅰ型的特异性酶替代治疗药物 【药品分享】海博麦布片——国产自主原研的胆固醇吸收抑制剂 【药品分享】盐酸可洛派韦胶囊——直接抗病毒药物（DAA）→ NS5A抑制剂 【药品分享】克拉考特酮乳膏——外用、非甾体、选择性雄激素受体（AR）抑制剂 【药品分享】非卢替尼片——全球首个用于多发性硬化的口服BTK抑制剂 【药品分享】Brenipatide注射液——GLP-1R/GIPR双受体激动剂（继替尔泊肽之后的第二款） 【药品分享】罗赛促红素α注射液——国产首个长效重组促红细胞生成素（EPO）创新药 【药品分享】贝组替凡片——全球首个口服小分子HIF-2α抑制剂 【药品分享】那米司特片——口服选择性PDE4B抑制剂 【药品分享】富马酸立康可泮胶囊——一款针对罕见病PNH的口服补体B因子抑制剂 【药品分享】醋酸索乐匹尼布片——高选择性脾酪氨酸激酶（Syk）抑制剂 【药品分享】甲磺酸艾多替尼片——全球首款专为肺癌脑转移设计的第三代EGFR-TKI 【药品分享】安瑞克芬注射液——全球首个获批镇痛适应症的高选择性外周κ-阿片受体（KOR）激动剂 【药品分享】Difelikefalin注射液——全球首个获批的外周选择性κ-阿片受体（KOR）激动剂 【药品分享】Obefazimod——口服、靶向 CBC、特异性增强miR-124的首创小分子 【药品分享】拉尼兰诺片——口服泛PPAR激动剂 【药品分享】舒洛地特注射液——抗血栓药、血管保护剂 【药品分享】贝普若韦生注射液——反义寡核苷酸（ASO）类乙肝新药 【药品分享】氨酚右敏口服溶液（奥肯能®）——中国内地唯一获批的氨酚右敏口服溶液 【药品分享】佩玛贝特片——新型过氧化物酶体增殖物激活受体α/δ双重激动剂 (PPARα/δ) 【药品分享】盐酸依匹斯汀乳膏——外用第二代非镇静抗组胺抗过敏药膏 【药品分享】注射用双羟萘酸帕瑞肽微球——一款用于治疗肢端肥大症的第二代长效生长抑素类似物（SRL）微球制剂 【药品分享】埃拉菲布拉诺片——治疗原发性胆汁性胆管炎（PBC）的口服靶向新药 【药品分享】泽卢克布仑钠注射液——新一代皮下注射型C5补体抑制剂 【药品分享】依达拉奉右莰醇注射用浓溶液——一款复方神经保护类注射剂 【药品分享】醋酸戈那瑞林注射液——促性腺激素释放激素（GnRH）类药物 【药品分享】甲磺酸贝舒地尔片——全球首个选择性ROCK2激酶抑制剂 【药品分享】伊托法替布软膏——外用JAK抑制剂（JAK1/JAK3） 【药品分享】注射用华卟啉钠——新型肿瘤光动力治疗（PDT）专用光敏剂 【药品分享】优替德隆胶囊——口服埃博霉素类微管抑制剂 【药品分享】艾普美妥司他片——EZH1/2双靶创新药 【药品分享】精氨酸艾曲莫德片——新型选择性鞘氨醇1-磷酸受体（S1P₁）调节剂 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。