Aprocitentan

Ad hoc announcement pursuant to Art. 53 LR Preparation is underway to publish the strong pediatric daridorexant data and engage with regulatory authorities on next steps Co-promotion of QUVIVIQ is being expanded across additional European markets to further accelerate growth Partnering discussions for TRYVIO™/JERAYGO™ are ongoing with several parties Allschwil, Switzerland – April 28, 2026 Idorsia Ltd (SIX: IDIA), a commercial-stage biopharmaceutical company with a portfolio of first- or best-in-class assets, today announced its financial results for the first quarter of 2026. Jean-Paul Clozel, Chairman and interim CEO of Idorsia, commented: “We have made a strong start to 2026. QUVIVIQ sales are tracking in line with our expectations, our pipeline is advancing, and we have delivered excellent results with daridorexant in children. Our focus is now firmly on executing the actions that will accelerate growth and unlock Idorsia’s full value. Building on the solid foundation established by our commercial team, we are working to further change the sales trajectory and accelerate growth, generating the cash flow required to continue advancing our breakthrough portfolio.” QUVIVIQ ® (daridorexant) QUVIVIQ continues to reshape the insomnia treatment landscape, and Idorsia is investing to accelerate its trajectory toward blockbuster status. Net sales increased 74% to CHF 44 million in Q1 2026 (Q1 2025: CHF 25 million) across North America and Europe. QUVIVIQ is now available in 13 countries across Europe, North America, China, and Japan, reflecting the continued global expansion of the franchise. Further market introductions are planned in Benelux, Ireland, Norway, Denmark, and Central and Eastern Europe, complemented by new strategic commercial alliances, most recently in Latin America, United Arab Emirates, Kuwait, Qatar, Oman, and Bahrain, to extend geographic reach and scale. QUVIVIQ has secured public reimbursement in key European markets, including France, Germany, the United Kingdom, and Austria. Efforts to further expand reimbursed access are ongoing, with active discussions in Spain – the largest insomnia market in Europe – and in the Nordics. In the United States, QUVIVIQ benefits from broad insurance coverage, although the current scheduled status continues to limit prescribing; the descheduling process for the DORA class remains ongoing. In Europe and Canada, Idorsia promotes QUVIVIQ to specialist prescribers, supported by co-promotion partnerships extending to primary care. Following partnerships in France in 2024 and Germany in 2025, co-promotions in the United Kingdom and Switzerland were launched in the first quarter of 2026. Additional co-promotion agreements are planned to further expand reach into primary care. Further sales acceleration is expected to be driven by increased private market awareness, including a strengthened presence in rapidly growing online prescription channels, alongside scalable direct-to-patient and adherence-focused initiatives designed to improve patient access. In parallel, Idorsia’s medical teams continue to generate additional clinical evidence, with ongoing studies in real‑world settings and in patients with co‑morbidities, including depression and anxiety, COMISA, major depressive disorder, alcohol and opioid use disorder, smoking cessation, and Alzheimer’s disease, reinforcing QUVIVIQ’s differentiated pro a broad range of patient populations. Daridorexant in pediatrics Outstanding Phase 2 results in children: statistically significant dose-dependent response on total sleep time with clinically meaningful improvements across multiple sleep measures in children with insomnia disorder, with especially pronounced efficacy in those with co-morbid neurodevelopmental disorders. Excellent safety and tolerability, confirmed for the first time in a pediatric population, including at the adult‑recommended 50 mg dose. Full analysis is ongoing with scientific publications and discussions with health authorities in preparation. TRYVIO™ / JERAYGO™ (aprocitentan) Growing base of HCP advocates across nephrology, cardiology, and internal medicine, with increasing uptake in leading academic centers and hypertension centers of excellence. On-market use is generating evidence that supports TRYVIO’s unique clinical profile, addressing a major unmet medical need by achieving meaningful reductions in both blood pressure and UACR in patients who previously could not reach treatment goals. New analyses of the PRECISION study to be presented by Prof. Markus Schlaich at the 35th Congress of the European Society of Hypertension on May 29, 2026. The oral presentation is entitled "Effect of the Dual Endothelin Receptor Antagonist Aprocitentan on Albuminuria". Idorsia’s CSO, Martine Clozel, will also speak at the event with a presentation entitled “From dream to reality: improving lives though endothelin-related innovations”. Ongoing partnering discussions to maximize the global value of TRYVIO/JERAYGO with several parties. Research & Development On track to initiate the Phase 3 program with lucerastat – potentially the first oral therapy for all patients with Fabry disease – in mid‑2026, with a potential regulatory filing as early as 2029. First-in-class, oral, selective CCR6 receptor antagonist for effective treatment of CCR6- and Th17-associated autoimmune indications. Proof‑of‑concept study in psoriasis is fully enrolled ahead of schedule – results now expected in Q4 2026. First-in-class, oral, CXCR7 (ACKR3) receptor antagonist, tailored to reduce central nervous system inflammation and promote remyelination through a dual mechanism of action. Proof‑of‑concept study in multiple sclerosis initiated in Q1 2026. First-in-class, oral, CXCR3 receptor antagonist with unique dual targeting of CD8+ CXCR3+ T cells offers potential for effective and safer treatment of immuno-dermatology and autoimmune disorders. Proof‑of‑concept study in vitiligo on track to initiating in Q2 2026. Daridorexant daytime functioning (IDSIQ) label‑enabling study in consultation with the US FDA. Idorsia’s synthetic glycan vaccine platform expected to deliver its next results in Q2 2026. Focused drug discovery efforts advancing on prioritized breakthrough projects such as Idorsia’s potential best-in-class orexin receptor agonist for narcolepsy and other orexin-related CNS disorders and Idorsia’s novel CFTR Type-IV corrector for cystic fibrosis. Financial highlights for Q1 2026 QUVIVIQ sales: CHF 44 million (excluding sales to partners) Contract revenues (one-off): CHF 11 million Non-GAAP operating expenses: CHF 78 million Non-GAAP operating loss: CHF 24 million (US GAAP: CHF 26 million) Financial Guidance for 2026 (unchanged) QUVIVIQ sales: CHF 200 million Non-GAAP operating expenses: ~CHF 330 million Non-GAAP operating loss: ~CHF 120 million (US GAAP operating loss: ~CHF 160 million) The financial guidance for 2026 reflects continued growth of QUVIVIQ (approximately 50% increase in sales in North America and Europe compared to 2025), investment in the lucerastat registration program, and development of the company’s immunology portfolio. TRYVIO/JERAYGO revenues and investments are not included, as these will be considered in any potential partnership agreement. All amounts exclude unforeseen events and any potential upsides from new direct-to-patient distribution models currently being implemented in several geographies and revenue related to additional business development activities. Financial results Q1 2026 US GAAP results First Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2026 2025 Net revenue 57 59 Operating expenses (84) 5 Operating income (loss) (26) 67 Net income (loss) (46) 63 Basic EPS (0.18) 0.33 Diluted EPS (0.18) 0.23 Basic weighted average number of shares 253 189 Diluted weighted average number of shares 253 271 Net revenue of CHF 57 million in the first quarter of 2026 resulted from product sales (CHF 44 million), product sales to partners (CHF 2 million), and contract revenues (CHF 11 million). This compares to net revenue of CHF 59 million in the first quarter of 2025 as a result of QUVIVIQ product sales (CHF 25 million), product sales to partners (CHF 1 million), and contract revenue (CHF 32 million). US GAAP operating expenses were CHF 84 million in the first quarter of 2026. In the first quarter of 2025, US GAAP operating expenses of CHF 5 million (income) were positively impacted by a one-off gain of CHF 90 million from the Viatris deal amendment. Excluding this one-off gain, US GAAP operating expenses were stable with, cost of sales of CHF 8 million increased by CHF 6 million due to higher product sales, R&D expenses of CHF 24 million decreased by CHF 3 million and SG&A expenses of CHF 53 million decreased by CHF 1 million compared to the first quarter of 2025. US GAAP net loss in the first quarter of 2026 amounted to CHF 46 million compared to CHF 63 million (net income) in the first quarter of 2025. The increased net loss in the first quarter of 2026 was primarily driven by the increase of the financial expenses and the one of gain of CHF 90 million in the first quarter of 2025. The US GAAP net loss resulted in a net loss per share of CHF 0.18 (basic and diluted) in the first quarter of 2026, compared to a net income per share of CHF 0.33 basic and CHF 0.23 diluted in the first quarter of 2025. Non-GAAP* measures First Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2026 2025 Net revenue 53 58 Operating expenses (78) (78) Operating income (loss) (24) (17) Net income (loss) (36) (25) Basic and diluted EPS (0.14) (0.13) Basic and diluted weighted average number of shares 253 189 * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in the first quarter of 2026 amounted to CHF 36 million; the difference versus US GAAP net loss was mainly driven by depreciation and amortization (CHF 4 million), share-based compensation (CHF 3 m), non-cash revenue recognized under the R-Bridge royalty monetization agreement (CHF 4 m), and accretion and issuance cost amortization (CHF 6 m). The non-GAAP net loss resulted in a net loss per share of CHF 0.14 (basic and diluted) in the first quarter of 2026, compared to a net loss per share of CHF 0.13 (basic and diluted) in the first quarter of 2025. Liquidity and indebtedness Liquidity on March 31, 2026, amounted to CHF 95 million. This amount does not include the remaining CHF 45 million available under the new money facility (term loan). (in CHF millions) Mar 31, 2026 Dec 31, 2025 Liquidity Cash and cash equivalents 95 89 Total liquidity* 95 89 Indebtedness Convertible loan 335 335 Convertible bonds 49 49 Debt notes** 766 753 Term loan 60 18 Other financial debt 185 187 Total indebtedness 1,395 1,342 *rounding differences may occur ** The debt notes issued by Idorsia Investments SARL in exchange for convertible bonds are senior secured with the shares in Idorsia Investments SARL. The A Notes only benefit from a limited and subordinated Swiss-law governed guarantee by Idorsia Ltd. Results Day Center Investor community: To make your job easier, we provide all relevant documentation, including the financial report, via the Results Day Center on our corporate website: . Events Annual General Meeting of Shareholders on May 6, 2026 Half-Year 2026 Financial Results reporting on July 30, 2026 Nine-month 2026 Financial Results reporting on October 29, 2026 Notes to the editor About Idorsia The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact Kevin Boss Director, Investor Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com – media.relations@idorsia.com – The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

吉诺昔替尼（Girocitinib，研发代号：TLL-018）是杭州高光制药自主研发的口服小分子JAK1/TYK2双重抑制剂，属于1类创新药，目前处于Ⅲ期临床阶段，尚未获批上市。 基本信息 通用名：吉诺昔替尼（Girocitinib） 研发代号：TLL-018 靶点：JAK1、TYK2（高选择性双重抑制） 药物类型：口服小分子靶向药，JAK-STAT通路抑制剂 开发企业：杭州高光制药股份有限公司 作用机制：通过高选择性抑制JAK1与TYK2激酶活性，阻断JAK-STAT信号通路，从而抑制炎症因子（如 IL-12、IL-23、IFN-γ等）的信号传导，减少炎症反应与免疫细胞活化，用于治疗自身免疫性与炎症性疾病。 与同类药物的区别 靶点特异性：主打JAK1/TYK2双重高选择性，区别于泛JAK抑制剂（如托法替尼）或JAK2/JAK1抑制剂（如巴瑞替尼），理论上脱靶风险更低、安全性更优。 研发定位：聚焦外周自身免疫/炎症疾病，与已上市JAK抑制剂的适应症布局形成差异化。 临床研发进展 慢性自发性荨麻疹（CSU）：Ⅲ期临床试验（NCT06396026）中期分析已达到主要终点，疗效显著优于安慰剂，安全性良好。 类风湿关节炎（RA）：同步开展Ⅲ期临床试验（NCT06887127、NCT06020144）。 其他潜在适应症：已布局特应性皮炎、银屑病、系统性红斑狼疮等自身免疫疾病的早期临床探索。 专利情况 吉诺昔替尼（TLL-018/Girocitinib）为杭州高光制药自主研发的JAK1/TYK2 双靶点抑制剂，目前处于Ⅲ期临床阶段，尚未上市。 1. 化合物核心专利 杭州高光制药于2017年9月30日申请，同步提交PCT国际申请，进入美、欧、日、澳等十余个主要国家/地区，预计2037年9月到期。保护通式结构覆盖JAK1/TYK2 双靶点抑制剂骨架，明确保护2-[(2R,5S)-5-[2-甲基呋喃并 [3,2-b] 咪唑并 [4,5-d] 吡啶-1-基] 四氢吡喃-2-基] 乙腈（吉诺昔替尼）的绝对构型与盐型。用于自身免疫性疾病、炎症性疾病（类风湿关节炎、荨麻疹、银屑病、特应性皮炎、SLE等）。 2. 晶型/盐型专利 已布局吉诺昔替尼游离碱、甲磺酸盐、盐酸盐等多晶型/盐型专利，覆盖稳定晶型、无定型、共晶。目的是延长专利保护期、提升制剂稳定性与生物利用度、阻挡仿制药晶型规避。 3. 制剂/组合物专利 保护吉诺昔替尼片剂、缓释/控释制剂的处方、工艺、溶出特性，覆盖复方组合（如与甲氨蝶呤、抗组胺药联用），拓展适应症与市场空间。 4. 合成工艺专利 保护吉诺昔替尼的关键中间体、手性合成路线、纯化方法（如以7-氯-6-硝基呋喃并 [3,2-b] 吡啶为起始原料的合成路径），形成工艺壁垒，降低仿制成本与合规风险。 5. 用途/适应症专利 保护慢性自发性荨麻疹、类风湿关节炎、银屑病、特应性皮炎、SLE等单一适应症的治疗方法与医药用途，每获批一个新适应症，专利保护范围同步扩大。 专利优势 全球独家：JAK1/TYK2 双靶点的高选择性抑制剂，无直接竞品专利冲突。 层级保护：化合物+晶型+制剂+工艺+用途的五层专利网，仿制药难度极高。 期限长：核心化合物专利2037年到期，叠加晶型/制剂专利，有效保护期可至2040年以后。 中国自主：高光制药100%持有全球专利权益，无对外授权（除TLL-041外）。 专利风险 尚未上市：专利期限补偿（PTA）需获批上市后申请，实际到期日存在不确定性。 临床风险：若Ⅲ期失败，专利商业价值归零。 规避风险：存在结构修饰、晶型规避、适应症外推等潜在侵权/规避可能。 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 【药品分享】磷酸芦可替尼乳膏——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 【药品分享】盐酸右哌甲酯缓释胶囊——治疗6岁及以上注意缺陷多动障碍（ADHD）的一线药物 【药品分享】抗菌肽PL-3301口腔凝胶——中国首创的抗菌肽类抗口腔真菌感染药物 【药品分享】Zasocitinib (TAK-279) 胶囊——新一代高选择性口服 TYK2 抑制剂 【药品分享】注射用Abelacimab——一款全人源IgG1单克隆抗体，靶向凝血因子XI（FXI） 【药品分享】Duvakitug注射液——首创性人源化IgG1-λ2单克隆抗体，靶向TL1A（TNFSF15） 【药品分享】醋酸氟轻松/氢醌/维A酸乳膏——治疗中重度黄褐斑疗效明确的外用复方 【药品分享】富马酸伏诺拉生氯化钠注射液——钾离子竞争性酸阻滞剂（P‑CAB）||东阳光药业研发的2.2,2.4类改良新型新药 【药品分享】盐酸阿曲生坦片——诺华研发的高选择性内皮素 A（ETA）受体拮抗剂||中国首个获批用于IgA 肾病的非免疫性口服靶向药 【药品分享】RGT-274-CR胶囊——上海齐鲁锐格医药研发的口服小分子GLP-1受体激动剂 【药品分享】酒石酸西尼必利片——高选择性5-HT₄受体激动剂类胃肠动力药 【药品分享】石杉碱甲控释片——采用双相控释/渗透泵技术的2.2类改良型新药 【药品分享】塞伐艾替尼片——口服、可逆、选择性酪氨酸激酶抑制剂（TKI） 【药品分享】Admilparant片——口服小分子LPA₁受体拮抗剂 【药品分享】瑞拉可兰胶囊——全球首个选择性糖皮质激素受体（GR）拮抗剂 【药品分享】盐酸依特卡肽注射液——全球首个、国内唯一获批的静脉注射型拟钙剂 【药品分享】Avacincaptad pegol玻璃体内注射液——全球首批用于AMD继发地图样萎缩（GA）的靶向药物 【药品分享】盐酸达利雷生片——新一代非管制、非苯二氮䓬类抗失眠药物 【药品分享】甲磺酸瑞索利塞片——高选择性PI3Kα小分子靶向抑制剂 || 全球首个获批用于特定卵巢癌的靶向新药 【药品分享】富马酸西他沙星注射液——新型喹诺酮类抗菌药物 【药品分享】Icotrokinra——全球首个获批的口服 IL-23 受体（IL-23R）选择性拮抗多肽 【药品分享】氘可来昔替尼片（Deucravacitinib）——全球首个口服、选择性 TYK2 变构抑制剂 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。