Aleniglipron

First patients dosed in aleniglipron (oral small molecule GLP-1 receptor agonist) Phase 3 ACCOMPLISH program for chronic weight management Data from Phase 1 SAD clinical trial of ACCG-2671 (oral small molecule dual amylin and calcitonin receptor agonist) and initiation of MAD clinical trial on track for Q3 2026 Topline 72-week aleniglipron ACCESS OLE data on track for Q3 2026; data from body composition, type 2 diabetes/obesity and SWITCH clinical trials on track for Q4 2026 Appointed metabolic commercial industry veteran John Berrios as Chief Commercial Officer ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Cash, cash equivalents and short-term investments of $1.3 billion as of June 30, 2026 expected to fund projected operations and key clinical milestones through 2028 SAN FRANCISCO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the second quarter ended June 30, 2026 and provided a business update including the initiation of the Phase 3 ACCOMPLISH program evaluating aleniglipron for chronic weight management. “Dosing the first patients in ACCOMPLISH-1 and -2 is a defining milestone for Structure as we advance aleniglipron, our potentially best-in-class oral GLP-1 receptor agonist, toward potential registration,” said Raymond Stevens, Ph.D., Chief Executive Officer of Structure Therapeutics. “As we enter this next stage of development, the appointment of John Berrios as our Chief Commercial Officer adds tremendous experience in obesity, diabetes, market access and commercialization to our senior leadership team, particularly given his leadership role in the GLP-1 space.” “Obesity is a chronic disease, and people need treatment options that can adapt to their individual goals over time,” continued Dr. Stevens. “We are building a comprehensive portfolio of oral small molecule medicines designed to provide greater choice, flexibility and accessibility across the treatment journey, from initial weight loss through long-term weight maintenance. As an important component of this strategy, we are advancing ACCG-2671, our potentially first-in-class oral small molecule dual amylin and calcitonin receptor agonist and remain on track to report initial single ascending dose data and initiate a multiple ascending dose clinical trial in the third quarter. We also look forward to initiating our combination GLP-1 and amylin receptor agonist clinical trial later this year. We believe these programs have the potential to provide meaningful, sustained weight and metabolic benefits through convenient and accessible oral treatment options.” Recent and Upcoming Milestones Aleniglipron – Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for Chronic Weight Management The Company announced that the first patients have been dosed in the Phase 3 ACCOMPLISH program, which includes two clinical trials evaluating aleniglipron, a once-daily oral small molecule GLP-1 receptor agonist. ACCOMPLISH-1 is evaluating aleniglipron in adults living with obesity or overweight with a weight-related comorbidity and will enroll up to 3,600 patients; ACCOMPLISH-2 is evaluating aleniglipron in adults living with obesity or overweight and type 2 diabetes mellitus (T2DM) and will enroll up to 1,100 patients. ACCOMPLISH-1 and ACCOMPLISH-2 are randomized, double-blind, placebo-controlled clinical trials designed to evaluate the long-term efficacy and safety of three maintenance doses of aleniglipron. Participants in the clinical trials will be randomized to one of four treatment arms, with three active doses (45 mg, 90 mg or 180 mg) or placebo. Patients will begin treatment at a 2.5 mg starting dose with 4-week titration increments. Together, the ACCOMPLISH clinical trials are designed to support global regulatory submissions for aleniglipron in chronic weight management. Additional information about ACCOMPLISH-1 and ACCOMPLISH-2, including endpoints, eligibility criteria and enrolling sites, is available at ClinicalTrials.gov under identifiers NCT07654361 and NCT07654374 , respectively. In June 2026, data from the Phase 2b ACCESS clinical trial of aleniglipron were published in Nature Medicine and highlighted in an oral presentation at the American Diabetes Association's (ADA) 86th Scientific Sessions. The publication and presentation detailed dose-dependent, clinically meaningful and statistically significant reductions in body weight, with continued weight loss beyond 36 weeks and up to 16.2% at 44 weeks observed during the open-label extension. The tolerability pro the well-known gastrointestinal-related adverse events typical of the GLP-1 class, with a favorable overall discontinuation rate of 10.4%. Structure plans to report new data from the following aleniglipron clinical trials in the second half of 2026: The ACCESS Open Label Extension (OLE) clinical trial is evaluating the tolerability of the dose titration regimen that includes a starting dose of 2.5 mg in placebo crossover patients. The clinical trial will be completed after a total of 72 weeks of treatment, where some participants have been exposed to 180 mg for a certain period of time. Data are expected in Q3 2026. The Body Composition clinical trial is assessing the effect of aleniglipron on body fat loss over a 44-week evaluation period. Data are expected in Q4 2026. The clinical trial in patients with T2DM with obesity/overweight is evaluating the potential for including participants with T2DM in the Phase 3 program. Data are expected in Q4 2026. The SWITCH clinical trial is assessing the transition from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for long-term weight loss maintenance. Data are expected in Q4 2026. Oral Small Molecule Dual Amylin and Calcitonin Receptor Agonists ACCG-2671, an oral small molecule dual amylin and calcitonin receptor agonist, continues to be evaluated in an ongoing Phase 1 single ascending dose (SAD) clinical trial assessing safety, tolerability, pharmacokinetics and food effect in healthy adult participants. Initial data, along with initiation of a multiple ascending dose (MAD) clinical trial, remain on track for Q3 2026. The Company plans to initiate a Phase 1 clinical trial of its second oral small molecule dual amylin and calcitonin receptor agonist candidate, ACCG-3535, in Q4 2026, demonstrating continued leadership in the oral small molecule amylin field. Combination of Oral Small Molecule GLP-1 and Amylin Receptor Agonists Preclinical combination data of aleniglipron and ACCG-2671 were presented at the ADA Scientific Sessions in June 2026 demonstrating additional weight loss compared to each monotherapy in non-human primates. A combination clinical trial is expected to be initiated in Q4 2026. Appointment of John Berrios as Chief Commercial Officer (CCO) Structure has appointed John Berrios as its CCO. Mr. Berrios brings more than 25 years of commercial leadership experience across the biopharmaceutical industry, with expertise spanning commercial strategy, sales, marketing, operations and market access. Most recently, he served as Head of U.S. Sales Strategy and Innovation for Obesity and Diabetes at Novo Nordisk and was instrumental in leading the strategic planning and commercial launch of its obesity and diabetes portfolio. Previously, he held senior leadership roles at Bayer Pharmaceuticals and AstraZeneca, where he led commercial organizations and supported the launch and growth of multiple products across obesity, diabetes, cardiovascular disease, and other therapeutic areas. Second Quarter 2026 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $1.3 billion as of June 30, 2026, compared to $1.5 billion as of March 31, 2026. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through the end of 2028, including costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension clinical trial, the supplementary clinical trials, and Phase 3 registrational program in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $100.1 million, as compared to $54.7 million for the same period in 2025. The increase in research and development expenses was primarily due to increases related to clinical trial costs, preclinical research and development expenses, and employee expenses (primarily due to an increase in personnel). General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $18.6 million, as compared to $15.7 million for the same period in 2025. The increase in G&A expenses was primarily due to increases in employee expenses as the Company expanded its infrastructure to drive and support the growth in operations as a publicly-traded company, and increases in professional services. Net Loss: Net loss for the second quarter of 2026 totaled $106.2 million, with non-cash share-based compensation expense of $12.6 million, compared to a net loss of $61.7 million for the same period in 2025, with non-cash share-based compensation expense of $7.5 million. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit . Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects, including its research and development activities; the design, initiation, enrollment, conduct, timing and completion of the Company’s clinical trials, including the aleniglipron Phase 3 ACCOMPLISH program, the ACCG-2671 multiple ascending dose (MAD) clinical trial, the ACCG-3535 Phase 1 clinical trial and the combination amylin/GLP-1 clinical trial and the timing of topline, interim, or additional data readouts from the Phase 1 single ascending dose (SAD) clinical trial of ACCG-2671, and the aleniglipron ACCESS OLE, Body Composition, SWITCH and type 2 diabetes/obesity clinical trials; the Company’s expectation that the aleniglipron ACCOMPLISH clinical trials will be sufficient to support global regulatory submissions for aleniglipron in chronic weight management; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects, competitive positioning (including any characterization of a product candidate as potential “best-in-class” or “first-in-class”) and future application of aleniglipron, ACCG-2671, ACCG-3535 and any other of the Company’s investigational compounds; any presumption that topline, interim or preliminary data will be representative of, or predictive of, final data from other or later clinical trials; the Company’s ability to support global regulatory submissions for its product candidates and to obtain, maintain and expand regulatory approvals; and the Company’s expectations regarding its cash, cash equivalents and short-term investments and its estimated cash runway, including its ability to fund projected operations and clinical milestones through the end of 2028. In addition, when or if used in this press release, the words and phrases “continue,” “could,” “anticipated,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “project,” “remain,” “target,” “suggests,” “to be,” “to begin,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: the risk that topline, interim or preliminary data the Company reports are based on a preliminary analysis of then-available efficacy and safety data, and such data may change following a more comprehensive review of the data related to the applicable clinical trial, and such topline, interim or preliminary data may not accurately reflect the complete or final results of a clinical trial; the preliminary nature of clinical results given the length of the applicable clinical trial and sample size, and the fact that results from earlier clinical trials are not necessarily predictive of future results; potential delays in the commencement, enrollment, conduct or completion of the Company’s planned and ongoing clinical trials, including the Phase 3 ACCOMPLISH program; the risk that clinical trial results may not support further development or regulatory approval of aleniglipron, ACCG-2671, ACCG-3535, or the Company’s other therapeutic candidates; the Company’s ability to obtain and maintain regulatory approval of, and ultimately successfully commercialize, its therapeutic candidates; the effect of competitive products or therapeutic approaches on the commercial value of the Company’s product candidates; the Company’s ability to fund its development activities and achieve its development goals; and other risks and uncertainties described in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Quarterly Report on Form 10-Q, and other reports the Company has filed or may the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 cdavis@lifesciadvisors.com Jen Robinson Structure Therapeutics Inc. ir@structuretx.com Media: Dan Budwick 1AB Dan@1abmedia.com STRUCTURE THERAPEUTICS INC. Condensed Consolidated Statements of Operations (unaudited) (In thousands) THREE MONTHS ENDED SIX MONTHS ENDED JUNE 30, JUNE 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 100,057 $ 54,710 $ 166,564 $ 97,577 General and administrative 18,573 15,741 41,445 29,185 Total operating expenses 118,630 70,451 208,009 126,762 Loss from operations (118,630 ) (70,451 ) (208,009 ) (126,762 ) Interest and other income, net 12,705 8,929 26,306 18,505 Loss before provision for income taxes (105,925 ) (61,522 ) (181,703 ) (108,257 ) Provision for (benefit from) income taxes 234 139 424 237 Net loss $ (106,159 ) $ (61,661 ) $ (182,127 ) $ (108,494 ) Research and development $ 7,054 $ 3,461 $ 12,155 $ 6,160 General and administrative 5,580 4,048 12,118 7,267 Total share-based compensation $ 12,634 $ 7,509 $ 24,273 $ 13,427 STRUCTURE THERAPEUTICS INC. Condensed Consolidated Balance Sheet Data (unaudited) (In thousands) JUNE 30, DECEMBER 31, 2026 2025 Assets Current assets: Cash, cash equivalents and short-term investments $ 1,342,658 $ 1,446,197 Prepaid expenses and other current assets 29,370 124,106 Total current assets 1,372,028 1,570,303 Property and equipment, net 6,332 6,653 Operating right-of-use assets 6,060 6,245 Other non-current assets 40,995 717 Total assets $ 1,425,415 $ 1,583,918 Liabilities and shareholders’ equity Current liabilities: Accounts payable $ 11,131 $ 13,864 Accrued expenses and other current liabilities 52,387 46,543 Operating lease liabilities, current portion 2,595 2,878 Total current liabilities 66,113 63,285 Operating lease liabilities, net of current portion 3,633 3,609 Other non-current liabilities 1,265 647 Total liabilities 71,011 67,541 Total shareholders’ equity 1,354,404 1,516,377 Total liabilities and shareholders’ equity $ 1,425,415 $ 1,583,918

阿柏西普眼内注射溶液（艾力雅®，Eylea）是Bayer AG（拜耳）研发的一款重组人源VEGF融合蛋白的治疗用生物制品，仅用于玻璃体腔眼内注射给药。 基本信息 作用机制：可同时结合VEGF‑A、VEGF‑B、PlGF（胎盘生长因子），抑制眼底异常新生血管，降低血管渗漏，减轻黄斑水肿；靶点覆盖多于单纯抗VEGF单抗类眼科药物。 国内获批适应症（原研艾力雅）：新生血管（湿性）年龄相关性黄斑变性 (nAMD)；糖尿病性黄斑水肿 (DME)；视网膜静脉阻塞继发黄斑水肿 (RVO‑ME)；糖尿病视网膜病变（DR）。 国内获批规格与用法用量 ✅2mg规格（40 mg/mL）：单次玻璃体腔注射给药2 mg（50 μL） nAMD：前3针每月1次，之后每8周给药1次； DME/RVO‑ME：前5针每月1次，后续按需给药。 ✅8mg高剂量规格（114.3 mg/mL，艾力雅） 国内获批适应症：湿性年龄相关性黄斑变性（nAMD） 给药方案：初始连续3个月每月玻璃体腔注射8 mg；之后依据视力、眼底解剖评估，最长可每4个月（16周）给药一次，大幅降低注射频次。 关键Ⅲ期PULSAR研究：96周，8 mg组平均注射8.2次，对比2 mg组少约 4 次注射，视力获益等效，未新增显著安全风险信号。 给药方式：必须由具备玻璃体腔注射资质的眼科医生操作。 主要风险：眼内炎、视网膜脱离、眼压升高、玻璃体出血等注射相关眼部不良反应。 上市情况 国外上市信息 2 mg原研拜耳（Eylea/艾力雅®）：FDA 2011‑11获批上市，全球多国上市，适应症覆盖nAMD、DME、RVO‑ME、DR、近视性CNV、早产儿视网膜病变等。 8mg 高剂量版 Eylea FDA：2023‑08获批，后续陆续批准nAMD、DME、DR、RVO‑ME；2026‑04 美国批准最长5个月给药间隔。 欧盟：2024‑01 获批，适应症为nAMD、DME。 中国上市信息 2 mg 规格（40 mg/mL）：NMPA 2018‑02获批，商品名艾力雅®。适应症为nAMD、DME、RVO‑ME、糖尿病视网膜病变（DR）。 8 mg 高剂量规格（114.3 mg/mL，艾力雅）：NMPA 2025‑05‑22获批，国内仅获批nAMD（湿性老年黄斑变性），DME/RVO‑ME暂未获批 8 mg适应症。 国内生物类似药上市信息（均仅 2 mg规格，暂无 8mg） 美国紫皮书信息 注册受理信息 临床试验信息 专利情况 原研专利 核心化合物/序列专利 制剂/处方/组合物专利 用途/新适应症专利 给药装置/给药方案/组合疗法相关专利 基因/AAV/细胞/制备纯化相关专利 国内申请人专利（非原研） 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 【药品分享】柯美奇拜单抗注射液——鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者的福音 【药品分享】吉诺昔替尼——口服小分子JAK1/TYK2双重抑制剂 【药品分享】洛替拉纳（Lotilaner）——GABA 门控氯离子通道非竞争性拮抗剂 || 兼具兽医驱虫与人用眼科两大用途 【药品分享】CagriSema——由卡格列肽（cagrilintide）2.4 mg与司美格鲁肽（semaglutide）2.4 mg组成的强效减重复方药 【药品分享】苹果酸卡博替尼——口服、多靶点酪氨酸激酶抑制剂（TKI） 【药品分享】迪高替尼（Delgocitinib）——一款外用泛JAK抑制剂 【药品分享】拉氟莫司(Laflunimus)——口服免疫抑制剂 || 兼具免疫抑制与抗炎双重活性 【药品分享】伏昔尼布片——全球首个IDH1/IDH2双重突变抑制剂靶向药 【药品分享】盐酸奥昔布宁片——M受体抗胆碱药 【药品分享】贝泽昔替尼片——国内首款获批的高选择性JAK2单靶点抑制剂 【药品分享】苯甲酸安达艾替尼胶囊——新型小分子酪氨酸激酶不可逆抑制剂（EGFR-TKI） 【药品分享】伏欣奇拜单抗注射液——全人源抗IL‑1β单克隆抗体 || 用于急性痛风性关节炎的1类创新生物药 【药品分享】利多卡因丁卡因乳膏 【药品分享】伐米奇拜单抗注射液——玻璃体内注射用抗IL-6人源化单抗 【药品分享】依赛弗酶α注射液（Efzimfotase alfa 注射液）——第二代重组组织非特异性碱性磷酸酶（TNSALP）酶替代疗法 【药品分享】格达托利西布（Gedatolisib）——first‑in-class 泛 PI3K/mTORC1/2 双重抑制剂 【药品分享】伯瑞替尼肠溶胶囊——中国原研、高选择性c-MET小分子抑制剂 || 首个获批MET扩增NSCLC单药治疗的靶向药 【药品分享】力胜克拉片——中国首个申报上市的原研Bcl-2抑制剂、全球第二款Bcl-2抑制剂 【药品分享】BGM0504注射液——GLP-1/GIP 双受体激动剂 【药品分享】塞利尼索片——全球首个口服选择性核输出蛋白XPO1抑制剂 【药品分享】Seltorexant薄膜包衣片——选择性食欲素2受体（OX2R）高选择性拮抗剂 【药品分享】盐酸埃克替尼片——国内首个自主研发的一代EGFR-TKI 【药品分享】盐酸伊普可泮胶囊——全球首个口服补体B因子抑制剂 【药品分享】恩考芬尼胶囊——靶向BRAF V600突变的口服激酶抑制剂 【药品分享】Enpatoran——口服、选择性TLR7/8小分子抑制剂 【药品分享】硝酸异康唑阴道片——抗真菌外用药物 【药品分享】Zorevunersen注射液——全球独家ASO上调蛋白表达技术 【药品分享】妥拉美替尼胶囊——全球首个针对NRAS突变黑色素瘤的MEK抑制剂 【药品分享】盐酸替那帕诺片——全球首创NHE3抑制剂类新型降磷药物 【药品分享】注射用莱古比星——新型蒽环类抗肿瘤药 【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】伊那利塞片——中国首个PIK3CA突变乳腺癌精准靶向药 【药品分享】呋喹替尼胶囊——中国首个自主研发VEGFR-TKI || VEGFR靶点靶向抗癌药 【药品分享】琥珀酸瑞波西利片——CDK4/6抑制剂 【药品分享】盐酸替那帕诺片——全球首个且唯一获批的肠道磷吸收抑制剂 【药品分享】芬布替尼片——口服、可逆、可透过血脑屏障的BTK抑制剂 【药品分享】炔丙基半胱氨酸胶囊——全球首个进入临床的硫化氢（H₂S）供体I类创新药 【药品分享】Balcinrenone达格列净胶囊——选择性盐皮质激素受体拮抗剂（MRA）+SGLT-2抑制剂 【药品分享】诺拉西班（Nolasiban）分散片——选择性口服催产素受体拮抗剂 || 早产二线/辅助治疗药物 【药品分享】塞多明基注射液——国内首款裸质粒基因治疗药物 【药品分享】鲁兹诺雷钠片——国产首个高选择性URAT1抑制剂 【药品分享】玛伐凯泰胶囊——全球首创、中国唯一获批的心肌肌球蛋白抑制剂 【药品分享】依托芬那酯凝胶——外用非甾体抗炎镇痛药 【药品分享】聚卡波非钙片——国际指南首选容积性缓泻剂 【药品分享】Mezigdomide胶囊——新一代IMiDs/cereblon E3泛素连接酶调节 【药品分享】洛布替尼片——全球首款共价+非共价双机制第四代 BTK 靶向药 【药品分享】奥莱泊肽注射液——PEG修饰长效GLP‑1单靶点激动剂 【药品分享】安瑞曲替尼胶囊 ——国内第二款国产二代NTRK广谱抗癌药 【药品分享】麦格司他胶囊——抑制葡萄糖神经酰胺合成酶的罕见病口服靶向药 【药品分享】乌帕替尼片（Upadacitinib）——选择性JAK1抑制剂 【药品分享】Dordaviprone胶囊——全球首款、目前唯一获批用于 H3 K27M 突变型弥漫性中线胶质瘤（DMG）的靶向药 【药品分享】屈昔多巴胶囊——去甲肾上腺素前体药物  || 帕金森、多系统萎缩、神经源性体位低血压一线对症用药 【药品分享】康特替尼颗粒——第二代ALK多靶点激酶抑制剂 【药品分享】盐酸兰诺可泮片——国产首个获批上市的补体因子B（CFB）抑制剂 【药品分享】Elinzanetant软胶囊——全球首款NK1/NK3双重神经激肽受体拮抗剂 【药品分享】Fosmanogepix注射液——全球首创（First-in-class）Gwt1抑制剂类抗真菌前药 【药品分享】Zorevunersen注射液——反义寡核苷酸药物 【药品分享】宗艾替尼片——高选择性不可逆HER2（ERBB2）酪氨酸激酶抑制剂（TKI） 【药品分享】甲苯磺酸他拉唑帕利胶囊——高选择性PARP抑制剂 【药品分享】Bexicaserin口服溶液——选择性5-HT2C受体激动剂口服液体制剂 【药品分享】醋酸伏诺拉生注射用浓溶液——钾离子竞争性酸阻滞剂（P-CAB） 【药品分享】甲苯磺酸依仑司群片——新一代口服选择性雌激素受体降解剂（SERD） 【药品分享】硫酸瑞美吉泮口崩片——CGRP 受体拮抗剂（降钙素基因相关肽）|| 偏头痛靶向特效药 【药品分享】阿托吉泮片——全球首款口服长效CGRP靶点预防偏头痛药物 【药品分享】乌布吉泮片——CGRP受体拮抗剂 || 第二代口服偏头痛急性期药物 【药品分享】扎维吉泮鼻喷雾剂——高选择性CGRP受体拮抗剂  || 全球唯一获批鼻喷CGRP吉泮类急性期药物 【药品分享】培来加南喷雾剂——全球首款上市加南类多肽抗菌药（FIC） 【药品分享】艾沙利酮片——高选择性非甾体醛固酮受体拮抗剂（MRA）  || 全球首个上市的非甾体选择性MR拮抗剂 【药品分享】布美他尼鼻喷雾剂——全球首款、唯一鼻内给药袢利尿剂 【药品分享】注射用盐酸依拉环素——新型全合成氟环素类（四环素衍生物）静脉抗生素 【药品分享】舒瑞基奥仑赛注射液——全球首款实体瘤自体CLDN18.2靶向CAR-T细胞新药 【药品分享】盐酸环喷托酯滴眼液——儿童验光首选短效睫状肌麻痹剂之一 【药品分享】盐酸赛庚啶口服溶液——抗过敏抗组胺药 【药品分享】Rinzimetostat (ORIC-944)——口服选择性 EED别构型PRC2表观遗传抑制剂 【药品分享】Empasiprubart注射用浓溶液——全球首创靶向补体C2人源化IgG1清扫型单克隆抗体 【药品分享】阿更葡糖钠注射液——全球第二款、中国首款自主研发的环糊精类靶向肌松逆转剂 【药品分享】盐酸罗哌卡因缓释溶液——国产自主长效局麻缓释制剂 || 填补国内切口原位长效镇痛空白 【药品分享】Telisotuzumab Adizutecan 注射用粉末——抗c-Met抗体偶联药物（ADC） 【药品分享】L606 (曲前列尼尔脂质体吸入混悬液)——靶向肺动脉高压 【药品分享】佩米替尼片——选择性FGFR1/2/3酪氨酸激酶抑制剂 【药品分享】唑尼沙胺胶囊——磺酰胺类结构 || 广谱抗癫痫药，偏头痛预防 【药品分享】琥珀酸安维吖啶片——双靶点胆碱酯酶抑制剂 【药品分享】布莱昔替尼片（Bleximenib）——口服高选择性Menin-KMT2A相互作用抑制剂 【药品分享】利厄替尼片——第三代EGFR-TKI靶向药 【药品分享】注射用苯磺酸瑞马唑仑——苯二氮䓬类短效静脉镇静/麻醉药 【药品分享】瑞维鲁胺片——国产全新二代雄激素受体抑制剂 【药品分享】塞普替尼胶囊——全球首款高选择性RET靶向药  || 国内唯一拥有12岁以上儿童甲状腺肿瘤完整临床证据的RET抑制剂 【药品分享】注射用和厚朴酚脂质体冻干粉——全球首创小分子脂质体靶向制剂 【药品分享】注射用顺铂聚合物胶束——前沿纳米化疗创新赛道  || 改良型新药-纳米靶向注射制剂 【药品分享】奥普雷顿片——国内首个获批的口服OX2R选择性激动剂 【药品分享】琥珀酸思普可泮片——口服选择性补体B因子（CFB/FB）小分子抑制剂  || 全球首个每日一次口服FB抑制剂 【药品分享】苹果酸法米替尼胶囊——多靶点TKI创新药  || 国内唯一获批用于宫颈癌的口服抗血管TKI 【药品分享】盐酸伊普可泮胶囊 【药品分享】枸橼酸伊沙佐米胶囊——第二代、全球首个口服可逆性蛋白酶体抑制剂 【药品分享】注射用西罗莫司（白蛋白结合型）——mTOR 激酶抑制剂  || 白蛋白纳米粒递送系统 【药品分享】Bleximenib片——Menin抑制剂（KMT2A/Menin 相互作用抑制剂） 【药品分享】Eloralintide注射液——选择性长效胰淀素（Amylin）受体激动剂（AMY1R激动剂） 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。