Pamiparib

Sofetabart mipitecan (Sofe-M) in combination with bevacizumab demonstrated a 79% confirmed objective response rate and 100% disease control rate, with similar activity observed across FRα expression levels Clinical activity with Sofe-M was maintained even in patients with prior PARP inhibitor exposure, patients who typically experience poor outcomes with platinum-based chemotherapy Sofe-M is currently being studied in both platinum-sensitive and platinum-resistant ovarian cancer in multiple Phase 3 studies as part of the FRAmework-01 master protocol INDIANAPOLIS, Oct. 24, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new Phase 1 data showing that its investigational folate receptor alpha (FRα) antibody-drug conjugate (ADC) sofetabart mipitecan (Sofe-M) plus bevacizumab achieved a confirmed objective response rate (cORR) of 79% and a disease control rate (DCR) of 100% in patients with platinum-sensitive ovarian cancer (PSOC). A cORR of 79% or higher was seen in both poly (ADP-ribose) polymerase inhibitor (PARPi)-treated and PARPi-naïve patients. These data will be shared in an oral presentation at the European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain. FRα is expressed in almost all ovarian cancers, at much higher levels than in healthy tissue, making it a target that can help direct treatment to tumor cells. Sofe-M is an FRα-targeting ADC composed of an Fc-silent, FRα-specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker. The antibody is designed to bind FRα on the surface of tumor cells, delivering exatecan directly into the tumor cell to disrupt DNA replication. Jacob Van Naarden, Executive Vice President and President of Lilly Oncology: "The standard of care for platinum-sensitive ovarian cancer has remained unchanged for a decade and demands new treatment options. Results for Sofe-M show a promising efficacy and tolerability profile across both platinum-resistant and platinum-sensitive ovarian cancer, regardless of FRα expression levels or prior treatment. These data give us confidence as we continue to study Sofe-M in our Phase 3 FRAmework-01 program to bring this potential new medicine to the women who need it." The Phase 1 study is evaluating Sofe-M plus bevacizumab in patients with advanced solid tumors, including a cohort of 33 women with PSOC who received Sofe-M (4 mg/kg) plus bevacizumab (15 mg/kg). Patients received a median of three prior systemic regimens (range 1–6), including prior PARPi (67%) and prior bevacizumab (70%). As of the July 6, 2026, data cutoff, the cORR among the 29 patients with measurable disease was 79.3% (23/29; 6 complete responses [CR, 20.7%] and 17 partial responses [PR, 58.6%]), and DCR was 100%. Responses were consistent across FRα expression levels and prior PARPi exposure. Median duration of response (DOR) and median progression-free survival (PFS) were not reached at median follow-ups of 6.2 and 10.2 months, respectively. Chrisann Kyi, MD, Gynecologic Medical Oncologist & Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center: "The durable and robust responses we've seen in patients with platinum-sensitive ovarian cancer are important, particularly in a PARPi pretreated population, where the response rate seen with Sofe-M exceeds what has been reported in published platinum re-challenge studies. The observed safety profile and low discontinuation rates, combined with early efficacy results, support the continued investigation of Sofe-M as a potentially meaningful new option for patients." Sofe-M plus bevacizumab demonstrated a safety profile consistent with the known profiles of each medicine. No new safety signals were observed. The most common treatment-emergent adverse events (TEAEs) across all patients included epistaxis (73%), nausea (73%), anemia (58%), neutropenia (55%), and fatigue (52%). The most common Grade ≥3 TEAEs were neutropenia (42%) and anemia (24%); febrile neutropenia occurred in 3% of patients, and G-CSF prophylaxis was not mandated. Any-grade neuropathy occurred in 9% of patients, with no Grade ≥3 events. Dose reductions occurred in 42% of patients, and 6% discontinued treatment due to an adverse event. The FRAmework-01 program is evaluating Sofe-M in three global Phase 3 trials across both platinum-resistant and platinum-sensitive ovarian cancer: Part A tests Sofe-M as monotherapy in platinum-resistant disease; Part B tests Sofe-M plus bevacizumab in platinum-sensitive disease that progressed on or within six months of completing a PARPi; and Part C tests Sofe-M plus bevacizumab in PARPi-naïve platinum-sensitive disease. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). For more information on Lilly's oncology pipeline, click here. Frequently Asked Questions What is sofetabart mipitecan (Sofe-M)? Sofetabart mipitecan (Sofe-M) is an investigational folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) being studied for the treatment of ovarian cancer and other solid tumors. It is designed to selectively bind to cancer cells expressing FRα and deliver a topoisomerase I inhibitor payload directly to those cells. What is an antibody-drug conjugate? An antibody-drug conjugate (ADC) is a type of medicine that pairs an antibody with a cell-killing payload. The antibody is designed to recognize and bind to a specific protein found on the surface of cancer cells, and the payload is released once the ADC reaches its target, allowing the medicine to attack cancer cells while limiting exposure to healthy tissue.1 How is Sofe-M different from other FRα-targeted ADCs? Sofe-M is designed to target FRα across a broad range of expression levels, including in tumors with lower FRα expression. In this Phase 1 study, Sofe-M plus bevacizumab showed a confirmed objective response rate of 79.3% in platinum-sensitive ovarian cancer (PSOC), with consistent activity across FRα expression levels and regardless of prior PARP inhibitor exposure. Earlier studies in platinum-resistant ovarian cancer (PROC) also demonstrated responses observed across all FRα expression levels and in patients previously treated with mirvetuximab soravtansine (MIRV).2 These results are being further evaluated in Lilly's ongoing Phase 3 FRAmework-01 program, which is studying Sofe-M across both platinum-resistant and platinum-sensitive ovarian cancer. What are the results with sofetabart mipitecan (Sofe-M) in the treatment of platinum-sensitive ovarian cancer (PSOC)? The Phase 1 study demonstrated encouraging clinical activity, including a confirmed objective response rate (cORR) of 79.3% and a disease control rate (DCR) of 100%, in heavily pretreated patients with platinum-sensitive ovarian cancer. Activity was observed across FRα expression levels and regardless of prior PARP inhibitor exposure. Median duration of response (DOR) and median progression-free survival (PFS) were not reached at median follow-ups of 6.2 and 10.2 months, respectively. Sofetabart mipitecan (Sofe-M) plus bevacizumab demonstrated a safety profile consistent with the known profiles of each medicine, with no new safety signals observed and a low rate of discontinuation due to adverse events (6%). These findings support continued investigation of Sofe-M in the ongoing Phase 3 FRAmework-01 trial. In this study Sofe-M was dosed at 4 mg/kg. Why is it dosed at 3mg/kg in the Phase 3 FRAmework-01 trial? The 3 mg/kg dose of Sofe-M was selected as the recommended phase 3 dose (RP3D), based on analysis of the safety, efficacy and PK data as monotherapy. The ORR was comparable between the two doses, with ORRs of 59.0% (95% CI 42.1, 74.4) and 58.8% (95% CI 32.9, 81.6), at 4 mg/kg and 3mg/kg doses, respectively. Safety signals were higher at 4 mg/kg versus 3 mg/kg, with Grade ≥3 TRAEs at 56.4% vs 35.3% and dose reductions of 41.0% vs 23.5%. What are historical clinical trial results for standard of care in platinum-sensitive ovarian cancer (PSOC)? For patients who recur after platinum-based chemotherapy and PARP inhibitor (PARPi) maintenance, published real world data on subsequent platinum re-challenge have shown modest response rates, with an objective response rate (ORR) of 41.9%.3 Other studies of platinum-based regimens, such as OCEANS, were conducted prior to the routine use of PARPi maintenance and did not include patients previously treated with a PARPi,4 a population that now represents a majority of patients with recurrent PSOC, including those enrolled in Sofe-M's Phase 1 study. What is platinum-sensitive ovarian cancer (PSOC)? Platinum-sensitive ovarian cancer (PSOC) is characterized as ovarian cancer that comes back more than six months after platinum-based chemotherapy. While people with PSOC can often be treated with platinum again, the disease tends to return, and each recurrence can leave fewer treatment options and shorter remissions.5 What is the current unmet need in platinum-sensitive ovarian cancer (PSOC)? The standard of care for PSOC has remained largely unchanged for more than a decade, even as understanding of which patients benefit from it has evolved. Approximately 50% of PSOC patients have HRD-positive tumors, meaning their tumors carry a specific DNA-repair deficiency.6 These patients tend to have longer progression-free survival with upfront platinum-based chemotherapy plus a PARP inhibitor (PARPi).6 However, when these patients do recur after PARPi maintenance, response rates to subsequent platinum-based treatment are modest.6 Patients with non-HRD-positive tumors see minimal benefit from PARPi to begin with and generally have a poorer prognosis overall.6 Despite these different outcomes between HRD-positive and HRD-negative patients, treatment approaches for PSOC have not meaningfully changed to reflect that distinction. What is the difference between platinum-resistant (PROC) and platinum-sensitive ovarian cancer (PSOC)? The difference comes down to timing. If ovarian cancer returns more than six months after platinum-based chemotherapy, it's considered platinum-sensitive, and patients often respond well to platinum treatment again. If the cancer returns within six months, or continues growing during treatment, it's considered platinum-resistant, and platinum-based chemotherapy is generally no longer effective. Because platinum resistance tends to develop gradually, each recurrence can bring a shorter remission, even while a patient's disease is still classified as platinum-sensitive.6 What is folate receptor alpha (FRα), and why is FRα expression level important in treating ovarian cancer? FRα is expressed in almost all ovarian cancers, at much higher levels than in healthy tissue, making it a target that can help direct treatment to tumor cells.7 FRα expression level refers to the amount of the protein present on a tumor and may influence eligibility for or response to certain FRα-targeted therapies.7 How is the FRAmework-01 clinical trial designed? FRAmework-01 is a global, three-part Phase 3 trial studying sofetabart mipitecan (Sofe-M) across both platinum-resistant and platinum-sensitive ovarian cancer in a single program: Part A tests Sofe-M as monotherapy in platinum-resistant disease; Part B tests Sofe-M plus bevacizumab in platinum-sensitive disease that progressed on or within six months of completing a PARPi; and Part C tests Sofe-M plus bevacizumab in PARPi-naïve platinum-sensitive disease. The trial's main measure of success across all three parts is how long patients go without their cancer progressing. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). Enrollment is ongoing globally with first registrational dose in Q4 2025 for PROC and in Q1 2026 for PSOC. About Ovarian Cancer Ovarian cancer is the sixth leading cause of cancer death among women in the United States.8 While most patients initially respond to platinum-based chemotherapy, approximately 70% will experience recurrence, leading to progressively shorter remission periods with each subsequent treatment.6 When cancer recurs during or within six months of platinum therapy, known as platinum-resistant disease, patients face limited treatment options.6,9 About Sofetabart Mipitecan Sofetabart mipitecan (Sofe-M; LY4170156) is composed of an Fc-silent, folate receptor alpha (FRα) specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink). Sofe-M was designed to target FRα across all expression levels with improved therapeutic index. FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth. FRα is overexpressed in many solid tumors such as ovarian and endometrial cancers. Sofe-M has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for platinum-resistant ovarian cancer (PROC) and is currently being evaluated in the Phase 3 FRAmework-01 program. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). About FRAmework-01 FRAmework-01 (NCT07213804) is a Phase 3, randomized, open-label, three-part study evaluating sofetabart mipitecan (Sofe-M; LY4170156) in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Part A tests Sofe-M as monotherapy in platinum-resistant disease; Part B tests Sofe-M plus bevacizumab in platinum-sensitive disease that progressed on or within six months of completing a PARPi; and Part C tests Sofe-M plus bevacizumab in PARPi-naïve platinum-sensitive disease. The primary endpoint is progression-free survival (PFS), assessed by the investigator in Part A and by blinded independent central review (BICR) in Parts B and C. Key secondary endpoints are overall survival, objective response rate, duration of response, and safety. The FRAmework-01 study is in partnership with the European Network for Gynecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). More information on FRAmework-01 can be found on clinicaltrials.gov. References Drago JZ, Modi S, Chandarlapaty S. Unlocking the potential of antibody-drug conjugates for cancer therapy. Nat Rev Clin Oncol. 2021;18(6):327-344. doi:10.1038/s41571-021-00470-8 2. Ray-Coquard, et al. Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study, Annals of Oncology (2026), doi: . Romeo M, Gil-Martín M, Gaba L, et al. Multicenter real-world data of subsequent chemotherapy after progression to PARP inhibitors in a maintenance relapse setting. Cancers (Basel). 2022;14(18):4414. Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012;30(17):2039-2045. Lesnock JL, Temin S, Bouberhan S, et al. Systemic Treatment of Ovarian Cancer Recurrence: ASCO Living Guideline, Version 2026.1.0. J Clin Oncol. Published online July 13, 2026. doi:10.1200/JCO-26-01591. Lheureux S, Braunstein M, Oza AM. Epithelial ovarian cancer: evolution of management in the era of precision medicine. CA Cancer J Clin. 2019;69(4):280-304. doi:10.3322/caac.21559. Bax HJ, Chauhan J, Stavraka C, et al. Folate receptor alpha in ovarian cancer tissue and patient serum is associated with disease burden and treatment outcomes. Br J Cancer. 2023;128(2):342-353. doi:10.1038/s41416-022-02031-x. American Cancer Society. Cancer Facts for Women. Accessed September 9, 2026. . Colombo N, Sessa C, du Bois A, et al. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Ann Oncol. 2019;30(5):672-705. doi: 10.1093/annonc/mdz062. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY © Lilly USA, LLC 2026. ALL RIGHTS RESERVED. MSK Disclosure: Dr. Kyi has financial interests related to Eli Lilly and Company. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about sofetabart mipitecan plus bevacizumab and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that any of these therapies will prove to be a safe and effective treatment or receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Momelotinib（莫美替尼，CYT387）片是Cytopia研发的口服ATP竞争性激酶抑制剂，为骨髓纤维化合并贫血患者提供新的治疗选择。 基本信息原研信息 最早起源：Cytopia（后续并入YM Biosciences）；之后权益转让给Gilead（吉利德）；2018年Gilead将momelotinib资产出售给Sierra Oncology；2022年GSK收购Sierra Oncology，成为当前上市持有人与原研主体。 上市持有人：GlaxoSmithKline（GSK，葛兰素史克） CAS：1056636-06-6（游离碱） 规格：150 mg（以游离碱计），口服片剂，每日一次给药。靶点：JAK1、JAK2、ACVR1（ALK2）；对 JAK2 V617F突变同样有抑制活性；对JAK3、TYK2抑制活性弱。 作用机制：Momelotinib 为口服ATP竞争性激酶抑制剂，具备三重通路调控特点： 抑制JAK1/JAK2 → 阻断JAK‑STAT异常信号，减轻骨髓纤维化患者脾脏肿大、全身症状（乏力、盗汗、骨痛等）； 抑制ACVR1（ALK2） → 下调肝脏铁调素（hepcidin）表达，提升铁可利用度、促进红系造血，改善贫血、减少输血依赖，这是区别于传统 JAK 抑制剂最核心差异化优势； 主要活性代谢产物M21同样保留对JAK1/JAK2/ACVR1的抑制活性 适应症：成人中高危骨髓纤维化（MF），包括原发性骨髓纤维化、真性红细胞增多症后骨髓纤维化、原发性血小板增多症后骨髓纤维化，伴贫血患者。 美国FDA：无论既往是否接受JAK抑制剂治疗，均可使用。 EMA/英国MHRA：限定既往使用过鲁索替尼或不适合鲁索替尼、且不适合异基因干细胞移植、伴中重度贫血的MF成人患者。竞品信息（骨髓纤维化JAK抑制剂赛道） 差异化定位：贫血、输血依赖MF人群首选品种；无直接头对头，MOMENTUM对比最佳现有治疗（BAT）证实输血独立率优势。 上市情况 美国FDA：2023-9-15批准。 美国橙皮书信息 溶出方法 日本PMDA：2024-6批准。 欧盟EMA：2024-1-25批准。 中国NMPA：尚未获批。 注册与受理信息：2026-10-21，CDE受理了GSK申报的Momelotinib片进口临床申请。 全球临床试验信息 专利情况 FDA橙皮书专利 中国专利 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【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） 【药品分享】阿柏西普眼内注射溶液——重组人源VEGF融合蛋白的治疗用生物制品 【药品分享】艾托莫德片——高选择性S1PR1（鞘氨醇‑1‑磷酸受体1）小分子激动剂 【药品分享】GBI268注射液——复方局部镇痛注射剂 【药品分享】Edecesertib片——IRAK‑4小分子激酶抑制剂 【药品分享】阿布昔替尼片——高选择性JAK‑1小分子抑制剂 【药品分享】盐酸阿思尼布片——全球首个且目前唯一基于ABL肉豆蔻酰口袋（STAMP）创新机制的靶向药物 【药品分享】Venglustat——葡萄糖神经酰胺合成酶（GCS/UGCG）抑制剂 【药品分享】塞瑞替尼胶囊——第二代ALK酪氨酸激酶抑制剂（ALK-TKI） 【药品分享】泊那替尼片——第三代BCR-ABL酪氨酸激酶抑制剂（TKI）|| 唯一能够有效抑制BCR‑ABL T315I耐药突变的TKI 【药品分享】盐酸阿那格雷胶囊——PDE3抑制剂 【药品分享】奥雷巴替尼片——国内首个获批可有效抑制T315I突变的三代BCR-ABL抑制剂 【药品分享】比克恩丙诺片——HIV‑1感染单片复方抗病毒药 【药品分享】甲磺酸奥希替尼片——第三代EGFR靶向药 【药品分享】醋酸戈舍瑞林缓释植入剂——促性腺激素释放激素激动剂缓释皮下植入制剂 【药品分享】拉考沙胺缓释胶囊——钠通道调节剂 【药品分享】纳曲酮利培酮植入剂——新的缓释植入剂型 【药品分享】普那布林注射用浓溶液——GEF‑H1（ARHGEF2）激动剂 【药品分享】Petrelintide注射液——长效胰淀素（Amylin）受体激动剂 【药品分享】酒石酸凡瑞格拉替尼片——1类高选择性FGFR口服小分子创新药 【药品分享】醋酸兰瑞肽缓释注射液（预充式）——长效生长抑素类似物（SSA） 【药品分享】吡非尼酮胶囊——多细胞因子通路调节剂 【药品分享】罗替高汀贴片——非麦角类多巴胺受体激动透皮贴剂  || 全球首个经皮吸收的帕金森治疗药物 【药品分享】芦沃美替尼片——高选择性MEK1/2（丝裂原活化蛋白激酶激酶 1/2）抑制剂 【药品分享】硫酸阿托品滴眼液——竞争性 M‑胆碱（毒蕈碱）受体拮抗剂 【药品分享】盐酸恩沙替尼胶囊——国产第二代间变性淋巴瘤激酶(ALK)-酪氨酸激酶抑制剂(TKI)靶向药 【药品分享】富马酸奥赛利定注射液——新型静脉镇痛药物 || G蛋白偏向性μ‑阿片受体激动剂 【药品分享】司美格鲁肽微针贴片——用于2型糖尿病与肥胖体重管理的新剂型药品 【药品分享】甲苯磺酸利特昔替尼胶囊——国内首个获批可用于12–17岁青少年重度斑秃的口服系统治疗药物 【药品分享】艾曲帕米鼻喷雾剂——经鼻给药的速效钙通道阻滞剂 【药品分享】盐酸替扎尼定胶囊——中枢性α2肾上腺素受体激动剂 【药品分享】格贝前列素滴眼液——单分子双功能NO供体型前列腺素前药 【药品分享】盐酸伊司特韦片——全球首个依托DEL结合AI技术成功获批的原创小分子药物 【药品分享】布格替尼片——口服小分子ALK酪氨酸激酶抑制剂 【药品分享】司来帕格片——口服选择性前列腺素受体（IP受体）激动剂 【药品分享】甲磺酸伏美替尼片——国产第三代EGFR靶向药（EGFR-TKI） 【药品分享】帕替罗姆山梨醇钙干混悬剂——不吸收入血的口服阳离子交换聚合物类新型降钾药物 【药品分享】塞拉维诺片——CCR5（C-C 趋化因子受体 5）拮抗剂 【药品分享】盐酸西替利嗪滴眼液——局部抗组胺滴眼液  || 高选择性 H₁组胺受体拮抗剂（第二代抗组胺） 【药品分享】注射用莱古比星——全球首创的小分子偶联化疗药 【药品分享】尤帕卡塞钠注射液——CaSR钙敏感受体正向变构调节剂 【药品分享】马来酸依格美妥司他片——口服小分子EZH2表观遗传抑制剂 【药品分享】Laroprovstat瑞舒伐他汀片——口服小分子 PCSK9 抑制剂 【药品分享】利扎布替尼片（Rilzabrutinib片）——全球首款获批用于ITP的BTK抑制剂 【药品分享】Trontinemab注射液——罗氏Brainshuttle™平台开发的2+1型双特异性IgG1抗体 【药品分享】Risankizumab注射液——人源化IgG1单克隆抗体 【药品分享】Zasocitinib (TAK-279) 片——口服小分子别构TYK2抑制剂 【药品分享】双氯芬酸依泊胺凝胶贴膏——全新活性成分凝胶贴膏 || 美国首个获批的NSAID外用凝胶贴膏 【药品分享】拉索昔芬片——第三代选择性雌激素受体调节剂（SERM） 【药品分享】苯丁酸氮芥片——非靶向细胞毒烷化剂 【药品分享】达依泊汀α注射液——第二代长效重组促红细胞生成素（ESA，红细胞生成刺激剂） 【药品分享】Ferric Bepectate IV Injection——静脉用三价铁胶体补铁制剂 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。