Axitinib

311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, as of January 10, 2024 First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025 Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR BEDFORD, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to redefining the retina experience, outlined exceptional clinical progress across its registrational program for AXPAXLI™ in wet age-related macular degeneration (wet AMD), plans to advance AXPAXLI in non-proliferative diabetic retinopathy (NPDR), and the Company’s strategic outlook for 2025 in its presentation at the 43rd Annual J.P. Morgan Healthcare Conference (JPM 2025). “Wet AMD is the leading cause of blindness in the U.S., but it does not need to be. Diabetic retinopathy is the leading cause of blindness in the working population in the U.S., but it does not need to be. We have a proven target, VEGF, and proven treatments for decades, the anti-VEGFs. Unfortunately, we also have a treatment regimen that is simply not sustainable for many patients. Our mission at Ocular is to correct this,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “Last year, we started with wet AMD. We recruited SOL-1 well ahead of schedule and, yesterday at JPM 2025, I announced that we have already enrolled 311 patients in various stages of loading and randomization in SOL-R, our second registrational study in wet AMD. The historic pace of recruitment in both studies underscores the enthusiasm in the retina community for AXPAXLI. In 2025, we will also target diabetic retinopathy. Our HELIOS study has demonstrated that a single injection of AXPAXLI has the potential to reduce the risk of vision loss in NPDR to literally zero at 48 weeks. In HELIOS, every single patient with non-center involved DME treated with a single injection of AXPAXLI, improved at week 48. Therefore, AXPAXLI has the potential to not only prevent vision loss, but also to treat existing vision threatening complications, such as DME.” Dr. Dugel concluded, “In 2025, Ocular will target the two most impactful global diseases in retina, wet AMD and diabetic retinopathy. We believe we have the infrastructure, finances and expertise to succeed and redefine the global retina experience.” J.P. Morgan Presentation Highlights Complementary wet AMD registrational program. Ocular’s wet AMD registrational program for AXPAXLI is comprised of two complementary studies, SOL-1 and SOL-R, strategically designed with the intent of de-risking patient populations, aligning with regulatory standards, enhancing each other’s enrollment, and providing a broad evaluation of AXPAXLI’s durability, repeatability, and flexibility. SOL-1 is being conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA), while SOL-R received alignment with the FDA through a written Type C response. The FDA previously agreed that together, these studies could constitute two adequate and well-controlled trials to support a potential New Drug Application (NDA) and label for AXPAXLI in wet AMD. SOL-1 (Phase 3, wet AMD) randomization complete in December 2024. In total, more than 300 subjects were randomized across greater than 100 clinical trial sites located in the U.S. and Argentina. SOL-1 is a superiority trial comparing a single AXPAXLI injection to a single aflibercept (2 mg) injection in treatment naïve wet AMD subjects with a nine-month primary endpoint and up to two-year follow-up. SOL-1 is the first registrational trial for AXPAXLI in wet AMD and was designed to establish AXPAXLI’s durability, and potentially enable a superiority claim on a potential future label. The Company expects topline results for SOL-1 to be available in the fourth quarter of 2025. SOL-R (Phase 3, wet AMD) outstanding enrollment progress to date. 311 subjects enrolled across various stages of loading and randomization in the U.S. and South America as of January 10, 2024. SOL-R is a non-inferiority trial comparing repeat AXPAXLI injections every six months to repeat aflibercept (2 mg) injections every eight weeks, with a 56-week primary endpoint. SOL-R is the second registrational trial for AXPAXLI in wet AMD and was designed to inform real world treatment decisions, establish AXPAXLI’s safety and efficacy with repeat dosing, and provide commercially relevant data. Ocular plans to seek FDA feedback in H1 2025 on the clinical trial design for AXPAXLI in NPDR. Following positive results from the Phase 1 HELIOS trial of AXPAXLI shared in 2024, Ocular plans to continue clinical development in NPDR. In the HELIOS trial, after a single AXPAXLI injection, no patients receiving AXPAXLI (N=13) developed a vision threatening complication (VTC) at 48 weeks compared to nearly 40% in the sham-treated patients (N= 8). Further, all patients in the AXPAXLI arm who presented with non-center-involved diabetic macular edema (non-CI-DME) at baseline (N=8) had improvement in their DME based on Optical Coherence Tomography (OCT) image analysis at week 48 compared to none of the sham-treated subjects (N=3). All subjects who received AXPAXLI showed diabetic retinopathy severity scale (DRSS) improvement or stability, while any worsening of DRSS occurred only in sham-treated subjects. Arshad M. Khanani, MD, MA, FASRS, Director of Clinic Research at Sierra Eye Associates, Reno, Nevada noted, “Real-world evidence shows that 40 to 50% of patients with wet AMD discontinue their injections due to the high treatment burden, putting them at increased risk of blindness. This issue is even more pronounced in patients with diabetic retinopathy. My team, our patients, and I are excited to support the SOL studies, and delighted that Ocular will soon target diabetic retinopathy, a huge unmet need in our space. If approved, I believe AXPAXLI will be rapidly adopted, as it has the potential to significantly reduce treatment burden with a durability of 6-12 months." Patricio G. Schlottmann, MD, Director of the Research Department at the Charles Ophthalmic Center and Ophthalmology Department Director at Organización Médica de Investigación in Buenos Aires, Argentina, commented, “Wet AMD and diabetic retinopathy are global diseases in which millions of patients around the world lose vision because we have an unsustainable treatment regimen. I continue to enthusiastically support the SOL programs in wet AMD and am particularly happy that Ocular will also target diabetic retinopathy. If approved, I believe Axpaxli will be enthusiastically adopted and has the potential to positively impact millions of patients around the world.” About AXPAXLI AXPAXLI™ (axitinib intravitreal injection, also known as OTX-TKI) is an investigational, bioresorbable, hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic retinopathy, and other retinal diseases. About the SOL-1 Study The registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group study that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed randomization of more than 300 evaluable treatment-naïve subjects with a diagnosis of wet AMD in the study eye. The superiority study has an eight-week loading segment prior to randomization, a 9-month treatment segment, and a safety follow-up. During the loading segment, subjects who have 20/80 vision or better and who satisfy other enrollment criteria receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Eligible subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 or gain at least 10 early treatment diabetic retinopathy (ETDRS) letters at Day 1 are then randomized to receive a single dose of AXPAXLI or a single dose of aflibercept (2 mg) and assessed monthly for the duration of the study. The clinical trial protocol requires that, during the study, subjects in any arm meeting pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA, at Week 36. The study is being conducted under a Special Protocol Agreement (SPA) with the FDA. About the SOL-R Study The registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm study that will involve sites located in the U.S. and the rest of the world. The trial is intended to randomize approximately 825 subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within three months prior to enrollment. The non-inferiority study reflects a patient enrichment strategy that includes multiple loading doses of aflibercept (2 mg) and monitoring to exclude subjects with significant retinal fluid fluctuations. Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Week 24. Subjects in the second arm receive aflibercept (2 mg) on-label every 8 weeks. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Week 24, aligned with the AXPAXLI treatment arm for adequate masking. Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The primary endpoint of SOL-R is non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at one year. In a written Type C response received in August 2024, the FDA agreed that the SOL-R repeat dosing wet AMD study should be appropriate as an adequate and well-controlled study in support of a potential New Drug Application and product label. About Wet AMD Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14 million individuals globally and 1.65 million in the United States alone (2023 Market Scope® Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events and up to 40% patient discontinuation within one year of initiating treatment with continued disease progression. Taken together, these factors lead to undertreatment and a lack of long-term vision improvement for patients. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (axitinib intravitreal injection, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, and in its product candidate PAXTRAVA™ (travoprost intracameral injection or OTX-TIC), which is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Follow the Company on its website, LinkedIn, or X. The Ocular Therapeutix logo and DEXTENZA® are registered trademarks of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Forward-Looking Statements Any statements in this press release about future expectations, plans, and prospects for the Company, including the development and regulatory status of the Company’s product candidates; the design of, and the timing of the enrollment and randomization of patients in and the availability of data from the Company’s SOL-1 and SOL-R Phase 3 clinical trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI and its other product candidates, including in additional indications such as NPDR; the potential utility or adoption, if approved, of any of the Company’s product candidates; and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “designed”, “goal”, “may”, “might”, “plan”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue”, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of any product or product candidate that receives regulatory approval; the initiation, design, timing, conduct and outcomes of ongoing and planned clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the Special Protocol Assessment for the SOL-1 trial; the risk that the FDA may not agree that the protocol and statistical analysis plan of SOL-R or the data generated by the SOL-1 and SOL-R trials support marketing approval, even if the trials are successful; the risk that the Company and the FDA may not agree on the registrational pathway for AXPAXLI for NPDR or any other indication; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials, whether preliminary or interim data from a clinical trial will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. 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. Investors & Media Ocular Therapeutix, Inc. Bill Slattery Vice President, Investor Relations bslattery@ocutx.com

辉瑞之于ADC的野心，早就不是秘密。 2023年12月，辉瑞完成对ADC明星巨头Seagen的收购，耗资430亿美元。借该次收购，辉瑞获得4个已获批ADC产品（Adcetris、Padcev、Tivdak、Disitamab vedotin），以及众多处于临床阶段的ADC管线。 加上2009年收购惠氏（Wyeth）而获得的奥加依妥珠单抗、吉妥珠单抗，辉瑞已至少手握6个ADC产品，这在MNC中首屈一指。 经历过COVID-19产品销售大幅下降而带来的营收缩水之后，找到新故事，是这家“宇宙大药厂”的首要任务。而在ADC板块的渐次布局，无疑是一条重要的“故事线”。 这条故事线还在不断延展，今年1月7日，辉瑞与AI初创公司PostEra的合作进一步深化，就ADC药物开发达成一项新合作。 据外媒报道，双方将利用PostEra的AI平台Proton来推进包括多个ADC药物、小分子药物的开发，交易总金额高达3.5亿美元。其中，辉瑞为ADC药物开发支付的预付款达1200万美元。 这本次合作将如何助力ADC药物开发？“起大早赶晚集”的辉瑞，现如今在ADC“战场”上的实力如何？ 1 首付款1200万美元，优化有效载荷 这并不是辉瑞与PostEra的首次合作。 早在2020年底，辉瑞就曾与PostEra围绕小分子药物发现开启了首次合作。随后不久，2022年1月，双方决定扩大多靶点研究合作，并共同成立AI实验室，共同推进多个临床前药物发现项目。 官网信息显示，PostEra成立于2019年，是一家以AI技术辅助药物开发的公司，目前已建成一个端到端平台，以打通药物化学从设计、制造到测试的闭环，提高药物开发速度和质量。 针对本次与辉瑞的合作将如何赋能ADC药物开发，PostEra首席执行官Aaron Morris日前接受采访时称，PostEra将利用其平台优化ADC中的有效载荷。 “ADC领域的关键创新，正在于将ADC的载荷设计视为小分子化学挑战的思维方式，”Morris说，“载荷部分通常是一种类似细胞毒性天然产物的小分子。这里的重点创新在于思考——我们能否更好地设计载荷以针对特定机制或靶点，并利用AI来完善载荷的设计？” 从采取非人源化抗体到采取人源化抗体、全人源化抗体，ADC药物已经历三代技术变革。包括有效载荷优化等在内的ADC技术迭代升级，被视为ADC行业的下一步重要研发趋势。 图源：BCG波士顿咨询《新征程、新视野——抗体偶联药物的崛起与展望》 就药物结构来看，ADC由抗体、有效载荷和连接子组成，是以能够结合抗体的特异性和有效载荷的高细胞毒性，进而实现对肿瘤细胞的精准打击、减少对正常细胞的损害。 至于起效过程，简单来说，进入血液循环后，ADC的抗体部分能够特异地识别、结合肿瘤细胞表面的靶抗原，形成ADC-靶抗原复合物并由此进入细胞。随后，连接子将在特定环境下发生裂解，释放出有效载荷、杀伤肿瘤细胞。 载荷被认为是ADC的“魔法弹头”。目前，FDA批准的ADC，有效载荷包括抗有丝分裂剂、DNA损伤剂、拓扑异构酶I抑制剂等。通常而言，大多数有效载荷具有中等至高水平的疏水性，这使其能够从表达靶标的肿瘤细胞扩散到邻近的、靶标表达有限甚至不表达靶标的细胞，整个过程被称为“旁观者效应”。 由于异质性肿瘤中同时存在表达抗原的细胞和未表达抗原的细胞，旁观者效应对于成功根除异质肿瘤至关重要——它能够确保即便部分细胞不表达靶标，也能够被有效载荷杀死。 不过，疏水性也可能带来一些负面影响。例如，疏水有效载荷易被多药耐药蛋白识别并转运，进而降低ADC药物在细胞内的浓度；疏水ADC分子更倾向于聚集在一起、形成较大聚集体，这导致其易被免疫系统识别为外来物质而清除，并可能引发免疫原性反应。此外，疏水性偏高的ADC更容易被肝脏摄取，有引发肝毒性的风险。 寻得ADC药物疗效和毒性之间的平衡至关重要。在这方面，AI或许能够为更高细胞毒性、更低免疫原性、更好稳定性的载荷设计提供新思路。除此之外，针对ADC药物的耐药性局限，不同于传统的新型载荷或许也能带来突破。 辉瑞的此次“加码”前景还未可知，但值得期待。毕竟，PostEra的实力正在更广范围内得到认可——辉瑞之外，PostEra还于2023年与安进签署一项协议，并与NIH就抗病毒药物开发达成合作。 2  “起大早赶晚集”：进军ADC坎坷之路 用“起大早赶晚集”来形容辉瑞的ADC开发之路，再贴切不过。 现如今，ADC已经成为肿瘤治疗领域一个备受青睐的热门赛道，以至于有“人人都爱ADC”一说。但早在2009年，这个赛道还远没这么拥挤时，辉瑞就通过收购惠氏，拥有2000年获批的全球首款ADC药物Mylotarg（吉妥珠单抗）。 Mylotarg用于治疗急性髓系白血病，一度被视为肿瘤领域的重大突破。但遗憾的是，由于在上市后的SWOG S0106研究中未能继续证实该药物的临床获益以及观察到的安全性问题，辉瑞于2010年主动将其撤市并重新进行研究。 2017年，改良版Mylotarg回归，用于初诊CD33阳性AML的成人患者，以及复发或难治性CD33阳性AML的成人和2岁及以上儿童治疗。同年，辉瑞第二款ADC药物Besponsa（奥加伊妥珠单抗）在欧盟和美国获批上市，用于前体B细胞急性淋巴细胞性白血病。 不过，前述二者的商业化均并不理想，与“巨弹药物”相差甚远。以2023年为例，Besponsa全年仅产生营收2.36亿美元，同一时期，由罗氏和ImmunoGen共同研发的Kadcyla（恩美曲妥珠单抗）超22亿美元，几乎是Besponsa的十倍。 伴随着ADC潜力的显露和越来越多“十亿美元大药”的出现，也考虑到COVID-19翻篇和部分药物专利保护期迫近所带来的业务下滑和营收压力，加之自身并无什么拿得出手的药物开发平台，2023年，辉瑞按捺不住再次下场，豪资430亿美元拿下ADC明星药企Seagen。 后者一度是ADC界的“龙头”——彼时，全球获批上市的16款ADC药物中，除Seagen自主研发的三款（Adcetris、Padcev、Tivdak）、与荣昌生物联合开发的一款（Disitamab vedotin）之外，还有两款使用了Seagen的ADC技术（Polivy和Blenrep）。 这笔交易对辉瑞的加持是多方面的：一来，能够通过专利保护时间尚算充裕的四款商业化ADC药物缓和营收下滑的颓势——2023年，辉瑞的营收几乎腰斩，从逾千亿美元跌至584.96亿美元。而Seagen已诞育出“巨弹”：其开发的Adcetris，主要用于治疗霍奇金淋巴瘤（HL）和系统性间变性大细胞淋巴瘤（sALCL），2023年销售额超16亿美元。 二来，Seagen的ADC平台能够带来相对可观的想象力，以其在ADC领域的多年积累和技术能力，未来也许能够开发出足以让辉瑞持续位列ADC一线MNC的新品。 2023年年度回顾中，辉瑞首席执行官Albert Bourla预计，Seagen将在2024年及以后成为重要的增长贡献者；2024年2月底的肿瘤创新日活动上，辉瑞再度表示，伴随着Seagen的并入，公司将进一步加强ADC药物的开发，瞄准新靶点、改进差异化有效载荷。 结合2024年度前三季度财报来看，Seagen也的确在一定程度上扛起了部分“大旗”。在明星药物Ibrance、Inlyta营收下滑的情况下，辉瑞2024年前三季度在肿瘤领域的营收分别为：35.49亿美元、39.56亿美元、40.43亿美元，合计115.48亿美元。 其中，Seagen自主开发的三款药物为之贡献超20亿美元。但距离罗氏那款连续三年销售额都超22亿美元的Kadcyla，无疑仍有距离。 (上下滑动查看更多) 辉瑞2024年前三季度在肿瘤领域的营收；图源辉瑞官网 430亿美元的投入能否换得相当的回报，还有待进一步考察。不过，讨论这笔交易是否存在溢价之余，辉瑞后续的研发支持、团队搭建和商业化能力也尤为重要。 团队方面，完成对Seagen的收购后，辉瑞一度成立集研发与商业化业务于一体的肿瘤事业部，由公司前研发主管Chris Boshoff独立领导。但后者已于2024年11月被任命为辉瑞首席科学家兼研发总裁，任命自2025年1月1日起生效。 而辉瑞的肿瘤学研发团队将保持其完全整合的结构，由Roger Dansey担任临时首席肿瘤学负责人。Dansey退休前将协助Boshoff选择一名新任负责人。 3 逾70条ADC在研管线，临床II期过半 ADC赛道的想象力还远未被发掘，而辉瑞正在以不容置疑的姿态布局、追赶。 弗若斯特沙利文数据分析显示，全球ADC药物市场规模始终保持高速增长，已从2018年的20亿美元增长至2023年的104亿美元，年复合增长率为39.1%；2023年到2030年期间仍旧将以30.3%的年复合增长率继续增长，预计2030年全球ADC药物市场规模将增长至662亿美元。 就药物开发来看，ADC巨头第一三共仍是手握最多在研管线的公司，截至2024年9月30日，该公司共有83条ADC管线，而辉瑞紧随其后，以74条位居次席。 然而值得注意的是，就管线推进进度来看，辉瑞并不算十分靠前——整体来看，辉瑞开展的ADC药物管线超一半（39）集中于临床II期阶段。若以进入临床III期的管线数量为计，排名第一的是阿斯利康（28），第二是第一三共（27），默沙东和恒瑞分别以19、14占据第三、第四位，而辉瑞以12条排在第五。 在2024年第三季度财报相关的发言中，Bourla特别提及了三款ADC药物，分别为目前处于临床III期的Sigvotatug vedotin、预计于2025年进行注册试验的PDL1V（系潜在“first-in-class”PD-L1靶向ADC），以及Disitamab vedotin——该药物正在进行两项针对尿路上皮癌的注册意向试验。 今年初，辉瑞登记了一项Sigvotatug Vedotin+Keytruda联合一线治疗PD-L1高表达非小细胞肺癌的III期临床试验，拟与Keytruda单药治疗“头对头”对照；此前，Sigvotatug Vedotin已在二线治疗中启动与多西他赛的“头对头”III期临床试验。 而Disitamab vedotin已在中国获批治疗特定胃癌和尿路上皮癌患者，并获美国FDA授予的突破性疗法认定，作为单药治疗接受过2种以上全身治疗的HER2阳性局部晚期或转移性尿路上皮癌患者。该药物与Keytruda联用，一线治疗尿路上皮癌患者的III期临床试验已经启动。辉瑞高管此前指出，这一组合可能成为一线治疗HER2阳性尿路上皮癌的新标准。 对数百亿美元市场的争夺俨然一场战争。目前来看，辉瑞已经备下足够多“子弹”，至于最终的战果如何，时间会告诉我们答案。 参考资料： 1.Pfizer Inc. - Financials 2.弗若斯特沙利文《偶联药物行业现状与发展趋势蓝皮书》（2024） 3.https://mp.weixin.qq.com/s/jv9SgzWXuzcmKTd5nE_zYA 4.https://mp.weixin.qq.com/s/wjSgVnV2IiTA7HlcLDitiQ 5.https://mp.weixin.qq.com/s/fayRjngY25VgHhAKTxFNuw 6.https://mp.weixin.qq.com/s/5F602no7Ic8hO2AeTQxhmw 7.https://mp.weixin.qq.com/s/zAuh7sq8YCXlXeOOtQygJQ 8.https://postera.ai/news/ 同写意媒体矩阵，欢迎关注↓↓↓