Iloperidone

精彩内容 今年以来，石药集团喜讯不断：10个品种获批上市，10款1类新药首次获批临床，达成4项重磅BD交易等。石药集团以创新研发为发展引擎，2025年上半年研发费用达26.83亿元，占成药收入比重26.2%。目前公司有78款1类新药、19款2.2类改良新药/生物类似药在国内处于申请临床及以上阶段，其中有19款已步入NDA或III期临床，上市在即；35个新分类申报品种在审，10余个暂无首仿（含剂型首仿）获批。 首仿、1类新药获批！独家新药销售大涨 9月18日，石药集团发布2025年中期报告，报告期内公司实现收入总额132.73亿元，归母净利润25.48亿元。从分业务收入看，成药收入102.48亿元，原料产品收入20.75亿元，功能食品及其他收入9.5亿元。 作为石药集团的主营业务，成药业务受集采影响显著，2025年上半年神经系统、抗肿瘤、抗感染、心血管、呼吸系统、消化代谢六大领域收入均有不同程度的下滑；但授权费收入达10.75亿元，成为成药业务新增长动力。 2025H1石药集团成药板块分治疗领域销售情况（单位：亿元） 来源：公司公告，米内网整理 在传统业务承压之下，石药集团将目光投向了创新转型。近年来，公司持续加大研发投入，研发费用由2021年的约34亿元增长至2024年的近52亿元，2025上半年以约27亿元再创新高，研发费用占成药收入比重也由2021年的约15%持续提升至2025年上半年的超26%。 近年来石药集团研发费用情况（单位：亿元） 来源：公司公告，米内网整理 在持续且高强度的研发投入下，石药集团创新药管线逐渐步入兑现期，2022年拿下2.2类新药盐酸米托蒽醌脂质体注射液，2023年喜提1类新药纳鲁索拜单抗注射液（RANKL单抗）、新型冠状病毒mRNA疫苗，2024年收获1类新药恩朗苏拜单抗注射液（PD-1单抗）、甲磺酸瑞泽替尼胶囊（三代EGFR抑制剂）及生物类似药注射用奥马珠单抗，2025年以来斩获1类新药普卢格列汀片（DPP4抑制剂）等。 此外，早前石药集团获批的新药在商业化方面也有亮眼的表现。米内网数据显示，在2025年上半年中国三大终端六大市场（统计范围详见本文末），丁苯酞氯化钠注射液销售额超20亿元，丁苯酞软胶囊销售额超10亿元，聚乙二醇化重组人粒细胞刺激因子注射液销售额超8亿元，注射用重组人TNK组织型纤溶酶原激活剂销售额超4亿元且同比大涨约238%。 今年以来，石药集团持续推动1类创新药、2类改良型新药、生物类似药及化药仿制药的研发。 1类创新药方面，DPP4抑制剂普卢格列汀片获批上市；HER2双抗药物安尼妥单抗注射液提交NDA申请获受理；SYHX1901片（JAK/SyK双靶点抑制剂）、SYS6010（EGFR ADC）等首次启动III期临床；21款1类新药获批临床，其中有10款为首次获批，且均已启动临床，包括3款ADC药物SYS6045、SYS6041、SYS6040，PDE4B抑制剂SYH2059片、PD-1/IL-15双功能融合蛋白JMT108注射液、口服GLP-1激动剂SYH2067胶囊、siRNA药物SYH2068注射液等。 2025年以来石药集团国内首次获批临床的1类新药 来源：米内网中国申报进度（MED）数据库 2类化药新药方面，司美格鲁肽注射液提交NDA，该药目前在国内暂无国产批文获批，原研产品2024年在中国三大终端六大市场的销售额超过60亿元；SYH9016注射液（亮丙瑞林缓释注射液）、普卢格列汀二甲双胍缓释片(Ⅰ、Ⅱ)等首次获批临床且已启动临床；生物类似药方面，度普利尤单抗注射液、SYS6036注射液、仑卡奈单抗注射液等获批临床。 仿制药方面，9个品种获批生产并视同过评，包括艾普拉唑肠溶片、美洛昔康注射液(Ⅲ)两款重磅首仿；20余个品种以新注册分类报产，其中布瑞哌唑片、利那洛肽胶囊、布地奈德肠溶胶囊、乌帕替尼缓释片等暂无国产仿制药获批。 今年以来石药集团获批上市的仿制药 注：标*为首仿 来源：米内网中国申报进度（MED）数据库 创新驱动！78款1类新药亮眼 含合作引进的产品在内，目前石药集团有78款1类新药（不含已有批文品种、疫苗等）在国内处于申请临床及以上阶段，集中在抗肿瘤药领域，自身免疫、消化代谢、心脑血管、呼吸、神经等也有所涉及。 石药集团国内在研的1类创新药 来源：米内网综合数据库 从药品类型看，41款为小分子化学药，既布局了BTK、FGFR、CDK9、PTK、GLP-1等热门靶点，也有全新结构的first in class药物，此外在小核酸药物方面也有布局；36款为大分子生物药，涵盖单抗、双抗、ADC、CAR-T、融合蛋白等药物形式。 从研发进展看，FcRn抑制剂巴托利单抗注射液、HER2双抗安尼妥单抗注射液分别于2024年7月、2025年9月提交NDA，有望于今年及明年获批上市，为全身性重症肌无力（MG）患者、胃/胃-食管结合部腺癌患者带来新的治疗选择。 10款1类新药处于III期临床（不含Ib/III期、II/III期），上市可期。其中，M701为双抗药物，目前公司已有10款双抗药物/双特异性融合蛋白在国内处于获批临床及以上阶段，涉及EpCAM、CD3、PD-L1、TGF-β、HER2、CD38、VEGF、CLDN6等靶点；DP303c、JSKN003、SYS6010均为ADC药物，目前公司已有11款ADC药物在国内处于I期临床及以上阶段，涉及HER2、Claudin18.2、Nectin-4、HER3、ROR1等靶点。 除了1类新药，石药集团还有12个2.2类改良新药、7个生物类似药在国内处于申请临床及以上阶段。 石药集团国内在研的制剂改良新药/生物类似药 来源：米内网综合数据库 乌司奴单抗注射液、SYHX2011、司美格鲁肽注射液分别于2024年11月、2024年12月、2025年8月提交NDA，有望于今年或明年迎来好消息。其中，SYHX2011是以注射用紫杉醇（白蛋白结合型）为基础，采用专利技术开发的创新型纳米制剂，具有更显著的疗效获益。 注射用西罗莫司(白蛋白结合型)、注射用多西他赛(白蛋白结合型)2款2.2类新药处于III期临床，目前均暂无企业拥有上述品种的生产批文；帕妥珠单抗注射液、司库奇尤单抗注射液2款生物类似药亦处于III期临床，原研产品2024年在中国三大终端六大市场的销售额均超过30亿元。 在仿制药开发方面，目前石药集团有35个品种以新注册分类申报在审，其中，注射用柔红霉素阿糖胞苷脂质体、右美沙芬安非他酮缓释片、伊曲茶碱片、伊潘立酮片、盐酸毛果芸香碱滴眼液、乌帕替尼缓释片、替比培南匹酯细粒剂、利那洛肽胶囊、坎地沙坦酯氨氯地平片、布瑞哌唑片、布地奈德肠溶胶囊等暂无仿制药获批。 达成多项重磅BD合作，国际化进程提速 随着创新药研发管线稳步推进，石药集团也在积极与国内外药企开展BD合作，拓展创新药研发边界，加速国际化进程。今年以来，石药集团已达成4项重磅BD合作，总金额高达97.1亿美元。 2025年7月，石药集团与Madrigal订立协议，将口服小分子GLP-1受体激动剂SYH2086在全球的开发、生产及商业化独家授权给Madrigal。石药集团有权收取1.2亿美元的预付款、最高可达19.55亿美元的潜在开发、监管及商业里程碑付款等。 2025年6月，石药集团与阿斯利康达成战略研究合作，旨在利用公司AI引擎双轮驱动的高效药物发现平台，发现和开发新型口服小分子候选药物。石药集团将收取1.1亿美元的预付款，最高16.2亿美元的潜在研发里程碑付款和最高36亿美元的潜在销售里程碑付款等。 2025年5月，石药集团与Cipla订立独家许可协议，授予Cipla在美国商业化伊立替康脂质体注射液的权益。石药集团将收取1500万美元的首付款，最高达2500万美元的潜在首次商业销售和监管里程碑付款及最高达10.25亿美元的潜在额外商业销售里程碑付款等。 2025年2月，石药集团宣布，旗下石药巨石自主研发的靶向ROR1的ADC药物SYS6005已与美国Radiance达成独家授权协议，将获得1500万美元首付款，并有资格获得最高1.5亿美元的开发和监管里程碑付款、最高10.75亿美元的销售里程碑付款等。 此外，今年以来，石药集团在创新药出海方面亦进展不断：SYS6040（ADC）、SYH2046片、JMT202（抗β-Klotho单抗）、SYS6041（ADC）、JMT108（PD-1/IL-15双功能融合蛋白）、SYH2051（选择性ATM抑制剂）、SYH2059片（PDE4B抑制剂）、SYS6043（ADC）等获得美国临床试验批准；CPO301（EGFR ADC）获FDA授予第三项快速通道资格，用于治疗NSCLC成年患者等。 结语 石药集团2025年半年报提示公司正处于“新老交替”的关键阶段，传统业务承压，创新药尚未全面释放营收潜力，短期内可能面临一定的业绩压力。但从长期来看，石药集团的创新转型路径已逐渐清晰：通过授权交易快速变现研发成果，补充现金流；持续加码研发投入，夯实创新药管线储备；推进创新药海外进展，提升全球化能力。 资料来源：米内网数据库、公司公告等 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至9月25日，如有疏漏，欢迎指正！ 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。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024 Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. Continue Reading Fanapt® TRx and NBRx "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April as an increasing number of prescribers are adding Fanapt to their therapeutic armamentarium," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and development pipeline. The addition of imsidolimab alongside Ponvory establishes an anti-inflammatory franchise that we believe has significant growth potential. These accomplishments have been possible because of our talented employees, who for the first time surpassed 400 in number, a 22-year high." Financial Highlights Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $50.0 million in the first quarter of 2025, a 5% increase compared to $47.5 million in the first quarter of 2024. Fanapt® net product sales were $23.5 million in the first quarter of 2025, a 14% increase compared to $20.6 million in the first quarter of 2024. HETLIOZ® net product sales were $20.9 million in the first quarter of 2025, a 4% increase compared to $20.1 million in the first quarter of 2024. PONVORY® net product sales were $5.6 million in the first quarter of 2025, a decrease of 18% compared to $6.8 million in the first quarter of 2024. Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. The net loss in the first quarter of 2025 reflects expenses associated with the payment of $15.0 million related to the exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab and increased commercial activities. Cash, cash equivalents and marketable securities (Cash) was $340.9 million as of March 31, 2025, representing a decrease to Cash of $33.7 million compared to December 31, 2024. The decrease to Cash reflects the payment of $15.0 million during the first quarter of 2025 related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab. Key Operational Highlights – Commercial Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions (TRx)1 increased by approximately 14% and Fanapt® net product sales increased by 14%. Additionally, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by nearly threefold in the same period. Fanapt® total prescriptions (TRx) for the week of April 25, 2025 reached the milestone of 2,000, making Fanapt® one of the fastest growing atypical antipsychotics.1 Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives. HETLIOZ® (tasimelteon) Through the first quarter of 2025, HETLIOZ® continues to retain the largest portion of market share despite generic competition for over two years.2 PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has re-enforced the PONVORY® sales leadership team and announced an expansion of its PONVORY® sales force to approximately 40 representatives. Key Operational Highlights – Regulatory & Clinical Development Key Regulatory Milestones Tradipitant New Drug Application (NDA) for motion sickness accepted for filing by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. Fanapt® Marketing Authorization Application (MAA) for bipolar I disorder and schizophrenia submitted to the European Medicines Agency (EMA) in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted to the EMA in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025. Key Clinical Highlights Fanapt® (iloperidone) Schizophrenia: A Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the treatment of schizophrenia in relapse prevention is ongoing. Hypertension: Vanda initiated a study of the Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon. Bysanti™ (milsaperidone) The NDA for Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Exclusivity for Bysanti™, including pending patent applications, could extend into the 2040s. Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing. Results are expected in 2026. HETLIOZ® (tasimelteon) HETLIOZ® clinical programs in pediatric insomnia and delayed sleep phase disorder (DSPD) are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for SMS is pending with the EMA. PONVORY® (ponesimod) Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide). Results are expected in the third quarter of 2025. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab (IL-36R antagonist mAb). A BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate the Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. GAAP Financial Results Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. Diluted net loss per share was $0.50 in the first quarter of 2025 compared to diluted net loss per share of $0.07 in the first quarter of 2024. 2025 Financial Guidance Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year-end 2025 Cash. Vanda expects to achieve the following financial objectives in 2025: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 7, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9941754. A replay of the call will be available on Wednesday, May 7, 2025, beginning at 8:30 PM ET and will be accessible until Wednesday, May 14, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 9941754. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Based on blended data analysis About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance" above and statements regarding the growth potential of Vanda's anti-inflammatory franchise; Vanda's plans for pursuit of FDA approval of Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines; Vanda's plans for pursuit of EMA approval of Fanapt® for the treatment of bipolar I disorder and schizophrenia and HETLIOZ® and HETLIOZ LQ® for the treatment of SMS; Vanda's clinical development plans and expected timelines for Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension, Bysanti™ for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the expected timing of the results of the tradipitant clinical trial for the prevention of vomiting induced by Wegovy; and the potential to extend patent exclusivity for Bysanti™ into the 2040s are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; Vanda's ability to obtain regulatory approval and execute a successful commercial launch of imsidolimab, and increase PONVORY® revenue; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda's ability to complete and submit the BLA for imsidolimab in 2025; Vanda's ability to obtain EMA approval of the MAAs for Fanapt® and HETLIOZ® and HETLIOZ LQ®, Vanda's ability to begin enrolling patients in the Fanapt® LAI study within the specified timeframe; Vanda's ability to complete the Phase III clinical study for Bysanti™ for MDD and receive results in 2026; Vanda's ability to complete the clinical trial of tradipitant for the prevention of vomiting induced by Wegovy and receive results in the third quarter of 2025; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; and Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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