Paliperidone Palmitate

作者｜momo在全球医药产业持续创新驱动与精准战略布局的背景下，2024年医药行业延续稳健增长态势，核心治疗领域呈现明显分化特征。默沙东Keytruda以创纪录的294.82亿美元年销售额巩固其PD-1抑制剂市场霸主地位，强生Darzalex（达雷妥尤单抗）则通过差异化多发性骨髓瘤治疗方案实现19.8%的同比增速。值得关注的是，代谢疾病领域迎来爆发式增长，礼来GLP-1/GIP双受体激动剂Mounjaro凭借卓越的减重疗效实现销售三连跳，而诺和诺德司美格鲁肽通过口服剂型创新及心血管获益证据扩展，构建起超200亿美元的市场护城河，共同推动糖尿病/肥胖治疗市场规模突破千亿美元大关。图1.2024年制药巨头最畅销药物在这里，我们将根据2024年销售趋势介绍制药巨头销售额前三名的药品（图1），并探索它们成功背后的因素。  TOP 1：强生  2024年总营收：888.21亿美元销售额前三名药物：Darzalex、Stelara、Invega Sustenna/Xeplion/Invega Trinza/Trevicta状元：Darzalex2024年销售额：116.7亿美元Darzalex（达雷妥尤单抗）是一款靶向CD38的人源化单克隆抗体。CD38在多发性骨髓瘤细胞上过表达，Darzalex通过清除有CD38的细胞起到杀伤多发性骨髓瘤癌细胞的作用。2015年，FDA批准Darzalex用于接受过过往治疗的多发性骨髓瘤治疗。2024年Darzalex持续放量，全年销售额高达116.7亿美元，同比增长19.8%。这是该药自2015年上市以来，销售额首次突破百亿美元，成为强生旗下最畅销的药物。榜眼：Stelara2024年销售额：103.61亿美元Stelara（乌司奴单抗）是治疗自身免疫性疾病的药物，对银屑病、克罗恩病等病症有着出色的疗效，通过精准调节免疫系统来减轻炎症反应。它主要是通过靶向特定的免疫相关通路发挥作用。2009年，Stelara获FDA批准上市。在欧洲，它也被广泛用于相关疾病的治疗。在全球市场，Stelara已成为众多自身免疫病患者的重要治疗选择之一。根据强生公司公告，2024年Stelara在全球实现了103.61亿美元高额销售额，为强生公司在自免药物领域的营收做出了重要贡献。然而，由于欧洲等市场生物类似药竞争，2024年Stelara全年销售额出现了明显下滑。探花：Invega Sustenna/Xeplion/Invega Trinza/Trevicta2024年销售额：42.22亿美元Invega Sustenna/Xeplion/Invega Trinza/Trevicta是强生旗治疗精神分裂的系列药物，是强生在神经科学板块最核心的产品，2024年全年营收40.22亿美元，占比8%，同比增长10.1%。  TOP 2：罗氏  2024年总营收：688.92亿美元销售额前三名药物：Ocrevus、Hemlibra、Vabysmo状元：Ocrevus2024年销售额：76.80亿美元Ocrevus （奥瑞利珠单抗）是一种靶向CD20阳性B细胞单克隆抗体，用于治疗多发性硬化症（MS）。临床前研究显示，Ocrevus可与表达在某些B细胞表面上的CD20蛋白结合，但不与干细胞或浆细胞结合，因此患者仍可维持其免疫系统的重要功能。在神经领域，多发性硬化症药物Ocrevus多年稳坐罗氏的头牌。2024年，Ocrevus销售额高达76.80亿美元，同比增长9%。为了巩固Ocrevus地位，罗氏于在欧美推出Ocrevus的皮下制剂。此外，罗氏还在开发更高剂量的Ocrevus，已处于III期临床阶段，有望于2025年申报上市。榜眼：Hemlibra2024年销售额：51.28亿美元Hemlibra（艾美赛珠单抗）是罗氏开发的一款重组人源化双抗，通过连接FX和FIXa恢复缺失的FVIII的功能，以恢复A型血友病患者的凝血功能。目前该产品已在欧、美、日、中等全球多国获批上市。2024年，Hemlibra以约51.28亿美元的销售额（+12%）位居罗氏畅销药榜单的第二名。探花：Vabysmo2024年销售额：44.00亿美元适应症：Vabysmo（法瑞西单抗）是一种抗血管内皮生长因子（VEGF）和血管生成素-2（Ang-2）的人源化双特异性免疫球蛋白G1（IgG1）抗体，用于治疗由于视网膜静脉阻塞（RVO）引起的黄斑水肿导致的视力损害、新生血管性年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。该药物于2022年1月在美国获批上市，上市第三年，其全球销售额已达44.00亿美元，同比增长68%，正式成为罗氏的增长支柱。  TOP 3：辉瑞  2024年总营收：636.27亿美元销售额前三名药物：Eliquis、Prevnar family、Paxlovid状元：Eliquis2024年销售额：73.66亿美元Eliquis（阿哌沙班）是BMS和辉瑞公司联合研发的一种新型凝血因子Xa抑制剂，2012 年获得FDA批准用于非瓣膜性心房颤动患者，以降低中风和血栓的风险。2014年，它被批准用于治疗深静脉血栓形成（DVT）和肺栓塞（PE）。现主要用于多种血栓栓塞性疾病的临床使用。2024年全年销售额73.66亿美元，同比增长9%，继续在抗凝血药物市场中占据重要地位。该产品在美国和欧洲的某些市场或因非瓣膜性房颤适应症份额增加，部分抵消了仿制药竞争造成的影响，营收增速相较2023年小幅提升。榜眼：Prevnar family2024年销售额：64.11亿美元Prevnar family肺炎球菌疫苗（Prevnar 20&13）2024年共创收64.11亿美元，同比减少1%。得益于美国和国际发达国家市场需求，Prevnar family为辉瑞2024年业绩增长提供了强劲驱动力。探花：Paxlovid2024年销售额：57.16亿美元Paxlovid（帕罗韦德）是辉瑞研发的一款口服抗病毒药物，该药为口服小分子新冠病毒治疗药物，用于治疗成人伴有进展为重症高风险因素的轻至中度新型冠状病毒肺炎（COVID-19）患者。2024年，Paxlovid和Comirnaty两款新冠产品为辉瑞带来超110亿美元销售额。  TOP 4：默沙东  2024年总营收：641.68亿美元销售额前三名药物：Keytruda、Gardasil/Gardasil 9、Lynparza状元：Keytruda2024年销售额：294.82亿美元Keytruda（帕博利珠单抗）是一款PD-1免疫检查点蛋白抑制剂，目前已在美国、欧洲、中国、日本及全球其他国家和地区获批用于治疗转移性或不可切除、复发性头颈部鳞状细胞癌患者。2024年，Keytruda以18%的增长速度创收294.82亿美元，登顶全球药王宝座，其销售额约占默沙东总营收的46%。为巩固其地位，默沙东通过拓展早期适应症、进行联用布局以及开发皮下制剂等策略试图将K药的临床价值和商业化价值最大化。榜眼：Gardasil/Gardasil 92024年销售额：85.83亿美元Gardasil是第一款获批的人乳头瘤病毒（HPV）预防性疫苗，于2006年获美国FDA批准上市，包括四价疫苗Gardasil和九价疫苗Gardasil 9。Gardasil/Gardasil是默沙东的另一王牌产品，2024年全年销售额为85.83亿美元，同比下降3%。在2024Q3财报中，Gardasil系列产品就初显颓势，主要原因在于中国地区的需求减少。而需求减少的背后，与激烈的竞争息息相关，国产九价已在路上，二价HPV疫苗更是陷入价格战。探花：Lynparza2024年销售额：13.11亿美元Lynparza（奥拉帕利）则是一种“first-in-class”的PARP抑制剂，也是首个合成致死靶向治疗药物，用于靶向带有同源重组修复（HRR）缺陷的细胞/肿瘤。目前，Lynparza已在美国、欧盟、日本及许多其他国家和地区获批，用于治疗gBRCAm、HER2阴性高危早期乳腺癌或gBRCAm、HER2阴性转移性乳腺癌。2024年，Lynparza则为默沙东带来了13.11亿美元的收入。  TOP 5：艾伯维  2024年总营收：563.34亿美元销售额前三名药物：Skyrizi、Humira、Rinvoq状元：Skyrizi2024年销售额：117.18亿美元Skyrizi（利生奇珠单抗）是一种白细胞介素 - 23（IL - 23）抑制剂，主要用于治疗中重度斑块状银屑病、银屑病关节炎等自身免疫性疾病。它通过精准作用于特定靶点，有效减轻皮肤炎症和关节症状。Skyrizi已在全球多个国家和地区获批上市，包括美国、欧洲等地。在临床应用中，为众多自身免疫疾病患者带来了新的治疗选择。2023年Skyrizi全球销售额合计77.63亿美元，2024年销售额接近120亿美元，同比增长50.9%，成为艾伯维继Humira之后的下一个百亿大单品。凭借在炎症性肠病和皮肤病治疗等领域广泛的应用前景，该产品被《Nature》预测将进入2025年全球畅销榜前五名。2024年6月，Skyrizi获得FDA批准用于治疗中度至重度活动性溃疡性结肠炎成人患者，至此该产品已斩获含斑块状银屑病、银屑病关节炎、克罗恩病等在内的7项适应症。榜眼：Humira2024年销售额：89.93亿美元Humira（阿达木单抗）是一种全人源化抗肿瘤坏死因子 - α（TNF - α）单克隆抗体，用于治疗多种自身免疫性疾病，包括类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病等。它能特异性地与 TNF - α结合，从而抑制炎症反应。1998年，Humira在美国获批上市，之后在全球众多国家和地区广泛应用，极大地改善了患者的病情和生活质量。近年来，阿达木单抗多年来一直是全球销售额领先的药物之一，为艾伯维公司创造了巨大的收益。然而，因专利到期和生物类似药竞争影响，2024年Humira销售额以37.6%的下滑速度降至89.93亿美元。尽管优势逐渐减弱，但Skyrizi和Rinvoq依然保持超过50%的增速。同时，艾伯维开始更加关注外部交易以扩大自免管线布局。探花：Rinvoq2024年销售额：59.71亿美元Rinvoq（乌帕替尼）是一种口服的选择性 Janus 激酶（JAK）抑制剂，用于治疗多种自身免疫性疾病，包括类风湿关节炎、银屑病关节炎、特应性皮炎、溃疡性结肠炎等。它通过抑制 JAK 信号通路，从而减少炎症反应，缓解患者症状。据艾伯维2024年业绩报告显示，Rinvoq 2024年销售额为59.71亿美元，同比增长50.5%，是艾伯维在自免领域的重要支柱产品。  TOP 6：阿斯利康  2024年总营收：540.73亿美元销售额前三名药物：Farxiga、Tagrisso、Imfinzi状元：Farxiga2024年销售额：77.17亿美元Farxiga（达格列净）是一款“first-in-class”钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂。作为饮食调节和运动的辅助措施用于改善成人T2D患者的血糖控制。此外，它还用于治疗心力衰竭和慢性肾病（CKD）成人患者。Farxiga在2024年仍旧保持着高收入增长率，全年收入77.17亿美元，同比增长31%。Farxiga的制剂专利和晶型专利将在2027-2028年到期，为了应对专利悬崖，阿斯利康就Farxiga开发了一系列复方药物进一步扩大达格列净在心肾领域的影响力。榜眼：Tagrisso2024年销售额：65.80亿美元Tagrisso（奥希替尼）是第三代不可逆EGFR-酪氨酸激酶抑制剂（TKI），因其治疗非小细胞肺癌的有效性而得到认可。阿斯利康持续探索Tagrisso治疗不同阶段转移性EGFR突变NSCLC患者的潜力。包括美国、欧盟（EU）、中国和日本在内的100多个国家已批准Tagrisso作为独立疗法。据阿斯利康2024年财报显示，Tagrisso阿斯利康在抗肿瘤领域的顶梁柱，全年销售额达65.80亿美元，同比增长13%。探花：Imfinzi2024年销售额：47.17亿美元Imfinzi（度伐利尤单抗）是一种人源化的单克隆抗体。通过与PD-L1的结合，阻断PD-L1与PD-1和CD80蛋白的结合，进而抑制肿瘤的免疫逃逸机制。Imfinzi是唯一一款适用于广泛期小细胞肺癌（ES-SCLC）和局限期小细胞肺癌（LS-SCLC）的免疫药物，并进一步覆盖了早期NSCLC患者的围手术期治疗。2024年，Imfinzi取得了瞩目的销售成绩，全年创收47.17亿美元，同比增长21%，实现了强劲的双位数增长。  TOP 7：拜耳  2024年总营收：503.43亿美元销售额前三名药物：Xarelto、Eylea、Nubeqa状元：Xarelto2024年销售额：37.59亿美元Xarelto（利伐沙班）是一款口服凝血因子Xa抑制剂，用于治疗或预防血栓。作为拜耳的拳头药物，2024年Xarelto为拜耳贡献了 37.59 亿美元的销售额。但由于利伐沙班在中国的专利已经到期，并将于 2026 年和 2027 年在欧洲和美国失去专利保护，迎来仿制药冲击，利伐沙班的销售额快速下滑 14.7%。榜眼：Eylea2024年销售额：35.71亿美元Eylea（阿柏西普）是一种主要成分为VEGF抑制剂的眼部注射剂。它的作用机制为通过阻断参与血管生成的生长因子VEGF-A与胎盘生长因子（PLGF），进而阻断新生血管生成，并降低眼内血管通透性。2024年Eylea销售额为35.71亿美元，同比增长2.3%，然而，由于Eylea的专利也将陆续到期，来自仿制药的竞争压力与日俱增，未来该药的销售额也恐将大幅缩水。探花：Nubeqa2024年销售额：16.45亿美元Nubeqa（达罗他胺）是一款口服雄激素受体抑制剂（ARi），能够与雄激素受体以高亲和力结合并且表现出强力的拮抗活性，抑制雄激素受体向细胞核内转移，和其介导的基因表达，从而达到抑制前列腺癌细胞增殖的目的。2019年7月获得美国FDA批准用于治疗非转移性去势抵抗性前列腺癌（nmCRPC）患者。2024 年销售额为16.45亿美元，大幅增长75.3%。  TOP 8：诺华  2024年总营收：503.17亿美元销售额前三名药物：Entresto、Cosentyx、Kesimpta状元：Entresto2024年销售额：78.22亿美元Entresto（沙库巴曲缬沙坦）是诺华开发的一种血管紧张素Ⅱ受体阻断剂，2015年7月获FDA批准用于治疗射血分数下降心衰（HFrEF）患者，又在2017年7月获NMPA批准用于治疗射血分数下降心衰（HFrEF）患者。Entresto 是迄今为止首个获批用于治疗两种主要类型慢性心衰的药物。Entresto作为诺华在心血管领域的王牌产品已上市10年，其销售额连续攀升，每年保持着两位数或以上的增长率，2024年全年收入达78.22亿美元，同比增长31%。然而，Entresto不久将面临专利到期和进入美国第一轮医保谈判降价名单的威胁。诺华已开始全面调整其商业化战略。诺华已裁员数百人，并转而将重点放在其他潜力心血管药物上。榜眼：Cosentyx2024年销售额：61.41亿美元Cosentyx（司库奇尤单抗）被广泛用于治疗多种自身免疫性疾病，包括中重度斑块状银屑病、银屑病关节炎和强直性脊柱炎等。它通过特异性地阻断白细胞介素 - 17A（IL - 17A）信号通路，抑制炎症反应，从而减轻疾病症状。2024年销售额为61.41亿美元，同比增长25%，化脓性汗腺炎（HS）适应症和静脉制剂的推出为该药的增长带来了新的动力。Cosentyx针对风湿性多肌痛（PMR）和巨细胞动脉炎（GCA）的III期临床研究预计会在2025年公布结果，未来该药还有进一步增长的机会，诺华预计其销售峰值有望突破70亿美元。探花：Kesimpta2024年销售额：32.24亿美元Kesimpta（奥法妥木单抗）是一种抗人CD20的全人源免疫球蛋白G1单克隆抗体，靶向CD20分子，通过诱导B细胞溶解达到治疗作用。用于治疗成人复发型多发性硬化（RMS），包括临床孤立综合征、复发缓解型多发性硬化和活动性继发进展型多发性硬化。Kesimpta作为首个患者可以自行注射使用的CD20单抗，其在市场上保持着强劲的增长势头，2024年收入32.24亿美元，同比增长49%。  TOP 9：百时美施贵宝  2024年总营收：483.00亿美元销售额前三名药物：Eliquis、Opdivo、Revlimid状元：Eliquis2024年销售额：133.33亿美元Eliquis（阿哌沙班）在2024年扛起BMS的业绩大旗，创造了133.33亿美元的收入，同比增长9%。然而，Eliquis仍然要面临其核心专利到期的风险。榜眼：Opdivo2024年销售额：93.04亿美元Opdivo（纳武利尤单抗）是一种PD-1免疫检查点抑制剂，旨在帮助恢复抗肿瘤免疫反应，利用人体自身的免疫系统来对抗癌症。Yervoy则靶向抑制CTLA-4。CTLA-4抗体通过增强T细胞活性来提高肿瘤杀伤能力。该产品已于2011年获得美国FDA批准治疗晚期黑色素瘤，是全球首个获批上市的CTLA-4抗体药物。2024年，Opdivo的全球销售额为93.04亿美元，同比增长3%，是BMS第二大创收产品。虽然Opdivo的专利独占权将于2028年到期，BMS也采取了积极的举措来延长Opdivo产品生命周期，比如领先K药推出了皮下制剂。探花：Revlimid2024年销售额：57.73亿美元Revlimid（来那度胺）是一种免疫调节剂，不仅能抑制肿瘤细胞增殖，还能增强T细胞和自然杀伤细胞的活性，进一步巩固免疫系统对肿瘤的攻击能力。用于治疗多发性骨髓瘤、骨髓增生异常综合征以及套细胞和滤泡性淋巴瘤。Revlimid长期以来一直是多发性骨髓瘤的一线治疗药物，也是BMS的最佳治疗药物，它的专利保护使它在十多年的时间里占据了市场的主导地位。然而，在2022年专利到期，仿制药的引入导致去年BMS的销量下降。2024年，Revlimid全年销售额为57.73亿美元，同比下降5%。  TOP 10：礼来  2024年总营收：450.43亿美元销售额前三名药物：Mounjaro、Verzenio、Trulicity状元：Mounjaro2024年销售额：115.40亿美元Mounjaro（替尔泊肽）是首个双作用葡萄糖依赖性胰岛素性多肽（GIP）和GLP-1受体激动剂，被批准用于治疗2型糖尿病。它以GIP受体为靶点，补充GLP-1的作用，改善胰岛素调节和血糖控制。2023年11月，FDA还批准用于成人肥胖患者的慢性体重管理（Zepbound）。Mounjaro问世即进入爆发期，在上市当年畅销近5亿美元，第二年便高涨至51.63亿美元，2024年更是直接冲破百亿美元大关（115.401亿美元，+124%），荣升为礼来的第一款超级重磅产品。榜眼：Verzenio2024年销售额：53.07亿美元Verzenio（阿贝西利）是一种CDK4/6抑制剂。在HR+乳腺癌细胞系中，细胞周期蛋白D1和CDK4/6促进细胞周期进展和细胞增殖。Verzenio能够阻断细胞周期的进展，导致细胞衰老和凋亡。它已经被FDA批准作为一线疗法治疗HR+，HER2-晚期乳腺癌患者。得益于拓展了早期乳腺癌人群，2024年Verzenio延续高增长率，全年收入达到53.07亿美元，同比增长37%。探花：Trulicity2024年销售额：52.54亿美元Trulicity（度拉糖肽）是一种GLP-1受体激动剂，可增强葡萄糖依赖型胰岛素的分泌，在控制成人2型糖尿病患者的血糖水平方面发挥关键作用，2014年9月获批用于2型糖尿病患者。Trulicity是礼来保持糖尿病市场竞争力的上一代重磅武器，其销售额在2022年达到峰值（74.40亿美元），自此以后开始下降，2024年收入缩减至52.535亿美元（-26%）。这主要是由于GLP-1R/GIPR激动剂替尔泊肽的强势入场所致。度拉糖肽的中国序列专利已在2024年到期，美国序列专利将在2027年到期。  TOP 11：赛诺菲  2024年总营收：445.61亿美元销售额前三名药物：Dupixent、Polio/Pertussis/Hib vaccines & Boosters、Influenza vaccines状元：Dupixent2024年销售额：141.79亿美元作为赛诺菲和再生元合作开发的核心自免药物，自上市以来一直是医药领域的焦点。这款针对自身免疫疾病的重磅药物在中重度特应性皮炎、中重度哮喘、慢性鼻炎等多种适应证中表现出卓越疗效，成为了这些领域治疗的重要选择。它是全球首个获批治疗中重度特应性皮炎的生物制剂，适应证拓展能力极强。2024年，Dupixent销售额高达141.79亿美元，同比增长23.1%，成为新一代的自免“药王”，为赛诺菲和再生元带来了可观的收入。后续随着适应证进一步拓展和市场渗透率的提高，Dupixent在未来无疑将持续巩固其在自免药物领域的领先地位，销售额有望持续攀升。榜眼：Polio/Pertussis/Hib vaccines & Boosters2024年销售额：29.60亿美元脊髓灰质炎、百日咳乙型肝炎疫苗Polio/Pertussis/Hib vaccines & Boosters成为赛诺菲畅销药榜单的第二名。2024年全年销售额高达29.60亿美元，同比增长1.2%。探花：Influenza vaccines2024年销售额：27.60亿美元Influenza Vaccines是用来预防流行性感冒病毒引起的流行性感冒的疫苗。2024年Influenza vaccines位居赛诺菲畅销药榜单的第三名，全年销售额高达27.60亿美元。  TOP 12：诺和诺德  2024年总营收：421.49亿美元销售额前三名药物：Ozempic、Wegovy、Rybelsus司美格鲁肽是一种长效GLP-1类似物，它与天然GLP-1的氨基酸序列具有94%的同源性，能起到GLP-1受体激动剂的作用。2024年，司美格鲁肽大卖293亿美元，同比增长38.18%，几乎追平K药，有望成为下一届药王。具体来看，降糖用司美格鲁肽注射液Ozempic在2024年销售174.66亿美元，同比增长26%；口服司美格鲁肽片Rybelsus销售33.82亿美元，同比增长26%；减肥用司美格鲁肽注射液Wegovy创收84.48亿美元，同比增长86%。参考资料[1]各大公司财报、公告、官微、官网，各种公开资料[2]https://www.linkedin.cn/共建Biomedical创新生态圈！如何加入BiG会员？

PRINCETON, N.J., April 6, 2025 /PRNewswire/ -- Luye Pharma Group today announced that ERZOFRI® (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder. ERZOFRI, administered once a month, delivers the active ingredient, paliperidone, through a long-acting, extended-release delivery system. It simplifies treatment by enabling single-dose initiation due to its unique 351 mg initiation dose. The currently prescribed monthly paliperidone palmitate long-acting injectable (LAI) requires two initiation doses, on Day 1 and Day 8. ERZOFRI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis. The most common side effects of ERZOFRI include injection site reactions, sleepiness or drowsiness, dizziness, feeling restless or like you need to move, and abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes. Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurrent relapses[1]. Non-adherence to medication is a major challenge in patients with such conditions. Failure of follow-up care after discharge significantly increases patients' non-adherence to prescribed medications, relapse and rehospitalization[2]. LAI antipsychotics, with a reduced dosage frequency compared to oral antipsychotics, effectively improve medication adherence and reduce the risk of healthcare providers not knowing if their patients fail to follow the prescribed dosage regimen[3]. ERZOFRI's approval by the FDA is based on the results of an open-label, randomized, multiple-dose, parallel-group study evaluating its pharmacokinetic (PK) profile and relative bioavailability at steady state versus an established paliperidone palmitate LAI drug for reference. The study demonstrated the bioequivalence of ERZOFRI to the listed drug at steady state (treatment day 8) without the need for a second initiation injection. Comparable total drug exposure and a safety profile consistent with the listed drug were established. In addition to the unique 351 mg/2.25mL initiation dose, ERZOFRI is available in single-use kits in the following strengths: 39 mg/0.25mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL. "This newly approved long-acting injectable antipsychotic for the management of schizophrenia can help address treatment initiation complexities and provides an exciting alternative to help patients reach their treatment goals." said Christoph U Correll, MD, Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, New York, USA. Rongbing Yang, President of Luye Pharma Group, added: "Medication adherence and discontinuation present a major challenge in the treatment of schizophrenia and schizoaffective disorder. Using LAIs is effective in increasing medication adherence. ERZOFRI, with its simplified dosage regimen eliminating the need for a second dose when initiating treatment is expected to increase treatment adherence in the initial stage. Its commercial launch in the U.S. marks a major milestone in our commitment to addressing the unmet medical needs of patients in the U.S. The central nervous system is a key therapeutic area of focus for Luye Pharma, and we are committed to providing innovative therapies to combat mental disorders and expand treatment options." ERZOFRI® (paliperidone palmitate) extended-release injectable suspension INDICATIONS What is ERZOFRI® (paliperidone palmitate)? ERZOFRI is a prescription medicine given by injection by a healthcare provider and used to treat: schizophrenia in adults schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants It is not known if ERZOFRI is safe and effective in children. IMPORTANT SAFETY INFORMATION FOR ERZOFRI (paliperidone palmitate) ERZOFRI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis. Do not receive ERZOFRI if you are allergic to paliperidone, risperidone, or any of the ingredients in ERZOFRI. What are the possible serious side effects of ERZOFRI? Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic Malignant Syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms: high fever stiff muscles confusion sweating changes in your breathing, pulse, heart rate, or blood pressure Problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms: passing out or feeling like you will pass out dizziness feeling as if your heart is pounding or missing beats Uncontrolled body movements (tardive dyskinesia). ERZOFRI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ERZOFRI. Tardive dyskinesia may also start after you stop taking ERZOFRI. Problems with your metabolism such as: High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who are treated with ERZOFRI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment and during your treatment with ERZOFRI. Call your healthcare provider if you get any of these symptoms of high blood sugar during treatment with ERZOFRI: feel very thirsty feel very hungry feel sick to your stomach need to urinate more than usual feel weak or tired feel confused, or your breath smells fruity Increased fat levels (cholesterol and triglycerides in your blood). Your healthcare provider may check your cholesterol and triglyceride levels during treatment with ERZOFRI. Weight gain. You and your healthcare provider should check your weight regularly during treatment with ERZOFRI. Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Falls. ERZOFRI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. Low white blood cell counts. Your healthcare provider may do blood tests during treatment with ERZOFRI. Increased prolactin levels in your blood (hyperprolactinemia). ERZOFRI may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection. Sleepiness, drowsiness feeling tired, difficulty thinking and doing normal activities. Seizures (convulsions). Difficulty swallowing that can cause food or liquid to get into your lungs. Prolonged or painful erection lasting more than 4 hours (priapism). Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours. Problems with control of your body temperature so that you feel too warm. Before taking ERZOFRI, tell your healthcare provider about all of your medical conditions including if you: have never taken paliperidone or risperidone before have had neuroleptic malignant syndrome (NMS) have or had heart problems, including heart attack, heart failure, abnormal heart rhythm, or long QT syndrome have or had low levels of potassium or magnesium in your blood have or had uncontrolled movements of your tongue, face, mouth or jaw (tardive dyskinesia) have or had kidney or liver problems have or had high blood sugar, diabetes or have a family history of diabetes have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol have Parkinson's disease or a type of dementia called Lewy Body Dementia have or had problems with dizziness or fainting or are being treated for high blood pressure have or had a low white blood cell count have or had seizures or epilepsy are pregnant or plan to become pregnant. It is not known if ERZOFRI will harm your unborn baby. If you become pregnant during treatment with ERZOFRI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit . Babies born to women who are treated with ERZOFRI during their third trimester of pregnancy may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare provider know if these symptoms occur. are breastfeeding or plan to breastfeed. ERZOFRI can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you receive ERZOFRI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERZOFRI and certain other medicines may affect each other causing possible serious side effects or affect the way each other works. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine. The most common side effects of ERZOFRI include: injection site reactions sleepiness or drowsiness dizziness feeling restless or like you need to move abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ERZOFRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at or call 1-800- FDA-1088. About Luye Pharma Group Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 20 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies. Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast-growing emerging markets. SOURCE Luye Pharma Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED