Teprotumumab-TRBW

▎Armstrong 2024年6月21日，双鹭药业发布公告，对普乐康医药投资4000万元，投前估值3亿元，投后3.4亿元，双鹭药业持股11.765%。 普乐康医药的两款核心管线，PHP1003为IGF-1R抗体，用于治疗甲状腺眼病，目前处于二期临床阶段。PHP0101为非毛果芸香碱治疗老花眼药物，今年1月获批临床。 此次增资完成后，普乐康持股11.765%，上海国鸿智言持股12.717%，苏州因耐宝持股7.826%，元生资本持股7.673%，海松资本股7.673%，苏州工业园区领军创投持股3.836%，中心苏州工业园区创投持股3.453%，朱大夯持股0.710%。 总结 Horizon的Tepezza为全球首款IGF-1R抗体，年销售额超过20亿美元，Horizon被安进280亿美元收购。国内方面，信达生物的IGF-1R抗体（与Tepezza同分子，不同剂型）已经申报上市，泽纳仕（Viridian引进）、明慧医药的IGF-1R抗体也进入临床阶段。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理； 补体靶向药物技术全梳理； 补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理； 靶点冷暖，行业自知； 中国大分子新药研发格局； 被炮轰的“me too”； 佐剂百年史； 胰岛素百年传奇； CUSBEA：风雨四十载； 中国新药研发的焦虑； 中国生物医药企业的研发竞争； 中国双抗竞争格局； 中国ADC竞争格局； 中国双抗技术全梳理； 中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理； 亘喜生物技术全梳理； 康哲药业技术全梳理； 科济药业技术全梳理； 恺佧生物技术全梳理； 同宜医药技术全梳理； 百奥赛图技术全梳理； 腾盛博药技术全梳理； 创胜集团技术全梳理； 永泰生物技术全梳理； 中国抗体技术全梳理； 德琪医药技术全梳理； 德琪医药技术全梳理2.0； 和铂医药技术全梳理； 荣昌生物技术全梳理； 再鼎医药技术全梳理； 药明生物技术全梳理； 恒瑞医药技术全梳理； 豪森药业技术全梳理； 正大天晴技术全梳理； 吉凯基因技术全梳理； 基石药业技术全梳理； 百济神州技术全梳理； 百济神州技术全梳理第2版； 信达生物技术全梳理； 信达生物技术全梳理第2版； 中山康方技术全梳理； 复宏汉霖技术全梳理； 先声药业技术全梳理； 君实生物技术全梳理； 嘉和生物技术全梳理； 志道生物技术全梳理； 道尔生物技术全梳理； 尚健生物技术全梳理； 康宁杰瑞技术全梳理； 科望医药技术全梳理； 科望医药技术全梳理2.0； 岸迈生物技术全梳理； 礼进生物技术全梳理； 康桥资本技术全梳理； 余国良的抗体药布局； 荃信生物技术全梳理； 安源医药技术全梳理； 三生国健技术全梳理； 仁会生物技术全梳理； 乐普生物技术全梳理； 同润生物技术全梳理； 宜明昂科技术全梳理； 派格生物技术全梳理； 迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理； 普米斯生物技术全梳理； 普米斯生物技术全梳理2.0； 三叶草生物技术全梳理； 贝达药业抗体药全梳理； 泽璟制药抗体药全梳理； 恒瑞医药抗体药全梳理； 齐鲁制药抗体药全梳理； 石药集团抗体药全梳理； 豪森药业抗体药全梳理； 华海药业抗体药全梳理； 科伦药业抗体药全梳理； 百奥泰技术全梳理； 凡恩世技术全梳理。

The “strong efficacy” was maintained through Week 52 in both of the picankibart cohorts, Innovent said. Innovent’s psoriasis contender to IL-23 drugs like Tremfya and Skyrizi cleared skin and improved the severity of disease in a phase 3 test, setting up the company to seek approval from Chinese regulators. The anti-IL-23 monoclonal antibody, called picankibart, hit all primary and key secondary endpoints in the late-stage CLEAR-1 trial of 500 Chinese patients with moderate to severe plaque psoriasis. Specifically, 80.3% of patients who received picankibart achieved a 90% or greater improvement in their Psoriasis Area and Severity Index (PASI) score at 16 weeks compared to just 2% of participants who received placebo. A physician’s assessment at the same point—the other primary endpoint of the trial—produced similar results, with 93.5% of patients achieving clear or almost-clear skin compared to 13.1% of the placebo cohort. Patients who received picankibart started with a 200-mg injection and then received the same dose again at weeks 4 and 8 before being split into those who received either a 100-mg or 200-mg dose every 12 weeks. The “strong efficacy” was maintained through Week 52 in both of the picankibart cohorts, said Innovent, although yearlong data were only shared for the 200-mg group. Of these patients, 84.9% still had a PASI score of 90% or above at this point, while 85.9% maintained their clear or almost-clear skin. “These results underpin the long-term robust efficacy of picankibart in treating moderate to severe psoriasis,” the biotech said in the May 27 release. Picankibart is designed to be given less frequently than some rivals. While the FDA has already approved antibodies in the U.S. against the IL23p19 subunit—with Sun Pharma’s Ilumya joining Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi among the authorized products—Innovent sees value in developing an extended half-life treatment that can be dosed less frequently. “Achievement of all primary and key secondary endpoints in CLEAR-1 has supported picankibart's outstanding efficacy and favorable safety as a new generation of IL-23p19 target drugs,” said Lei Qian, M.D., Ph.D., vice president of clinical development at Innovent. Innovent will use yesterday’s results ­to prepare an application to Chinese regulators to approve picankibart as a “more convenient, friendly and effective treatment regimen for patients with moderate to severe plaque psoriasis,” Qian said. J&J has another IL-23 psoriasis option in the works courtesy of an IL-23R antagonist peptide called JNJ-2113. The Protagonist Therapeutics-partnered candidate fell short of the high bar set by injectable treatments in a phase 2 trial last year, but the convenience of oral delivery means the companies have still pushed the asset into phase 3. The picankibart results mark the latest in a string of clinical wins for Innovent this year. A thyroid eye disease rival to Amgen’s Tepezza hit its phase 3 endpoints, while the GLP-1R/GCGR dual agonist mazdutide licensed from Eli Lilly has demonstrated success in both diabetes and weight loss.