A Phase I Randomized, Double-Blind, Placebo-Controlled, Multiple Oral Dose Trial to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IBI353 (Orismilast) in Healthy Subjects

This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.

开始日期2022-11-30

申办/合作机构

信达生物制药（苏州）有限公司

CTR20222393 / Completed临床1期

评估IBI353在中国健康受试者中多次口服给药的药代动力学、安全性和耐受性的随机、双盲、安慰剂对照、I期临床研究

主要目的：评估IBI353在中国健康受试者中多次口服给药后的药代动力学特征。次要目的：评估IBI353在中国健康受试者中多次口服给药后的安全性和耐受性。

开始日期2022-11-24

申办/合作机构

信达生物制药（苏州）有限公司

[+2]

NCT05469464 / Active, not recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

开始日期2022-07-11

申办/合作机构

UNION Therapeutics A/S

100 项与 Orismilast 相关的临床结果

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100 项与 Orismilast 相关的转化医学

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100 项与 Orismilast 相关的专利（医药）

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项与 Orismilast 相关的文献（医药）

2023-12-26·Journal of the European Academy of Dermatology and Venereology : JEADV

Orismilast for the treatment of mild to severe hidradenitis suppurativa: Week 16 data from OSIRIS, a Phase 2a, open-label, single-centre, single-arm, dose-finding clinical trial.

Article

作者: C G Frederiksen ; F B Sedeh ; E H Taudorf ; D M Saunte ; G B E Jemec

BACKGROUND:

Hidradenitis suppurativa (HS) is a disease with an unmet need for treatment.

OBJECTIVE:

To examine tolerability, safety and efficacy of oral phosphodiesterase-4 (PDE4) inhibitior orismilast 10-40 mg twice daily (BID) in HS.

METHODS:

A Phase 2a, single-arm, single-centre, open-label, 16-week trial in HS patients. Adjustments in maximal dose and titration were allowed, to improve tolerability, dividing the study population in two groups who completed and discontinued 16 weeks of treatment. Descriptive statistics were applied to efficacy data from patients who completed treatment and patients who discontinued treatment prematurely. A last-observation-carried-forward (LOCF) approach was used for patients who discontinued treatment. The primary endpoint was percent change in the total number of abscesses and nodules (AN-count) at Week 16, with the HS Clinical Response with a 50% reduction in the AN-count (HiSCR50) as key secondary endpoint.

RESULTS:

Of the 20 patients included, 9 completed 16 weeks of treatment and 11 discontinued treatment prematurely. The mean AN-count was reduced with 33.1% in patients who completed treatment and with 12.0% in patients who discontinued. HiSCR50 was achieved by 67.0% and 27.0% of patients who completed and discontinued treatment, respectively. Most adverse events were mild to moderate.

CONCLUSIONS:

Oral orismilast demonstrated a dose-dependent tolerability, with mild to moderate adverse effects. Further, the results of this exploratory trial indicate that orismilast may lead to clinical improvements in HS. However, larger trials with tolerable dose ranges are warranted. The Trial is registered at Clinicaltrials.gov (UNI50007201) and EudraCT.ema.europa.eu (2021-000049-42).

2023-11-09·Journal of the American Academy of Dermatology

Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, phase 2b trial (IASOS).

Article

作者: Richard B Warren ; Lars E French ; Andrew Blauvelt ; Richard G Langley ; Alexander Egeberg ; Ulrich Mrowietz ; Hamish J A Hunter ; Melinda Gooderham ; Per Soerensen ; Philippe Andres ; Morten O A Sommer ; Anna Carlsson ; Kim D Kjøller ; Bruce E Strober

BACKGROUND:

Orismilast is a novel oral phosphodiesterase 4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis.

OBJECTIVE:

To evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis.

METHODS:

This multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419). Efficacy endpoints were analyzed using multiple imputation.

RESULTS:

Of 202 randomized patients, baseline characteristics were balanced across arms, except greater severe disease proportions for orismilast versus placebo. Orismilast showed significant improvements in the primary endpoint, percentage change in Psoriasis Area and Severity Index (PASI), from baseline to week 16 (orismilast -52.6% to -63.7%; placebo, -17.3%; all P<0.001). Greater proportions receiving orismilast achieved PASI75 (39.5% to 49.0%; P<0.05) and PASI90 (22.0% to 28.3%; P<0.05 for 20 and 40 mg) versus placebo (PASI75, 16.5%; PASI90, 8.3%) at week 16. Safety findings were as expected with PDE4 inhibition; dose-dependent tolerability effects observed.

LIMITATIONS:

Small sample size, disease severity imbalance between groups, limited duration and diversity in study population.

CONCLUSION:

Orismilast demonstrated greater efficacy versus placebo and a safety profile in line with PDE4 inhibition.

2022-12-17·Journal of the European Academy of Dermatology and Venereology : JEADV

Pharmacology of orismilast, a potent and selective PDE4 inhibitor.

Article

作者: J I Silverberg ; L E French ; R B Warren ; B Strober ; K Kjøller ; M O A Sommer ; P Andres ; J Felding ; A Weiss ; D Tutkunkardas ; Tine Skak-Nielsen ; E Guttman

BACKGROUND:

There remains an unmet need for oral medications that are safe and efficacious for long-term management of chronic inflammatory skin diseases (CISD). Inhibition of phosphodiesterase 4 (PDE4) can modulate a broad range of pro-inflammatory cytokines that play a major role in CISD pathogenesis. Orismilast is a second generation PDE4 inhibitor in clinical development for CISD treatment.

OBJECTIVES:

The objective of this study was to examine the PDE4 enzymatic activity and anti-inflammatory effects of orismilast in vitro, ex vivo, and in vivo.

METHODS:

The PDE1-11 enzymatic activity of orismilast was tested in vitro using a single concentration of 308 nM orismilast. The PDE4 selectivity and inhibitory potency was further examined in a radiometric assay. Orismilast was tested on human whole blood and human peripheral blood mononuclear cells (PBMC) to determine effects on its cytokine secretion and inhibition profile ex vivo. Orismilast was orally administered in a murine model of chronic oxazolone-induced ear skin inflammation. Ear thickness, a marker of inflammation, and inflammatory cytokines were analysed.

RESULTS:

Orismilast selectively inhibited PDE4 and demonstrated potent inhibition of PDE4B and PDE4D subtype splice variants in vitro. Orismilast inhibited whole blood and PBMC production of tumour necrosis factor α (TNFα), and the secretion of T-helper (Th)1 (TNFα and IFNγ), Th17 (IL-22 and IL-23), and Th2 (IL-4, IL-5, and IL-13) related cytokines in PBMC. In vivo, 10 mg/kg and 30 mg/kg doses of orismilast significantly reduced ear thickness and inflammation markers (p<0.0001, respectively).

CONCLUSION:

Orismilast displayed selective and potent PDE4 inhibition and broad-spectrum anti-inflammatory activity in several pre-clinical models. The results of the study support clinical development of oral orismilast as a novel treatment option for CISD including psoriasis, atopic dermatitis, and hidradenitis suppurativa.

项与 Orismilast 相关的新闻（医药）

2024-03-21

·医药观澜

信达生物：2023年研发投入超19亿元，8个产品在NDA或关键注册临床阶段！

▎药明康德内容团队编辑3月20日晚间，信达生物发布了2023年度业绩报告。根据报告，信达生物在2023年研发投入19.75亿元。目前该公司已有10款商业化产品，同时还有8个产品在上市申请（NDA）或关键注册临床阶段，18个产品已进入临床研究阶段。此外，信达生物还在报告中提到了其研发引擎“国清院”，其在2023年成功交付8款创新分子进入IND准备阶段。信达生物成立于2011年，其研究领域涵盖肿瘤、代谢及心血管、自身免疫、眼科等疾病领域，并已建立包括单克隆抗体、多特异性抗体、免疫细胞因子、抗体偶联药物（ADC）、细胞治疗和小分子药等在内的一系列创新药物形式的产品管线。本文将根据信达生物公告分享其部分产品的最新进展，仅供读者参阅。截图来源：参考资料[1]商业化产品增至十款根据公告，截至目前，信达生物已有10款产品实现商业化，包括自研产品、合作开发产品以及获得商业化权益的产品。信迪利单抗注射液：与礼来公司（Eli Lilly and Company）共同开发的一款创新全人源抗PD-1单克隆抗体，已在中国获批用于治疗肺癌、肝癌、胃癌、食管癌、典型霍奇金淋巴瘤等7项适应症，信达生物与礼来还计划于2024年上半年递交达信迪利单抗联合呋喹替尼治疗2L子宫内膜癌（EMC）的新适应症上市申请（sNDA）。贝伐珠单抗注射液（达攸同）：一款全人源抗VEGF单克隆抗体，已在中国获批用于治疗8项适应症，包括非小细胞肺癌（NSCLC）、转移性结直肠癌、成人复发性胶质母细胞瘤、晚期或不可切除的肝细胞癌、卵巢上皮癌、输卵管癌、或原发性腹膜癌和宫颈癌。阿达木单抗注射液（苏立信）：一款全人源抗TNF-α单克隆抗体，已在中国获批用于治疗8项适应症，包括类风湿关节炎、强直性脊柱炎、银屑病、葡萄膜炎、多关节型幼年特发性关节炎、儿童斑块状银屑病、克罗恩病和儿童克罗恩病。利妥昔单抗注射液（达伯华）：与礼来共同开发的一款重组人-鼠嵌合抗CD20单克隆抗体，已在中国获批准用于治疗多项血液瘤，包括非霍奇金淋巴瘤和慢性淋巴细胞白血病。佩米替尼片：信达生物从Incyte公司引进的一款成纤维细胞生长因子受体（FGFR）亚型1/2/3的强效选择性口服抑制剂，已在中国大陆、台湾和香港地区获批用于治疗既往接受过治疗、肿瘤具有FGFR2基因融合或重排、不可手术切除的局部晚期或转移性胆管癌成人患者。奥雷巴替尼片：与亚盛医药联合开发及商业化的一款新型BCR-ABL TKI，已在中国获批用于治疗任何TKI耐药，并采用经充分验证的检测方法诊断为伴有T315I突变的慢性期CML（CML-CP）或加速期CML（CML-AP），以及对第一代和第二代TKI耐药和/或不耐受的CML-CP患者。雷莫西尤单抗：礼来公司研发的一款VEGFR2拮抗剂，信达生物获授权在中国大陆地区进行商业化；该药已在中国大陆获批两项适应症，包括用于特定的晚期或转移性胃或胃食管结合部腺癌患者的二线治疗，以及特定的肝细胞癌患者的治疗。塞普替尼：礼来公司研发的一款选择性强效RET激酶抑制剂，信达生物获授权在中国大陆地区进行商业化；在中国大陆，塞普替尼已获有条件批准用于治疗特定的NSCLC成人患者、特定的甲状腺髓样癌（MTC）成人和12岁及以上的儿童患者，以及以及特定甲状腺癌（TC）成人和12岁及以上的儿童患者。托莱西单抗：一款新型全人源抗PCSK9单克隆抗体，已在中国获批与他汀类药物、或者与他汀类药物及其他降脂疗法联合用药，用于治疗特定的原发性高胆固醇血症（包括杂合子型家族性和非家族性高胆固醇血症）和混合型血脂异常的成人患者。伊基奥仑赛注射液：与驯鹿生物合作开发的一款全人源靶向BCMA的CAR-T细胞疗法，已在中国获批准用于复发/难治多发性骨髓瘤成人患者。3款产品正在NDA审评中，18个产品进入临床研究根据报告，除了上述商业化的产品，目前信达生物还有3款产品正在NDA审评中，5款候选药物正进行或准备注册或关键临床研究，18个产品已进入临床研究阶段。肿瘤领域两款肺癌靶向药物上市申请优先审评中，预计2024年获批，包括：IBI344(他雷替尼)：与葆元生物合作开发的新型下一代ROS1 TKI，NMPA于2023年第四季度受理了他雷替尼治疗既往接受过ROS1 TKI治疗的局部晚期或转移性ROS1阳性NSCLC成人患者的上市申请并将其纳入优先审评，并于2024年3月受理了他雷替尼1L治疗既往未接受过ROS1 TKI治疗的局部晚期或转移性ROS1阳性NSCLC成人患者的上市申请并将其纳入优先审评。IBI351(氟泽雷塞)：与劲方医药合作开发的一款新型KRAS G12C抑制剂，NMPA于2023年11月受理了IBI351单药治疗既往至少接受过一次系统性治疗的携带KRAS G12C突变的晚期NSCLC患者的上市申请并将其纳入优先审评。同时，在"IO+ADC"方向，信达生物也布局了多款产品，包括：信迪利单抗：一款抗PD-1单抗，已达成多项联合治疗临床试验合作，与多款ADC联用探索治疗实体瘤；IBI343：一款重组靶向CLDN18.2的ADC，已于2023年获得该药治疗三线胃癌患者的1b期临床试验的积极PoC数据，计划于2024年启动IBI343单药治疗三线胃癌患者的多中心3期临床试验；IBI310：抗CTLA-4单克隆抗体，计划于2024年启动IBI310联合信迪利单抗用于可手术切除的MSI-H/dMMR结肠癌新辅助治疗的3期临床试验。此外，信达生物还有多款双抗、三抗及ADC进入早期临床探索。其中，IBI363 （PD-1/IL-2双特异性抗体融合蛋白）已取得针对多个IO耐药/不响应瘤种的初步PoC数据，并准备启动美国临床2期研究。同时信达生物还开发了IBI389（新型CLDN18.2/CD3双特异性抗体）、IBI334 (EGFR/B7H3双特异性抗体)、IBI3003 (GPRC5D/BCMA/CD3三抗)、IBI3001（EGFR/B7H3靶向ADC）、IBI130(TROP2靶向ADC)、IBI133 (HER3靶向ADC)等一系列创新分子。代谢与心血管领域除了前述已获批的抗PCSK9单抗托莱西单抗注射液，信达生物在代谢与心血管领域还开发了多款产品，包括：玛仕度肽(IBI362)：与礼来合作的新一代GLP-1R/GCGR双靶点激动剂，首个减重适应症已递交上市申请，并有五项临床3期研究和更多研究进行中；信达生物计划于2024年根据3期临床试验DREAMS-1及DREAMS-2的数据读出结果，递交玛仕度肽用于2型糖尿病治疗的第二项上市申请。IBI128：新一代痛风高尿酸血症候选分子，海外多中心3期临床研究进行中，将于2024年启动中国1/2期临床研究；IBI3016：新一代高血压小核酸疗法，与圣因生物共同开发，计划2024年启动1期临床研究。自身免疫领域IBI112（匹康奇拜单抗）：创新长效抗IL-23（p19亚基）单克隆抗体，信达生物计划于2024年取得3期临床试验(CLEAER)结果，并向NMPA提交IBI112治疗银屑病的上市申请。IBI353：PDE4抑制剂，可口服治疗银屑病、特应性皮炎，已在海外2期临床研究中获得积极结果。IBI355（CD40L）、IBI356 (OX40L)、IBI3002 (IL-4Rα/TSLP)：创新性免疫分子，已进入临床，拟开发适应症包括原发性干燥综合征(pSS)、系统性红斑狼疮(SLE)、特应性皮炎(AD)、哮喘等疾病。眼科领域IBI302 (efdamrofusp alfa)：一款抗VEGF/补体双特异性融合蛋白，在两项治疗nAMD的2期临床研究中，不同剂量的IBI302分别达到主要终点，已启动治疗新生血管性年龄相关性黄斑病变的3期临床研究。IBI311：一款重组抗IGF-1R单克隆抗体，3期临床研究已达终点，信达生物计划于2024年向NMPA提交IBI311治疗甲状腺眼病（TED）的NDA。IBI324（VEGF-A/ANG-2）、IBI333（VEGF-C/VEGF-A）：目前处于1期临床研究阶段，拟开发的适应症分别为糖尿病黄斑水肿(DME)、新生血管性年龄相关性黄斑变性 (nAMD)。限于篇幅，文中仅对信达生物的部分产品管线进展做了介绍。欲知更多详情，可点击阅读原文查看“信达生物2023年完整版业绩报告”。参考资料：[1]信達生物製藥截至2023年12月31日止年度年度業績公告. Retrieved Mar 20, 2024. From https://pdf.dfcfw.com/pdf/H2_AN202403201627323644_1.pdf?1710959589000.pdf[2]信达生物公布2023年度业绩及公司进展. Retrieved Mar 21, 2024. From https://www.prnasia.com/story/440545-1.shtml本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

抗体药物偶联物上市批准临床申请细胞疗法申请上市

2024-03-21

·美通社

信达生物公布2023年度业绩及公司进展

商业化与研发创新双轮驱动公司高质量发展美国罗克维尔和中国苏州 2024年3月21日 /美通社/ -- 信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、代谢及心血管、自身免疫、眼科等重大疾病领域创新药物的生物制药公司，公布2023年度业绩和公司进展。信达生物制药集团创始人、董事长兼 CEO 俞德超博士表示："2023年是公司新十年发展中实现重要转折的一年，实现了多方面高质量进展，包括：收入实现快速增长，营运效益持续提升，财务表现显著改善，ESG管治水平不断提高，保障了我们业务的长期可持续发展。于过去一年，公司创新研发重要进展频出，肿瘤和综合产品线并进，全球创新潜力管线加码布局，加固了我们全球创新的战略定位。公司将在新十年坚定两大发展战略—可持续成长和全球创新，保证商业运营的高质量成长和产品管线的持续拓宽，也希望与业界同仁一起努力，研发出更多的创新药，为我们的患者、员工、股东及社会持续创造价值。" 公司收益显著提升，财务指标大幅改善收入加速增长，再创新高： 2023年实现总收入人民币 62.06 亿元，同比增长 36.2% ；产品收入人民币 57.28 亿元，同比增长 38.4% ，充分展现公司创新产品组合的强劲市场需求及可持续业务模式优势。公司收益显著提升 ,财务指标大幅改善：得益于收入的快速增长，以及精益运营各方面效率持续提高，各项核心财务指标和盈利能力得到大幅改善，2023年实现：销售费率49.3%，同比下降7.3个百分点行政开支比率8.8%，同比下降5.3个百分点研发投入19.75亿元；现金储备109.70亿人民币（折合约15亿美元），为公司持续专注长期发展提供坚实保障息税折旧及摊销前净亏损（EBITDA Loss）6.00亿元，同比大幅缩减73.0% 注：本文提及的财务数据均采用非国际财务报告准则计量，详情请参阅集团业绩公告。巩固肿瘤领先地位，构建 CVM领域商业化平台商业化产品增至十款，持续拓展新适应症、新市场及医保覆盖，提升用药可及性 [1] , [2] ：达伯舒 ® 、达攸同 ® 、苏立信 ® 、达伯华 ® 、达伯坦 ® 、耐立克 ® 、希冉择 ® 、睿妥 ® 、信必乐 ® （新增，用于治疗高胆固醇血症和混合血脂异常）、福可苏 ® （新增，用于治疗复发难治性多发性骨髓瘤）；达伯舒 ® 七项获批适应症均已成功纳入国家医保药品目录（NRDL），也是目前NRDL中唯一用于治疗一线胃癌及EGFR突变非小细胞肺癌的PD-1抑制剂；亦于2024年2月澳门市场获批；耐立克 ® 首个适应症成功纳入NRDL，新获批第二项适应症，扩大受益CML患者群体；达攸同 ® 、苏立信 ® 、达伯华 ® 所有新增适应症纳入NRDL。打造肿瘤和综合产品线两大增长动力：肿瘤产品线：达伯舒 ® 在内8款产品、近3,000人成熟商业化团队、覆盖全国、卓越专业的品牌形象，巩固肿瘤领域领导地位；综合产品线：数年战略性布局，涵盖心血管及代谢（CVM）、自身免疫、眼科等疾病领域，以期为公司长期成长新添增长动力；在CVM领域系统制定平台架构及商业化策略，有序建立商业化能力、人员和配套支持，保障多款高潜力后期产品管线的价值释放，建立长期品牌形象和竞争优势。后期开发及早期创新并进，里程碑进展频出 8个产品在上市申请（NDA）或关键注册临床，18个产品进入临床研究肿瘤：深化协同价值，加速全球创新两款肺癌靶向药物 NDA优先审评中，预计2024年获批 IBI344 (ROS1，他雷替尼) ：一线及二线ROS1突变肺癌 IBI351 (KRAS G12C，氟泽雷塞) ：二线KRAS G12C突变肺癌发挥"IO+ADC"双项优势达伯舒 ® （ PD-1）：达成多项联合治疗临床试验合作，与多款ADC联用探索治疗实体瘤 IBI343 (CLDN18.2 ADC) ：将准备开展三线胃癌首个多中心临床3期研究；胰腺癌概念验证（Proof of Concept, PoC）研究进行中 IBI310 (CTLA-4)：联合达伯舒 ® （PD-1）启动结肠癌新辅助临床3期研究多款双抗、三抗及 ADC进入早期临床探索 IBI363 (PD-1/IL-2)：多个IO耐药/不响应瘤种取得初步PoC数据；准备启动美国临床2期研究 IBI389（CLDN18.2/CD3）、IBI334 (EGFR/B7H3)、IBI3003 (GPRC5D/BCMA/CD3)、IBI3001（EGFR/B7H3 ADC）、IBI130 (TROP2 ADC)、IBI133 (HER3 ADC)等一系列具有全球创新潜力的创新分子代谢与心血管：多款新一代产品取得重要进展信必乐 ® （ PCSK9) ：唯一获批中国原研 PCSK9单抗，治疗高脂血症玛仕度肽 (GLP-1R/GCGR) ：全球首个处于 NDA阶段的新一代GLP-1R/GCGR双靶点激动剂，首个减重适应症已递交上市申请，五项临床3期研究和更多研究进行中 IBI128 (XOI): 新一代痛风高尿酸血症候选分子，海外 MRCT 3期临床研究进行中，2024年启动中国1/2期临床研究 IBI3016（AGT siRNA）: 新一代高血压小核酸疗法，与圣因生物共同开发， 2024年启动1期更多早期项目即将进入 IND，扩大 CVM战略地位和竞争优势自身免疫：立足全球未满足的临床需求 IBI112 (IL-23p19) ：潜在最佳的疗效优势和延长给药间隔，3期银屑病注册临床2024年将读出数据并申报NDA IBI353 (PDE4）：口服治疗银屑病及特应性皮炎，海外 2期临床研究读出积极信号 IBI355（CD40L）、IBI356 (OX40L)、IBI3002 (IL-4Rα/TSLP)：特色创新性免疫分子进入临床，探索全球自免细分领域，包括原发性干燥综合征 (pSS)、系统性红斑狼疮(SLE)、特应性皮炎(AD)、哮喘等疾病的未满足临床需求眼科：致力提升治疗标准 IBI302 (VEGF/C) ：临床3期研究启动，治疗新生血管性年龄相关性黄斑病变，长间隔给药有望实现优异疗效，潜在改善黄斑萎缩 IBI311 (IGF-1R) ：临床 3期研究达终点，甲状腺眼病突眼改善显著，安全性良好，计划2024年递交NDA IBI324（VEGF-A/ANG-2）、IBI333（VEGF-C/VEGF-A）：临床 1期研究探索差异化临床价值坚持全球创新，保持战略定力研发引擎—国清院： 2023年成功交付8款创新分子进入IND准备阶段肿瘤及综合产品线立项均衡布局、共同引领创新浪潮国际顶级国际学术期刊 /会议发表 ,其中： IBI363 (PD-1/IL-2)的临床前研究发表于Nature Cancer IBI334（EGFR/B7H3）,IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) 的临床前研究入选 2024年AACR大会重磅研究（Late-Breaking Research）大规模产能，坚守高质量生产标准苏州基地 6万升抗体产能和ADC产业化生产线，保障高质量产能供应杭州基地 17万升抗体产能（一期8万升已建成，二期9万升规划中），可保证全球供应上海研发中心 2024年启用切实践行 ESG承诺，承担企业社会责任 MSCI ESG评级跃升至A，在中国医药行业处于领先水平加强 ESG管理实践，探索可持续发展道路，积极响应联合国可持续发展目标（SDGs），持续推进"卓越治理"、"惠享健康"、"品质为先"、"以人为本"和"绿色生态" 截止目前，信达生物创新产品已惠及 250万患者，其中患者援助项目已惠及17余万普通患者，药物捐赠总价值超34亿元人民币积极开展校园招聘，累计为应届生提供 1600多份就业岗位截至目前，信达生物制药集团共纳税超 30亿人民币，为推动经济发展和社会建设做出贡献关于信达生物 "始于信，达于行"，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于开发、生产和销售肿瘤、代谢及心血管、自身免疫、眼科等重大疾病领域的创新药物。公司已有10款产品获得批准上市，同时还有3个品种在NMPA审评中，5个新药分子进入III期或关键性临床研究，另外还有18个新药品种已进入临床研究。公司与海内外药企深入合作加速药物创新，与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson癌症中心等国际合作方达成30多项战略合作。信达生物在不断开发创新药物、谋求自身发展的同时，始终心怀科学善念，坚守"以患者为中心"，心系患者并关注患者家庭，积极履行社会责任。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号www.linkedin.com/company/innovent-biologics/。声明：信达不推荐任何未获批的药品 /适应症使用。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用"预期"、"相信"、"预测"、"期望"、"打算"及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 [1] 达伯舒 ® ：一线食管癌、一线胃癌获納入2022年版NRDL（2023年3月生效）；EGFR突变非小细胞肺癌获纳入2023年版NRDL（谈判目录，2024年1月生效）；耐立克 ® 新药首个适应症纳入2022年版NRDL（谈判目录，2023年3月生效）；达攸同 ® 、苏立信 ® 、达伯华 ® 所有适应症纳入NRDL（常规目录）。 [2] 达伯舒 ® 新增的医保支付范围为：表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗失败的 EGFR 基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者的治疗；不可切除的局部晚期、复发或转移性食管鳞癌的一线治疗；不可切除的局部晚期、复发或转移性胃及胃食管交界处腺癌的一线治疗。

财报医药出海核酸药物申请上市

2024-03-20

·BioSpace

Innovent Announces 2023 Annual Results and Business Updates

A transformative year of strong performance and material innovation progress ROCKVILLE, M.D. and SUZHOU, China, March 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2023 annual results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated:"2023 marked a transformative year for Innovent with material progress. We delivered strong revenue growth, improved operational efficiency and financial performance, and enhanced ESG management practices that underline our sustainable business model. Concurrently, we have achieved material innovation progress in both late- and early-stage R&D development, advanced pipeline portfolio across oncology and general biomedicine, and broadened our global pipeline development scope, reinforcing our global innovation strategy. These achievements underscore the dedication to our strategic goals in the second decade – sustainable growth and global innovation. We will continue our high-quality business growth and advance global innovation progress, and create sustainable value for patients, employees, shareholders and society." Solidified business operations with strong revenue performance and improved financials Strong revenue growth: total revenue RMB6,206.1 million in the year of 2023, an increase of 36.2% compared with the year of 2022; product sales revenue RMB5,728.3 million in the year of 2023, an increase of 38.4% compared with the prior year, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Enhanced operational efficiency and financial performance : EBITDA Loss was significantly narrowed, whose key drivers include strong revenue growth, enhanced operational efficiency and remarkable financial improvement. The selling and marketing expenses of total revenue was 49.3%, a year-over-year decrease of 7.3 percentage points The administration and expenses of total revenue was 8.8%, a year-over-year decrease of 5.3 percentage points R&D expenses was RMB1974.9 million; cash and short-term financial assets was RMB10969.6 million, or approximately USD1.5 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB600.1 million, a notable year-over-year decrease of 73.0% Note: The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company's 2023 annual results announcement. Solidify oncology leadership; build CVM commercialization capability Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage[1],[2] and patient access: Ten approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® (new product, for the treatment of RRMM) and SINTBILO® (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia). All seven approved indications of TYVYT® (sintilimab injection) were included in the NRDL. It is also the only PD-1 inhibitor in the NRDL for the treatment of GC and EGFR-mutated NSCLC. As for market expansion, TVYVT® (sintilimab injection) was newly approved in the Macau market in February 2024. Olverembatinib's first indication was included in the NRDL; and its second indication was newly approved to benefit broader CML patients. All indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection) and SULINNO® (adalimumab injection) were also included in the NRDL. Oncology and general biomedicines as key growth pillars of the company: Oncology: we have launched eight products including TYVYT® (sintilimab injection), established a mature commercial presence of nearly 3,000 employees, nationwide patient access and a well-recognized brand image. We will continue to solidify leadership and expand business in oncology. General biomedicine: we have made considerable progress in past years advancing and expanding our pipeline in general biomedicine, including cardiovascular and metabolism (CVM), autoimmune, and ophthalmology, which we believe will result in substantially increased commercial opportunities and diversified long-term growth. Therefore, as part of the strategic plan, we have been steadily establishing our commercialization capability in the CVM field with systematic approaches. We plan to implement a comprehensive structure and form strategies for key factors, such as patient access, distribution channels, and marketing activities, to ensure all capabilities, personnel and strategies are in place to facilitate effective operations of our business, and to foster long-term brand image and competitive advantage in this new area. Material innovation progress in both late- and early-stage clinical development 8 assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early Phase 1/2 clinical studies Oncology: robust leadership spanning all phases of R&D and novel modalities Deepened synergies of product portfolio with two target therapies for lung cancer under NDA priority review, which are anticipated to launch in 2024: IBI344 (ROS1, taletrectinib): 1L and 2L ROS1 positive NSCLC IBI351 (KRAS G12C, fulzerasib): 2L KRAS G12C mutated NSCLC Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors IBI310 (CTLA-4)：plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer IBI343 (CLDN18.2 ADC)：preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications; a PoC trial in PDAC is ongoing Advancing multiple bi-/tri-specific antibodies and ADCs with global potential in early-stage clinical trials IBI363 (PD-1/IL-2) : preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S. Multiple programs ongoing including IBI389(CLDN18.2/CD3), IBI334 (EGFR/B7H3), IBI3003 (GPRC5D/BCMA/CD3), IBI3001(EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) CVM : multiple new-generation product candidates achieved substantial R&D milestones SINTBILO® (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia Mazdutide (GLP-1R/GCGR): globally the first GLP-1R/GCGR dual agonist in the NDA stage. First NDA of mazdutide was accepted for chronic weight management. Five Phase 3 registrational trials and more clinical trials are underway. IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is undergoing overseas Phase 3 clinical trials conducted by our partner LG Chem. We plan to initiate Phase 1 and Phase 2 clinical trials in China in pace with the global registrational progress. IBI3016（AGT siRNA）: a new-generation siRNA drug candidate to address unmet need in hypertension. We will collaborate with SanageneBio and plan to initiate a Phase 1 clinical trial in 2024. Next-generation projects will enter into IND-enabling stage in 2024, underscoring our dedication to expanding our strategic presence in the CVM field Autoimmune: address global unmet needs in various autoimmune diseases IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. We anticipate completing the Phase 3 registrational clinical trial in support of an NDA submission in 2024. IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis attained positive topline results. IBI355 (CD40L) , IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP): innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases, such as primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE), atopic dermatitis (AD) and asthma. Ophthalmology: a long-standing commitment to elevate standard-of-care IBI302 (VEGF/C): Phase 3 study initiated for the treatment of nAMD, based on the observed stable and robust visual benefit under extended dosing interval and potential inhibition effect in macular atrophy in two Phase 2 studies. IBI311 (IGF-1R): Phase 3 clinical trial met the primary endpoint, demonstrating favorable safety and excellent efficacy; we plan to submit an NDA in 2024 IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy. Global innovation as unwavering long-term strategic priority Innovent Academy as the innovation powerhouse: In 2023, Innovent Academy has successfully delivered eight high quality novel molecules into IND enabling stage. A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, forming another important growth pillar of global innovation as oncology counterparts. Research innovation published in high-impact scientific journals and medical conferences, such as: Preclinical results publication of IBI363 in Nature Cancer Preclinical results of IBI334 (EGFR/B7H3), IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) are accepted as Late-breaking Researches by the American Association for Cancer Research (AACR) 2024 Manufacturing capacity adhering to high-standard quality: Suzhou manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Hangzhou manufacturing site: 170,000L production capacity (first phase of 80,000L completed construction, second phase of 90,000L in plan) to secure global supply Shanghai R&D center will be operational in 2024 Devoted to responsible business practices and enhancing ESG management practices Innovent has been upgraded to 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. In active support of the United Nations' sustainable development goals (SDGs) and in fulfilling our social responsibilities, we continued to enhance ESG management across several key dimensions, including: "Excellent governance", "Enjoying good health", "High-quality as key", "People first" and "Green ecology". About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or is otherwise inaccurate. Company Codes: HongKong:1801, OTC-PINK:IVBIY, HongKong:01801

临床3期临床2期上市批准临床结果临床1期

100 项与 Orismilast 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
银屑病	临床2期	波兰更多	UNION Therapeutics A/S 更多
化脓性汗腺炎	临床2期	丹麦更多	UNION Therapeutics A/S 更多
特应性皮炎	临床2期	匈牙利更多	UNION Therapeutics A/S 更多
斑块状银屑病	临床2期	波兰更多	UNION Therapeutics A/S 更多
自身免疫性疾病	临床2期	中国更多	信达生物制药（苏州）有限公司更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05190419 (CTgov)	临床2期	斑块状银屑病	202	Placebo (Placebo Tablets BID)	顧淵製選簾顧築鹽鹹夢(顧顧憲夢觸廠餘壓製淵) = 醖網衊鹹鏇製築鏇遞繭襯鹹廠製艱製艱廠顧觸 (範壓鏇淵鑰築築膚鬱糧, 糧糧築範鹽蓋憲衊願憲 ~ 夢鹹簾鹽齋願構觸壓選) 更多	-	2024-04-16
				Orismilast modified release tablets (Orismilast Modified Release Tablets 20 mg BID)	顧淵製選簾顧築鹽鹹夢(顧顧憲夢觸廠餘壓製淵) = 淵顧構範壓淵壓壓鹽觸襯鹹廠製艱製艱廠顧觸 (範壓鏇淵鑰築築膚鬱糧, 選餘鏇艱艱範淵淵衊蓋 ~ 繭觸淵鏇夢觸餘築範鬱) 更多
EADV 12022 \| EADV 22022	临床2期	银屑病	36	Orismilast IR	夢衊製簾糧壓鑰繭憲膚(願膚獵築構窪遞鹽憲壓) = The high GI AE (88.9%) and discontinuation rates in the phase 2a trial led to the development of an MR tablet to improve the GI tolerability by changing the release profile of orismilast. In the phase 1 trial, part 1 showed that orismilast MR achieved comparable PK, including t max , to orismilast IR, despite a slower dissolution rate. No nausea was observed in the MR arm and the rate of GI AEs was lower in the MR arm vs the IR arm (16.7% vs 33.3%, respectively). 襯襯夢網鏇齋醖壓範鬱 (獵夢顧選襯製夢襯積醖 )	-	2022-09-07
				Placebo
NCT05190419 (IASOS, EADV2023)	临床2期	银屑病	202	Orismilast 20 mg	窪遞簾築願鏇廠觸遞衊(膚製齋願觸衊夢觸齋鑰) = 夢夢獵範廠鏇壓選獵壓窪鹹鑰鹽觸積鏇艱觸餘 (醖齋顧築膚襯餘醖憲鹽 ) 更多	积极	2023-10-11
				Orismilast 30 mg	窪遞簾築願鏇廠觸遞衊(膚製齋願觸衊夢觸齋鑰) = 範觸夢蓋窪壓衊蓋衊衊窪鹹鑰鹽觸積鏇艱觸餘 (醖齋顧築膚襯餘醖憲鹽 ) 更多
EADV2023	临床2期	化脓性汗腺炎	20	Orismilast 10 mg	襯鹹築構範選壓醖願顧(獵構鏇鹽膚選齋壓廠構) = 齋積遞蓋繭鹽願壓範簾繭顧築積構窪鏇醖窪壓 (醖艱構齋顧鬱製窪鏇簾 ) 更多	-	2023-10-11
				Orismilast 40 mg BID	襯鹹築構範選壓醖願顧(獵構鏇鹽膚選齋壓廠構) = 鏇壓鹹觸繭鬱壓醖壓憲繭顧築積構窪鏇醖窪壓 (醖艱構齋顧鬱製窪鏇簾 ) 更多