A Phase II/III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines

The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines

开始日期2026-03-01

申办/合作机构

北京诺诚健华医药科技有限公司

NCT07251998

/ Recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Patients With Moderate to Severe Plaque Psoriasis

The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe plaque psoriasis.

开始日期2025-12-22

申办/合作机构

北京诺诚健华医药科技有限公司

NCT07236099

/ Recruiting临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis

Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)

开始日期2025-11-27

申办/合作机构

北京诺诚健华医药科技有限公司

100 项与 Soficitinib 相关的临床结果

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100 项与 Soficitinib 相关的转化医学

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100 项与 Soficitinib 相关的专利（医药）

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项与 Soficitinib 相关的文献（医药）

2024-10-02·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Recent progress in tyrosine kinase 2 inhibitors for atopic dermatitis

Review

作者: Liu, Qi ; Xia, Yuan ; Li, Yumei ; Zhou, Yuan ; Liu, Lin

INTRODUCTION:

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by persistent itching. Conventional treatments for AD include topical corticosteroids and calcineurin inhibitors, but there are emerging therapies targeting the JAK-TYK2 pathway that are promising for the treatment of AD.

AREAS COVERED:

This review comprehensively explores the pathogenesis, triggers, clinical manifestations, and conventional treatment options for AD. In addition, we discuss novel therapeutic agents targeting alternative signaling pathways, with a focus on clinical trials evaluating tyrosine kinase 2 (TYK2) inhibitors, including systemic and topical agents. We also provide a detailed assessment of ICP-332 efficacy, safety, and potential adverse effects in moderate-to-severe AD.

EXPERT OPINION:

Janus kinase inhibitors that have been recently approved have shown promise for the treatment of AD, especially for patients with severe phenotypes. Preliminary findings from randomized controlled trials suggest that TYK2 inhibitors exhibit rapid efficacy and acceptable safety in the management of AD; however, additional investigations, including long-term trials, are warranted to fully understand their efficacy and safety profile.

JAMA Dermatology

Safety and Efficacy of ICP-332 for Moderate to Severe Atopic Dermatitis

Article

作者: Zhang, Chunlei ; Yin, Wenhao ; Du, Yue ; Zhou, Wei ; Xu, Ai’e ; Liang, Yunsheng ; Duan, Xinsuo ; Zheng, Jie ; Zhang, Litao ; Yang, Wenlin ; Li, Zhiming ; Zhang, Ruzhi ; Fang, Hong ; Xu, Jinhua ; Lei, Tiechi ; Fan, Danbing ; Tao, Xiaohua ; Ding, Yangfeng ; Zhang, Guoqiang ; Chen, Rixin ; Li, Linfeng ; Ji, Chao

Importance:

ICP-332 is a tyrosine kinase 2 inhibitor currently under investigation for the treatment of atopic dermatitis (AD).

Objective:

To evaluate the safety and efficacy of ICP-332 for moderate to severe AD.

Design, Setting, and Participants:

This double-blind, placebo-controlled, phase 2 randomized clinical trial was conducted between February 6 and November 7, 2023, across 19 centers in China. Individuals aged 18 to 75 years who had diagnosis of AD for 1 year or longer and a history of contraindication or inadequate response to topical therapies were included.

Intervention:

Participants were randomized 1:1:1 to receive ICP-332 at 80 mg or 120 mg, or placebo orally once daily for 4 weeks. Study participants and personnel were blinded to group assignment.

Main Outcomes and Measures:

The primary outcome was safety. The key efficacy outcome was the percentage change from baseline in Eczema Area and Severity Index (EASI) at week 4. Other outcomes included percentages of patients achieving EASI-75 (a ≥75% improvement in EASI) and Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with 2 or more points improvement.

Results:

This study included 75 patients (mean [SD] age, 37.3 [18.0] years in the ICP-332 groups and 44.5 [17.4] years in the placebo group; 21 women [28%] and 54 men [72%]). Among the 74 patients included in the safety set, 17 of 25 (68%) in the placebo group, 19 of 25 (76%) in the 80-mg ICP-332 group, and 18 of 24 (75%) in the 120-mg ICP-332 group experienced treatment-emergent adverse events, with all events being mild or moderate. The most common adverse event was decreased blood fibrinogen (1 of 25 [4%] in the placebo group, 6 of 25 [44%] in the 80-mg ICP-332 group, and 5 of 24 [21%] in the 120-mg ICP-332 group). Percentage reductions in EASI at week 4 were −78.2% (95% CI, −89.8% to −66.6%) in the 80-mg ICP-332 group, −72.5% (95% CI, −84.3% to −60.7%) in the 120-mg ICP-332 group, and −16.7% (95% CI, −28.7% to −4.6%) for those receiving placebo. Mean differences vs placebo for percentage reductions from baseline at week 4 in EASI were −61.6% (95% CI, −78.4% to −44.7%; P &lt; .001) and −55.8% (95% CI, −72.8% to −38.9%; P &lt; .001) for 80-mg ICP-332 and 120-mg ICP-332, respectively. There was a statistically significant higher EASI-75 response rate with both ICP-332 doses (64.0% for each; difference vs placebo, 56.0%; 95% CI, 34.4%-77.6%; P &lt; .001) than with placebo and a greater percentage of Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and improvement of 2 or more points at week 4 in the 80-mg ICP-332 group vs placebo (36.0%; difference vs placebo, 32.0%; 95% CI, 11.7%-52.3%; P = .005).

Conclusions and Relevance:

In this phase 2 randomized clinical trial, ICP-332 demonstrated a favorable safety profile and encouraging efficacy, supporting further development for AD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT05702268

233

项与 Soficitinib 相关的新闻（医药）

2026-02-26

·今日头条

诺诚健华（上交所代码：688428；港交所代码：09969）是一家商业化阶段的生物医药高科技公司，2025年首次实现年度扭亏为盈，主要得益于核心产品奥布替尼的持续放量、坦昔妥单抗的获批上市，以及2025年达成的两项高价值BD交易，预计2025年全年实现营收约23.65亿元，同比增长134%，归母净利润约6.33亿元，较上年同期增加约10.74亿元。一、主要业务构成 1. 核心药品研发与商业化 - 奥布替尼（宜诺凯®）：作为公司首个商业化产品，是高选择性BTK抑制剂，2020年12月首次获批上市，2021年被纳入国家医保目录。截至2025年，已在国内获批四个血液瘤适应症，包括边缘区淋巴瘤（MZL）、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）等，其中MZL是公司独家获批的适应症。 - 坦昔妥单抗（明诺凯®）：中国首个获批用于治疗复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）的CD19单抗，2025年5月获得NMPA批准，2025年9月在中国全面启动商业化，已在20多个省份实现处方落地。 - mesutoclax（ICP-248）：自主研发的新型BCL2抑制剂，联合奥布替尼用于一线治疗CLL/SLL的注册性III期临床试验已于2026年2月完成患者入组，有望为患者提供更深层次的缓解。 2. 研发管线布局 - 血液肿瘤领域：已构建以奥布替尼、坦昔妥单抗及mesutoclax三大疗法为基石的产品矩阵，覆盖CLL/SLL、套细胞淋巴瘤（MCL）、MZL及DLBCL四大核心适应症。 - 自身免疫疾病领域：两款TYK2抑制剂soficitinib（ICP-332）和ICP-488分别聚焦中重度特应性皮炎、银屑病等大适应症，其中soficitinib治疗中重度特应性皮炎的III期临床试验已完成患者入组。 - 多元化技术平台：已构建覆盖小分子、PROTAC（蛋白降解靶向嵌合体）、分子胶、环肽、双特异性抗体（双抗）、T细胞衔接器（TCE）、抗体药物偶联物（ADC）等多个前沿技术领域的研发平台。 3. 商务拓展（BD）与全球化战略 - BD交易：2025年达成两项重大BD交易，1月与Prolium达成CD20×CD3双特异性抗体ICP-B02的授权合作，10月与Zenas BioPharma达成奥布替尼及两项临床前资产的授权协议。 - 全球化布局：通过与Zenas合作，加速奥布替尼在多发性硬化症（MS）等自身免疫疾病领域的全球III期临床开发，实现"出海"战略。二、扭亏为盈的核心动力 1. 核心产品放量增长 - 奥布替尼持续放量：2025年前三季度，奥布替尼销售收入达10.1亿元，同比增长45.8%，已超过2024年全年收入。其放量主要得益于独家适应症MZL的持续放量以及2025年4月获批的一线治疗CLL/SLL新适应症。 - 坦昔妥单抗上市贡献：2025年5月获批后，该产品迅速商业化，已在中国20多个省份实现处方落地，为公司带来新的收入增长点。 - 市场潜力：DLBCL是非霍奇金淋巴瘤（NHL）中最常见的亚型，约40%至55%的患者在一线治疗后会出现复发或耐药，坦昔妥单抗的关键研究数据显示总体缓解率（ORR）达57.5%，中位持续缓解时间为43.9个月。 2. BD交易带来的收入增长 - 2025年1月Prolium交易：获得1750万美元的首期及近期付款，按50%比例与康诺亚共享，后续还可获得最高5.025亿美元的额外里程碑付款及产品净销售额的分层特许权使用费。 - 2025年10月Zenas交易：获得1亿美元首付款和近期里程碑付款，以及700万股Zenas普通股，交易总额超过20亿美元，同时有权按产品年度净销售额收取最高17%-19%的分层特许权使用费。 3. 全球化战略加速推进 - "出海"战略：通过与Zenas合作，诺诚健华借助对方在自免领域的丰富经验快速推进全球临床研究，不仅能获得可观的现金收益，还可通过股权安排分享合作资产及Zenas公司的价值增长红利。 - 产品价值最大化：Zenas专注于自免疾病领域，其团队在多发性硬化等自免疾病领域拥有深厚经验，有助于最大化奥布替尼在全球范围内的临床与商业价值。 4. 研发管线的协同效应 - 血液瘤管线协同：BTK抑制剂（奥布替尼）与BCL2抑制剂（mesutoclax）的联用有望为血液瘤患者带来更大获益，尤其是对于BTK抑制剂耐药后的患者。 - 研发效率提升：2025年前三季度研发投入6.8亿元，同比增长9.9%，公司已构建多元化研发平台，2026年计划推动5至7款临床前分子提交新药临床试验（IND）申请。三、未来展望诺诚健华已从依赖外部"输血"的早期阶段，逐步发展为具备自主"造血"能力的创新药企。

2026-02-26

·BioSpace

InnoCare Announces Key Developments of Critical Clinical Studies

BEIJING, Feb. 26, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today key clinical development progress, including the completion of patient enrollment of multiple Phase III registrational trials. The Company completed patient enrollment of a Phase III registrational clinical trial of BCL2 inhibitor mesutoclax (ICP-248) in combination with BTK inhibitor orelabrutinib for treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Mesutoclax is a novel, highly selective oral BCL2 inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. The fixed-duration treatment of mesutoclax in combination with orelabrutinib will provide deeper remission for treatment-naïve CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure to treatment-naïve CLL/SLL patients. In addition, InnoCare also accelerated the clinical development of two novel TYK2 inhibitors. The company has completed patient enrollment in the Phase III registrational trial of soficitinib (ICP-332) for the moderate to severe atopic dermatitis (AD) and in the Phase III registrational trial of ICP-488 for the treatment of psoriasis recently. These important milestones mark a crucial step forward in addressing the huge unmet needs in AD with soficitinib and in psoriasis with ICP-488. Meanwhile, InnoCare has also completed patient enrollment in the Phase II clinical trial of soficitinib for the treatment of vitiligo. Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including AD, vitiligo, prurigo nodularis, CSU, and psoriasis. ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction pathways of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. Contact Media Investors Chunhua Lu 86-10-66609879 chunhua.lu@innocarepharma.com 86-10-66609999 ir@innocarepharma.com

临床2期临床3期

2026-02-18

·郑州广播电视报速递

医保催化+商业化放量，创新药5大龙头企业！

朋友们注意了！沉寂许久的创新药，正在悄悄酝酿新一轮行情。很多人还在纠结短期波动，却没看到行业底层逻辑已经彻底反转：从“仿制药为主”到“创新药出海”，从“持续烧钱”到“逐步盈利”，拐点，往往就在市场最犹豫的时候悄然到来。 2026年更是中国创新药“大药验证”的关键之年，多个临床里程碑即将闪耀全球，引发产业价值重估。IO双抗领域，康方生物AK112的全球临床尤为值得关注，其一线鳞癌非小细胞肺癌适应症三期临床关键数据将在年内读出，通过头对头与PD-1+化疗的直接比拼，有望重新定义肺癌一线治疗的基石标准。中国生物制药公司参与的新药对外许可授权交易在2025年再次创下历史新高，并突破了千亿美元大关。根据数据提供商Pharmcube的最新数据，2025年，中国企业签署了1377亿美元总规模的对外许可交易，较2021年增长了近10倍，交易数量达到186项。下面为大家梳理了5大龙头企业，供大家参考研究。第一家：诺诚健华核心亮点：公司是国内领先的创新药研发企业，旗下ICP-332在海外完成首例受试者给药，在国内完成了治疗AD的临床I期研究并取得积极结果。第二家：兴齐眼药核心亮点：公司在研产品SQ-22031滴眼液为治疗用生物制品1类创新药物，适应症为神经营养性角膜炎和干眼症，目前该产品的I期临床试验已取得临床研究报告。第三家：康辰药业核心亮点：国内血凝酶制剂的领先企业，核心产品苏灵是血凝酶类止血药里唯一的国家一类新药，以创新药研发为重点，产品竞争力显著。第四家：睿智医药核心亮点：公司拥有超过15年的生物药研发服务经验，布局了ADC、多肽药物、PROTAC、CAR-T/NK等众多新型技术服务平台，为客户开发创新治疗方案。第五家：翰宇药业核心亮点：公司是国内多肽制剂龙头，新药利拉鲁肽及利拉鲁肽注射液、特立帕肽及特立帕肽注射液已获得临床批件，同时从外部引进用于治疗II型糖尿病的创新药甲磺酸溴隐亭片。【文末彩蛋】承蒙大家一直以来的支持与厚爱！如果对本文内容还意犹未尽，相信您会在这个号中找到更多共鸣。👇👇👇 风险提示：本文仅作为学习、研究使用，不作为投资建议。股市有风险，入市须谨慎，且市场情况瞬息万变。投资者应独立判断，审慎决策，并自行承担投资风险

抗体药物偶联物免疫疗法细胞疗法临床1期蛋白降解靶向嵌合体

100 项与 Soficitinib 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性荨麻疹	临床3期	中国	北京诺诚健华医药科技有限公司	2026-03-01
非节段型白癜风	临床3期	中国	北京诺诚健华医药科技有限公司	2025-05-09
特应性皮炎	临床3期	中国	北京诺诚健华医药科技有限公司	2024-11-14
中度特应性皮炎	临床3期	中国	广州诺诚健华医药科技有限公司	2024-09-29
重度特应性皮炎	临床3期	中国	广州诺诚健华医药科技有限公司	2024-09-29
斑块状银屑病	临床2期	中国	北京诺诚健华医药科技有限公司	2025-12-22
结节性痒疹	临床2期	中国	北京诺诚健华医药科技有限公司	2025-11-27
荨麻疹	临床申请批准	中国	广州诺诚健华医药科技有限公司	2025-12-16
白癜风	临床申请批准	中国	广州诺诚健华医药科技有限公司	2024-11-25

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临床结果

适应症

分期

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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


NCT05702268 (Pubmed \| JAMA Dermatol) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎	74	ICP-332 80 mg	膚獵簾繭襯艱窪淵鑰壓(壓鏇選襯獵積顧鏇膚鹽) = 繭範鏇艱構壓鑰製鹽構鹹積遞膚蓋餘築醖選窪 (構鹹築網製夢網憲齋艱 ) 更多	积极	2026-01-14
				ICP-332 120 mg	膚獵簾繭襯艱窪淵鑰壓(壓鏇選襯獵積顧鏇膚鹽) = 繭選壓壓齋糧構衊鑰簾鹹積遞膚蓋餘築醖選窪 (構鹹築網製夢網憲齋艱 ) 更多
NCT05702268 (Corporate Publications) 人工标引	临床2期	重度特应性皮炎	75	ICP-332 80毫克组	艱築膚鏇顧繭網構製積(積膚蓋範壓選憲糧鏇糧) = 憲艱構鑰鬱鑰選淵觸齋鹽鹹繭範網衊鏇膚襯鹽 (艱範糧壓夢艱製鑰淵衊 ) 达到更多	积极	2024-03-11
				ICP-332 120毫克组	艱築膚鏇顧繭網構製積(積膚蓋範壓選憲糧鏇糧) = 觸獵窪餘積壓醖餘廠鏇鹽鹹繭範網衊鏇膚襯鹽 (艱範糧壓夢艱製鑰淵衊 ) 达到更多
Corporate Publications 人工标引	临床2期	特应性皮炎	-	ICP-332 80mg	憲淵憲鹹艱蓋鏇願網鹽(齋淵壓網構獵構簾觸範) = 襯積齋遞網鏇糧製鬱鹹鏇構餘鹽蓋膚網繭選遞 (糧範獵窪廠顧鹹齋醖壓 ) 达到更多	积极	2023-12-17
				ICP-332 120mg	憲淵憲鹹艱蓋鏇願網鹽(齋淵壓網構獵構簾觸範) = 糧範選淵憲遞積壓範壓鏇構餘鹽蓋膚網繭選遞 (糧範獵窪廠顧鹹齋醖壓 ) 达到更多
NCT05399030 (NEWS) 人工标引	临床1期	-	8	ICP-332	積製顧鬱鬱壓積醖壓衊(構艱糧淵製獵範窪鑰淵) = 安全且具有良好耐受性夢繭觸獵糧淵齋繭遞願 (窪積構鹽醖窪膚製鬱夢 )	积极	2022-08-21
				Placebo