BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that phase II clinical study results of novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-488 met the primary endpoint in adult patients with moderate-to-severe plaque psoriasis..

北京——（商业新闻短讯）——专注于治疗癌症和自身免疫性疾病的领先生物制药公司InnoCare Pharma（香港交易所：09969；苏格兰证券交易所：688428）今天宣布，新型TYK2（酪氨酸激酶2）抑制剂ICP-488的II期临床研究结果符合中重度斑块状银屑病成年患者的主要终点。。

ICP-488, in psoriasis patients treated for 12 weeks, demonstrated an excellent efficacy and safety profile. ICP-488 achieved multiple efficacy endpoints including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (improvement of at least 75%, 90% and 100% in PASI score from baseline) and static Physician’s Global Assessment (sPGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) in both the 6mg and 8mg dosing group respectively..

ICP-488在治疗12周的牛皮癣患者中表现出优异的疗效和安全性。ICP-488实现了多个疗效终点，包括银屑病面积和严重程度指数（PASI）75，PASI 90，PASI 100（PASI评分从基线改善至少75%，90%和100%）和静态医师全球评估（sPGA）0/1（分别在6mg和8mg给药组中得分为0“清晰”或1“几乎清晰”）。。

Following the 12-week treatment with 6mg or 9mg once-daily dosing of ICP-488, PASI 75 reached 77.3% and 78.6% respectively, compared to 11.6% for patients receiving placebo (p<0.0001); PASI 90 reached 36.4% and 50.0% respectively, compared to 0% for patients receiving placebo (p<0.0001); PASI 100 reached 11.4% and 11.9% respectively, compared to 0% for patients receiving placebo (p<0.05); sPGA 0/1 reached 70.5% and 71.4% respectively, compared to 9.3% for patients receiving placebo (p<0.0001)..

在用6mg或9mg每日一次的ICP-488治疗12周后，PASI 75分别达到77.3%和78.6%，而接受安慰剂的患者为11.6%（p＜0.0001）；PASI 90分别达到36.4%和50.0%，而接受安慰剂的患者为0%（p＜0.0001）；PASI 100分别达到11.4%和11.9%，而接受安慰剂的患者为0%（p＜0.05）；sPGA 0/1分别达到70.5%和71.4%，而接受安慰剂的患者为9.3%（p＜0.0001）。。

ICP-488 demonstrated good tolerability and a favorable safety profile, with most treatment emergent adverse events (TEREs) and treatment-related adverse events (TRAEs) being mild or moderate.

ICP-488表现出良好的耐受性和良好的安全性，大多数治疗紧急不良事件（TEREs）和治疗相关不良事件（TRAEs）为轻度或中度。

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, ' Psoriasis requires long-term management, and there remains a significant unmet medical need for new treatments. We are excited to see the positive results from the phase II study of ICP-488, and we will further accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases.”.

。我们很高兴看到ICP-488的II期研究取得了积极的结果，我们将进一步加速其临床开发，使牛皮癣和其他自身免疫性疾病患者受益。”。

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study aimed at evaluating the efficacy, safety, PK and PD characteristics of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients were enrolled in this study. Patients were randomly assigned to one of three treatment groups in a 1:1:1 ratio, a 6mg once-daily group, a 9mg once-daily group, and a placebo group, for 12 consecutive weeks of treatment..

这是一项多中心，随机，双盲，安慰剂对照的II期临床研究，旨在评估ICP-488在中国成年中重度斑块型银屑病患者中的疗效，安全性，PK和PD特征。共有129名患者参加了这项研究。患者被随机分配到三个治疗组中的一个，比例为1:1:1，每天一次6mg组，每天一次9mg组和安慰剂组，连续治疗12周。。

ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokine, thereby inhibiting the pathological process of autoimmune and inflammatory diseases.

ICP-488是一种口服，有效和选择性的TYK2变构抑制剂。通过与JH2结构域结合，ICP-488阻断IL-23，IL-12，1型IFN和其他炎性细胞因子的信号转导，从而抑制自身免疫和炎性疾病的病理过程。

Recent data indicates that approximately seven million people in China are currently living with psoriasis1, and this number is on the rise2. Existing treatment options do not fully address the needs of those affected by this condition, highlighting a significant gap in available therapies. There is a particularly acute demand for new, oral medications.

最近的数据表明，中国目前约有700万人患有牛皮癣1，并且这个数字正在上升2。现有的治疗方案并没有完全满足受这种情况影响的人的需求，突出了现有治疗方法的巨大差距。对新型口服药物的需求特别迫切。

Many patients, especially those with moderate-to-severe psoriasis, continue to be persistently undertreated or remain untreated altogether3..

许多患者，尤其是中度至重度牛皮癣患者，仍然持续未得到治疗或未得到治疗3。。

About InnoCare

关于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 cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States..

InnoCare是一家商业化阶段的生物制药公司，致力于发现、开发和商业化一流和/或一流的药物，用于治疗中国和全球未满足医疗需求的癌症和自身免疫性疾病。InnoCare在北京、南京、上海、广州、香港和美国设有分公司。。

Forward-looking Statement

前瞻性声明

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.

本报告披露了一些前瞻性声明。除事实陈述外，所有其他陈述均可被视为前瞻性陈述，即关于我们或我们管理层未来将或可能发生的意图、计划、信念或期望。这些报表是我们管理层根据其经验和对历史趋势、现状、预期未来发展和其他相关因素的了解所做出的假设和估计。

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..

本前瞻性声明并不保证未来的业绩，实际结果、发展和业务决策可能与前瞻性声明的预期不符。我们的前瞻性陈述也受到大量风险和不确定性的影响，这可能会影响我们的短期和长期业绩。。

1 Epidemiological Investigation on Psoriasis

1银屑病流行病学调查

2 2021. Progress in Epidemiological Investigation of Psoriasis, Journal of Diagnostics Concepts & Practice. 2021.

2021年。牛皮癣流行病学调查进展，诊断概念与实践杂志。2021

3 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018). Chinese Journal of Dermatology. 2019. Research on the Situation of Psoriasis Healthcare in China based on the Global Monitoring Project of Psoriasis and the Causal Relationship between Psoriasis and Obesity and Type II Diabetes.

3中国银屑病诊断和治疗指南（2018）。中国皮肤病学杂志。2019年。基于牛皮癣全球监测项目以及牛皮癣与肥胖和II型糖尿病之间的因果关系，研究中国牛皮癣医疗保健状况。

2020.

2020.