HONG KONG

香港

,

，

April 18, 2025

2025年4月18日

/PRNewswire/ -- Akeso, Inc. (9926.HK) ('Akeso' or the 'Company') is pleased to announce that ebdarokimab, an investigational monoclonal antibody developed by the company, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients..

/PRNewswire/ -- 康方生物（9926.HK）（“康方”或“公司”）欣然宣布，其研发的在研单克隆抗体依达罗克单抗（ebdarokimab）已获得中国国家药品监督管理局（NMPA）批准上市，用于治疗中度至重度斑块型银屑病成人患者。

Ebdarokimab is the company's first Class 1 new drug approved for autoimmune diseases and the second non-oncology new drug to receive marketing approval, following ebronucimab (PCSK9). This approval expands Akeso's commercial portfolio outside of oncology.

依达罗克单抗是该公司首个获批用于自身免疫性疾病的一类新药，也是继依洛努西单抗（PCSK9）之后第二个获得上市批准的非肿瘤新药。此次获批扩大了康方生物在肿瘤领域之外的商业化产品组合。

Ebdarokimab was evaluated in five clinical studies involving Chinese patients with moderate-to-severe plaque psoriasis. Two pivotal Phase III studies demonstrated ebdarokimab's efficacy and safety at both 16 weeks and 52 weeks in these patients.

埃巴单抗在涉及中国中度至重度斑块型银屑病患者的五项临床研究中进行了评估。两项关键的III期研究证明了埃巴单抗在这些患者中于16周和52周时的有效性和安全性。

Positive Short-Term Efficacy:

短期疗效积极：

Patients receiving ebdarokimab injection 135mg with two doses at weeks 0 and 4 showed a significantly positive efficacy, with a PASI 75 response rate of 79.4% at week 16.

接受135mg依巴拉单抗注射的患者在第0周和第4周给药两剂后显示出显著的阳性疗效，第16周时PASI 75应答率达到79.4%。

Sustained Long-Term Efficacy:

长期持续的有效性：

Patients receiving ebdarokimab injection 135mg every 12 weeks (Q12W) for maintenance therapy achieved long-term durable efficacy, with a PASI 75 response rate of 77.9% at week 52.

每12周（Q12W）接受135mg依达罗克单抗注射进行维持治疗的患者实现了长期持久的疗效，第52周时PASI 75反应率达到77.9%。

Significant Improvement in Quality of Life:

生活质量显著改善：

Long-term maintenance treatment with ebdarokimab significantly improved patients' quality of life, alongside the improvement of skin lesions. After 16 weeks of treatment, the impact of skin disease on patients' quality of life decreased by more than 55%, further decreasing to over 65% by week 52.

长期使用依柏多金单抗维持治疗显著改善了患者的生活质量，同时皮肤病变也得到了改善。在治疗16周后，皮肤病对患者生活质量的影响减少了55%以上，并在第52周进一步减少超过65%。

Good Safety Profile:

良好的安全性：

The incidence of adverse events was low and numerically lower than that of the placebo group.

不良事件的发生率较低，且数值上低于安慰剂组。

Convenience of Administration:

管理的便利性：

Ebdarokimab, administered as four subcutaneous injections annually, provides treatment convenience and provides long-term, stable improvements in treatment efficacy and patients' quality of life.

每年通过四次皮下注射给药的Ebdarokimab提供了治疗便利性，并在治疗效果和患者生活质量方面带来长期、稳定的改善。

The clinical data for ebdarokimab was previously reported at the European Academy of Dermatology and Venereology (EADV) congress in 2023 and 2024.

Ebdarokimab的临床数据此前曾在2023年和2024年的欧洲皮肤病与性病学会（EADV）大会上公布。

Professor

教授

Jianzhong Zhang

张建忠

, lead investigator of the pivotal trials and Director of Peking University People's Hospital Dermatology Department

北京大学人民医院皮肤科主任及关键试验的首席研究员

, commented: 'Clinical data consistently demonstrate ebdarokimab's rapid onset, durable efficacy, and excellent safety profile. With only four doses per year, it offers enhanced treatment adherence, enabling long-term disease control and improved quality of life. As clinicians, we believe ebdarokimab will provide a more accessible, effective, and convenient therapeutic option for patients.'.

评论道：“临床数据一致显示，ebdarokimab起效迅速、疗效持久且安全性极佳。每年仅需四次给药，便可提高治疗依从性，实现长期疾病控制并改善生活质量。作为临床医生，我们相信ebdarokimab将为患者提供一种更易获取、更有效且更便捷的治疗选择。”

Dr.

博士

Yu Xia

夏雨

, Founder, Chairwoman, President and CEO of Akeso,

，创始人、董事长、总裁兼首席执行官 of Akeso，

stated: 'In addition to our oncology focus, Akeso has built a forward-looking, innovative pipeline targeting high-prevalence, high-potential disease areas, including metabolic, autoimmune, inflammatory, and neurodegenerative diseases. Our products are steadily entering the commercialization phase. With the successful launches of ebronucimab and ebdarokimab, along with the late-stage clinical development of competitive pipelines like gumokimab (IL-17 monoclonal antibody) and mandokimab (IL-4R monoclonal antibody), as well as the progress of new mechanism drugs, such as the first IL-4R/ST2 bispecific antibody in autoimmune diseases and therapies for neurodegenerative conditions, Akeso's global portfolio and competitive edge in non-oncology fields are strengthening.

表示：“除了专注于肿瘤学领域，Akeso还建立了一条前瞻性的创新研发管线，针对高发性和高潜力的疾病领域，包括代谢、自身免疫、炎症和神经退行性疾病。我们的产品正稳步进入商业化阶段。随着依诺奇单抗和依达洛单抗的成功上市，以及古莫单抗（IL-17单克隆抗体）和曼多单抗（IL-4R单克隆抗体）等具有竞争力的管线进入晚期临床开发，加上新型机制药物的进展，如首个用于自身免疫疾病的IL-4R/ST2双特异性抗体和针对神经退行性疾病的疗法，Akeso在全球非肿瘤领域的布局和竞争优势正在不断增强。

We eagerly anticipate the early approval of more of Akeso's independently developed non-oncology drugs, offering improved treatment outcomes for patients worldwide.'.

我们热切期待康方生物自主研发的更多非肿瘤药物早日获批，为全球患者带来更好的治疗效果。

About Ebdarokimab (IL - 12/IL - 23 Monoclonal Antibody)

关于Ebdarokimab（IL-12/IL-23单克隆抗体）

Ebdarokimab is a novel humanized monoclonal antibody targeting IL-12/IL-23, developed by Akeso. Ebdarokimab is indicated for the treatment of psoriasis, ulcerative colitis, and other autoimmune disorders. By inhibiting the biological activity of cytokines IL-12 and IL-23, it provides therapeutic benefits in autoimmune diseases.

埃巴单抗是一种新型的人源化单克隆抗体，靶向IL-12/IL-23，由康方生物开发。埃巴单抗用于治疗银屑病、溃疡性结肠炎及其他自身免疫性疾病。通过抑制细胞因子IL-12和IL-23的生物活性，它在自身免疫疾病中提供了治疗益处。

Psoriasis pathogenesis is associated with dysregulated immune responses, where IL-12 and IL-23, cytokines sharing a common p40 subunit, play pivotal roles in inflammation and immune modulation. IL-12 induces the activation and proliferation of Th1 cells (T helper cells 1), which secrete interferon-γ and TNF-α (tumor necrosis factor α), while IL-23 is involved in the differentiation of Th17 cells (T helper cells 17), leading to the release of IL-17 (interleukin-17).

银屑病的发病机制与免疫反应失调有关，其中共享共同p40亚基的细胞因子IL-12和IL-23在炎症和免疫调节中起关键作用。IL-12诱导Th1细胞（辅助T细胞1）的活化和增殖，这些细胞分泌干扰素-γ和TNF-α（肿瘤坏死因子α），而IL-23参与Th17细胞（辅助T细胞17）的分化，导致IL-17（白细胞介素-17）的释放。

These cytokines are key mediators in inflammatory processes. Ebdarokimab binds to the p40 subunit of IL-12 and IL-23, preventing their interaction with cell surface receptors, thereby attenuating the release of cytokines such as interferon-γ, TNF-α, and IL-17 from T cells. This inhibition of cytokine-driven immune responses effectively modulates the aberrant immune activity in psoriasis..

这些细胞因子是炎症过程中的关键介质。埃达鲁单抗与IL-12和IL-23的p40亚基结合，阻止它们与细胞表面受体的相互作用，从而减弱T细胞释放干扰素-γ、TNF-α和IL-17等细胞因子。这种对细胞因子驱动的免疫反应的抑制有效调节了银屑病中的异常免疫活动。

About Akeso Inc.

关于康方生物

Akeso,Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative antibody drugs that are affordable to patients worldwide. Since the Company's inception, the Company has established an end-to-end comprehensive drug development platform (ACE Platform), encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant production.

康方生物科技（开曼）有限公司是一家致力于研究、开发、生产及商业化全球病人可负担的创新抗体新药的生物制药公司。自成立以来，该公司已建立端对端全面整合的药物开发平台（ACE平台），涵盖了包括靶点验证、抗体药物的发现与开发、CMC生产工艺开发以及符合GMP标准的生产等完全集成的药物发现和开发功能。

The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology) that can overcome three CMC challenges in the development and manufacturing of bi-specific antibodies: 1.low expression levels, 2. process development hurdles, and 3. antibody stability and druggability..

公司还成功开发了能够克服双特异性抗体开发和生产中的三个CMC挑战的双特异性抗体药物开发技术（Tetrabody技术）：1.表达水平低，2.工艺开发障碍，3.抗体稳定性和成药性。

The Company currently has a portfolio of over 50 innovative programs covering the therapeutic areas of oncology, autoimmune and metabolic diseases. Among these programs are 6 approved products independently developed by the Company and 2 products under NDA review by the NMPA. We are conducting Phase III clinical trials of 12 products, and Phase I/II clinical trials of other 12 products.

公司目前拥有超过50个创新项目的产品组合，涵盖肿瘤、自身免疫和代谢疾病治疗领域。其中6款产品为公司自主研发并已上市，2款产品正在接受NMPA的新药申请审评。我们正在进行12款产品的III期临床试验，以及其他12款产品的I/II期临床试验。

15 of the products are potential global first-in-class (FIC) or best-in-class (BIC) bi-specific antibodies/polyclonal antibodies/bi-specific ADCs. The Company's vision is to become a leading global biopharmaceutical company through focused innovation in R&D, the establishment of world class manufacturing, and continued expansion commercial network..

其中15种产品是潜在的全球首创（FIC）或同类最佳（BIC）双特异性抗体/多克隆抗体/双特异性ADC。公司愿景是通过专注研发创新、建立世界级制造能力以及不断扩展商业化网络，成为全球领先的生物制药公司。

SOURCE Akeso, Inc.

来源：康方生物

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