在血液肿瘤领域，目前，奥布替尼在国内已获批用于四个血液瘤适应症，其中三个适应症已纳入医保， 今年4月，新增用于治疗一线 CLL/SLL，市场渗透率在不断增加。 资料显示，交易方Zenas于2024年在纳斯达克上市，是一家聚焦自身免疫性疾病领域的全球生物制药公 司，核心管线以obexelimab和奥布替尼为主，与诺诚健华的主攻方向较为契合。Zenas方面称，借助本 次交易，可以构建优势互补的均衡管线组合。 据了解，作为诺诚健华核心产品的奥布替尼，是一款中枢神经系统强渗透性BTK抑制剂，具有较高的 靶点选择性和良好的安全性。该药品早在2021年就已实现商业化，并于2022年被纳入国家医保目录。 在自身免疫性疾病领域，奥布替尼已于今年第三季度启动针对PPMS的III期临床试验，预计在2026年第 一季度启动SPMS的III期临床试验。同时，上述两项试验均获得美国 FDA及欧洲EMA的认可。此外， ITP中国III期注册临床完成患者入组，预计2026年上半年递交上市申请。 10月8日，诺诚健华披露公告称，其全资子公司与美国生物制药公司Zenas BioPharma签署一项潜在总 额超过20亿美元的全球授权许可协议。 ...

诺诚健华(上交所代码：688428；香港联交所代码：09969)和Zenas BioPharma公司(以下简称Zenas，纳 斯达克代码：ZBIO)今天联合宣布，双方达成重磅授权许可协议，Zenas将获得奥布替尼在多发性硬化 领域的全球开发和商业化权益，以及奥布替尼在非肿瘤的其他治疗领域的开发与商业化权益。Zenas还 获得两款临床前分子(一款新型口服IL-17AA/AF抑制剂和一款透脑性口服TYK2抑制剂)的相关权益。 根据协议条款，Zenas将向诺诚健华支付达1亿美元的首付款和近期里程碑付款，包括2026年达成的里程 碑付款，以及向诺诚健华发行达700万股Zenas普通股股票，包括2026年初达成里程碑向诺诚健华发行的 股票，加上其他达成临床开发、注册和商业化里程碑的付款，总交易金额超过20亿美元。 此外，诺诚健华有权就授权产品的年度净销售额收取最高达百分之十几的分级特许权使用费。 Zenas将获得奥布替尼在多发性硬化领域的全球独家开发、生产和商业化权利，以及奥布替尼在非肿瘤 领域除大中华区及东南亚地区以外区域的权利。诺诚健华将保留奥布替尼在肿瘤领域的全球权利，以及 在大中华区和东南亚地区非肿瘤领域的权利 ...

奥布替尼（Orelabrutinib）是一款中枢神经系统强渗透性以及高选择性的口服小分子布鲁顿酪氨 酸激酶（BTK）抑制剂，有望成为Best-in-class创新药，目前奥布替尼治疗进展型多发性硬化 （MS）进入全球III期临床开发 奥布替尼治疗原发进展型多发性硬化（PPMS）的III期注册临床试验已启动；治疗继发进展型多 发性硬化（SPMS）的III期注册临床试验预计2026年第一季度启动 一款新型口服IL-17AA/AF抑制剂和一款透脑性口服TYK2抑制剂，预计2026年进入临床试验 诺诚健华将于北京时间2025年10月9日早上8:30召开电话会议 Zenas将于美东时间2025年10月8日早上8:00召开电话会议 诺诚健华（上交所代码：688428；香港联交所代码：09969）和Zenas BioPharma公司（以下 简称Zenas，纳斯达克代码：ZBIO）今天联合宣布，双方达成重磅授权许可协议， Zenas将 获得奥布替尼在多发性硬化领域的全球开发和商业化权益，以及奥布替尼在非肿瘤的其他治 疗领域的开发与商业化权益。Zenas还获得两款临床前分子（一款新型口服IL-17 AA/AF抑制 剂和一款透脑 ...

格隆汇9月22日丨维立志博-B(09887.HK)宣布，美国食品药品监督管理局("美国FDA")已于2025年9月19 日批准其自主研发药物LBL-047的新药临床试验("IND")申请。LBL-047是一种由人源化抗血液树突状细 胞抗原2(BDCA2)抗体及经改造的跨膜激活剂和钙调亲环素配体相互作用分子(TACI)胞外域组成的双特 异性融合蛋白。目前全球范围内尚无同时靶向BDCA2及TACI的融合蛋白获批或处于临床阶段，表明 LBL-047具有同类第一的潜力。 LBL-047以BAFF/APRIL和BDCA2为靶点，旨在同时抑制pDC的活性以及B细胞及浆细胞的分化及激 活。通过糖基化修饰，LBL-047能够更强效、广泛地抑制多种异常免疫应答，对B细胞及╱或pDC发挥 关键作用的自身免疫性疾病(包括系统性红斑狼疮(SLE)、皮肌炎、IgA肾病(IgAN)及乾燥综合征)具有强 大治疗潜力。LBL-047通过Fc区改造延长半衰期，可降低给药频次，提高患者依从性。 B细胞及浆细胞样树突状细胞(pDC)在多种自身免疫性疾病的发病机制中发挥至关重要的协同作用。 BAFF(B细胞激活因子)及APRIL(增殖诱导配体)是促 ...

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Shanghai Huao Tai Biopharmaceutical Co., Ltd., has received FDA approval to conduct Phase I clinical trials for the injectable HB0043 in the United States, targeting autoimmune diseases [1] Group 1: Company Developments - The HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both human interleukin-17A and human interleukin-36 receptor, demonstrating high binding and blocking activity [1] - The company has invested approximately 71.11 million yuan in the research and development of this project [1]

智通财经APP讯，智翔金泰(688443.SH)公告，公司收到国家药品监督管理局核准签发的《药物临床试 验批准通知书》，公司在研产品GR2301注射液的临床试验申请获得批准。公告显示，GR2301注射液是 一款由公司自主研发的重组全人源抗IL-15单克隆抗体，可通过结合人IL-15，阻断IL-15与IL-15Rα以及 IL-15&IL-15Rα复合物与IL-2Rβ&IL-2Rγ复合物结合，抑制下游IAK-STAT信号通路，达到治疗因IL-15表 达失调导致的白癜风等自身免疫性疾病的效果。 ...

Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has achieved positive results in a pivotal Phase III clinical trial for its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, with plans to submit a marketing authorization application soon [1][3]. Group 1: Product Information - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1][2]. - The drug works by binding with high affinity to IL-17A and selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1][2]. Group 2: Clinical Trial Details - The Phase III clinical trial (JS005-005-III-PsO) was a multicenter, randomized, double-blind, parallel, placebo-controlled study conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital [3]. - The primary objective was to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of 0 or 1 at week 12, with results showing significant improvement compared to placebo [3]. Group 3: Disease Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2.0%-3.0%, while in China, it is approximately 0.47%, affecting around 125 million people worldwide [2]. - The disease is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, highlighting the urgent need for effective treatments [2].

Core Viewpoint - The company has achieved positive results in a pivotal Phase III clinical trial for its humanized anti-IL-17A monoclonal antibody (JS005) for the treatment of moderate to severe plaque psoriasis, with significant statistical and clinical improvements in primary and key secondary endpoints [1][4]. Company Summary - The company plans to submit a marketing authorization application for JS005 to regulatory authorities in the near future [1]. - The company reported a revenue increase of approximately 382 million yuan, a growth rate of 48.64% year-on-year for the first half of 2025, primarily driven by sales of commercialized drugs, with Tuoyi® achieving sales of 954 million yuan, a year-on-year increase of about 42% [1]. Product Summary - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, which effectively alleviates symptoms of autoimmune diseases by blocking the interaction between IL-17A and its receptors [2]. - The Phase III clinical trial for JS005 in treating moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II trial for treating active ankylosing spondylitis has completed its primary endpoint visits and entered an extended treatment phase [2][4]. Industry Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2%-3%, and approximately 47% in China, affecting around 125 million people worldwide [4]. - Moderate to severe psoriasis significantly impacts patients' physical and mental health, increasing the risk of comorbidities such as metabolic syndrome and cardiovascular diseases, as well as mental health issues like depression and anxiety [4].

Core Viewpoint - Shanghai Junshi Biosciences has announced positive results from a Phase III clinical trial of its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, achieving both primary and key secondary endpoints with statistical significance and clinical relevance [1][3]. Group 1: Drug Information - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1]. - The drug works by binding with high affinity to IL-17A, selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1]. - The Phase III clinical trial for moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II trial for active ankylosing spondylitis has completed its primary endpoint visits and entered an extended treatment phase [1][3]. Group 2: Clinical Trial Details - The Phase III clinical trial (study number: JS005-005-III-PsO) was a multicenter, randomized, double-blind, parallel, placebo-controlled study conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital [3]. - The primary objective was to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 12, with results showing significant improvement compared to placebo [3]. - The study demonstrated that JS005 significantly improved the psoriasis lesions and severity in participants, with a favorable safety profile, and results are planned to be presented at future international academic conferences [3]. Group 3: Disease Context - Psoriasis is a common chronic, relapsing, inflammatory, systemic disease with a global prevalence of 2.0%-3.0%, while in China, the prevalence is 0.47%, affecting approximately 125 million people worldwide, with an increasing trend [2]. - The disease is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, significantly impacting patients' physical and mental well-being [2].

Group 1 - The core point of the news is that Fosun Pharma has signed a licensing agreement with Aikeno for the exclusive rights to research, develop, produce, register, and commercialize the AC-201 molecule in China and Hong Kong, Macau for human disease diagnosis, prevention, and treatment [1] - Fosun Pharma will pay up to RMB 156 million to Aikeno, which includes upfront and milestone payments [1] - AC-201 is an oral small molecule JAK inhibitor developed by Aikeno, primarily aimed at autoimmune diseases, with its first indication (moderate to severe plaque psoriasis) having completed Phase II clinical trials in China [1] Group 2 - The collaboration aims to leverage the group's strengths in drug clinical development, registration, production, and commercialization to enrich the product pipeline in the autoimmune field and enhance the group's core competitiveness in this treatment area [2]