Envudeucitinib的临床疗效，综合两项试验的数据显示： Alumis 1月6日宣布，其 下一代口服TYK2抑制剂Envudeucitinib （ESK-001）在两项针对中度至重度 斑块状银屑病 的关键性 三期临床试验 （ONWARD1和ONWARD2）中 取得了积极的顶线结果 。数据 表明，该药物在 皮肤清除率方面表现出 Best-in-class 的潜力 ，所有主要终点和次要终点均以极高的统 计学显著性达成。受此消息影响，周二 Alumis股价大涨95.31%，市值近17亿美元。 从机制上看，envudeucitinib作为一种新一代的高选择性口服TYK2抑制剂，能够最大限度地抑制 TYK2，从而阻断IL-23和IL-17这两条关键通路，实现对疾病的全面控制。Alumis首席医疗官 Jörn Drappa博士指出，这种机制转化为了临床上快速的起效时间和高比率的皮肤清除率，其症状 改善程度在口服疗法中名列前茅。在安全性方面，该药物在两项试验中均表现出良好的耐受性， 安全性特征与此前的II期项目一致，未发现新的安全信号。治疗期间出现的不良事件大多为轻度 至中度，最常见的包括头痛、鼻咽炎、上呼吸道感染 ...

据华尔街报道， 礼来 正在就以超过10亿美元收购生物技术公司 Ve n t y x Bios c i e n c e s (NAS D AQ:VTYX) 进行后期谈判，美股收盘后股价暴涨57%。 Clinical catalysts represent three potential paths to meaningful value creation in 2025: Late-stage Inflammatory Bowel Disease portfolio provides potential additional source of value: Internally Discovered Clinical-Stage Pipeline Addressing Autoimmune, Inflammatory and Neurodegenerative Diseases with High Unmet Need | 最高: 25.00 | 今开:7.90 | 成交量: 639.75万股 | 换手:8.97% | | --- | --- | --- | --- | | 最低: 7.08 | 昨收:7.8 ...

这两项临床试验均为随机、双盲、安慰剂对照，soficitinib治疗中重度特应性皮炎的III期注册临床试验 共入组579例患者，治疗型白癜风的II期临床试验共入组162例患者。 2026年1月2日，中国北京——生物医药高科技公司诺诚健华（香港联交所代码：09969；上交所代码： 688428）宣布，公司自主研发的新型TYK2抑制剂soficitinib（ICP-332）的临床研究获得重大进展，治疗 中重度特应性皮炎（AD）的III期注册临床试验已完成患者入组。这一重要里程碑标志着soficitinib解决 AD疾病迈出了关键一步，为尽早惠及中国广大的AD患者奠定了重要基础。与此同时，soficitinib治疗白 癜风的II期临床试验也已经完成患者入组。 诺诚健华联合创始人、董事长兼首席执行官崔霁松博士说："特应性皮炎和白癜风都是严重影响患者生 活质量的慢性疾病，当前仍存在大量未被满足的临床需求。很高兴看到我们自主研发的新型TYK2抑制 剂soficitinib在这两项自身免疫性疾病治疗中取得重大进展。我们将继续加快推进soficitinib的临床开 发，期待这款创新药能够早日为自身免疫性疾病患者带来新的治疗希 ...

BEIJING, Dec. 23, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a phase II clinical trial of its novel TYK2 inhibitor ICP-488 for the treatment of cutaneous lupus erythematosus (CLE). ICP-488 is an oral, potent, a ...

Core Viewpoint - Nocera Biopharma (09969) has received approval from the National Medical Products Administration (NMPA) to conduct Phase II/III clinical trials for its novel TYK2 inhibitor soficitinib (ICP-332) aimed at treating chronic spontaneous urticaria (CSU) [1] Company Summary - Nocera Biopharma's stock rose by 3.87% to HKD 13.69, with a trading volume of HKD 37.91 million [1] - Soficitinib is a highly selective oral TYK2 inhibitor developed for various T-cell related autoimmune diseases, with a focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - The mechanism of soficitinib involves blocking cytokine signaling pathways that activate mast cells and inflammatory responses, thereby alleviating symptoms of CSU [1] Industry Summary - There are approximately 50 million patients suffering from chronic spontaneous urticaria globally, with the CSU market expected to reach USD 3 billion by 2029 [2]

Group 1 - The core viewpoint of the article highlights that Nocera Biopharma (09969) has received approval from the National Medical Products Administration (NMPA) to conduct Phase II/III clinical trials for its novel TYK2 inhibitor soficitinib (ICP-332) aimed at treating Chronic Spontaneous Urticaria (CSU) [1] - Soficitinib is a highly selective oral TYK2 inhibitor developed by the company, targeting various T-cell related autoimmune diseases, with a strong focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - The TYK2 enzyme plays a crucial role in the JAK-STAT signaling pathway, which is significant in the inflammatory disease mechanism, and soficitinib works by blocking cytokine signaling pathways that activate mast cells and inflammatory responses, thereby alleviating symptoms of CSU [1] Group 2 - There are approximately 50 million patients suffering from Chronic Spontaneous Urticaria globally, and the CSU market is projected to reach $3 billion by 2029 [2]

Core Viewpoint - InnoCare Pharma has received approval for a Phase II/III clinical trial of its novel TYK2 inhibitor, soficitinib, aimed at treating chronic spontaneous urticaria (CSU), addressing significant unmet medical needs in the dermatology market [1][6]. Group 1: Drug Development - Soficitinib is a selective TYK2 inhibitor being developed for various T-cell related autoimmune disorders, including CSU, atopic dermatitis, and vitiligo [2]. - The drug works by blocking signaling pathways such as IL-4, IL-13, and IL-31, which are involved in mast cell activation and inflammation, thereby reducing symptoms like itch and wheals in CSU patients [3]. Group 2: Market Potential - Chronic spontaneous urticaria affects approximately 50 million patients globally, with the CSU treatment market projected to reach $3 billion by 2029 [5]. - The disease typically lasts two to five years, with some cases extending beyond five years, indicating a substantial need for long-term treatment options [4]. Group 3: Company Overview - InnoCare Pharma is focused on developing first-in-class and best-in-class drugs for cancer and autoimmune diseases, with a robust pipeline targeting ten major autoimmune diseases [6]. - The company operates in multiple locations, including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States, emphasizing its commitment to addressing unmet medical needs both in China and globally [6].

Investment Rating - The report recommends a "Buy" rating for multiple companies in the pharmaceutical sector, including Junshi Biosciences, Hualing Pharmaceutical-B, Aorite, and others [1]. Core Views - The pharmaceutical sector experienced a 3.29% increase this week, outperforming the CSI 300 index by 4.37 percentage points. Sub-sectors such as pharmaceutical commerce, pharmacies, and innovative drugs performed well, while medical devices and consumables lagged [2][12]. - The report emphasizes the importance of market pricing power and the impact of liquidity and risk appetite on investment strategies, particularly in innovative drugs and related supply chains [2][12]. - The report highlights the upcoming patent expirations for small molecule drugs, which are expected to create significant demand for raw materials, with a projected sales impact of $390 billion from 2025 to 2030 [3][13]. Summary by Sections Industry Performance - The pharmaceutical sector's performance this week was characterized by a 3.29% increase, with notable performances in pharmaceutical commerce (+7.31%), pharmacies (+6.83%), and innovative drugs (+5.01%). In contrast, medical devices (0.16%) and new medical infrastructure (1.18%) showed weaker performance [17][29]. - The overall price-to-earnings (P/E) ratio for the pharmaceutical industry is reported at 30.84 times, with a premium of 25.08% compared to the overall A-share market excluding the financial sector [33]. Company Dynamics - Notable company announcements include: - Prologis Pharmaceuticals received a European certificate for its product, enhancing its international market prospects [18]. - Jianyou Co. announced FDA approval for its production site, expanding its manufacturing capabilities [19]. - Fuyuan Pharmaceuticals received a drug registration certificate from the National Medical Products Administration, allowing for the marketing of its product [20]. - The report suggests focusing on companies benefiting from domestic innovative drug support policies, such as Yangguang Nuohuo and Nuosige, as well as those with strong overseas business prospects [15][7]. Raw Materials - The report indicates that the raw materials sector is expected to see a significant increase in demand due to patent expirations, with a projected sales impact of $390 billion from 2025 to 2030. The production of raw materials in H1 2025 reached 1.935 million tons, reflecting an 8.2% year-on-year increase [3][13]. - Companies recommended for attention in the raw materials sector include Aorite, Prologis Pharmaceuticals, and Aoxiang Pharmaceuticals, focusing on innovation and strong performance [3][16].

InnoCare Collaboration - Zenas BioPharma has a collaboration agreement with InnoCare Pharma, a biopharmaceutical company with a market cap exceeding $4.5 billion USD, two marketed products, and over 10 candidates in clinical development[9] - InnoCare will receive global rights to Orelabrutinib and ZB022, and global rights to ZB021 excluding China and Southeast Asia, while retaining global rights to Orelabrutinib in oncology indications[11] - Zenas will receive $35 million USD in cash and 5 million shares of Zenas common stock upfront from InnoCare[11] - Zenas is eligible for up to an additional 2 million shares of Zenas stock and up to $240 million USD in development and regulatory milestone payments for Orelabrutinib, as well as commercial sales milestone payments and tiered royalties on net sales[11] Orelabrutinib (BTKi) Program - A Phase 3 PPMS registration-directed trial has been initiated in the U S for Orelabrutinib, with a Phase 3 SPMS registration-directed trial expected to initiate in Q1 2026[11] - Orelabrutinib treatment in a Phase 2 RRMS trial resulted in a significant reduction in new GdE+ T1 lesions, with a >90% reduction observed at the 80mg QD dose at week 12 (P=0 0018)[48] - The global MS market is expected to exceed $30 billion USD, with SPMS and PPMS representing >$12 billion USD[61] Pipeline Programs - IND clearance and enrollment of the first patient for ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain penetrant TYK2 inhibitor, are expected in 2026[11] - The anti-IL-17 biologics market is currently a $10 billion USD global market with ~50% average annual growth since first approval[74] Obexelimab Program - Phase 3 INDIGO trial for IgG4-RD is fully enrolled with topline results expected around year-end 2025[83] - Phase 2 MoonStone trial for RMS is fully enrolled with (12-week) data expected early Q4 2025[83] - Phase 2 SunStone trial for SLE is enrolling with (24-week) data expected mid-2026[83] - Obexelimab represents a compelling $1 billion+ USD commercial revenue opportunity in the U S alone for IgG4-RD[120]

Core Viewpoint - InnoCare Pharma Inc. has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, granting Zenas rights to develop, manufacture, and commercialize certain products, including the BTK inhibitor Orelabrutinib for multiple sclerosis and other preclinical assets [1][2]. Group 1: Licensing Agreement Details - The agreement allows Zenas exclusive rights to develop and commercialize Orelabrutinib for multiple sclerosis globally, while InnoCare retains rights in oncology and certain regions for non-oncology applications [1]. - Zenas will pay InnoCare up to $100 million in upfront and milestone payments, along with issuing up to 7 million shares of Zenas common stock [2]. - The total potential value of the transaction exceeds $2 billion, including tiered royalties based on annual net sales of the licensed products [2]. Group 2: Product Development and Clinical Trials - Orelabrutinib is a late-stage clinical candidate with potential best-in-class advantages, currently undergoing Phase III trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [3]. - InnoCare has completed patient enrollment for a Phase III trial for immune thrombocytopenia (ITP) and plans to submit a new drug application in mid-2026 [3]. - Zenas aims to lead in the development and commercialization of transformative therapies for autoimmune diseases, leveraging an experienced leadership team and a robust product pipeline [3].