北京商报讯（记者 王寅浩 宋雨盈）12月23日，诺诚健华宣布，公司自主研发的新型TYK2抑制剂ICP- 488治疗皮肤型红斑狼疮获国家药品监督管理局药品审评中心批准开展II期临床试验。 据悉，ICP-488是一款口服的高选择性TYK2变构抑制剂，通过特异性结合TYK2 JH2结构域，阻断IL- 23、IL-12和I型干扰素等炎性细胞因子的信号转导，从而抑制自身免疫性疾病和炎症性疾病的病理过 程。 ...

人民财讯12月23日电，诺诚健华今日宣布，公司自主研发的新型TYK2抑制剂ICP-488治疗皮肤型红斑狼 疮(CLE)获国家药品监督管理局(NMPA)药品审评中心(CDE)批准开展Ⅱ期临床试验。 ...

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector [1] Core Insights - The oral treatment landscape for psoriasis has established a dual leadership pattern with TYK2 and IL23 inhibitors, highlighting the potential of companies like Yifang Biopharma, Nocankang, and Haishike [1][16] - The A-share pharmaceutical index has shown a year-to-date increase of 14.49%, while the Hang Seng Healthcare Index has surged by 65.28% [4][9] - The report emphasizes the importance of innovative drugs, with a ranking of preferred sub-industries: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10][12] Industry Trends - The report notes that the A-share pharmaceutical index has underperformed relative to the CSI 300 index, with a slight decrease of 0.14% this week [4][9] - The report highlights the strong performance of the medical commercial sector (+4.94%) and medical devices (+1.16%) this week, while the chemical pharmaceuticals sector saw a decline of -1.74% [4][9] - The report identifies key companies to watch in the TYK2 space, including Yifang Biopharma and Nocankang, as well as those involved in oral IL23 treatments like Haishike [16][12] Company-Specific Recommendations - Recommended companies in the innovative drug sector include: - Yifang Biopharma - Nocankang - Haishike - Heng Rui Medicine - Bai Jie Shen Zhou - Shi Yao Group - Zai Jian Medicine - Di Zhe Medicine [12][16] - In the CXO and research services sector, recommended companies include: - WuXi AppTec - Hao Yuan Medicine - Aopumai - Kingsray Biotech [12] - For traditional Chinese medicine, companies to focus on include: - Zuo Li Pharmaceutical - Fang Sheng Pharmaceutical - Dong E E Jiao [12] Market Performance - The report indicates that the A-share pharmaceutical index has shown a year-to-date increase of 14.49%, while the Hang Seng Healthcare Index has increased by 65.28% [4][9] - The report also notes that the medical commercial sector has performed well this week, with a gain of 4.94% [4][9]

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]

Core Viewpoint - Nocera Biopharma's new TYK2 inhibitor soficitinib has received approval for II/III clinical trials for treating chronic spontaneous urticaria (CSU), which is expected to enhance the company's market position in the dermatology sector [1][2] Company Summary - Nocera Biopharma's stock rose over 4%, currently trading at 13.69 HKD with a transaction volume of 37.91 million HKD [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 approval from the National Medical Products Administration (NMPA) marks a significant milestone for the company in advancing its clinical pipeline [1] Industry Summary - There are approximately 50 million patients suffering from chronic spontaneous urticaria globally, with the CSU market projected to reach 3 billion USD by 2029 [2]

Group 1 - The core point of the article is that Nocera Biopharma (09969) has seen its stock price increase by over 4% following the announcement of the approval for its new TYK2 inhibitor, soficitinib, to conduct Phase II/III clinical trials for chronic spontaneous urticaria (CSU) [1] - Soficitinib is a highly selective oral TYK2 inhibitor developed by the company, aimed at treating various T-cell related autoimmune diseases, with a focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - TYK2 is a key kinase in the JAK-STAT signaling pathway, playing an important role in the inflammatory disease mechanism, and soficitinib works by blocking cytokine signaling pathways that drive mast cell activation and inflammation, 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]

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 - As of December 18, a total of 87 stocks in the Shanghai and Shenzhen markets have experienced net financing inflows for five consecutive days or more, indicating strong investor interest in these stocks [1] Group 1: Stocks with Longest Net Inflows - The stocks with the longest consecutive net inflows are AVIC Jonhon Optronic Technology and Liyuan Heng, both achieving net inflows for 11 consecutive trading days [1] - Other notable stocks with significant net inflows include China Ping An, Shengmei Shanghai, Chuangzhong Technology, Changchun High-tech, Trina Solar, Aerospace Electric, Nocera Health, and China Shipbuilding Special Gas [1]

Core Viewpoint - Nocera Biopharma's stock has experienced a significant decline recently, despite a strong year-to-date performance, indicating potential volatility in the market [1][2]. Group 1: Company Overview - Nocera Biopharma, established on November 3, 2015, and listed on September 21, 2022, is primarily engaged in the research, production, and commercialization of biopharmaceuticals, focusing on unmet clinical needs in oncology and autoimmune diseases [2]. - The company's revenue composition includes 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and research services [2]. - Nocera Biopharma operates mainly in China and the United States, with a product pipeline that includes ICP-022, ICP-B04, ICP-490, ICP-192, and ICP-723 [2]. Group 2: Financial Performance - For the period from January to September 2025, Nocera Biopharma reported a revenue of 1.115 billion yuan, reflecting a year-on-year growth of 59.85%, while the net profit attributable to shareholders was -64.41 million yuan, an increase of 76.61% year-on-year [2]. - The company's stock price has increased by 78.99% year-to-date, but it has seen declines of 7.76% over the last five trading days, 9.06% over the last 20 days, and 18.29% over the last 60 days [1]. Group 3: Shareholder Information - As of September 30, 2025, Nocera Biopharma had 16,500 shareholders, an increase of 8.66% from the previous period [2]. - The top ten circulating shareholders include various funds, with notable changes such as a decrease in holdings by 富国精准医疗灵活配置混合A and new entries like 万家优选 and 平安医疗健康混合A [3].

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].