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国元国际:给予诺诚健华目标价16.81港元 评级“买入”
Zhi Tong Cai Jing· 2025-12-24 07:12
Group 1 - The core viewpoint of the report is that Nuo Cheng Jian Hua (09969) is expected to achieve revenues of RMB 2.01 billion, RMB 2.06 billion, and RMB 2.56 billion for the years 2025-2027, with net profits of RMB 117 million, RMB 17 million, and RMB 188 million respectively. The company holds approximately RMB 7.2 billion in cash and equivalents, which is sufficient for innovative research. The company is driven by scientific innovation and has strong product capabilities. A DCF model gives a target price of HKD 16.81, indicating a potential upside of 28% from the current price [1] Group 2 - The company focuses on hematological malignancies, solid tumors, and autoimmune diseases. The drug Oubutini has shown excellent performance in the SLE IIb trial, with a SRI-4 response rate of 57.1% in the 75mg group, significantly higher than the placebo group at 34.4%. In subgroups with baseline BILAG≥1A or ≥2B, the response rate improved by 35%, and in those with BILAG≥1A or ≥2B and SLEDAI-2K score ≥4, it improved by 43%. The CDE has approved the initiation of a Phase III clinical trial for Oubutini in SLE, with the first patient expected to be enrolled in Q1 2026 [2] Group 3 - The product pipeline is advancing rapidly, with the new TYK2 inhibitor ICP-488 approved for Phase II clinical trials for cutaneous lupus erythematosus (CLE). ICP-488 specifically binds to the TYK2 JH2 domain, blocking the signaling of inflammatory cytokines such as IL-23, IL-12, and type I interferons. The NMPA has approved the company's Zolbetin (ICP-723) for treating adult and adolescent patients with NTRK fusion gene-positive solid tumors, showing excellent clinical data with an objective response rate of 89.1% and a disease control rate of 96.4%. The 24-month PFS is 77.4%, and the 24-month OS is 90.8%, outperforming first-generation TRK inhibitors. The Phase III registration trial for Oubutini in immune thrombocytopenia (ITP) has completed patient enrollment, with plans to submit a new drug application in the first half of 2026 [3] Group 4 - The company has made significant progress in business development, reaching an agreement with Zenas Bio Pharma in October 2025. Zenas has been granted rights for Oubutini for non-oncological indications outside Greater China and Southeast Asia, as well as for multiple sclerosis globally. Zenas will pay a cash upfront of USD 100 million. The total potential value of this transaction exceeds USD 2 billion, and the collaboration with Zenas will significantly accelerate the overseas clinical development of products [4]
国元国际:给予诺诚健华(09969)目标价16.81港元 评级“买入”
智通财经网· 2025-12-24 07:09
Core Viewpoint - Guoyuan International expects Nuo Cheng Jianhua (09969) to achieve revenues of RMB 2.01 billion, 2.06 billion, and 2.56 billion for the years 2025-2027, with net profits of RMB 117 million, 17 million, and 188 million respectively. The company holds approximately RMB 7.2 billion in cash and equivalents, sufficient for innovative research. The company is driven by scientific innovation and has strong product capabilities. A DCF model gives a target price of HKD 16.81, indicating a potential upside of 28% from the current price [1]. Group 1 - Acalabrutinib shows excellent performance in SLE IIb trials, with a SRI-4 response rate of 57.1% in the 75mg group, significantly higher than the placebo group at 34.4%. In subgroups with baseline BILAG≥1A or ≥2B, the response rate improved by 35%, and in those with BILAG≥1A or ≥2B and SLEDAI-2K score ≥4, it improved by 43%. The CDE has approved the initiation of Phase III clinical trials for Acalabrutinib in SLE, with the first patient expected to be enrolled in Q1 2026 [2]. Group 2 - The company has accelerated its product pipeline, with the new TYK2 inhibitor ICP-488 approved for Phase II clinical trials for cutaneous lupus erythematosus (CLE). ICP-488 specifically binds to the TYK2 JH2 domain, blocking the signaling of inflammatory cytokines such as IL-23, IL-12, and type I interferons. The NMPA has approved the company's Entrectinib (ICP-723) for treating adult and adolescent patients with NTRK fusion gene-positive solid tumors, showing high objective response rates (89.1%) and disease control rates (96.4%), with a 24-month PFS of 77.4% and OS of 90.8%, outperforming first-generation TRK inhibitors. Acalabrutinib's Phase III registration trial for immune thrombocytopenia (ITP) in China has completed patient enrollment, with plans to submit a new drug application in H1 2026 [3]. Group 3 - The company has made significant progress in business development, reaching an agreement with ZenasBio Pharma in October 2025. Zenas has been granted rights for Acalabrutinib for non-oncology indications outside Greater China and Southeast Asia, as well as global rights for multiple sclerosis; IL-17i rights are granted for regions outside Greater China and Southeast Asia, and global rights for CNS TYK2i. Zenas will pay a cash upfront of USD 100 million, with the total potential value of the deal exceeding USD 2 billion, which will significantly accelerate the overseas clinical development of products [4].
InnoCare Announces NMPA Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Cutaneous Lupus Erythematosus
Globenewswire· 2025-12-23 10:00
Core Viewpoint - InnoCare Pharma has received approval for a phase II clinical trial of its TYK2 inhibitor ICP-488 for treating cutaneous lupus erythematosus, marking a significant step in addressing unmet medical needs in autoimmune diseases [1][4]. Company Overview - InnoCare Pharma is a biopharmaceutical company focused on developing first-in-class and best-in-class drugs for cancer and autoimmune diseases, with operations in China and the United States [5]. Product Details - ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor that blocks the signal transduction of inflammatory cytokines, potentially offering a new treatment option for autoimmune diseases [2]. - The drug has shown favorable efficacy and safety in a phase II clinical trial for psoriasis, with plans for a phase III study nearing completion [4]. Disease Context - Cutaneous lupus erythematosus (CLE) is a common autoimmune disease characterized by skin lesions, which can progress to systemic lupus erythematosus affecting multiple organs [3].
诺诚健华宣布新型TYK2抑制剂ICP-488治疗皮肤型红斑狼疮II期临床试验获CDE批准
Zheng Quan Shi Bao Wang· 2025-12-23 03:03
Group 1 - The core point of the news is that Innovent Biologics has received approval from the National Medical Products Administration (NMPA) to conduct Phase II clinical trials for its novel TYK2 inhibitor ICP-488, aimed at treating Cutaneous Lupus Erythematosus (CLE) [1] - ICP-488 is an oral, highly selective TYK2 allosteric inhibitor that blocks the signaling of inflammatory cytokines such as IL-23, IL-12, and type I interferons, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases [1] - CLE is a common type of lupus characterized by diverse skin lesions, with some patients potentially progressing to systemic lupus erythematosus affecting internal organs [1] Group 2 - Innovent Biologics is a commercial-stage biopharmaceutical high-tech company focused on the development of novel drugs for malignant tumors and autoimmune diseases [2] - The company has multiple new drug products at various stages of commercialization, clinical trials, and preclinical development [2] - Innovent Biologics has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [2]
诺诚健华新型TYK2抑制剂ICP-488临床试验获批
Bei Jing Shang Bao· 2025-12-23 02:00
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。 ...
诺诚健华新型TYK2抑制剂ICP-488治疗皮肤型红斑狼疮Ⅱ期临床试验获CDE批准
Zheng Quan Shi Bao Wang· 2025-12-23 01:37
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。 ...
医药生物行业跟踪周报:银屑病口服TYK2/IL23双雄并立格局确立,建议关注益方生物,诺诚健华,海思科等-20251222
Soochow Securities· 2025-12-21 23:30
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]
诺诚健华上涨,自研新型TYK2抑制剂ICP-332治疗CSU获批准开展II/III期临床试验
Zhi Tong Cai Jing· 2025-12-19 04:51
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]
港股异动 诺诚健华(09969)涨超4% 自研新型TYK2抑制剂ICP-332治疗CSU获批准开展II/III期临床试验
Jin Rong Jie· 2025-12-19 04:05
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]
诺诚健华涨超4% 自研新型TYK2抑制剂ICP-332治疗CSU获批准开展II/III期临床试验
Zhi Tong Cai Jing· 2025-12-19 03:29
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]