TYK2作为Janus激酶（JAK）家族成员，是JAK-STAT信号通路的关键激酶，在炎症发病机制中扮演重 要角色。 中证报中证网讯（记者 傅苏颖）1月2日，诺诚健华宣布，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，III期注册临床试验已完成患者入组，标志着soficitinib解决AD疾 病迈出了关键一步。 ...

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]

Core Viewpoint - Lingke Pharmaceutical (Zhejiang) Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on innovative small molecule inhibitors for autoimmune and inflammatory diseases [1] Group 1: Company Overview - Lingke Pharmaceutical is a leading developer of differentiated small molecule inhibitors targeting the JAK-STAT signaling pathway [1] - The company's key products include LNK01001, a second-generation JAK1 inhibitor, and LNK01004, a third-generation pan-JAK inhibitor, both aimed at autoimmune and inflammatory diseases [1] - LNK01006 is a high-selectivity TYK2 inhibitor that can penetrate the central nervous system, targeting related diseases [1] - The company has established an innovative proprietary IsoNova protein degradation platform to enhance target selectivity and reduce off-target effects [1] Group 2: Financial Performance - In 2023, 2024, and the first three quarters of 2025, the company reported revenues of approximately 20.57 million, 16.98 million, and 54.78 million yuan, respectively, with net losses of approximately -260 million, -312 million, and -145 million yuan [2] - The net loss in 2024 increased compared to 2023, primarily due to a surge in R&D expenses related to the advancement of LNK01001 into Phase III clinical trials [2] - As of September 30, 2025, the cumulative loss reached 1.1033 billion yuan [2] - The net cash flow from operating activities for the same periods was approximately -227.6 million, -240.9 million, and -85.7 million yuan [2] Group 3: Supply Chain and Dependency - The company relies heavily on the success of its clinical or preclinical candidates, having invested significant resources in the development of LNK01001 and LNK01004 [3] - The proportion of procurement from the top five suppliers increased from 53.2% in 2023 to 68.5% in 2025, indicating rising supply chain concentration [2] - This concentration may weaken bargaining power and could impact clinical progress if core suppliers face capacity constraints or terminate cooperation [2]

Core Viewpoint - Lingke Pharmaceutical (Zhejiang) Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on innovative small molecule inhibitors for autoimmune and inflammatory diseases, with a strong emphasis on the JAK-STAT signaling pathway [1] Group 1: Company Overview - Lingke Pharmaceutical is a leading developer of differentiated small molecule inhibitors targeting autoimmune and inflammatory diseases [1] - The company's clinical pipeline includes key products such as LNK01001, a selective second-generation JAK1 inhibitor, and LNK01004, a potential first-in-class third-generation pan-JAK inhibitor [1] - LNK01006 is a cutting-edge, highly selective TYK2 inhibitor that can penetrate the central nervous system, targeting related diseases [1] - The company has established an innovative proprietary IsoNova protein degradation platform to enhance target selectivity and reduce off-target effects [1] Group 2: Financial Performance - In the first three quarters of 2023, 2024, and 2025, the company reported revenues of approximately 20.573 million, 16.978 million, and 54.78 million respectively, with net losses of about 260 million, 312 million, and 145 million [2] - The net loss in 2024 is expected to widen compared to 2023, primarily due to increased R&D expenses from advancing LNK01001 into Phase III clinical trials [2] - As of September 30, 2025, the cumulative loss reached 1.1033 billion [2] - The net cash flow from operating activities for the first three quarters of 2023, 2024, and 2025 was approximately -227.6 million, -240.9 million, and -85.7 million respectively [2] Group 3: Supply Chain and Dependency - The proportion of procurement from the top five suppliers increased from 53.2% in 2023 to 68.5% in 2025, indicating a rising concentration in the supply chain [2] - This increasing concentration may weaken bargaining power and could directly impact clinical progress if core suppliers face capacity constraints or terminate cooperation [2] Group 4: Drug Development Risks - The company's future business and financial outlook heavily depend on the successful development of its candidate drugs, particularly LNK01001 and LNK01004 [3] - The success of these candidate drugs relies on multiple factors, many of which are beyond the company's control, including favorable safety and efficacy data, timely patient recruitment, and reliable performance from third-party service providers [3] - Even with regulatory approval, candidate drugs may lose competitiveness due to changes in clinical preferences, evolving industry standards, or innovations from competitors [3]

Core Viewpoint - Lingke Pharmaceutical (Zhejiang) Co., Ltd. has submitted an application for listing on the Hong Kong Stock Exchange, aiming for a main board listing, with CITIC Securities (Hong Kong) Co., Ltd. and Jianyin International Financial Limited as joint sponsors [1] Company Overview - The company is a leading developer of innovative differentiated small molecule inhibitors for autoimmune and inflammatory diseases [1] - The clinical pipeline primarily focuses on the Janus kinase-signal transducer and activator of transcription (JAK-STAT) signaling pathway [1] Key Products - The core products include LNK01001, a highly selective second-generation JAK1 inhibitor with potential to become a best-in-class treatment [1] - LNK01004 is a potential first-in-class third-generation soft pan-JAK inhibitor targeting autoimmune and inflammatory diseases [1] - LNK01006 is an advanced, highly selective allosteric TYK2 inhibitor that can penetrate the central nervous system, targeting diseases related to the central nervous system [1] Innovation Platform - The company has established an innovative proprietary IsoNova protein degradation platform, utilizing robust single-molecule design to eliminate inactive isomers, thereby providing clearer and superior safety profiles [1]

Core Viewpoint - The company has successfully established an evaluation scheme for in vitro STAT6 inhibitors/degraders, aiding in the development of drugs targeting STAT6 for autoimmune diseases [1] Group 1: Company Developments - The in vitro pharmacological efficacy department of the company has developed a new evaluation scheme [1] - The focus of the evaluation scheme is on STAT6, a key member of the JAK-STAT signaling pathway [1] Group 2: Scientific Background - STAT6 acts as a transcriptional regulatory hub for the IL-4/IL-13 signaling pathway [1] - It plays a crucial role in immune processes such as Th2 cell differentiation and IgE class switching [1] - The protein is significant in regulating immune homeostasis and the pathological processes of autoimmune diseases [1]