Core Insights - The focus of cancer drug development is shifting towards targeting "undruggable" targets, moving from traditional optimization of mature targets to innovative strategies that aim to overcome long-standing challenges in drug development [1][16][29] Target: MYC - MYC has been considered a classic "undruggable" target due to its dynamic protein structure and lack of stable binding pockets, making traditional small molecules ineffective [1][16] - The mini-protein therapy OMO-103 has shown promising early activity signals in human studies, with manageable safety profiles and no dose-limiting toxicities observed, particularly in advanced solid tumors [2][17] - A targeted degradation approach using VHL E3 ligase recruitment has demonstrated the ability to dose-dependently clear endogenous MYC protein, showing biological activity in breast and prostate cancer models [2][17] Target: KRAS - KRAS is recognized as one of the most representative "undruggable" targets in oncology, with drug development hindered by its unique molecular biology [3][18] - The KRAS G12C inhibitors sotorasib and adagrasib have received FDA approval, marking a shift towards broader precision interventions [3][18] - The RAS(ON) tri-complex inhibitor zoldonrasib has shown a 61% objective response rate in previously treated non-small cell lung cancer patients, indicating effective pharmacological control over the KRAS G12D mutation [3][18][20] Target: MTAP - MTAP deficiency presents a unique challenge, as it is not a traditional oncogenic driver but is prevalent in various tumors, leading to a lack of clear drug development pathways [6][21] - The PRMT5 inhibitor AMG193 has shown selective inhibition of tumor cells with MTAP deficiency, demonstrating initial anti-tumor activity in late-stage solid tumor patients [6][21][22] - Other candidates like MRTX1719 and TNG462 are in early clinical studies to further validate the synthetic lethality strategy associated with MTAP deficiency [6][22] Target: TP53 - TP53 mutations are widespread in human cancers, complicating traditional inhibitor strategies due to the loss of tumor suppressor function [7][23] - MDM2 inhibitors aim to restore p53 function by relieving its inhibition, with early studies confirming the activation of the p53 pathway and tumor growth suppression [7][23][25] - Small molecule correction strategies targeting mutant TP53 have shown preliminary clinical response signals, indicating potential for restoring p53 function [7][25] Target: WNT/β-catenin Pathway - The WNT/β-catenin pathway is essential for physiological processes but poses safety challenges in therapeutic development due to its role in embryonic development and tissue homeostasis [8][11][26] - The PORCN inhibitor zamaporvint has shown clinical benefit in combination with PD-1 inhibitors in specific colorectal cancer patients, achieving a disease control rate of 57.1% [8][11][26] - Downstream regulatory strategies, such as β-catenin–TBL1 complex inhibitors, are being explored for their potential to selectively modulate tumor activity while maintaining normal physiological functions [8][11][27]

Company Overview - Lingke Pharmaceutical (Zhejiang) Co., Ltd. has submitted an application for listing on the Hong Kong Stock Exchange, with CITIC Securities and Jianyin International as joint sponsors [1] - The company is a leading developer of innovative differentiated small molecule inhibitors targeting autoimmune and inflammatory diseases, focusing on the JAK-STAT signaling pathway [3] Product Pipeline - Key products include LNK01001, a highly selective second-generation JAK1 inhibitor, and LNK01004, a potential first-in-class third-generation soft pan-JAK inhibitor, both targeting autoimmune and inflammatory diseases [3] - LNK01006 is a cutting-edge, highly selective allosteric TYK2 inhibitor designed to penetrate the central nervous system, targeting related diseases [3] - The company has developed the proprietary IsoNova protein degradation platform, which enhances target selectivity and reduces off-target effects, expanding the range of degradable targets [3][4] Market Potential - The global JAK inhibitor market is projected to grow from $5.5 billion in 2019 to $13.9 billion in 2024, with expectations to reach $25.6 billion by 2028 and $40.8 billion by 2033 [6][16] - In China, the JAK inhibitor market is expected to expand from RMB 400 million in 2019 to RMB 3.8 billion in 2024, with forecasts of RMB 17.1 billion by 2028 and RMB 46.5 billion by 2033 [6][16] Clinical Development - As of the last feasible date, the company has 53 issued patents and 106 pending patent applications, with 34 issued patents and 45 pending applications related to its core and key products [7] - LNK01001 is currently undergoing multiple Phase III clinical trials, with new drug application stages expected in 2026 and 2027 for various indications [7] - LNK01004 has completed Phase II trials in China and plans to initiate Phase III trials in mid-2027 [7] Financial Performance - The company reported other income of RMB 20.57 million in 2023, RMB 16.98 million in 2024, and RMB 54.78 million for the nine months ending September 30, 2025 [9] - Annual losses were approximately RMB 260 million in 2023, RMB 312 million in 2024, and RMB 145 million for the nine months ending September 30, 2025 [10] - Research and development expenses were RMB 186 million in 2023, RMB 223 million in 2024, and RMB 121 million for the nine months ending September 30, 2025 [11] Industry Overview - The global market for autoimmune and inflammatory disease drugs grew from $133 billion in 2019 to $160.8 billion in 2024, with a compound annual growth rate (CAGR) of 3.9% [13] - The Chinese market for autoimmune and inflammatory disease drugs is expected to grow from RMB 42.7 billion in 2019 to RMB 66.5 billion in 2024, with a CAGR of 9.3% [13][14]

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