机构：天风证券 研究员：杨松/曹文清 事件 公司的PD-L1 小分子抑制剂ABSK043 联合KRAS G12C 抑制剂戈来雷塞片开展联合用药治疗KRAS G12C 突变的NSCLC 的临床研究申请获CDE 批准。此前，公司已经与艾力斯就联合用药达成了合作协 议。 ABSK043 初步临床数据疗效和安全性平衡，联合疗法瞄准近半NSCLC 市场ABSK043 具有FIC 潜力， 全球暂无PD-（L）1 小分子药物上市。ABSK043 是一款口服PD-L1 抑制剂，可与PD-L1 受体特异性结 合并诱导其从细胞表面内吞，有效地抑制PD-1/PD-L1 的相互作用，解除PD-L1 介导的T 细胞活化抑制 作用。ABSK043 在多个临床前模型中展现出与已获批PD-L1 抗体相当的抗肿瘤功效。PD-（L）1 口服 抑制剂研发的一大障碍就是出现周围神经病变的风险更高（如Incyte 的INCB086550），而ABSK043 在 临床试验中展现出良好的安全性和显著的抗肿瘤活性。在共入组77 例患者的实体瘤I 期临床中，87.0% 的患者出现TEAE，其中29.9%为≥3 级，无周围神经病变。 除NSCLC 以外，ABS ...

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company’s PD-L1 small molecule inhibitor ABSK043 has received approval for clinical research to treat KRAS G12C mutated NSCLC in combination with the KRAS G12C inhibitor, adagrasib [1] - ABSK043 shows potential as a first-in-class (FIC) oral PD-L1 inhibitor, with no other oral PD-(L)1 drugs currently available globally [2] - The initial clinical data indicates a balance of efficacy and safety, with 87% of patients experiencing treatment-emergent adverse events (TEAEs) and no peripheral neuropathy observed [2] - ABSK043 is designed specifically for combination therapy, offering advantages such as a short half-life, reduced immunogenicity, and oral administration flexibility [3] - The market potential for ABSK043 is significant, targeting approximately 45%-60% of NSCLC cases, with ongoing clinical trials in various treatment settings [3] Financial Projections - The company is projected to achieve revenues of 630 million, 685 million, and 637 million yuan for the years 2025, 2026, and 2027 respectively [5] - Expected net profits for the same period are 45 million, 70 million, and 102 million yuan [5] - The target price for the stock is set at 22.88 HKD, with the current price at 19.62 HKD [5] Pipeline Developments - The company has several key assets nearing milestones, including: 1. KRAS-G12D inhibitor ABSK141, expected to receive IND approval in the second half of 2025 [4] 2. Pan-KRAS inhibitor ABSK211, anticipated to enter clinical stages in 2026 [4] 3. CSF-1R inhibitor ABSK021, with an NDA submission planned for the second half of 2025 [4] 4. A bispecific antibody-drug conjugate (BsADC) targeting two pan-cancer targets, expected to achieve preclinical candidate status in early 2026 [4]

Core Insights - The FGFR4 inhibitor ABSK011 combined with atezolizumab shows significant clinical potential for treating advanced hepatocellular carcinoma (HCC) with FGF19 overexpression, as highlighted in the phase II clinical study results presented at ESMO GI 2025 [1] - The study included 15 first-line (1L) and 18 second-line (2L) patients, with an overall objective response rate (ORR) of 51.7% and a median progression-free survival (mPFS) of 7.0 months [1][2] - ABSK011 has entered the registration clinical trial phase, with ongoing studies demonstrating its efficacy in both 1L and 2L HCC settings [2][3] Group 1: Clinical Study Results - ABSK011 shows a 50.0% ORR and 7.0 months mPFS in the 1L HCC subgroup, outperforming existing therapies like sorafenib and atezolizumab plus bevacizumab [2] - In the 2L HCC setting, ABSK011 demonstrates a 52.9% ORR and an expected mPFS of 8.3 months, significantly better than current treatments with ORR ranging from 5.9% to 12% and mPFS between 2.8 to 5.4 months [2] Group 2: Company Pipeline and Financial Projections - The company has a robust pipeline with over 20 drug candidates, including 10 in clinical development, primarily targeting solid tumors [3] - Revenue projections for the company are estimated at 630 million, 684 million, and 634 million yuan for 2025-2027, with net profits expected to be 45 million, 68 million, and 98 million yuan respectively [3]

Investment Rating - The report maintains a "Buy" rating for the company [6][7][15] Core Insights - The FGFR4 inhibitor ABSK011 shows exceptional potential in treating advanced hepatocellular carcinoma (HCC) in combination with atezolizumab, as evidenced by its inclusion in the "Top Trials" list at ESMO GI 2025 [1] - ABSK011 demonstrates significant clinical value in both first-line (1L) and second-line (2L) treatment settings for HCC, with an overall objective response rate (ORR) of 51.7% and a median progression-free survival (mPFS) of 7.0 months [2] - The 1L subgroup for ABSK011 shows an ORR of 50.0% and mPFS of 7.0 months, outperforming existing therapies such as sorafenib and atezolizumab plus bevacizumab [3] - ABSK011 has entered the registration clinical trial phase, with five ongoing IST clinical trials, including the ABSK-011-201 and ABSK-011-205 studies [4] - The company has a robust pipeline with over 20 drugs in development, including several in clinical stages targeting solid tumors [5] Financial Projections - Projected revenues for the company are estimated at CNY 630 million, CNY 684 million, and CNY 634 million for the years 2025 to 2027, respectively [6] - Expected net profits for the same period are projected to be CNY 45 million, CNY 68 million, and CNY 98 million [6]

Group 1 - The central economic meeting has a "preview" effect on the main sectors for the upcoming year, with most sectors showing excess performance within 20 trading days after the meeting [2][36] - The main sectors for the year need to meet both the "pre-selection" effect of the meeting and industrial logic, with communication, electronics, home appliances, and automobiles showing significant gains [2][36] - The report suggests that the AI sector and new consumption will be the main themes for the upcoming year, with a potential early performance in Q1 due to the DeepSeek catalyst [2][36] Group 2 - The report indicates that when the economic cycle is in the Plinger phase 2-4, stocks generally perform well, with a focus on the sustainability of M1 recovery as a key indicator [3][41] - The social financing pulse has shown a rebound, with new government bonds increasing year-on-year, while new RMB loans have turned negative [3][41] - The report emphasizes the importance of monitoring external shocks, such as the US economic recession risk, as the AH market may continue to be revalued globally [3][41] Group 3 - The report highlights the performance of the AI sector, particularly with the upcoming GTC conference and the expected launch of the GB300 series, which may significantly enhance computing performance [12] - The global data center investment is projected to reach $57 billion in 2024, driven by AI demand, with a notable increase in the share of intelligent computing centers [12] - The report suggests that the demand for computing power remains strong, with a significant reduction in vacancy rates in data centers [12] Group 4 - The report discusses the strong performance of the rare earth sector, with prices steadily rising and expectations for policy support to boost confidence [21] - The report identifies strategic opportunities in the rare earth sector, particularly for companies like China Rare Earth, Guangsheng Nonferrous, and leading companies in the magnetic materials field [21] - The report notes that the prices of light rare earth oxides and heavy rare earth oxides have increased, indicating a tightening supply situation [21] Group 5 - The report outlines the high demand for photovoltaic materials, with a focus on the carbon fiber sector, which is expected to see continued growth due to the expansion of the renewable energy sector [22] - The report highlights the importance of electronic materials, particularly in the context of domestic substitution trends in upstream raw materials [22] - The report suggests that the wind power sector is experiencing significant growth, with a focus on the concentrated market for wind turbine blades [22]