中泰证券（600918）发布研报称，维持和誉-B(02256)"买入"评级，医药核心产品ABSK021近日获得 NMPA批准上市，成为中国首个自主研发的腱鞘巨细胞瘤治疗药物，其NDA也已获FDA受理。该产品的 成功获批标志着公司正式进入商业化阶段，验证了其从研发到上市的全周期创新能力。长期随访数据显 示ABSK021缓解率随时间持续提升，结合与默克的商业化合作，有望为公司提供稳定现金流。 中泰证券主要观点如下： 近期事件 近日，根据NMPA官网最新公示，公司核心产品ABSK021的NDA已获得批准，用于治疗手术切除可能 会导致功能受限或出现较严重并发症的症状性成人腱鞘巨细胞瘤(TGCT)患者。该药物是和誉医药旗下 首个获批上市的自研创新药产品，也是中国首个自主研发的腱鞘巨细胞瘤(TGCT)系统性治疗药物。随 后，ABSK021用于腱鞘巨细胞瘤(TGCT)患者系统性治疗的NDA亦获FDA正式受理。 此事件标志着和誉医药正式从临床研发阶段进入到商业化阶段，公司具备差异化多管线价值进入兑现阶 段，ABSK021的成功上市，首次完整验证了公司从靶点选择、分子设计、临床开发到获批上市的完整 周期创新能力，极大提升了后续 ...

此事件标志着和誉医药正式从临床研发阶段进入到商业化阶段，公司具备差异化多管线价值进入兑现阶 段，ABSK021的成功上市，首次完整验证了公司从靶点选择、分子设计、临床开发到获批上市的完整 周期创新能力，极大提升了后续管线成功开发的可兑现性。 智通财经APP获悉，中泰证券发布研报称，维持和誉-B(02256)"买入"评级，医药核心产品ABSK021近 日获得NMPA批准上市，成为中国首个自主研发的腱鞘巨细胞瘤治疗药物，其NDA也已获FDA受理。该 产品的成功获批标志着公司正式进入商业化阶段，验证了其从研发到上市的全周期创新能力。长期随访 数据显示ABSK021缓解率随时间持续提升，结合与默克的商业化合作，有望为公司提供稳定现金流。 中泰证券主要观点如下： 近期事件 近日，根据NMPA官网最新公示，公司核心产品ABSK021的NDA已获得批准，用于治疗手术切除可能 会导致功能受限或出现较严重并发症的症状性成人腱鞘巨细胞瘤(TGCT)患者。该药物是和誉医药旗下 首个获批上市的自研创新药产品，也是中国首个自主研发的腱鞘巨细胞瘤(TGCT)系统性治疗药物。随 后，ABSK021用于腱鞘巨细胞瘤(TGCT)患者系统性治疗 ...

Core Viewpoint - The company has received approval from CDE for clinical research on its PD-L1 small molecule inhibitor ABSK043 in combination with KRAS G12C inhibitor for treating KRAS G12C mutated NSCLC, indicating significant potential in the market for this combination therapy [1] Group 1: ABSK043 Development - ABSK043 is an oral PD-L1 inhibitor designed for combination therapy, showing a balance of efficacy and safety in preliminary clinical data [1][3] - The drug targets nearly half of the NSCLC market and has first-in-class (FIC) potential, with no other PD-(L)1 small molecule drugs currently available globally [1][3] - In a Phase I clinical trial involving 77 patients, 87.0% experienced treatment-emergent adverse events (TEAEs), with 29.9% being grade 3 or higher, and no peripheral neuropathy reported [1] Group 2: Clinical Efficacy - In a study of 10 lung cancer patients who had not received prior immune checkpoint inhibitor (ICI) treatment, the overall response rate (ORR) was 40%, with 50% of both EGFR and KRAS mutation patients achieving partial response (PR) [2] - Among EGFR mutation patients, those with PD-L1 TPS ≥50% showed progression after at least one line of EGFR TKI treatment [2] Group 3: Market Potential and Future Trials - ABSK043 has significant market potential in KRAS and EGFR NSCLC, which account for approximately 45%-60% of NSCLC cases, covering various treatment scenarios [3] - The company is also conducting a Phase II clinical trial combining ABSK043 with the third-generation EGFR TKI, furmonertinib, with preliminary safety data expected by Q4 2025 [3] - Beyond NSCLC, ABSK043 is involved in Phase I trials for monotherapy in solid tumors and in combination with FGFR2/3 inhibitors in China [3] Group 4: Other Key Assets and Financial Projections - The company is advancing multiple core assets, including the KRAS-G12D inhibitor ABSK141, which is expected to receive IND approval in H2 2025 [4] - The Pan-KRAS inhibitor ABSK211 is anticipated to enter clinical stages by 2026, while the CSF-1R inhibitor ABSK021 is expected to submit an NDA to the FDA in H2 2025 [4] - Financial projections estimate revenues of 630 million, 685 million, and 637 million yuan for 2025-2027, with net profits of 45 million, 70 million, and 102 million yuan respectively [4]

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]