ABSK011 已进入注册性临床试验阶段 ABSK011 目前共开展了5 项IST 临床试验，其中进展较快的是两项II 期临床，分别是2021 年年底启动 的ABSK-011-201 研究，适应症为ABSK011 联合阿替利珠单抗治疗HCC；以及2025 年5 月启动的ABSK- 011-205 注册性临床研究，适应症为ABSK011 联合最佳支持治疗2L 治疗FGF19 过表达HCC。 机构：天风证券 研究员：杨松/曹文清 近期，FGFR4 抑制剂ABSK011 联合阿替利珠单抗治疗FGF19 过表达的晚期肝细胞癌（HCC）的Ⅱ期临 床研究（ABSK-011-201）结果，在ESMO GI 2025上发布，展现了该疗法的临床潜力，研究入选ESMO GI 2025 官方汇总的"TopTrials"试验榜单。 ABSK011 在初治和经治HCC 患者中均展现出较大的临床潜力，未来可期在初治人群和免疫治疗失败后 人群中，该方案均展现出显著临床价值。研究显示，截至2024 年11 月19 日，共纳入15 例1L 患者和18 例接受过治疗即2L 的患者，其中16 例既往接受过ICI 治疗。平均年龄54.8 岁，84. ...

港股公司报告 | 公司点评 和誉-B（02256） 证券研究报告 ABSK011 在经治 HCC 适应症上展现出卓越潜力 事件 ABSK011 已进入注册性临床试验阶段 ABSK011 目前共开展了 5 项 IST 临床试验，其中进展较快的是两项 II 期临 床，分别是 2021 年年底启动的 ABSK-011-201 研究，适应症为 ABSK011 联 合阿替利珠单抗治疗 HCC；以及 2025 年 5 月启动的 ABSK-011-205 注册性 临床研究，适应症为ABSK011 联合最佳支持治疗2L 治疗FGF19 过表达HCC。 和誉在研管线丰富，形成从临床前到注册临床阶段的全周期梯队布局 和誉目前有超过 20 款在研药物，有 10 余款药物已进入临床研发阶段，适 应症多数集中在实体瘤领域，包括 NSCLC、TNBC、HCC 等。其中研发进度 最高的药物是 CSF-1R 抑制剂 ABSK021，腱鞘巨细胞瘤 NDA 已获得 CDE 受 理，大中华区权益已经授予默克。此外，FGFR 2/3 高选择性抑制剂 ABSK061 和口服 PD-L1 抑制剂 ABSK043 正在开展关于具有 FGFR2/3 突变的 ...

Core Insights - The Chinese government emphasizes the importance of strengthening pharmaceutical innovation and research to support public health and the development of innovative drugs and medical devices [1] - The trend of Chinese innovative drugs going global is gaining momentum, with significant increases in business development (BD) transactions and funding [2][3] - The pharmaceutical sector is expected to recover in 2025, driven by high-value BD transactions and an improving policy environment [3][4] Industry Developments - The Chinese innovative drug market is projected to see a surge in international collaborations, with over 80 BD projects completed by 2025, indicating a growing global competitiveness [2] - In Q1 2025 alone, BD transactions reached 41, with a total value of approximately 369.29 billion USD, nearing the total for the previous year [2] - Major transactions include the licensing of PD-1/VEGF dual antibody SSGJ-707 to Pfizer for 60.5 billion USD and the global rights for Tislelizumab to Vor Bio for up to 42.3 billion USD [2] Company Highlights - Companies like 基石药业-B (02616) showcased innovative products at the AACR annual meeting, highlighting their advancements in clinical research [5] - 和誉-B (02256) received priority review for its CSF-1R inhibitor for treating TGCT, indicating regulatory support for innovative therapies [6] - 和铂医药 (02142) entered a significant strategic partnership with AstraZeneca, securing 1.75 billion USD in upfront payments and potential milestone payments totaling up to 44 billion USD [6] - 信达生物 (01801) aims to achieve 20 billion RMB in product sales by 2027, with multiple catalysts expected in the coming years, including potential drug launches and data readouts [7]

Core Viewpoint - The company maintains its profit forecasts for 2025 and 2026 at 0.45 billion and 3.20 billion respectively, while upgrading the target price by 22.8% to HKD 11.3, indicating a potential upside of 17.7% from the current stock price [1] Group 1 - The company presented the latest phase II clinical trial data for the FGFR4 inhibitor Irpagratinib (ABSK-011) combined with Atezolizumab for treating advanced hepatocellular carcinoma patients at the ESMO GI conference [2] - The combination therapy showed impressive efficacy and good safety in both first-line and later-line advanced hepatocellular carcinoma patients, with an objective response rate (ORR) of ≥50% and a median progression-free survival (mPFS) of ≥7 months in the 220mg BID dosage group [3] - In patients previously treated with immune checkpoint inhibitors (ICI), the ORR reached 52.9% with an mPFS of 8.3 months, and the treatment was well-tolerated with a 45.5% incidence of grade 3 or higher treatment-emergent adverse events (TEAE) [3] Group 2 - The company is advancing the domestic registration clinical trial for Irpagratinib, with the first patient dosed on June 16, and the therapy received breakthrough therapy designation from the National Medical Products Administration (NMPA) in May [4] - The company received an $85 million global commercialization option exercise fee from Merck for Pimigatinib (ABSK021), which is expected to significantly benefit the company's 2025 performance [5] - The domestic application for Pimigatinib has been accepted by the NMPA for treating giant cell tumor of tendon sheath, with priority review and breakthrough therapy designations already granted [5]

Core Insights - The data indicates significant trading volume increases for various companies, suggesting heightened investor interest and potential market movements [1][2][3][4][5] Group 1: Companies with Notable Volume Increases - 阳光能源 (00757) reported a volume ratio of 2.35, indicating strong trading activity [2] - 长城汽车 (02333) had a volume ratio of 2.21, reflecting increased investor engagement [2] - 郑煤机 (00564) showed a volume ratio of 1.92, suggesting a notable rise in trading [2] Group 2: Additional Companies with Increased Trading Activity - 万国数据-SW (09698) recorded a volume ratio of 1.83, indicating significant market interest [2] - 映恩生物-B (09606) had a volume ratio of 1.78, reflecting heightened trading activity [2] - 超盈国际控股 (02111) reported a volume ratio of 1.71, suggesting increased investor focus [2] Group 3: Companies with Moderate Volume Ratios - 中国能源建设 (03996) had a volume ratio of 1.70, indicating a solid level of trading activity [2] - 亚信科技 (01675) reported a volume ratio of 1.60, reflecting moderate investor interest [2] - 金宝通 (00320) showed a volume ratio of 1.53, suggesting a rise in trading volume [2] Group 4: Companies with Lower Volume Ratios - 中国水务 (00855) had a volume ratio of 1.52, indicating stable trading activity [2] - 广汽集团 (02238) reported a volume ratio of 1.52, reflecting consistent investor engagement [2] - 凯莱英 (06821) showed a volume ratio of 1.52, suggesting steady trading interest [2]

Core Viewpoint - The announcement of the inclusion of ABSK011 (Ipagotinib) as a breakthrough therapy for advanced hepatocellular carcinoma (HCC) patients who have failed previous treatments marks a significant milestone for the company, indicating its potential to become a "billion-dollar molecule" [1][2][3]. Group 1: Breakthrough Therapy Designation - ABSK011 has been officially designated as a breakthrough therapy for treating FGF19 overexpressing advanced HCC patients who have previously undergone immune checkpoint inhibitors (ICI) and multi-targeted tyrosine kinase inhibitors (mTKI) [1][2]. - This designation follows the earlier approval of Pimicotinib (ABSK021), making ABSK011 the second major product of the company to receive such recognition [1]. Group 2: Clinical Data and Efficacy - Recent clinical data presented at the ESMO conference showed that the 220mg BID dosage of ABSK011 achieved an overall response rate (ORR) of 44.8% in patients with FGF19 overexpressing HCC who had previously been treated with ICIs and mTKIs [3][4]. - The drug demonstrated a median duration of response (mDOR) of 7.4 months and a median progression-free survival (mPFS) of 5.5 months, significantly outperforming existing therapies [3][4]. Group 3: Market Potential and Competitive Advantage - The global liver cancer market is projected to reach approximately $5.3 billion by 2029, with immunotherapy accounting for about 72.2% of the market share [6]. - The company has developed ABSK011 as the first small molecule inhibitor targeting the aberrant activation of the FGF19/FGFR4 signaling pathway, which is expected to provide a differentiated treatment option for HCC patients [2][6]. Group 4: Financial Performance and Investment Value - The company has achieved its first full-year profitability in 2024, generating substantial cash flow and signaling a sustainable growth trajectory [8]. - The management has been actively repurchasing shares, reflecting confidence in the company's future and commitment to returning value to investors [8][9]. Group 5: Stock Market Performance - Following a period of volatility, the company's stock price rebounded significantly, reaching a peak of 8.95 HKD, with a maximum increase of 62.14% over a one-and-a-half-month period [11]. - This price recovery indicates strong market interest and confidence in the company's fundamentals and growth potential [11].

Summary of Key Points Core Viewpoint - The company He Yu-B has been actively repurchasing its shares, indicating a strategy to enhance shareholder value and confidence in its stock performance [2]. Share Buyback Details - On May 22, 2025, He Yu-B repurchased 500,000 shares at a price range of HKD 8.680 to HKD 8.790, totaling HKD 4.3635 million [2]. - The closing price on the same day was HKD 8.770, reflecting a decrease of 0.45% with a total trading volume of HKD 38.8446 million [2]. - Year-to-date, the company has conducted 27 buybacks, acquiring a total of 7.595 million shares for a cumulative amount of HKD 56.769 million [2]. Historical Buyback Data - The buyback activity includes various dates with specific details: - May 19: 150,000 shares at a maximum price of HKD 8.280, totaling HKD 1.2358 million [2]. - May 16: 100,000 shares at a maximum price of HKD 8.250, totaling HKD 824,000 [2]. - May 14: 347,000 shares at a maximum price of HKD 8.000, totaling HKD 2.756 million [2]. - Other notable buybacks include: - May 12: 800,000 shares at a maximum price of HKD 7.530, totaling HKD 5.7781 million [2]. - April 17: 860,000 shares at a maximum price of HKD 6.970, totaling HKD 5.9273 million [2]. Overall Market Performance - The stock has shown fluctuations in price, with the highest recorded buyback price being HKD 8.790 and the lowest at HKD 6.580 during the reported period [3].

Investment Rating - The report initiates coverage with an OUTPERFORM rating, targeting a price of HK$13.40 from a current price of HK$8.06 [2]. Core Insights - The company is focused on precision therapy with small molecules in oncology and is expected to achieve profitability in 2024, driven by significant revenue growth from licensing agreements [3][4]. - The core pipeline includes Pimicotinib, which is anticipated to submit a global NDA in 2025, with potential peak sales exceeding USD 2 billion [4][19]. - The company has a robust pipeline targeting FGFR mutations, with potential coverage for approximately 1.9 million patients globally [4][39]. Financial Projections - Revenue projections for FY24, FY25, FY26, and FY27 are RMB 504 million, RMB 595 million, RMB 420 million, and RMB 560 million respectively, with net profit expected to reach RMB 28 million in FY24 [3][8]. - The company is projected to achieve a net profit of RMB 173 million by FY27, with a significant increase in diluted EPS from RMB 0.04 in FY24 to RMB 0.25 in FY27 [3][8]. Pipeline Development - The company has advanced clinical trials for Pimicotinib, which has shown promising results in treating TGCT with an ORR of 87.5% [28]. - The pipeline includes multiple candidates targeting FGFR, with ABSK011 and ABSK061 expected to achieve peak sales of over USD 3 billion collectively [14][39]. - The oral PD-L1 inhibitor ABSK043 is positioned to capture a share of the USD 52 billion PD-(L)1 market, with a projected launch in 2030 [6][14]. Management and Team - The management team has extensive experience in drug development and commercialization, with backgrounds in leading pharmaceutical companies [11][13]. - The company emphasizes early-stage R&D, allocating over 30% of its budget to this area, which supports a pipeline of over 15 preclinical candidates [7][10]. Market Opportunity - The global market for PD-(L)1 therapies is substantial, with no approved small molecule PD-1/PD-L1 drugs currently available, indicating a significant opportunity for the company's oral PD-L1 inhibitor [6][14]. - The unmet medical needs in the treatment of cGvHD and TGCT present additional market opportunities for the company's pipeline [33][25].

Core Viewpoint - The company, He Yu-B, has been actively repurchasing its shares in the Hong Kong stock market, indicating a strategy to support its stock price amidst recent declines [1] Share Buyback Summary - On May 7, the company repurchased 600,000 shares at prices ranging from HKD 7.310 to HKD 7.860, totaling HKD 4.4488 million [1] - The stock closed at HKD 7.400 on the same day, reflecting a decline of 5.37%, with a total trading volume of HKD 41.6738 million [1] - Since April 25, the company has conducted buybacks for seven consecutive days, acquiring a total of 1.8 million shares for a cumulative amount of HKD 13.7038 million, during which the stock price fell by 5.97% [1] - Year-to-date, the company has executed 20 buybacks, totaling 5.398 million shares and an aggregate repurchase amount of HKD 39.5059 million [1] Detailed Buyback Data - The buyback details include various dates, number of shares repurchased, highest and lowest prices, and total amounts spent, showcasing a consistent effort to stabilize the stock price [1]

● 本报记者傅苏颖 近期，中国创新药行业利好消息不断，行业景气度提升。日前备受瞩目的美国癌症研究协会(AACR)年 会在芝加哥召开，多家中国创新药企受邀参会。与此同时，信达生物、康方生物等企业相关产品取得阶 段性突破；部分创新药企业一季报和年报数据亮眼，实现显著同比增长。业内人士认为，随着政策支 持、市场认可提升、投融资环境改善以及研发成果逐步显现，创新药板块发展前景广阔。受益于多个积 极因素推动，医药行业有望在2025年继续迎来估值修复。 创新药密集获批 作为全球规模最大的癌症研究会议之一，AACR年会一直是癌症领域最新研究成果的重要展示平台。近 年来，中国创新药在该会议上的影响力持续攀升。据不完全统计，今年有126家中国药企亮相AACR会 议，共发布近300项新药研究结果，其中包括超80项ADC研究、近40项双抗研究和超10项单抗研究，其 他药物类型还有多肽偶联药物、分子胶、细胞疗法、三抗、PROTAC等，展现出中国创新药研发的强大 实力。 4月28日，和誉医药和信达生物在AACR年会上展示多项最新临床前数据的信息和时间表。信达生物以 壁报的形式展示旗下一系列双抗、三抗及双抗体偶联药物(ADC)肿瘤管线的 ...