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 - Shuyou Shen's subsidiary, Beijitai, has received priority review status from the National Medical Products Administration (NMPA) for its product STSP-0601, which is intended for the treatment of bleeding in adult patients with hemophilia A or B with inhibitors, marking a significant advancement in the drug's approval process [2][3]. Company Developments - Shuyou Shen's stock price surged nearly 190% over a 10-day period, reaching a peak of 34.49 yuan per share, the highest since 2016, following the announcement of the priority review [4]. - The company has 13 major R&D projects in clinical research stages, focusing on unmet therapeutic needs, including monoclonal antibodies and protein drugs [4]. - The capitalized R&D expenditure for STSP-0601 (with inhibitors) is reported at 85.16 million yuan, while for STSP-0601 (without inhibitors) it stands at 10.89 million yuan [3]. Industry Context - The NMPA has also granted priority review status to other companies, including He Yu and Ke Ji Pharmaceuticals, indicating a broader trend in the industry towards expedited drug approvals [5][6]. - He Yu's drug ABSK021 has received multiple recognitions, including breakthrough therapy designation from the NMPA and FDA, and has seen a significant revenue increase due to licensing agreements [6][7]. - Ke Ji's product, a CAR-T cell therapy candidate, has also been recognized by the NMPA and FDA, highlighting the growing focus on innovative cancer treatments within the industry [7].

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].

Group 1: Hong Kong Monetary Environment - The President of the Hong Kong Monetary Authority, Yu Weiwen, stated that the current low interest rate environment for the Hong Kong dollar may not be sustainable, and citizens should consider potential risks when making property, investment, or borrowing decisions [1] - The supply of Hong Kong dollar funds has become abundant due to a significant increase in surplus, but future fluctuations in the Hong Kong dollar exchange rate and interest rates remain uncertain [1] Group 2: Financial Data and Tax Revenue - From January to April, the national general public budget revenue was 80,616 billion yuan, a year-on-year decrease of 0.4%, with tax revenue at 65,556 billion yuan, down 2.1% [3] - The securities transaction stamp duty reached 53.5 billion yuan, marking a year-on-year increase of 57.8% [3] Group 3: Company Developments - Xinhua Insurance is set to participate in the third batch of insurance fund long-term investment reform pilot projects, aiming to increase its allocation to Hong Kong stocks [3] - Zhaoyi Innovation plans to issue H-shares and list on the Hong Kong Stock Exchange, considering the interests of existing shareholders and market conditions [4] - CNOOC Defense expects the current shipbuilding market cycle to continue, supported by a balanced global shipyard capacity and demand for fleet renewal [5] - GCL-Poly Energy's assistant vice president indicated that the cost of granular silicon still has room for reduction, with inventory levels remaining low [5] - Nongfu Spring's chairman stated that while the company does not oppose outsourcing, all current products cannot be outsourced due to high dependency on water sources and customized production systems [6] - Hisense Visual released the industry's first "projection-level" home theater equipment, featuring advanced laser projection technology [7] - Huyou-B's CSF-1R inhibitor has been prioritized for review by the National Medical Products Administration for treating TGCT [8] - Shanghai Pharmaceuticals received FDA approval for its rivaroxaban tablets [9] - Tencent launched the first industrial-grade AIGC game content production engine, significantly enhancing game asset generation efficiency [10] Group 4: Financial Performance - ZTO Express reported a 40.9% year-on-year increase in net profit for Q1, reaching 2.0392 billion yuan, with a 19.1% increase in package volume [10] - Gome Retail achieved a profit of 405 million yuan, turning around from a loss, despite a 1.4% decrease in revenue [10] - Huazhu Group's Q1 net profit increased by 35.66% to 894 million yuan, with total revenue rising by 2.22% [11] - Bilibili reported a 24% increase in total revenue for Q1, reaching 7.003 billion yuan, with an adjusted net profit of 362 million yuan, marking a return to profitability [12]

Group 1 - On May 20, 2023, 3SBio announced a licensing agreement with Pfizer for its PD-1/VEGF bispecific antibody "SSGJ-707," granting Pfizer exclusive global rights outside mainland China, with a potential total deal value of $60.5 billion, exceeding 430 billion RMB at current exchange rates [1] - The agreement includes a non-refundable upfront payment of $1.25 billion and up to $4.8 billion in milestone payments for development, regulatory approval, and sales, along with a tiered sales royalty based on product sales in licensed regions [1] - Following the announcement, 3SBio's stock surged over 32%, reaching a market capitalization of 46 billion HKD [1] Group 2 - 3SBio's CEO stated that Pfizer's extensive development experience and international perspective will significantly accelerate the global development and commercialization of SSGJ-707, aiming to provide breakthrough treatment options for patients worldwide [2] - The trend of Chinese innovative drugs entering international markets is expanding, with recent agreements such as CSPC's exclusive licensing deal with Cipla for irinotecan liposome injection in the U.S., which includes a $15 million upfront payment and potential total payments nearing $1.1 billion [2] - Data from Yaozhi shows that in 2024, there were 94 completed outbound licensing transactions for Chinese innovative drugs, totaling $51.9 billion, a 26% year-on-year increase, with 41 transactions in the first quarter of 2025 alone, amounting to $36.9 billion, setting new historical highs [2] Group 3 - On May 12, 2023, former President Trump signed an executive order aimed at reducing prescription drug prices in the U.S., suggesting that prices should decrease by at least 59%, with potential reductions of 80% or 90% in certain cases [3] - Guoyuan Securities believes that the push for drug price reductions in the U.S. will not significantly impact the outbound licensing of innovative drugs from China, citing factors such as low prices for generics and intense competition in the U.S. market [3] - The firm anticipates that the pharmaceutical industry will enter a performance vacuum period starting in May, shifting market focus from earnings to fundamental changes in the industry and companies, maintaining a positive outlook on innovative drugs and international expansion [3] Group 4 - Related concept stocks include Cornerstone Pharmaceuticals, which showcased five innovative products at the AACR annual meeting, including a tri-specific antibody and several ADC molecules [4] - Hanyu Pharmaceuticals announced that its selective small molecule CSF-1R inhibitor has been prioritized for review by the Chinese National Medical Products Administration for treating TGCT patients [4] Group 5 - Hengrui Medicine entered a significant strategic collaboration with AstraZeneca, which includes licensing options for two preclinical immunotherapy projects, with Hengrui receiving $175 million in upfront and milestone payments, plus potential royalties based on net sales [5]

行 业 及 产 业 2025 年 05 月 16 日 诺诚健华 1Q25 业绩点评——核心产品持续放 行 业 研 究 / 行 业 点 评 量，上调全年销售指引 看好 ——海外消费周报（20250509-20250515） 本期投资提示： ⚫ 海外医药：诺诚健华 1Q25 业绩点评——核心产品持续放量，上调全年销售指引 1Q25 业绩：京东健康：1Q25，公司实现收入 166.45 亿元，同比增长 25.5%；期间盈利 9.34 亿元，同比增长 4.6%；non-IFRS 盈利 17.68 亿元，同比增长 47.7%。诺诚健华： 1Q25，公司实现营业收入 3.81 亿元，同比增长 129.9%；归母净利润 0.18 亿元，同比扭亏 为盈；扣非归母净利润 159 万元，同比扭亏为盈。 海外消费服务 国内医药公司更新进展：恒瑞医药即将港股上市：公司宣布计划发行约 2.25 亿股 H 股，其 中，香港公开发售占比为 5.5%，国际配售占比为 94.5%，发行价区间定为每股 41.45- 44.05 港元。公司 H 股预计于 2025 年 5 月 23 日在香港联交所挂牌并开始上市交易。石药 集团伊立替康脂质体签订对 ...

2025 年 05 月 14 日 行业日报 看好/维持 医药 医药 相关研究报告 <<太平洋医药日报（20250513）：诺和 诺德 Sogroya 三期临床成功>>-- 2025-05-14 <<生命科学上游系列研究（一）：供需 回暖，板块向上>>--2025-05-13 <<太平洋医药日报（20250509）：GSK 在研小分子linerixibat三期临床成 功>>--2025-05-13 证券分析师：周豫 电话： E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 证券分析师：张崴 电话： 太平洋医药日报（20250514）：默克匹米替尼拟纳入优先审评 ◼ 走势比较 ◼ 子行业评级 | 化学制药 | 无评级 | | --- | --- | | 中药生产 | 无评级 | | 生物医药Ⅱ | 中性 | | 其 他 医 药 医 | 中性 | | 疗 | | E-MAIL：zhangwei@tpyzq.com 分析师登记编号：S1190524060001 报告摘要 市场表现： 2025 年 5 月 14 日，医药板块涨跌幅+0.10%，跑输沪深 300 指数 1.1 ...