公司深度研究|和誉-B 匹米替尼开启全球商业化进程，后续临床管线储备丰富 风险提示：商业化不及预期风险；临床开发推进节奏不及预期风险；海外销 售及上市进度不及预期风险；在研新药授权进度不及预期风险等。 | 核心数据 | | --- | | | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业收入（百万元） | 19.1 | 504.0 | 612.1 | 678.8 | 627.2 | | 增长率 | | 2544.2% | 21.5% | 10.9% | -7.6% | | 归母净利润(百万元) | -431.6 | 28.3 | 82.2 | 133.8 | 98.4 | | 增长率 | -12.9% | -106.6% | 190.5% | 62.7% | -26.5% | | 每股收益（EPS） | -0.63 | 0.04 | 0.12 | 0.20 | 0.14 | | 市盈率（P/E） | -24.1 | 367.2 | 126.4 | 77.7 | 105.7 | | 市净率（ ...

默克行使匹米替尼全球商业化选择权，预计在 2025 年下半年向 FDA 递交 NDA。2025 年 5 月 29 日公司收到默克根据双方签订的授 权协议支付的行使匹米替尼(ABSK021)全球商业化选择权行权费 8,500 万美元；该合作中公司可收取最多 6.055 亿美元的款项， 包括首付款、开发及商业化里程碑付款，以及匹米替尼全球实际 年净销售额的两位数比例销售提成。目前，匹米替尼在国内已被 CDE 纳入优先审评，用于需要系统性治疗的腱鞘巨细胞瘤（TGCT） 成人患者；在海外，预计在 2025 年下半年向 FDA 递交 NDA，后续 获批上市销售放量值得期待。 其他多个创新管线快速推进中。其中，FGFR4 抑制剂 ABSK011 针 对既往接受过治疗的 FGF19+肝细胞癌(HCC)患者的注册试验已正 式启动；口服小分子 PD-L1 抑制剂 ABSK043 联合三代 EGFR TKI 一 线治疗 EGFR 突变 NSCLC 的 2 期临床、一线治疗 FGFR2 突变胃癌 的 2 期临床正在开展中，后续将启动联用 KRAS G12C 抑制剂一线 治疗 KRAS G12C 突变 NSCLC 2 期临床；FGF ...

Market Overview - The Hang Seng Index rose by 1.88%, gaining 470 points to close at 25,439 points, while the Hang Seng Tech Index increased by 2.35%. The early trading volume in Hong Kong stocks reached HKD 143.8 billion [1]. Biotechnology Sector - The Hang Seng Biotechnology Index surged by 3.77%, with pharmaceutical stocks collectively rising due to the debut of the "dual directory" for drug applications, promoting a "multi-level + innovative support" strategic transformation. Notable stock performances include: - Zhonghui Biotech-B (02627) up by 24% - Jiuyuan Gene (02566) up by 8.99% - Kintor Pharmaceutical (09939) up by 5.7% - Innovent Biologics (01801) up by 7.27% [1]. Individual Company Performances - Heyu-B (02256) increased by 7.38%, reaching a new high, driven by the exercise fee of Pimiatin boosting performance, with a 59% year-on-year increase in net profit for the first half of the year [2]. - Decent Pharmaceuticals-B (06996) rose over 15% as Claudin18.2 ADC is proposed for inclusion as a breakthrough therapy [3]. - Tencent-related companies reported generally better-than-expected earnings, with Tencent Music-SW (01698) up by 15%, and other companies like Reading Group (00772) and Weimob Group (02013) also seeing significant gains [3]. - Chongqing Machinery and Electric (02722) rose by 8.9%, expecting a 50% year-on-year increase in net profit due to rapid growth in AIDC demand [3]. - China Tobacco Hong Kong (06055) increased by over 7%, maintaining its position in the domestic cigarette export duty-free business, with earnings to be announced next Friday [4]. - Q Technology (01478) surged over 8%, with a 167% year-on-year increase in net profit for the first half of the year, leading to target price upgrades from multiple institutions [5]. - Hon Teng Precision (06088) rose over 9% post-earnings, with a 11% increase in revenue for the first half, although net profit declined by 3% [6]. - Minmetals Resources (01208) increased over 9%, with net profit soaring 15 times in the first half, while the company lowered its cost guidance for its mines [7]. - 361 Degrees (01361) fell over 10% post-earnings, with net profit growth slightly below revenue growth, aligning with expectations [8].

Core Viewpoint - HeYue-B (02256) has seen a significant stock price increase of nearly 9% post-earnings, with a cumulative rise of close to 40%, reaching a historical high of 14.65 HKD, driven by strong financial performance and positive market sentiment [1] Financial Performance - For the first half of the year, HeYue reported revenue of 612 million HKD, representing a year-on-year growth of 23% [1] - The company's profit reached 328 million HKD, marking a substantial year-on-year increase of 59% [1] Market Reactions - CICC noted that the company's performance exceeded expectations, primarily due to higher-than-expected income from Merck [1] - Citigroup highlighted that HeYue's current valuation is low, considering the high certainty of its two late-stage candidates, pimicotinib and irpagratinib, and the potential for differentiated innovation pipeline to secure external licensing [1] Future Catalysts - Citigroup anticipates key catalysts for HeYue in 2025 and 2026, focusing on the approval and commercialization of pimicotinib, the release of phase III data for irpagratinib, and updates on other candidates like ABSK043 and ABSK061, along with potential commercial collaborations [1]

Core Viewpoint - The stock price of HeYu-B (02256) has surged nearly 200% year-to-date, driven by favorable policies and a warming investment climate in the Hong Kong innovative drug sector, leading to increased emphasis on the commercialization capabilities of innovative drug companies [1][2]. Group 1: Stock Performance and Market Recognition - On August 11, the company's stock price surpassed the IPO price of HKD 12.46, closing up 5.93%, and reached a new high of HKD 13.67 the following day [1]. - HeYu was included in the MSCI Global Small Cap Index, which tracks over USD 17 trillion in assets, enhancing its market liquidity and international visibility [4]. Group 2: Innovation and Financial Performance - HeYu's core product, Pimicotinib, is the first Chinese-developed CSF-1R inhibitor entering global Phase III clinical trials, with significant potential in various indications [5][6]. - The company secured a high-value partnership with Merck, receiving an upfront payment of USD 70 million, which is expected to lead to its first annual profit in 2024 [5][7]. - HeYu has maintained around HKD 2 billion in cash reserves over the past three years, ensuring financial stability and supporting ongoing R&D efforts [9]. Group 3: Pipeline and Future Prospects - HeYu's pipeline includes multiple innovative drugs, with Pimicotinib and the FGFR4 inhibitor Irpagratinib being highlighted as potential blockbuster products [10]. - The company has presented promising preclinical results at major conferences, showcasing its advancements in small molecule innovation [10]. - HeYu's stock buyback program, amounting to HKD 200 million, reflects its commitment to returning value to shareholders while maintaining a low price-to-sales (PS) ratio of 13.38, indicating significant growth potential [11].

Investment Rating - The report maintains a "Buy" rating for the company, expecting a relative return of over 20% within the next six months [6]. Core Insights - The company reported a total revenue of 657 million yuan for H1 2025, representing a year-on-year growth of 20%, with a net profit of 328 million yuan, up 59% [1]. - The company has successfully reduced R&D expenses to 228 million yuan, with an R&D expense ratio of 37.25%, down 6 percentage points year-on-year [2]. - The drug Pimiatinib has shown potential as a breakthrough therapy, with a 54% overall response rate (ORR) in a clinical trial, significantly higher than the 3.2% in the placebo group [3]. - The company has initiated a clinical study for ABSK011, a drug targeting FGFR4, which has received breakthrough therapy designation, indicating its potential in treating HCC patients with FGF19 overexpression [4]. - The company is actively developing several pipeline drugs, including ABSK043 and ABSK061, with promising early data [5]. Financial Projections - The company is projected to achieve revenues of 630 million yuan, 684 million yuan, and 634 million yuan for the years 2025, 2026, and 2027, respectively [6]. - The expected net profit for the same years is forecasted to be 45 million yuan, 68 million yuan, and 98 million yuan [6].

Core Viewpoint - The company reported strong performance in 1H25, exceeding expectations primarily due to higher-than-expected income from Merck's exercise of rights [1]. Financial Performance - Revenue for 1H25 reached 612 million yuan, representing a year-on-year increase of 21.5% [1]. - Net profit attributable to shareholders was 328 million yuan, showing a year-on-year growth of 58.8% [1]. - The company received 85 million USD from Merck for global commercialization rights of Pimiatin, contributing significantly to revenue [1]. Development Trends - The company has increased R&D expenditure by 6% while reducing management expenses by 13%, leading to improved profitability [1]. - The company aims to keep operational cash consumption within 570 million yuan for the year, indicating a positive outlook for profitability [1]. - Progress on core pipelines includes the acceptance of the NDA for Pimiatin in China and the initiation of registration clinical trials for Ipagotini [1]. Pipeline Progress - The company is advancing its early-stage pipeline with ongoing clinical studies for oral PD-L1 ABSK043 and FGF2/3 inhibitor ABSK061 [2]. - ABSK061 has completed the first patient enrollment for achondroplasia and is moving forward with a Phase II trial for gastric cancer in combination with ABSK043 [2]. - The new generation brain-penetrable PRMT5-MTA inhibitor ABSK131 has also commenced patient dosing [2]. Profit Forecast and Valuation - Due to higher-than-expected licensing income, the net profit forecast for 2025 has been raised by 7.5% to 48.07 million yuan [2]. - The 2026 net profit forecast remains unchanged at 320 million yuan [2]. - The target price has been increased by 32.7% to 15 HKD, indicating a potential upside of 30.5% from the current stock price [2].

Core Viewpoint - The company has raised its 2025 net profit forecast by 7.5% to 48.07 million HKD due to better-than-expected revenue from the licensing agreement with Merck, maintaining its 2026 net profit forecast at 320 million HKD, and has increased the target price by 32.7% to 15 HKD, indicating a potential upside of 30.5% from the current stock price [1] Financial Performance - In the first half of 2025, the company reported revenue of 612 million HKD, a year-on-year increase of 21.5%, and a net profit attributable to shareholders of 328 million HKD, reflecting a 58.8% year-on-year growth, exceeding expectations primarily due to higher-than-expected income from Merck [2][3] Key Developments - The company received an 85 million USD licensing fee from Merck for the global commercialization rights of Pimiatinib, contributing to the reported revenue of 612 million HKD. The company has increased its R&D expenditure by 6% while reducing management expenses by 13%, leading to strong profitability in the first half of 2025 [3] - The company has made significant progress with its core pipelines, with the NDA for Pimiatinib accepted in China and plans to submit a U.S. application in the second half of 2025. The company also initiated the first patient dosing for Ipagotini in a registration clinical trial in China [4] Emerging Pipeline Potential - The company is advancing clinical studies for its oral PD-L1 ABSK043, both as a monotherapy and in combination with other treatments. The FGF2/3 inhibitor ABSK061 has completed its first patient enrollment for achondroplasia and is progressing in a Phase II trial for gastric cancer. Additionally, the new generation brain-penetrable PRMT5-MTA inhibitor ABSK131 has completed its first patient dosing [5]

Core Viewpoint - The company has experienced significant stock price growth and is actively repurchasing shares to reward investors, reflecting strong market recognition of its value [1][2]. Group 1: Financial Performance - As of June 30, the company achieved total revenue of 657 million RMB, a 20% year-on-year increase, with a net profit of 328 million RMB, up 59% from the previous year [3][4]. - The adjusted net profit reached 336 million RMB, marking a 56% increase year-on-year [4]. - The company has received over 150 million USD in cash from its collaboration with Merck, with potential future payments totaling up to 606 million USD [4]. Group 2: Product Development and Commercialization - The core product, Pimicotinib, has been recognized as a breakthrough therapy by multiple regulatory agencies, indicating strong commercial potential [2][3]. - The company has established a robust pipeline with 22 differentiated innovative research projects, focusing on oncology precision treatment and immune therapy [6][11]. - The second major product, Epagolatinib, has also been designated as a breakthrough therapy, showcasing the company's innovative capabilities in drug design [10][11]. Group 3: Market Position and Valuation - The company is positioned to capitalize on the growing global market for liver cancer treatments, projected to reach approximately 5.3 billion USD by 2029 [10][12]. - Current price-to-sales (PS) ratio stands at 14.01, indicating significant growth potential compared to peers with higher valuations [12].

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]