招商证券国际发表报告称，和誉开发的匹米替尼作为全球疗效最优CSF-1R小分子，即将在中美两地上 市，给公司带来持续销售分成。该行认为默克对该分子寄予厚望，有望在全球做到接近15亿美元高峰的 销售收入。花旗此前则表示，公司估值仅反映其两款后期候选药物匹米替尼及依帕戈替尼价值，其具高 授权潜力的差异化创新药则尚未被市场充分认可。 和誉-B(02256)早盘涨超8%，截至发稿，涨8.2%，报19.4港元，成交额5846.51万港元。 ...

招商证券国际发表报告称，和誉开发的匹米替尼作为全球疗效最优CSF-1R小分子，即将在中美两地上 市，给公司带来持续销售分成。该行认为默克对该分子寄予厚望，有望在全球做到接近15亿美元高峰的 销售收入。花旗此前则表示，公司估值仅反映其两款后期候选药物匹米替尼及依帕戈替尼价值，其具高 授权潜力的差异化创新药则尚未被市场充分认可。 智通财经APP获悉，和誉-B(02256)早盘涨超8%，截至发稿，涨8.2%，报19.4港元，成交额5846.51万港 元。 ...

肿瘤免疫治疗虽已取得突破进展，但有一些细分类别，依然存在较低响应率和较短生存期的问题。尤其 在中国高发的肝癌和胃癌领域，肿瘤免疫治疗带来的生存获益相对有限，目前肝癌依然是我国五年生存 率较低的癌症类别。该行认为靶向特定重要靶点的小分子药物或新型药物类别(如PROTAC或分子胶)有 望成为解决这类型癌症未满足的重要方案。和誉在FGFR靶点领域深耕十年，目前深度布局选择性 FGFR4抑制剂(ABSK011，针对FGF19过表达肝癌)、FGFR2/3抑制剂(针对胃癌和软骨发育不全)等。其 中FGFR4选择性小分子抑制剂依帕戈替尼已进入关键性注册临床三期研究，针对接受过免疫检查点抑制 剂和多靶点酪氨酸激酶抑制剂治疗失败的FGF19过表达晚期肝细胞癌患者。全球约30%的肝细胞癌患者 存在FGF19过表达，目前尚无FGFR4抑制剂获批上市。如果该临床试验取得成功，将是全球首款针对 FGFR4靶点的选择性靶向抑制剂。此外，目前全球针对RAS靶点的研发也如火如荼，除了较早实现突破 的G12C靶点，和誉选择性布局了G12D和pan-RAS两款早期分子，未来将为公司在肿瘤精准诊疗提供更 多的联合用药方案。 匹米替尼：该行预计默克 ...

深度探索FGFR和RAS两大类靶点，FGFR驱动下一轮新产品周期 招商证券香港发布研报称，首次覆盖和誉-B(02256)，予以增持评级，通过DCF方法计算，公司合理股 权价值为210亿港元，对应未来12个月目标价32.5港元。该行看好公司长期发展潜力和高效的小分子开 发能力，预计公司2025-2027年营业收入分别为6.8/5.2/6.3亿元人民币。 招商证券香港主要观点如下： 商业元年：和誉开发的匹米替尼作为全球疗效最优CSF-1R小分子，即将在中美两地上市，给公司带来 持续销售分成。公司积极布局FGFR和KRAS两大重要靶点家族，FGFR4作为晚期临床资产有望成为肝 癌领域全新靶向小分子 匹米替尼：该行预计默克全球销售有望达15亿美元峰值，为和誉提供持续现金流 在CSF-1R抑制剂的开发中，和誉通过高效严谨的临床推进，已经展示了TGCT全球最佳的疗效，安全性 和响应率均优于同类分子。该分子目前是德国默克管线中最重要的后期资产，经过23年12月的首次授权 合作，25年4月的行权扩大全球合作区域，以及两笔7,000万/8,500万美元的付款，已经为和誉带来了逾 1.5亿美元的现金收入。该行认为默克对该分子寄予 ...

Group 1 - The company is set to achieve its first commercial product with the development of small molecule therapies, focusing on FIC and BIC, and is expanding into non-tumor and macromolecule fields [1] - The company expects to transition from long-term losses to profitability in 2024 through external licensing agreements [1] - Pimitinib, a BIC CSF-1R inhibitor, has submitted an NDA application in China and is expected to launch in 2026, marking the company's first commercial product [1] Group 2 - Pimitinib has shown best-in-class ORR and significant safety advantages in key Phase III trials for TGCT, with the NMPA accepting its application for market approval [1] - The company has established exclusive commercialization cooperation with Merck for Pimitinib in several regions, reflecting confidence in the product's commercial potential [1] - The company is advancing I/II phase clinical trials for ABSK061, a selective FGFR2/3 inhibitor, with the first patient expected to be enrolled by June 2025 [2] Group 3 - The company is developing ABSK043, a PD-L1 small molecule inhibitor, which is currently the fastest progressing oral PD-L1 inhibitor globally, showing good safety and anti-tumor activity [2] - The company has initiated three II phase clinical trials for ABSK043 in combination therapies for various types of NSCLC and gastric cancer [2] - The company has a target price of 21.68 RMB, indicating a potential 41% upside from its market value as of September 17, 2025 [3]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [8][9]. Core Views - The company is a small molecule innovative drug developer on the verge of launching its first commercial product, Pimicotinib, which has shown significant efficacy and safety in clinical trials [6][8]. - The company is expected to transition from long-term losses to profitability in 2024, driven by licensing agreements and product commercialization [6][23]. - The partnership with Merck for Pimicotinib is a key growth driver, with potential milestone payments and sales royalties expected to enhance revenue [23][24]. Financial Data and Profit Forecast - Revenue projections for 2023 to 2027 are as follows: - 2023: 190 million RMB - 2024: 504 million RMB - 2025E: 612 million RMB - 2026E: 756 million RMB - 2027E: 627 million RMB - Net profit forecasts indicate a turnaround from a loss of 432 million RMB in 2023 to a profit of 28 million RMB in 2024, reaching 151 million RMB by 2026 [7][9]. - The expected PE ratios for 2025 to 2027 are 165X, 69X, and 78X respectively [9]. Product Pipeline and Development - The company has established a comprehensive pipeline with 22 candidate drugs, including 12 in clinical stages, focusing on oncology and expanding into non-oncology areas [30][34]. - Pimicotinib, a CSF-1R inhibitor, is positioned to be the first commercial product, with NDA submissions in China and the US expected in 2025 [34][43]. - Other notable candidates include Epagolatinib for liver cancer and ABSK061 for achondroplasia, showcasing the company's diverse therapeutic focus [8][34]. Market Position and Competitive Landscape - The company is recognized for its differentiated product offerings, with Pimicotinib demonstrating superior efficacy compared to existing treatments in clinical trials [40][41]. - The competitive landscape for CSF-1R inhibitors includes several approved drugs, but Pimicotinib's unique profile positions it favorably for market entry [38][37]. Management Team - The management team possesses extensive experience in drug development and international collaboration, enhancing the company's strategic capabilities [21][22].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [2][8]. Core Insights - The company is a small molecule innovative drug developer, poised to launch its first commercial product, Pimicotinib, which has shown promising results in clinical trials and is expected to generate significant revenue starting in 2024 [5][7][19]. - The financial projections indicate a substantial increase in revenue and profitability, with expected revenues of RMB 504 million in 2024 and RMB 612 million in 2025, transitioning from losses to profits [6][24]. - The partnership with Merck for Pimicotinib is a key driver for revenue growth, with potential milestone payments and sales royalties expected to enhance financial stability [24][26]. Financial Data and Earnings Forecast - Revenue projections for 2023 to 2027 are as follows: RMB 19 million in 2023, RMB 504 million in 2024, RMB 612 million in 2025, RMB 756 million in 2026, and RMB 627 million in 2027, with significant year-on-year growth rates [6][8]. - The net profit forecast shows a turnaround from a loss of RMB 432 million in 2023 to a profit of RMB 28 million in 2024, reaching RMB 63 million in 2025 and RMB 151 million in 2026 [6][8]. - The company’s price-to-earnings (PE) ratios are projected to be 369.2 in 2024, 164.9 in 2025, and 69.3 in 2026, indicating a strong growth trajectory [6][8]. Product Pipeline and Development - Pimicotinib, a CSF-1R inhibitor, is set to be the company's first commercial product, with NDA submissions in China and the US expected in 2025 [7][46]. - The company has a robust pipeline with 22 candidate drugs, including FGFR inhibitors and PD-L1 small molecules, indicating a diversified approach to drug development [31][53]. - The clinical data for Pimicotinib in treating TGCT shows a 54% overall response rate (ORR) in pivotal trials, outperforming competitors [43][44]. Market Position and Competitive Landscape - The company is positioned to capitalize on unmet medical needs in oncology, particularly with Pimicotinib addressing TGCT and cGvHD, where current treatment options are limited [42][48]. - The collaboration with Merck enhances the company's market presence and commercial capabilities, providing a competitive edge in the pharmaceutical landscape [24][47]. - The report highlights the differentiation of the company's products, suggesting a strong potential for sustained partnerships and revenue generation [10].

Core Viewpoint - The company is expanding its product portfolio from small molecule innovation in oncology to non-oncology treatments, with significant advancements in drug commercialization and clinical trials [1][2]. Group 1: Product Development - The company has received acceptance for the new drug application (NDA) of Pimicotinib for treating adult tenosynovial giant cell tumors (TGCT) by the National Medical Products Administration (NMPA) in China, with a target date of June 10, 2025 [1]. - Pimicotinib has also been granted breakthrough therapy designation (BTD) by the FDA and priority medicine (PRIME) designation by the EMA, indicating its potential for global commercialization [1]. - The company has initiated the first patient dosing in a registration study for Epaglutide in patients with FGF19 overexpressing hepatocellular carcinoma (HCC), with promising data from ongoing clinical trials [1]. Group 2: Clinical Trials and Collaborations - The company is exploring the combination of ABSK043 (an oral PD-L1 inhibitor) with other therapies for treating KRAS-G12C mutated non-small cell lung cancer (NSCLC) and is conducting a Phase II clinical study for ABSK043 combined with other agents for EGFR mutated NSCLC [2]. - The latest Phase II study results for Epaglutide combined with Atezolizumab showed an overall response rate (ORR) of ≥50% and progression-free survival (PFS) of ≥7 months [1]. Group 3: Financial Projections - Revenue forecasts for the company are projected at 612.1 million, 678.8 million, and 627.2 million yuan for 2025-2027, reflecting year-on-year growth rates of 21.5%, 10.9%, and -7.6% respectively [2]. - The current stock price corresponds to price-to-sales (PS) ratios of 17, 15, and 17 for the years 2025, 2026, and 2027, respectively, indicating potential investment opportunities as the company approaches product commercialization [2].

Investment Rating - The report assigns a "Buy" rating for the company [3][17]. Core Insights - The company, He Yu-B (2256.HK), is a small molecule innovative drug company focusing on oncology and expanding into non-oncology treatment pipelines. Since its establishment in 2016, it has concentrated on precision oncology and immunotherapy while exploring non-oncology indications [1][6]. - Pimicotinib has initiated its global commercialization process, with its New Drug Application (NDA) for treating adult tenosynovial giant cell tumors (TGCT) accepted by the National Medical Products Administration (NMPA) in China on June 10, 2025. The product has also received breakthrough therapy designation (BTD) from the FDA and priority medicine (PRIME) designation from the EMA [1][40]. - The company has a robust pipeline with 22 candidate drugs, 12 of which are in clinical development, focusing on small molecules for precision oncology and immunotherapy [32]. Financial Projections - Revenue projections for 2025-2027 are estimated at 612.1 million, 678.8 million, and 627.2 million yuan, reflecting year-on-year growth rates of 21.5%, 10.9%, and -7.6% respectively. The current stock price corresponds to price-to-sales (PS) ratios of 17, 15, and 17 for the respective years [3][17]. - The company achieved total revenue of 657.1 million yuan in the first half of 2025, primarily from Merck's licensing income of 612.1 million yuan (85 million USD), with a net profit of 328.5 million yuan [35]. Key Assumptions - The report highlights that the successful commercialization of Pimicotinib and the clinical data readouts for Ipagoatinib are critical catalysts for stock price appreciation. The company expects significant milestone revenues from Merck's licensing agreements and sales shares from Pimicotinib [15][17]. Pipeline Overview - The company has a diverse pipeline, including Pimicotinib for TGCT and Ipagoatinib for FGF19 overexpressing HCC, with promising clinical data indicating high objective response rates (ORR) and progression-free survival (PFS) [2][3][39].

Core Viewpoint - HeYue-B (02256) has seen a significant stock price increase of nearly 40% post-earnings, 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, the company reported revenue of 612 million HKD, representing a year-on-year growth of 23% [1] - The profit for the same period was 328 million HKD, showing a substantial year-on-year increase of 59% [1] Key Drivers - The earnings exceeded expectations primarily due to Merck's exercise of the commercialization option for pimicotinib, which resulted in a one-time fee of 85 million USD received in May [1] - The company announced that Merck exercised its global commercialization option for pimicotinib in April [1] Market Outlook - Citigroup has indicated that the current valuation of HeYue is low, considering the high certainty of its two late-stage candidates, pimicotinib and irpagratinib, along with a differentiated innovation pipeline that may lead to external licensing opportunities [1] - The firm anticipates significant catalysts for the company 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 [1]