Core Insights - The company, He Yu Pharmaceutical, is advancing in "source innovation" through strong new drug development, global clinical capabilities, and international collaborations [1][2] - The company has a robust pipeline with 22 drugs in development, over 10 of which are in clinical stages, highlighted during the R&D Day event on October 30 [1][2] R&D Strategy - He Yu emphasizes a dual-driven strategy of "depth + breadth" to enhance its pipeline, focusing on developing differentiated innovative therapies for unmet clinical needs [2][7] - The company has maintained a compound annual growth rate of 54% in R&D investment since its inception, ensuring a strong pipeline of over 10 clinical-stage oncology products [7] Key Products - The core product, Pimicotinib, is the first Chinese-developed CSF-1R inhibitor entering global Phase III clinical trials, with breakthrough therapy designation from multiple regulatory agencies [4][6] - Pimicotinib has shown significant potential in treating TGCT and other indications, with a projected global peak sales exceeding $2 billion [4][5] Clinical Data - Recent data presented at the ESMO Congress 2025 demonstrated Pimicotinib's strong and durable tumor response in TGCT patients, confirming its potential as a best-in-class treatment [5] - The drug is currently under priority review in China and is expected to submit an NDA in the U.S. by the end of the year, with potential approvals in 2026 [6] Pipeline Development - The company is also exploring FGFR and KRAS targets, with the FGFR4 inhibitor, Absk-011, showing promising clinical results in advanced HCC patients [8][9] - Absk-011 has received breakthrough therapy designation and is positioned to become a leading targeted therapy for liver cancer [8][9] Market Potential - Approximately 30% of global HCC patients have FGF19 overexpression, indicating a significant market opportunity for Absk-011 upon approval [9] - The company is advancing multiple promising candidates, including oral small molecule PD-L1 inhibitors and other innovative therapies, enhancing its commercial prospects [9][10] Financial Outlook - He Yu holds over 2 billion yuan in cash and is recognized for enhancing investor returns through stock buybacks while being in the early stages of commercialization [10] - Recent analyst reports have issued "buy" ratings for the company, with target prices indicating substantial upside potential [10]

Core Viewpoint - He Yu-B (02256.HK) is identified as a leading player in the small molecule innovative drug sector, with projected revenues and net profits showing consistent growth from 2025 to 2027 [1] Financial Projections - Expected revenues for He Yu-B are RMB 650 million, RMB 680 million, and RMB 730 million for the years 2025, 2026, and 2027 respectively [1] - Projected net profits are RMB 97 million, RMB 111 million, and RMB 142 million for the same years [1] - The DCF model indicates a target price of HKD 22.06, representing a potential upside of 48.5% from the current price [1] Analyst Ratings - The majority of investment banks have rated He Yu-B as a "Buy," with 7 firms issuing buy ratings in the last 90 days [1] - The average target price from these ratings is HKD 20.75 [1] - Tianfeng Securities recently issued a buy rating with a target price of HKD 22.88 [1] Market Position - He Yu-B has a market capitalization of HKD 9.985 billion and ranks 17th in the biopharmaceutical II industry [2] - Key financial metrics compared to the industry average show that He Yu-B has a return on equity (ROE) of 7.24%, which is below the industry average of 10.46% [2] - The company has a net profit margin of 53.66%, significantly outperforming the industry average of -381.46% [2] - He Yu-B's gross margin is 100%, the highest in the industry, while its debt ratio stands at 8.93%, well below the industry average of 74.41% [2]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leader in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a II phase study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotin for advanced hepatocellular carcinoma (HCC) has commenced, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a II phase study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leading player in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a Phase II study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotini for advanced hepatocellular carcinoma (HCC) is underway, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a Phase II study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Core Viewpoint - The stock of He Yu-B (02256.HK) has seen a significant increase, rising over 7% during trading, with a current increase of 6.06%, priced at 15.03 HKD, and a trading volume of 9.1686 million HKD [1] Group 1 - The stock price of He Yu-B reached 15.03 HKD, reflecting a 6.06% increase [1] - The trading volume for He Yu-B was reported at 9.1686 million HKD [1] - The stock experienced a peak increase of over 7% during the trading session [1]

Core Viewpoint - The stock of He Yu-B (02256) has seen a significant increase, rising over 7% during trading, with a current price of 15.03 HKD and a trading volume of 9.1686 million HKD, following the announcement of positive clinical trial results for its drug pimicotinib [1] Group 1: Company Developments - He Yu-B's subsidiary, Shanghai He Yu Biomedical Technology Co., Ltd., presented long-term efficacy and safety data from the global Phase III MANEUVER study of pimicotinib for treating tenosynovial giant cell tumor (TGCT) patients at the 2025 European Society for Medical Oncology (ESMO) conference [1] - Pimicotinib has been prioritized for review by the National Medical Products Administration (NMPA) in China for adult TGCT patients requiring systemic treatment and has received Breakthrough Therapy Designation (BTD) from the NMPA [1] - The drug has also been granted BTD by the U.S. Food and Drug Administration (FDA) and received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for overseas markets [1]

Core Viewpoint - The stock of He Yu-B (02256) has seen a significant increase, rising over 7% during trading, with a current price of 15.03 HKD and a trading volume of 9.1686 million HKD, following the announcement of positive clinical trial results for its drug pimicotinib [1] Group 1: Company Developments - He Yu-B's subsidiary, Shanghai He Yu Biomedical Technology Co., Ltd., presented long-term efficacy and safety data from the global Phase III MANEUVER study of pimicotinib for treating tenosynovial giant cell tumor (TGCT) patients at the 2025 European Society for Medical Oncology (ESMO) meeting [1] - Pimicotinib has been prioritized for review by the National Medical Products Administration (NMPA) in China for adult TGCT patients requiring systemic treatment and has received Breakthrough Therapy Designation (BTD) from the NMPA [1] - The drug has also been granted BTD by the U.S. Food and Drug Administration (FDA) and received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for overseas markets [1]

Core Viewpoint - The company announced the presentation of two pipeline projects, CDK4/2 inhibitor ABK-CDK-1 and SMARCA2 PROTAC degrader ABK-SM2-1, at the 37th AACR-NCI-EORTC International Molecular Targets and Cancer Therapeutics Conference, showcasing promising preclinical results [1]. Group 1 - The company has revealed the latest preclinical research results for two drug candidates [1]. - Both ABK-CDK-1 and ABK-SM2-1 demonstrated excellent preclinical characteristics [1].

和誉医药开发的ABK-CDK-1是一种新型、选择性、可透过血脑屏障的 CDK4/2抑制剂，具有克服现有 CDK4/6抑制剂局限性的潜力。其优异的疗效、选择性及其他特性，支持其进一步推进临床前研究并进 入临床开发阶段。ABK-SM2-1优异的临床前特性支持其推进临床前开发。 智通财经APP讯，和誉-B(02256)公布，公司的附属公司上海和誉生物医药科技有限公司已于第37届 AACR-NCI-EORTC国际分子靶标与癌症治疗大会(AACR-NCI-EORTC大会)上公布了两款管线项目— CDK4/2抑制剂ABK-CDK-1和SMARCA2 PROTAC降解剂ABK-SM2-1的最新临床前研究成果，两者均表 现出优异的临床前特性。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Abbisko Cayman Limited 和譽開曼有限責任公司 （於開曼群島註冊成立的有限公司） （股份代號：2256） 此為本公司刊發的自願性公告。本集團無法保證ABK-CDK-1以及ABK-SM2-1最 終將成功獲批上市。本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 承董事會命 和譽開曼有限責任公司 徐耀昌博士 主席 上海，2025年10月27日 於本公告日期，本公司董事會包括執行董事徐耀昌博士、喻紅平博士及嵇靖博 士；以及獨立非執行董事孫飄揚博士、孫洪斌先生及徐海音女士。 1 和譽醫藥在第37屆AACR-NCI-EORTC大會公佈新型CDK4/2抑制劑和 SMARCA2 PROTAC降解劑臨床前研究成果 2025年10月27日，上海和譽生物醫藥科技有限公司（「和譽醫藥」）宣佈，公司在 第37屆AACR-NCI-EORTC國際分子靶標與癌症治療大會（「AACR-NCI-EORTC 大會 ...