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 ...

Investment Rating - The report maintains a positive outlook on the pharmaceutical sector, indicating an "Overweight" rating for the industry, suggesting it is expected to outperform the overall market [32]. Core Insights - The report highlights that the Shenwan Pharmaceutical and Biological Index increased by 0.6% this week, while the Shanghai Composite Index rose by 2.9% and the Wind All A (excluding financials and petrochemicals) increased by 3.7% [4][6]. - The pharmaceutical sector's overall valuation stands at 30.4 times earnings, ranking 9th among 31 Shenwan primary industries [4][8]. - Significant collaborations and clinical trial results were reported, including a $11.4 billion global strategic partnership between Innovent Biologics and Takeda Pharmaceutical, which includes a $1.2 billion upfront payment [5][13]. - Key clinical trial results presented at the 2025 ESMO conference showed promising outcomes for several drugs, indicating advancements in treatment efficacy for various cancers [14][18][19]. Market Performance - The report details the performance of various sub-sectors within the pharmaceutical industry, with notable increases in medical devices (+0.2%), medical consumables (+1.7%), and medical research outsourcing (+5.5%), while traditional Chinese medicine and other biological products saw declines [4][8]. - The report also notes that 99 A-share pharmaceutical companies released their Q3 2025 earnings, with a total revenue of 94.15 billion yuan, reflecting a 1.3% year-on-year increase [20][22]. Key Events - The report mentions that Bairui Tianheng has passed the Hong Kong Stock Exchange hearing and is in the process of listing its H-shares [12]. - The report emphasizes the importance of the 2025 ESMO conference, where several companies presented significant clinical data, enhancing their market visibility and potential investment attractiveness [14][17][18]. Company Recommendations - The report recommends focusing on innovative drug sectors and companies with improving performance in medical devices and upstream sectors, including companies like Hengrui Medicine, Changchun High-tech, and Mindray Medical [5][20].

Core Viewpoint - The company announced the long-term efficacy and safety data of pimicotinib in treating TGCT patients, showcasing strong and durable tumor response rates from the global Phase III MANEUVER study presented at the 2025 ESMO meeting [1][3]. Group 1: Study Results - The MANEUVER study demonstrated a significant objective response rate (ORR) of 76.2% based on RECIST v1.1 criteria after a median follow-up of 14.3 months [3]. - The ORR for the pimicotinib treatment group reached 54% at week 25, compared to only 3.2% in the placebo group [2]. - Patients who switched from placebo to pimicotinib in the second part of the study achieved an ORR of 64.5% [3]. Group 2: Drug Profile - Pimicotinib is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor independently developed by the company [2][4]. - The drug has received breakthrough therapy designation (BTD) from both the NMPA in China and the FDA in the United States, as well as priority medicine designation (PRIME) from the EMA [4]. Group 3: Commercialization and Regulatory Status - The drug has been included in priority review by the NMPA for adult TGCT patients requiring systemic treatment [4]. - A commercialization agreement has been reached between the company and Merck, with Merck responsible for global commercialization of pimicotinib [4].

Core Viewpoint - The company announced the long-term efficacy and safety data of pimicotinib in treating patients with tenosynovial giant cell tumor (TGCT) at the 2025 ESMO conference, demonstrating strong and durable tumor response rates and clinical improvements [1][3]. Group 1: Study Results - The global Phase III MANEUVER study showed that the objective response rate (ORR) for pimicotinib reached 76.2% based on RECIST v1.1 criteria after a median follow-up of 14.3 months [3]. - The first part of the MANEUVER study reported an ORR of 54% for the pimicotinib group at week 25, compared to 3.2% for the placebo group [2]. - After switching from placebo to pimicotinib, patients showed an ORR of 64.5% based on RECIST v1.1 and tumor volume score (TVS) assessments [3]. Group 2: Drug Profile and Regulatory Status - Pimicotinib is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor developed independently by the company [2][4]. - The drug has received priority review status from the NMPA for adult patients with TGCT requiring systemic treatment and has been granted breakthrough therapy designation (BTD) [4]. - In December 2023, the company entered into a commercialization agreement with Merck for pimicotinib, which will be responsible for its global commercialization [4].

Core Viewpoint - The company announced the presentation of long-term efficacy and safety data for pimicotinib in treating patients with tenosynovial giant cell tumor (TGCT) at the 2025 ESMO conference, highlighting strong and durable tumor response rates and clinical improvements [1] Group 1: Study Results - The global Phase III MANEUVER study demonstrated strong and durable tumor response rates for pimicotinib, as assessed by the blinded independent review committee (BIRC) using RECIST v1.1 criteria and tumor volume scoring (TVS) [1] - Objective response rate (ORR) confirmed by the study indicates significant efficacy of pimicotinib in TGCT patients [1] Group 2: Clinical Outcomes - Clinical assessments showed meaningful and sustained improvements in joint mobility, stiffness, pain, and physical function among patients treated with pimicotinib [1] - The long-term feasibility of treatment with pimicotinib has been validated through consistent safety profiles compared to previous analyses [1]