Core Viewpoint - The announcement highlights the long-term efficacy and safety of pimicotinib in treating TGCT patients, reinforcing its potential for long-term application in suitable patients [1] Group 1: Company Information - The subsidiary Shanghai Heyu Biopharmaceutical Technology Co., Ltd. presented data at the CTOS 2025 conference regarding the global Phase III MANEUVER study of pimicotinib for TGCT patients [1] - The long-term analysis indicates that continuous treatment with pimicotinib leads to sustained improvements in tumor response and patient-reported outcomes, including pain and function [1] - The study emphasizes that the treatment maintains an acceptable safety profile, supporting the long-term use of pimicotinib in appropriate patients [1]

Core Viewpoint - The announcement highlights the long-term efficacy and safety of pimicotinib in treating TGCT patients, as presented at the CTOS 2025 conference, reinforcing its potential for long-term application in suitable patients [1] Group 1: Company Information - Shanghai Heyu Biopharmaceutical Technology Co., Ltd., a subsidiary of Heyu-B, showcased data from the global Phase III MANEUVER study on pimicotinib for TGCT patients [1] - The study results indicate that continuous treatment with pimicotinib leads to sustained improvements in tumor response and patient-reported outcomes, including pain and function [1] Group 2: Industry Insights - The findings from the MANEUVER study strengthen the position of pimicotinib in the treatment landscape for TGCT, suggesting a viable long-term treatment option for patients [1] - The acceptable safety profile maintained during the study supports the ongoing development and potential market introduction of pimicotinib for this indication [1]

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） 自願性公告 和譽醫藥於CTOS 2025年會展示匹米替尼臨床III期 MANEUVER研究長期療效和安全性數據 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11月17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 和譽開曼有限責任公司（「本公司」，連同其附屬公司統稱「本集團」）謹此隨附新 聞稿，以告知本公司股東及潛在投資者，本公司之附屬公司上海和譽生物醫藥科 技有限公司（「和譽醫藥」）宣佈，其在結締組織腫瘤學會（「CTOS」）2025年會上以 壁報形式展示了匹米替尼(pimicotinib/ABSK021)治療腱鞘巨細胞瘤（「TGCT」）患 者的全球III期MANEU ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 本月底法定/註冊股本總額： USD 50,000 致：香港交易及結算所有限公司 公司名稱: 和譽開曼有限责任公司 FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 呈交日期: 2025年11月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02256 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | ...

Core Viewpoint - UBS initiated coverage on Harmony Biosciences with a "Buy" rating and a target price of HKD 25.2, highlighting the company as an undervalued innovative oncology drug firm [1] Company Overview - Harmony has a robust pipeline with 12 clinical-stage assets and 10 disclosed preclinical candidates, indicating strong research and development capabilities [1] - The company entered a global licensing agreement with Merck for pimicotinib worth USD 605.5 million, showcasing its R&D potential [1] Financial Projections - UBS forecasts risk-adjusted peak sales for Harmony's core assets, pimicotinib and irpagratinib, at HKD 89 billion and HKD 48 billion, respectively, which exceed market expectations by 41% and 26% [1]

Core Viewpoint - He Yu Pharmaceutical announced the completion of the first patient dosing in a Phase II clinical study of its oral small molecule PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, Goresir, for the treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutations [1] Group 1: Clinical Study Details - The open-label Phase II clinical study aims to evaluate the safety, tolerability, and efficacy of ABSK043 combined with Goresir in patients with locally advanced or metastatic NSCLC carrying KRAS G12C mutations [1] - The study received approval from the National Medical Products Administration (NMPA) in China for a new drug clinical trial (IND) in August 2025 [1] - The successful dosing of the first patient marks a significant step in the clinical development of this promising combination therapy [1] Group 2: KRAS G12C Mutation Context - KRAS is the most common oncogenic driver gene in human cancers, with an occurrence rate of approximately 14% for KRAS G12C mutations in NSCLC patients [1] - The oral small molecule PD-L1 inhibitor ABSK043 has shown good safety and potential anti-tumor activity as a monotherapy in previous Phase I clinical studies involving advanced solid tumor patients, particularly in groups with high PD-L1 expression, EGFR mutations, and KRAS mutations [1]

Core Viewpoint - The announcement by He Yu-B (02256.HK) regarding the completion of the first patient dosing in a Phase II clinical study for its oral small molecule PD-L1 inhibitor ABSK043 in combination with Shanghai Ailis Pharmaceutical Technology Co., Ltd.'s KRAS G12C inhibitor, Goleirese, for treating KRAS G12C mutation-positive non-small cell lung cancer (NSCLC) [1] Group 1 - He Yu-B has initiated a Phase II clinical study for ABSK043 in combination with Goleirese [1] - The study targets patients with KRAS G12C mutation-positive NSCLC [1] - The first patient has been dosed in this clinical trial [1]

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） 自願性公告 和譽醫藥完成口服小分子PD-L1抑制劑ABSK043聯合 戈來雷塞治療NSCLC II期臨床首例患者給藥 和譽開曼有限責任公司（「本公司」，連同其附屬公司統稱「本集團」）謹此隨附新聞 稿，以告知本公司股東及潛在投資者，本公司之附屬公司上海和譽生物醫藥科技 有限公司（「和譽醫藥」）宣佈，其口服小分子PD-L1抑制劑ABSK043與上海艾力斯 醫藥科技股份有限公司（「艾力斯」）KRAS G12C抑制劑戈來雷塞聯合用於治療攜 帶KRAS G12C突變的非小細胞肺癌（「NSCLC」）的II期臨床研究已完成首例患者 給藥。 此為本公司刊發的自願性公告。本集團無法保證ABSK043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 ...

Core Insights - The article highlights the key strategies for the success of Chinese innovative pharmaceutical companies, emphasizing the importance of integrating the strengths of both small and large enterprises, focusing on unmet clinical needs, and ensuring long-term funding and talent reserves [2][3]. Group 1: Key Strategies for Success - The first strategy is to combine the agility of small companies with the platform vision of large companies, allowing for efficient and effective drug development [2]. - The second strategy focuses on addressing unmet clinical needs by developing "first-in-class" and "best-in-class" drugs rather than following trends with "me-too" drugs [2]. - The third strategy emphasizes the importance of building a stable long-term reserve of funding and talent to support sustained innovation in drug development [2]. Group 2: Career Achievements of Xu Yaochang - Xu Yaochang has played a pivotal role in the establishment of key research and development centers for multinational pharmaceutical companies in China, including Eli Lilly and Novartis, contributing to the growth of the innovative drug sector [3][4]. - His experience includes the successful establishment of a CRO company for Eli Lilly, which expanded from 20 to 150 employees, addressing the talent gap in the industry [3]. - Xu's leadership at Hansoh Pharmaceutical led to the development of innovative drugs, marking a significant transition from generic to innovative pharmaceuticals in China [4]. Group 3: Research and Development Strategy - Hansoh Pharmaceutical has developed a pipeline of over 20 candidate drugs, with 12 entering clinical stages, showcasing a focused strategy on differentiated targets and dynamic pipeline adjustments [5]. - The core product, ABKS021, initially targeted a specific condition but was later found to have potential for treating other diseases, demonstrating the adaptability of the company's research approach [5]. - The company plans to expand into non-oncology areas such as autoimmune diseases, cardiovascular diseases, and diabetes, based on its research capabilities and financial resources [6]. Group 4: Financial Performance and Investment Strategy - As of June 2025, Hansoh Pharmaceutical reported a cash balance exceeding 2.3 billion yuan, with a revenue increase of 23% and a net profit increase of 59% year-on-year [6]. - The company adopts a stringent financial strategy, ensuring that every expenditure is focused on core research and development activities while minimizing unnecessary administrative costs [6]. - The commitment to international research standards has facilitated partnerships with major pharmaceutical companies, enhancing the company's credibility and market position [7]. Group 5: Collaborations and Market Recognition - Hansoh Pharmaceutical has established deep collaborations with renowned global pharmaceutical companies, including Merck and Eli Lilly, which underscores the quality and standardization of its research processes [7]. - The company has successfully entered major stock indices, such as the MSCI Global Small Cap Index and the FTSE China Small Cap Index, reflecting its growing recognition in the capital market [7].

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, showcased during the 2025 R&D Day [1][3] R&D Strategy - He Yu emphasizes a dual-driven strategy of "depth + breadth" to enhance its pipeline, focusing on both innovative therapies in oncology and expanding into non-oncology indications [2][8] - The company has maintained a compound annual growth rate of 54% in R&D investment since its inception, ensuring a strong pipeline of differentiated Best-in-Class (BIC) and First-in-Class (FIC) drugs [8][11] Key Products - The core product, Pimicotinib, is the first Chinese-developed CSF-1R inhibitor entering global Phase III clinical trials, with significant potential in multiple indications [5][7] - Pimicotinib has received breakthrough therapy designation from regulatory agencies in multiple countries and is projected to achieve global sales peak of over $2 billion [5][6] Clinical Data and Market Potential - Recent data from the ESMO Congress 2025 demonstrated Pimicotinib's strong and durable efficacy in treating TGCT patients, reinforcing its potential as a best-in-class treatment [6][10] - The company is also developing the FGFR4 inhibitor, Absk-011, which has shown promising clinical results in advanced HCC patients, indicating a strong market opportunity [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 [11] - Recent analyst reports from various brokerages have given positive ratings for He Yu, with target prices indicating significant upside potential [11]