Core Viewpoint - The company, He Yu-B (02256), has seen its stock price increase by over 10% during trading, currently up by 8.44% at HKD 13.11, with a trading volume of HKD 34.21 million. This surge is attributed to the announcement that its self-developed FGFR4 inhibitor, Irpagratinib (ABSK-011), has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC) [1]. Group 1 - He Yu-B announced that Irpagratinib has received orphan drug designation from the EMA, which will support its clinical development, registration, and commercialization in Europe [1]. - Irpagratinib is a highly selective, orally administered small molecule FGFR4 inhibitor developed by He Yu-B [1]. - The drug has also received orphan drug designation and fast track designation from the U.S. FDA, as well as breakthrough therapy designation from the NMPA in China [1].

Core Viewpoint - The company has developed Irpagratinib, a highly selective oral small molecule FGFR4 inhibitor, which has shown promising safety, tolerability, and anti-tumor activity in clinical studies for advanced HCC patients with FGF19 overexpression [1][2] Group 1: Clinical Development - Irpagratinib is currently undergoing multiple clinical trials globally for advanced HCC patients with FGF19 overexpression, including combinations with various targeted immunotherapies for first-line treatment and as a monotherapy for second-line and later treatments [1] - The first patient dosing in the key registration clinical study for Irpagratinib was completed in June 2025, with the study covering over 50 research centers nationwide and progressing smoothly [1] Group 2: Regulatory Approvals - Irpagratinib has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for the treatment of HCC, which will support its clinical development, registration, and commercialization in Europe [2] - The drug has also previously obtained ODD and Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA), as well as Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China [1]

Core Viewpoint - The company announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its self-developed selective oral small molecule FGFR4 inhibitor, Irpagratinib (ABSK-011), for the treatment of hepatocellular carcinoma (HCC) [1] Group 1 - The orphan drug designation will support the clinical development, registration, and commercialization process of Irpagratinib in Europe [1] - Irpagratinib is currently undergoing clinical studies in multiple locations worldwide [1]

Group 1 - The core point of the article is that He Yu-B (02256) announced that its subsidiary, Shanghai He Yu Biopharmaceutical Technology Co., Ltd., has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its orally administered FGFR4 inhibitor, Irpagratinib, for the treatment of hepatocellular carcinoma (HCC) [1] - Irpagratinib has shown good safety, tolerability, and anti-tumor activity in previous clinical studies involving advanced HCC patients with FGF19 overexpression [1] - The key registration clinical study for Irpagratinib has completed its first patient dosing in June 2025 and is currently progressing smoothly across over 50 research centers nationwide [1] Group 2 - In addition to the EMA orphan drug designation, Irpagratinib has also received orphan drug designation (ODD) and fast track designation (FTD) from the U.S. FDA, as well as breakthrough therapy designation (BTD) from the NMPA in China [2] - The company aims to leverage the accelerated review advantages provided by these regulatory designations to advance the global clinical development and registration process of Irpagratinib, striving to offer this innovative therapy to HCC patients worldwide as soon as possible [2]

Group 1: Xiaomi Group Analysis - Xiaomi Group reported a revenue of approximately 457.29 billion yuan for 2025, representing a year-on-year growth of 24.97% and an adjusted net profit of approximately 39.17 billion yuan, up 43.8% year-on-year [3][4] - The smartphone segment experienced a revenue decline of 2.8% year-on-year, with a total revenue of approximately 186.4 billion yuan in 2025, primarily due to reduced shipments in the Indian market and lower average selling prices (ASP) in emerging markets [4] - The IoT and lifestyle products segment saw a revenue of approximately 1,232 billion yuan in 2025, growing 18.3% year-on-year, but faced a decline in Q4 2025 due to reduced national subsidies and increased competition [5] - The smart electric vehicle segment delivered approximately 410,000 new vehicles in 2025, with a revenue of approximately 103.3 billion yuan, marking a significant year-on-year growth of 221.8% [5][6] - Xiaomi continues to invest heavily in AI, with plans to exceed 200 billion yuan in R&D spending over the next five years, aiming to become a global leader in core technology [6][7] Group 2: Yuntianhua Analysis - Yuntianhua reported a revenue of 48.415 billion yuan for 2025, a decrease of 21.47% year-on-year, with a net profit of 5.156 billion yuan, down 3.40% year-on-year [10][12] - The company faced pressure from rising sulfur prices, which impacted domestic phosphate fertilizer sales, while overseas phosphate prices increased significantly, leading to improved margins in international sales [12][14] - In Q4 2025, Yuntianhua's revenue was 10.816 billion yuan, down 27.56% year-on-year, with a net profit of 427 million yuan, reflecting a significant decline due to increased costs and reduced sales [11][14] - The company has a phosphate resource reserve of nearly 800 million tons and has recently acquired mining rights for a new phosphate mine, which is expected to enhance its production capabilities [17][19] - Yuntianhua plans to distribute a cash dividend of 12 yuan per 10 shares, totaling approximately 2.188 billion yuan, which represents 49.50% of its net profit for 2025 [18][19] Group 3: HeYu-B Analysis - HeYu-B's report highlights its efficient small molecule R&D platform, which is expected to continue producing FIC/BIC molecules, driving long-term growth [22][23] - The company’s lead product, Pimitinib, has shown a 76.2% overall response rate in clinical trials and is set to launch commercially in 2026, marking a significant milestone for the company [22][23] - The platform's unique capabilities in targeting and molecular structure optimization are expected to provide a competitive edge in the biotech market, particularly in the liver cancer segment [22][23]

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） 承董事會命 和譽開曼有限責任公司 徐耀昌博士 主席 上海，2026年3月16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 和譽醫藥依帕戈替尼聯合靶免療法一線治療晚期肝細胞癌完成II期臨床首例 患者給藥 2026年3月16日，上海和譽生物醫藥科技有限公司（「和譽醫藥」）宣佈，其自主研 發的高選擇性口服小分子FGFR4抑制劑依帕戈替尼(Irpagratinib/ABSK-011)聯合 標準療法（特瑞普利單抗+貝伐珠單抗生物類似物），已在針對晚期或不可切除肝 細胞癌（「HCC」）一線治療的II期臨床研究中完成首例患者給藥。 自願性公告 和譽醫藥依帕戈替尼聯合靶免療法一線治療晚期肝細胞癌完成 II ...

Core Viewpoint - The FDA has granted Fast Track Designation (FTD) to Irpagratinib (ABSK-011), a selective FGFR4 inhibitor developed by the company, for the treatment of advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have previously received immune checkpoint inhibitors (ICI) and multi-target kinase inhibitors (mTKI) [1][4]. Group 1: FDA Fast Track Designation - The Fast Track Designation aims to expedite the development and review process of innovative therapies for serious diseases with unmet clinical needs, allowing for earlier and more frequent communication with the FDA [3]. - The designation will accelerate global clinical development and registration processes for Irpagratinib, potentially shortening the time to market [3]. Group 2: Clinical Data and Efficacy - In a Phase I clinical study presented at the 2024 ESMO annual meeting, Irpagratinib demonstrated an objective response rate (ORR) of 46.7% and a median progression-free survival (mPFS) of 5.5 months in HCC patients with FGF19 overexpression who had progressed after ICI and mTKI treatments [4]. - The safety and tolerability profile of Irpagratinib was reported to be favorable [4]. Group 3: Combination Therapy Exploration - The company is also exploring combination therapy with Irpagratinib and Roche's PD-L1 inhibitor Atezolizumab, which has shown an ORR exceeding 50% and mPFS over 7 months in both treatment-naive and previously treated FGF19 overexpressing HCC patients, with no new safety signals observed [4]. - The results suggest a potential synergistic mechanism between FGFR4 inhibitors and ICIs, aligning with accumulating preclinical and translational research evidence [4]. Group 4: Precision Oncology Shift - Irpagratinib represents a significant shift towards precision oncology in the treatment of liver cancer, moving away from relatively non-selective systemic therapies [5]. - The development path of Irpagratinib aligns closely with the global trend towards molecularly driven precision therapies, aiming to establish a new treatment paradigm for patients with FGF19 overexpression [5].

Core Viewpoint - The FDA has granted Fast Track Designation (FTD) to Irpagratinib (ABSK-011), a selective FGFR4 inhibitor developed by the company, for the treatment of advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have previously received immune checkpoint inhibitors (ICI) and multi-targeted kinase inhibitors (mTKI) [1][3][4]. Group 1: FDA Fast Track Designation - The Fast Track Designation aims to expedite the development and review process of innovative therapies for serious diseases with unmet clinical needs, allowing for earlier and more frequent communication with the FDA [3]. - The designation will accelerate global clinical development and registration processes for Irpagratinib, potentially shortening the time to market [3][4]. Group 2: Clinical Data and Efficacy - In a Phase I clinical study presented at the 2024 ESMO annual meeting, Irpagratinib demonstrated an objective response rate (ORR) of 46.7% and a median progression-free survival (mPFS) of 5.5 months in HCC patients with FGF19 overexpression who had progressed after ICI and mTKI treatments [4]. - The safety and tolerability profile of Irpagratinib was reported to be favorable, showing significant advantages over previous treatment data for HCC patients [4]. Group 3: Combination Therapy Exploration - The company is also exploring combination therapy with Irpagratinib and Roche's PD-L1 inhibitor Atezolizumab, which has shown an ORR exceeding 50% and mPFS over 7 months in both treatment-naive and previously treated HCC patients with FGF19 overexpression [4]. - No new safety signals were observed in the combination therapy, suggesting a potential synergistic mechanism between FGFR4 inhibitors and ICIs [4]. Group 4: Precision Oncology Shift - Irpagratinib represents a significant shift towards precision oncology in the treatment of liver cancer, aligning with global trends in molecularly driven precision therapies [5]. - The development of Irpagratinib aims to establish a new treatment paradigm for patients with FGF19 overexpression, promoting a more targeted approach in HCC treatment [5].

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 FGFR4抑制劑依帕戈替尼獲FDA快速通道資格，用於 治療HCC患者 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」）謹在此隨附 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，美國食品藥品監督管理局（「FDA」）已授 予和譽醫藥自主研發的高選擇性小分子FGFR4抑制劑依帕戈替尼(Irpagratinib/ ABSK-011)快速通道資格認定（「FTD」），用於治療既往接受過免疫檢查點抑制劑 （「ICIs」）和多靶點激酶抑制劑（「mTKIs」）治療，且存在FGF19過表達的肝細胞癌 （「HCC」）患者。 此為本公司刊發的自願性公告。本集團無法保證依帕戈替尼最終將成功獲批上 市。本公司股東及潛在投 ...

Core Insights - The article discusses the approval of the high-selectivity small molecule inhibitor, Pimitinib, by the National Medical Products Administration (NMPA) in China for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients [2] - Pimitinib is notable for being developed through a global synchronized clinical trial approach, marking a significant achievement for domestic pharmaceutical companies in China [2] Group 1: Product Development and Approval - Pimitinib is the first innovative drug in China to conduct multi-center Phase III clinical trials simultaneously in the US, Europe, and China, using the same data for the New Drug Application (NDA) [2] - The development of Pimitinib took 9 years and 7 months, significantly shorter than the global average of 15 years for innovative drugs [2] - The drug addresses a clear unmet clinical need for patients with TGCT, a rare disease with an incidence rate of approximately 44 per million in China [2] Group 2: Commercialization and Financial Aspects - The company signed a licensing agreement with Merck in December 2023, granting Merck commercialization rights for Pimitinib in mainland China, Hong Kong, Macau, and Taiwan, along with exclusive global commercialization rights [3] - The company received an upfront payment of $155 million and is set to receive over $400 million in milestone payments and ongoing sales royalties, providing substantial funding for future research and development [3] - Pimitinib has also received breakthrough therapy designation from the FDA and priority medicine designation from the EMA, with application processes in both regions progressing smoothly [3] Group 3: Future Development Pipeline - The company has established a research pipeline with over 20 projects, including a core liver cancer inhibitor, Ipagotene, which has entered critical registration clinical stages [3] - The company is also expanding its focus into areas such as autoimmune diseases, cardiovascular conditions, and diabetes [3]