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, He Yu-B (02256), announced that its subsidiary, Shanghai He Yu Biomedical Technology Co., Ltd. ("He Yu Medicine"), has received FDA approval for the clinical trial application (IND) of its selective small molecule FGFR2/3 inhibitor, ABSK061, for treating children with achondroplasia (ACH) [1]. Group 1 - The IND approval from the FDA will facilitate the acceleration of ABSK061's overseas clinical development process [1]. - The drug has previously been granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) by the FDA, which supports its development in the pediatric rare disease space [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]

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EMA授予孤兒藥資格， 用於治療肝細胞癌 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)已獲得歐洲藥品管理局（「EMA」）授予的孤兒藥 資格（「ODD」），用於治療肝細胞癌（「HCC」）。目前，依帕戈替尼正在全球多地 開展臨床研究，此次獲EMA授予ODD，將為該產品在歐洲的臨床開發、註冊申報 與商業化進程提供有力支持。 此為本公司刊發的自願性公告。本集團無法保證ABSK-011最終將成功獲批上 市。本公司股 ...

Core Viewpoint - The company announced that its subsidiary, Shanghai Heyu Biomedical Technology Co., Ltd., has received FDA approval for the clinical trial application of its selective small molecule FGFR2/3 inhibitor ABSK061 for treating children with achondroplasia (ACH) [1] Group 1 - The FDA has granted permission for the IND of ABSK061, which is a significant milestone for the company [1] - The approval is complemented by the previously awarded Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) by the FDA, which will facilitate the overseas clinical development of ABSK061 [1]

Core Viewpoint - The company, He Yu-B (02256), announced that its subsidiary, Shanghai He Yu Biopharmaceutical Technology Co., Ltd., has received FDA approval for the IND application of its selective small molecule FGFR2/3 inhibitor, ABSK061, aimed at treating achondroplasia in children [1] Group 1 - The IND approval from the FDA will accelerate the overseas clinical development process of ABSK061 [1] - The drug has previously been granted rare pediatric disease designation (RPDD) and orphan drug designation (ODD) by the FDA [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 FGFR2/3抑制劑ABSK061治療兒童軟骨發育不全的 IND獲FDA許可 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，其高選擇性小分子FGFR2/3抑制劑ABSK061用 於治療軟骨發育不全（「ACH」）兒童患者的新藥臨床試驗申請（「IND」）已獲得美 國食品藥品監督管理局（「FDA」）許可。結合此前FDA授予的罕見兒科疾病資格 （「RPDD」）與孤兒藥資格（「ODD」），該進展將助力和譽醫藥加快推進ABSK061 海外臨床開發進程。 此為本公司刊發的自願性公告。本集團無法保證ABSK061最終將成功獲批上市。 本公司股東及潛在投 ...

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]