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，概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 ( 於開曼群島成立之有限公司 ) (股份代號: 3933) 本集團產品德谷胰島素注射液獲批上市 本公告乃由聯邦制藥國際控股有限公司（「本公司」）自願發出。 德谷胰島素是新一代超長效基礎胰島素類似物，用于成人糖尿病的治療，可單獨使用 或與口服降糖藥、餐時胰島素聯合用藥，全面滿足臨床長期血糖管理需求。每日一次 皮下注射，具有超長平穩控糖、安全性高、給藥時間靈活等特點。現時，德谷胰島素 已納入國家醫保目錄（二零二五年版）乙類藥品，可及性與經濟性優勢顯著。 本次獲批是本公司在糖尿病領域實現關鍵技術突破的又一重要成果。未來，本公司將 持續致力於新產品研發，並重點提升在生物醫藥行業的競爭力及創造力，深耕慢病治 療領域，以更優質的產品、更完善的管線服務臨床、惠及患者，預期將為本公司及 ...

Core Viewpoint - The article discusses the promising results of autologous and allogeneic stem cell-derived islet therapy for Type 1 Diabetes (T1D), highlighting the need for long-term immunosuppression to prevent autoimmune attacks on transplanted islets [2][10]. Group 1: Research Background - A study published in The Lancet Diabetes & Endocrinology details the use of stem cell-derived islet therapy in three T1D patients, marking a significant advancement in diabetes treatment [3][4]. - The research utilized peripheral blood mononuclear cells (PBMC) from patients or healthy donors, reprogrammed into induced pluripotent stem cells (iPSC), to create endoderm stem cells (EnSC) for islet regeneration [4]. Group 2: Clinical Cases - Case 1 involved a 30-year-old female with a long history of T1D who initially did not respond to autologous E-islet transplantation but showed significant improvement after switching to a standard immunosuppressive regimen [6][7]. - Case 2 featured a 45-year-old male who achieved insulin independence for over 26 months following allogeneic E-islet transplantation under a standard immunosuppressive protocol, demonstrating the potential for long-term remission [8]. - Case 3 involved a 15-year-old female who, despite not fully achieving insulin independence, experienced significant improvements in blood sugar control and quality of life after receiving allogeneic E-islet transplantation [9]. Group 3: Implications and Future Directions - The study highlights the necessity of long-term immunosuppression to prevent autoimmune recurrence, even with autologous islet transplants [10]. - Future research will focus on identifying more precise immunosuppressive strategies and developing islet products that can evade immune responses without the need for ongoing immunosuppression [10].

Group 1 - The core viewpoint of the news is that Tonghua Dongbao has signed a commercialization cooperation agreement with Huisheng Bio, aiming to enhance their presence in the diabetes treatment sector through resource complementarity and collaborative development [1][2]. - The agreement grants Tonghua Dongbao exclusive commercialization rights for Huisheng Bio's insulin products in mainland China, specifically the biosimilar insulin injections, which are expected to improve the accessibility of diabetes treatments [2][3]. - Tonghua Dongbao, as a leading domestic insulin manufacturer, has a strong market foundation and a mature commercialization system, which positions it well to rapidly promote and distribute the new products [3]. Group 2 - The collaboration is expected to enrich Tonghua Dongbao's product matrix in the endocrine metabolism field and strengthen its competitive edge in diabetes treatment, contributing to sustainable long-term growth [1][2]. - The partnership will leverage both companies' strengths, with Tonghua Dongbao focusing on market promotion and clinical application, while Huisheng Bio will enhance its R&D and technical support for stable product supply [3].

Summary of Biomea Fusion FY Conference Call Company Overview - **Company**: Biomea Fusion (NasdaqGS: BMEA) - **Key Products**: - Icovamenib: An oral small molecule for diabetes - BMF-650: A GLP-1 receptor agonist for weight loss Core Insights and Arguments Icovamenib Development - **Clinical Trials**: - Currently moving into two clinical trials targeting insulin-deficient type 2 diabetes and patients inadequately controlled on GLP-1 therapy [3][11] - **Market Need**: - Diabetes is a significant health issue, with approximately 38 million people in the U.S. affected, and 80% of diabetes patients die from related complications [4][49] - **Efficacy**: - Icovamenib showed a significant reduction in A1C levels over time, with effects lasting up to 9 months post-treatment [5][10] - Mechanism involves the inhibition of menin, which enhances insulin production by increasing beta cell proliferation [6][7] - **Patient Population**: - Focus on patients with A1C levels between 7.5 and 10.5, BMI less than 32, and those who have failed 1-3 prior diabetes medications [25][26] BMF-650 Development - **Clinical Trials**: - Currently in Phase 1 studies, aiming for a favorable pharmacokinetic profile and consistent weight loss response [13][15] - **Weight Loss Efficacy**: - Initial studies in monkeys showed a weight reduction of approximately 12% to 15% over 28 days [14] - **Market Positioning**: - Positioned to address the needs of patients who are overweight or obese and require effective weight management solutions [95][104] Additional Important Points - **Regulatory Strategy**: - The current studies are not registrational but are designed to gather data that could support future Phase 3 trials [75][76] - **Commercial Focus**: - Targeting patients who are uncontrolled on standard therapies, particularly those failing GLP-1 treatments, to prevent progression to insulin dependency [44][49][92] - **Market Size**: - The diabetes market is substantial, with over 10 million insulin-dependent patients in the U.S. alone [44][49] - **Long-term Goals**: - Aim to provide a non-chronic treatment option that can restore beta cell function and reduce the healthcare burden associated with diabetes [61][62] Conclusion - Biomea Fusion is advancing its innovative diabetes treatments, Icovamenib and BMF-650, with a clear focus on addressing unmet needs in the diabetes market. The company is strategically positioning itself to capture a significant share of the market by targeting specific patient populations and demonstrating the efficacy of its therapies through ongoing clinical trials.

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 4% in the afternoon, currently up 3.85% at HKD 13.76, with a trading volume of HKD 12.1855 million. The company announced the completion of the first patient dosing in a Phase II clinical trial in the U.S. for its oral GLP-1 receptor agonist ASC30, aimed at treating type 2 diabetes, with plans to recruit approximately 100 patients across multiple centers in the U.S. The primary data from this 13-week study is expected to be released in Q3 2026 [1]. Group 1 - Gilead Sciences has initiated a Phase II clinical trial for ASC30, targeting type 2 diabetes treatment [1]. - The trial will involve around 100 patients and is set to take place in multiple centers across the U.S. [1]. - The company plans to announce the primary data from the trial in Q3 2026 [1]. Group 2 - The CEO of Gilead Sciences, Dr. Wu Jinzi, emphasized the strategic expansion into the diabetes treatment market with ASC30 [1]. - The company aims to showcase ASC30 as a potential best-in-class oral treatment option, administered once daily [1]. - The upcoming trial results are anticipated to provide significant insights into the efficacy of ASC30 for diabetes patients [1].

Core Viewpoint - The announcement of the completion of the first patient dosing in the Phase II clinical trial of ASC30 for type 2 diabetes treatment has positively impacted the stock price of the company, leading to a rise of over 4% [1] Company Developments - The company, Songlei Pharmaceutical, has initiated a Phase II clinical trial in the United States for its oral small molecule GLP-1 receptor agonist ASC30, targeting approximately 100 type 2 diabetes patients across multiple centers [1] - The primary data from this 13-week Phase II study is expected to be released in the third quarter of 2026 [1] - The founder and CEO, Dr. Wu Jinzi, emphasized the strategic importance of expanding ASC30's clinical development into the large diabetes treatment market, highlighting its potential as a best-in-class oral treatment option [1]

Core Findings - The research identified the olfactory receptor Or5v1/Olfr110 as a high-affinity receptor for the oxylipin 12(S)-HEPE, which promotes hepatic fatty acid oxidation and improves glucose homeostasis, thereby reducing obesity [3][5][7] - The activation level of the Or5v1/Olfr110-Gs signaling pathway is lower in obese patients compared to normal individuals, indicating a correlation between lower receptor activity and higher body mass index (BMI) [5][7] - The synthetic agonist HOR1-C59, developed based on structural analysis, shows beneficial effects on glucose homeostasis, highlighting the clinical application value of targeting olfactory receptors with small molecule compounds in disease treatment [6][7] Methodology - The research utilized a novel technique called "anonymous receptor identification by reverse-G-protein pull-down" (ARIG) to identify the orphan receptor Or5v1/Olfr110 as a receptor for oxylipids [5][7] - The study demonstrated that systemic or liver-specific knockout of Or5v1/Olfr110 impairs glucose homeostasis, even in the presence of 12(S)-HEPE stimulation [5][6] Implications - The findings suggest that targeting the olfactory receptor Or5v1/Olfr110 could provide new therapeutic strategies for treating obesity, diabetes, and fatty liver diseases [3][6][7] - The research emphasizes the importance of olfactory receptors in metabolic processes and their potential as drug targets [6][7]

Group 1 - The company Dongyangguang Pharmaceutical has received approval from the National Medical Products Administration of China for its SGLT-2 inhibitor, Ologliptin capsules, which are intended for improving blood glucose control in adults with type 2 diabetes [1] - The approval is based on two Phase III clinical trials that demonstrated statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with improvements in fasting blood glucose and postprandial blood glucose [1] - The product also showed additional metabolic benefits, including weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood glucose, weight, and blood pressure [1] Group 2 - Diabetes is now the third most serious chronic non-communicable disease globally, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The company has a comprehensive product line in diabetes treatment, including five insulin products that have been approved and are consistent in effectiveness, safety, and quality with original formulations [2] - The new product approval will enhance the company's diabetes product portfolio, and the company plans to leverage its established production system and marketing network for rapid commercialization while exploring further clinical applications for diabetes complications [2]

Group 1 - The company Dongyangguang Pharmaceutical has received approval from the National Medical Products Administration of China for its innovative drug, Ologliptin capsules, which are designed to improve blood sugar control in adults with type 2 diabetes [1] - The approval is based on two Phase III clinical trials that demonstrated statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with improvements in fasting blood glucose and postprandial blood glucose [1] - The product also offers additional metabolic benefits such as weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood sugar, weight, and blood pressure [1] Group 2 - Diabetes has become the third most serious chronic non-communicable disease globally, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The company has a comprehensive product line in the diabetes treatment field, including five insulin products that have been approved and are consistent in efficacy, safety, and quality with original formulations [2] - The approval of the new product will enhance the company's diabetes product portfolio, and it plans to leverage its established production system and marketing network for rapid commercialization while exploring further clinical applications for diabetes complications [2]

Group 1 - Dongyangguang Pharmaceutical (06887.HK) announced that its self-developed SGLT-2 inhibitor, Oloklignet capsules (brand name: Dongzean, specifications: 20mg, 50mg), received approval from the National Medical Products Administration of China for marketing, aimed at improving blood glucose control in adult patients with type 2 diabetes, either as monotherapy or in combination with metformin [1] - The registration approval was based on two multicenter, randomized, double-blind, placebo-controlled Phase III clinical studies, which showed statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with significant improvements in fasting blood glucose and postprandial blood glucose [1] - The product also demonstrated additional metabolic benefits, including weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood glucose, weight, and blood pressure [1] Group 2 - Diabetes has become the third most serious chronic non-communicable disease globally, following cancer and cardiovascular diseases, with the International Diabetes Federation reporting a diabetes prevalence rate of 13.79% among adults (ages 20-79) in China, translating to approximately 148 million patients, the highest in the world [2] - Over 90% of these cases are type 2 diabetes, with a poor medication adherence rate and an effective blood glucose control rate of only 50.1% [2] - The company has a comprehensive product line in the diabetes treatment field, having developed five insulin products that have been approved for marketing, all of which are consistent in efficacy, safety, and quality with original formulations and have been included in the national drug centralized procurement [2] - The approval of the new product will further enrich the company's diabetes product line, leveraging its established production system and marketing network for rapid commercialization, while also exploring clinical applications in diabetes complications to expand the range of indications [2]