Core Insights - A breakthrough in diabetes treatment has been achieved with the first successful transplantation of CRISPR-edited pancreatic cells into a type 1 diabetes patient, allowing for insulin secretion without the need for immunosuppressants [1][2]. Group 1: Research and Methodology - The study published in the New England Journal of Medicine and reported on Nature's website highlights the potential of CRISPR gene editing in treating type 1 diabetes, which affects approximately 9.5 million patients globally [2]. - Researchers extracted pancreatic cells from a 60-year-old deceased donor and utilized CRISPR-Cas12b technology to edit these cells by knocking out two key genes, B2M and CIITA, which typically signal T cells to attack foreign invaders [2][3]. - To further protect the edited cells from immune system attacks, a gene encoding the CD47 protein was introduced, which sends a "do not eat me" signal to the immune system [2]. Group 2: Clinical Application - The final cell preparation, named UP421, consisted of three types of cells: fully edited cells lacking HLA and expressing high levels of CD47, partially edited cells with some HLA and maintaining endogenous CD47 levels, and wild-type cells with varying CD47 levels [6]. - The edited pancreatic cells were implanted into a 42-year-old patient with 37 years of type 1 diabetes through 17 injections, totaling 79.6 million engineered cells [8][11]. - Remarkably, the entire procedure did not involve any glucocorticoids, anti-inflammatory drugs, or immunosuppressants, and after 12 weeks, the cells showed no signs of rejection while effectively regulating the patient's blood sugar levels [12]. Group 3: Results and Future Plans - C-peptide levels, a direct marker of endogenous insulin secretion, were undetectable at baseline but showed significant increases at weeks 4, 8, and 12 post-intervention, indicating successful insulin production [13]. - Even six months post-transplant, the edited cells continued to evade immune detection and attack [13]. - However, the study involved only one participant, and the treatment duration was insufficient to eliminate the need for insulin injections, prompting the company to plan further clinical trials starting next year for more comprehensive research [14].

Core Viewpoint - Fosen Pharmaceutical (01652) experienced a significant stock price surge, rising over 410% at one point and currently up 350%, trading at HKD 1.53 with a transaction volume of HKD 13.89 million [1] Group 1: Company Developments - Fosen Pharmaceutical announced that its research and development product, "Metformin and Empagliflozin Tablets (I)", has received approval from the National Medical Products Administration of China [1] - The approved indication for the product is for the treatment of adult patients with type 2 diabetes who are currently receiving Empagliflozin and Metformin hydrochloride, aimed at improving blood glucose control in these patients [1] - The board believes that Metformin and Empagliflozin Tablets (I) is an important addition to the company's product pipeline in the diabetes treatment sector, providing more treatment options for diabetes patients [1]

Core Viewpoint - Fosen Pharmaceutical (01652) experienced a significant stock price surge, rising over 410% at one point and currently up 350% to HKD 1.53, with a trading volume of HKD 13.89 million [1] Group 1: Product Approval - Fosen Pharmaceutical announced that its research and development product, Metformin and Empagliflozin Tablets (I), has received approval from the National Medical Products Administration of China [1] - The product is indicated for the treatment of adult patients with type 2 diabetes who are currently receiving Empagliflozin and Metformin Hydrochloride, aimed at improving blood glucose control in these patients [1] - The board believes that Metformin and Empagliflozin Tablets (I) is an important addition to the company's product pipeline in the diabetes treatment sector [1] Group 2: Market Impact - The approval of this product is expected to provide more treatment options for a large number of diabetes patients [1]

Core Viewpoint - Fosen Pharmaceutical has received approval from the National Medical Products Administration of China for its Metformin and Empagliflozin Tablets (I), aimed at improving blood sugar control in adult patients with type 2 diabetes [1][2]. Group 1: Product Details - The Metformin and Empagliflozin Tablets (I) are a combination formulation of Metformin hydrochloride and Empagliflozin, which work synergistically to enhance glucose control compared to standard monotherapy [1]. - Metformin reduces hepatic glucose production, inhibits intestinal glucose absorption, and increases peripheral glucose uptake, thereby improving insulin sensitivity [1]. - Empagliflozin, an SGLT2 inhibitor, decreases renal glucose reabsorption, lowers renal glucose threshold, and promotes glucose excretion through urine [1]. Group 2: Market Context - The National Health Commission of China has set a target for 2025, aiming for a 70% management rate and knowledge awareness rate among diabetes patients, indicating a growing demand for diabetes medications [2]. - The Metformin and Empagliflozin Tablets (I) are classified as a Category B drug under medical insurance, offering advantages such as effective glucose-lowering effects and good patient tolerance without serious adverse reactions [2]. - Bioequivalence studies have shown that the product is consistent with the reference formulation, supporting its efficacy in improving blood sugar control in adult patients with type 2 diabetes [2]. Group 3: Strategic Importance - The company views the Metformin and Empagliflozin Tablets (I) as a significant addition to its product pipeline in the diabetes treatment sector, providing more treatment options for patients [2].

Core Viewpoint - Fosun Pharma (01652) has received approval from the National Medical Products Administration of China for its compound formulation "Metformin and Ertugliflozin Tablets (I)", aimed at improving blood sugar control in adult patients with type 2 diabetes who are already on metformin and ertugliflozin treatment [1] Group 1: Product Details - "Metformin and Ertugliflozin Tablets (I)" is a combination of metformin hydrochloride and ertugliflozin, which works synergistically to provide better glycemic control compared to standard monotherapy [1] - Metformin reduces hepatic glucose production, inhibits intestinal glucose absorption, and increases peripheral glucose uptake and utilization, thereby enhancing insulin sensitivity [1] - Ertugliflozin, an SGLT2 inhibitor, lowers renal glucose reabsorption, decreases renal glucose threshold, and promotes glucose excretion through urine [1] Group 2: Market Implications - The approval of this product is seen as a significant addition to Fosun Pharma's product pipeline in the diabetes treatment sector, providing more treatment options for diabetes patients [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。 Fusen Pharmaceutical Company Limited 福 森 藥 業 有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：1652） 自願公告 「二甲雙胍恩格列淨片(I)」獲批上市 福森藥業有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」） 欣然宣佈，本集團研發的「二甲雙胍恩格列淨片(I)」，上市申請已獲得中國國家藥 品監督管理局批准，批准用於以下疾病的治療：本品配合飲食控制和運動，適用 於 正 在 接 受恩 格 列 淨 和 鹽 酸 二 甲 雙胍 治 療 的 2 型 糖 尿 病 成 人 患 者 ， 用於 改 善 這 些 患者的血糖控制。 「二甲雙胍恩格列淨片(I)」為鹽酸二甲雙胍、恩格列淨組成的複方製劑。藥理作用 如下：二甲雙胍可減少肝糖生成，抑制葡萄糖的腸道吸收，並增加外周組織對葡 萄糖 ...

Core Insights - Novo Nordisk is set to present 35 abstracts related to its diabetes and obesity portfolio at the EASD congress 2025, highlighting the health benefits and weight loss effects of semaglutide, along with new obesity pipeline therapies [1][3][4] Company Developments - The company will host an R&D investor event on 17 September to discuss the science and abstracts presented at the congress, which will be available via live webcast [2] - Semaglutide is recognized for having the broadest approved indications for obesity and type 2 diabetes, contributing to weight loss and cardiovascular protection [3] Research Presentations - Key presentations include the SOUL trial on oral semaglutide's cardiovascular outcomes, and various studies on the effectiveness of semaglutide and its impact on eating behaviors and body composition [5][7][8] - The REDEFINE trials will present data on the efficacy of cagrilintide and amycretin as next-generation obesity treatments [11][17] Product Information - Semaglutide is marketed under the brand names Wegovy® (2.4 mg injection), Ozempic® (1.0 mg injection), and Rybelsus® (14 mg oral) [14] - The drug has a well-established safety profile supported by over 33 million patient-years of exposure since its launch in 2018 [13]

Core Viewpoint - The biopharmaceutical sector has emerged as the best-performing segment in A-shares and Hong Kong stocks this year, with companies like HuaLing Pharmaceutical seeing their stock prices double due to industry trends and business breakthroughs [1] Financial Performance - In the first half of 2025, HuaLing Pharmaceutical achieved total revenue of approximately 217.4 million yuan, a year-on-year increase of 112% [2] - The company reported a pre-tax profit of 1.1839 billion yuan, largely due to the termination of an exclusive promotion agreement with Bayer, which resulted in a one-time deferred income of 1.2435 billion yuan [2] - The sales expense ratio significantly improved to 29.5%, down from 59.5% in the same period of 2024, indicating enhanced cost efficiency [2] - Gross margin increased by 7.7 percentage points to 54.2%, reflecting ongoing profitability [2] - As of June 30, the company held a cash balance of 1.0228 billion yuan, providing a solid financial foundation for future R&D and market expansion [2] Product Development and Market Strategy - HuaLing's flagship product, HuaTangNing, saw sales of 1.764 million boxes, a year-on-year increase of 108%, with net sales reaching 217.4 million yuan, also up 112% [2] - The product's market growth is attributed to its entry into the harvest phase and effective commercialization strategies [2] - The company is developing a fixed-dose combination of multi-glucose-lowering agents for patients who cannot control blood sugar with high doses of metformin, with plans to initiate bioequivalence studies in early 2026 [4] - HuaLing is also exploring combination therapies with GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors to expand indications beyond diabetes to include obesity and metabolic disorders [4] International Expansion and R&D - HuaLing is conducting a Phase I clinical trial at the University of Pennsylvania to evaluate the efficacy and safety of multi-glucose-lowering agents in cystic fibrosis-related diabetes patients, marking a significant step in international exploration [5] - The company is advancing its second-generation glucose kinase activator (GKA) research, with plans to initiate multi-dose escalation studies by the end of 2025 or early 2026, reinforcing its competitive edge in the GKA field [5] - Overall, the company's performance in the first half of 2025 reflects a successful combination of commercialization capabilities and the realization of its R&D pipeline, positioning it favorably for long-term growth in the metabolic disease sector [5]

Group 1 - The core point of the article is that Sihuan Pharmaceutical (00460) has seen its stock price increase by over 9%, currently trading at 1.54 HKD with a transaction volume of 113 million HKD, following the acceptance of a listing application for semaglutide injection by the National Medical Products Administration (NMPA) [1] - The semaglutide injection is intended for improving blood sugar control in adult patients with type 2 diabetes, marking a significant advancement in the drug development process for Sihuan Pharmaceutical [1] - The drug has also completed Phase III clinical enrollment for its weight loss indication and is currently in the follow-up stage, indicating ongoing progress in its clinical development [1] Group 2 - Diabetes treatment is a key focus area for Huisheng Biopharmaceutical, a non-wholly owned subsidiary of Sihuan Pharmaceutical, and the acceptance of the listing application enhances the company's competitive edge in this therapeutic area [1]

四环医药(00460)涨超9%，截至发稿，涨7.69%，报1.54港元，成交额1.13亿港元。 消息面上，四环医药公布，集团旗下非全资附属公司惠升生物制药股份有限公司开发的司美格鲁肽注射 液上市申请获得国家药品监督管理局(NMPA)受理，用于改善成人2型糖尿病患者的血糖控制。此外，司 美格鲁肽注射液用于减重的适应症已完成III期临床入组，处于随访阶段。 据悉，糖尿病领域为惠升生物重点布局领域，本次司美格鲁肽注射液上市申请获国家药监局受理，是该 款药物研发进程中的又一重要进展，将有助于进一步提升集团和惠升生物在糖尿病治疗领域的核心竞争 力。 ...