Core Viewpoint - Arecor Therapeutics has entered a co-development agreement with Sequel Med Tech for AT278, an ultra-concentrated insulin, and secured up to $11 million in non-dilutive funding through a royalty financing agreement with Ligand Pharmaceuticals, enhancing its strategic position in the diabetes management market [2][3][19]. Co-Development Agreement - Arecor and Sequel will co-fund development activities for the AT278-AID System, with each company committing up to $1.3 million to prepare for Phase 2 clinical trials [5][6]. - The collaboration aims to leverage Sequel's advanced AID technology, which offers superior dosing accuracy and faster occlusion detection, making it a suitable partner for AT278 [4][10]. Financial Aspects - The royalty financing agreement with Ligand includes a $7 million upfront payment and an additional $4 million contingent on achieving commercial milestones, extending Arecor's cash runway to the first half of 2027 [15][19]. - Arecor has monetized royalty rights related to AT220 and technology access fees for AT292, providing immediate capital for ongoing development [14][18]. Market Opportunity - The total addressable US insulin revenue market for AT278 is estimated at approximately $2.9 billion, targeting high-need segments such as patients requiring high daily insulin doses and those seeking extended-wear devices [11][12]. - The partnership with Sequel is expected to address unmet needs in diabetes management, potentially leading to significant growth opportunities for Arecor [7][11]. Strategic Intent - Both companies intend to establish a broader co-development and commercialization partnership for AT278, aiming to meet the needs of patients with Type 1 and Type 2 diabetes [7][13]. - Arecor's focus on high-value R&D opportunities is exemplified by the development of AT278 and a novel oral delivery platform for peptides, which are seen as key to generating shareholder value [13][18].

Core Viewpoint - MicroTech Medical-B (02235) has seen a stock increase of over 4%, currently trading at 8.06 HKD, following the approval of its core product, the Equil patch insulin pump, for use in children and adolescents aged 3-17 years with diabetes, expanding its market reach significantly [1][1][1] Group 1: Product Approval and Market Expansion - The National Medical Products Administration (NMPA) has approved the Equil patch insulin pump for pediatric use, which previously was only available for adult diabetes patients [1][1] - This approval provides a new treatment option for millions of children and adolescents with diabetes in China [1][1] Group 2: Clinical Trials and Efficacy - The clinical trials for this indication were led by the Children's Hospital affiliated with Zhejiang University School of Medicine, in collaboration with six top children's hospitals across the country [1][1] - The trials demonstrated the effectiveness and safety of Continuous Subcutaneous Insulin Infusion (CSII) in treating diabetes in children and adolescents [1][1] Group 3: Product Advantages - The patch insulin pump offers several advantages over traditional tube-based insulin pumps, including more precise and safe insulin delivery, ease of use, cost-effectiveness, enhanced privacy, and elimination of issues such as tube blockage and tangling [1][1][1]

Core Viewpoint - A domestic pharmaceutical company, Yabao Pharmaceutical, has halted the clinical research of its oral drug SY-009, an SGLT1 inhibitor, due to unsatisfactory results from its Phase II clinical trial, marking the second failure in diabetes drug development for the company [1][2]. Group 1: Company Overview - Yabao Pharmaceutical, originally focused on pediatric drugs, is transitioning towards innovative drugs, aiming to reduce its reliance on generic drugs from 90% to 40% by 2024 [1]. - The company has invested a total of 87.87 million yuan in the development of SY-009, which will be written off as a loss due to the termination of the project [2]. Group 2: Drug Development Details - SY-009 was approved for clinical trials in July 2018 and underwent three Phase I and one Phase II clinical trials over nearly six years [2]. - The Phase II trial results indicated a lack of achievement in primary efficacy endpoints, leading to the decision to terminate further development [2][3]. Group 3: Market Context - The global diabetes treatment market is projected to reach nearly $80 billion by 2024, with China's market exceeding 70 billion yuan [3]. - The competition in diabetes treatment is intense, with various classes of oral medications available, but SGLT1 inhibitors have limited presence in the market [3][4]. - The rise of GLP-1 class drugs has shifted the competitive landscape in diabetes treatment, with significant market potential and ongoing exploration of new indications [5].

Core Viewpoint - Novo Nordisk's weekly injectable diabetes drug has received EU approval, providing patients with an additional treatment option [1] Group 1: Drug Approval and Composition - The European Medicines Agency's drug review panel recommended the approval of Kyinsu for treating type 2 diabetes patients [1] - The drug is a combination of insulin and semaglutide, the active ingredient in Novo Nordisk's popular weight loss drug Ozempic, and is also known as IcoSema [1] Group 2: Clinical Efficacy - Clinical trials indicate that the drug helps type 2 diabetes patients better control their weight and lower blood sugar levels, outperforming daily insulin injections [1] - The drug is particularly beneficial for patients who struggle to manage diabetes through daily insulin injections [1] Group 3: Regulatory Challenges - The long-acting insulin component of the drug was previously rejected by the U.S. Food and Drug Administration due to the need for more detailed information regarding the manufacturing process and indications for type 1 diabetes [1]

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 ...