人民财讯10月10日电，国药现代(600420)10月10日公告，全资子公司国药威奇达收到国家药品监督管理 局关于原料药磷酸西格列汀的《化学原料药上市申请批准通知书》。磷酸西格列汀为DPP-4抑制剂，临 床上主要用于改善2型糖尿病患者的血糖控制。 转自：证券时报 ...

Summary of Biomea Fusion Conference Call - October 07, 2025 Company Overview - **Company**: Biomea Fusion (NasdaqGS: BMEA) - **Focus**: Development of acobaminib, a menin inhibitor for type 2 diabetes treatment Key Points from the Conference Call Clinical Study Results - **Study**: COVALENT-111, a phase 2 clinical trial assessing acobaminib's safety and efficacy in type 2 diabetes patients [5][6] - **Duration**: 52-week results presented, with a focus on the drug's effects on severe insulin-deficient patients and those on GLP-1 therapy [9][32] - **Efficacy**: - Severe insulin-deficient patients showed a mean HbA1c reduction of 1.5% compared to placebo, statistically significant with a p-value of 0.01 [16][32] - Patients on GLP-1 therapy who did not achieve target HbA1c levels experienced a 1.3% reduction [32] - **Durability**: HbA1c reductions were sustained for up to 52 weeks post-treatment, indicating potential long-term benefits [32][30] Mechanism of Action - **Menin Inhibition**: Acobaminib selectively inhibits menin, leading to increased beta cell mass and function, and enhanced GLP-1 receptor expression on beta cells [8][26] - **Clinical Implications**: This mechanism may provide a new treatment modality for patients with severe insulin deficiency, who currently have limited options [24][30] Safety Profile - **Safety Observations**: Acobaminib was generally well tolerated with no serious adverse events reported. The side effects included mild nausea and diarrhea [19][29] - **Long-term Monitoring**: Ongoing safety assessments are planned, especially regarding liver enzyme levels at higher doses [29][30] Future Directions - **Next Steps**: - Conducting a food effect study to optimize dosing and improve drug exposure [34] - Planning larger studies targeting severe insulin-deficient patients and those on GLP-1 therapy [33] - **Funding**: Recent public offering strengthens the company's financial position, extending cash runway into the second half of 2027 [34] Market Context - **Diabetes Treatment Landscape**: Current diabetes therapies often require chronic dosing and can have significant side effects. Acobaminib's episodic treatment approach may represent a significant advancement in diabetes care [30][64] - **Potential Impact**: If successful, acobaminib could become a cornerstone therapy for type 2 diabetes, particularly for difficult-to-treat patient populations [31][32] Additional Insights - **Patient Subtypes**: The study identified specific patient subtypes that respond best to acobaminib, including those with severe insulin deficiency and those inadequately controlled on GLP-1 therapies [9][33] - **Regulatory Pathway**: The company is optimistic about the FDA's acceptance of their novel treatment approach, which does not fit traditional chronic treatment guidelines [63][64] This summary encapsulates the critical findings and future directions discussed during the Biomea Fusion conference call, highlighting the potential of acobaminib in transforming diabetes treatment.

中国成人糖尿病患者人数达1.4亿，居世界第一，约占全球患病人数的四分之一。糖尿病病程长，长期 高血糖可导致心血管疾病、肾病、视网膜病变和神经病变等严重并发症，不仅威胁患者生命健康，也给 家庭和社会带来巨大的经济负担。 近年来，糖尿病的治疗理念逐渐由血糖控制过渡到"以患者为中心"、同时兼顾血糖管理、体重管理、心 血管危险因素及肝心肾合并症及并发症的2型糖尿病综合管理策略。 美国糖尿病协会(ADA)与欧洲糖尿病学会(EASD)联合发布的2型糖尿病高血糖的管理共识报告将"减 重"正式列入2型糖尿病管理目标之一，减重应作为改善血糖控制和降低体重相关并发症风险的治疗策 略，部分2型糖尿病患者应将减重5%-15%作为治疗首要目标。 玛仕度肽控糖减重优效，代谢肝心肾指标综合获益，助力健康中国2030 GCG/GLP-1双受体激动剂在GLP-1受体激动剂的基础上激动GCG受体，同时改善胰岛素分泌不足和胰岛 素抵抗两大糖尿病核心致病机制，帮助糖尿病患者更好的控制血糖，同时，还能为2型糖尿病患者带来 额外减重及心血管、肝酶改善、肾脏代谢的综合获益。因此，玛仕度肽作为安全、有效并且便捷的新型 治疗选择，可满足2型糖尿病患者长期血糖 ...

智通财经APP讯，福元医药(601089.SH)发布公告，近日，公司收到了国家药品监督管理局(以下简称"国 家药监局")颁发的吡格列酮二甲双胍片(15mg/850mg)(规格：每片含盐酸吡格列酮15mg(以C₁₉H₂₀N₂O₃S 计)和盐酸二甲双胍850mg)(以下简称"该药品")《药品注册证书》(证书编号：2025S02764)，批准该药品 生产。 吡格列酮二甲双胍片(15mg/850mg)的原研企业是武田药品工业株式会社，2005年8月获美国批准上市。 目前，原研厂家的吡格列酮二甲双胍片尚未在中国上市。本品适用于在饮食控制和运动的基础上，用于 目前使用盐酸吡格列酮和盐酸二甲双胍联合治疗的2型糖尿病患者或单用盐酸二甲双胍治疗后血糖控制 不佳的2型糖尿病患者。 ...

以下文章来源于肥胖世界ObesityWorld ，作者肥胖世界 肥胖世界ObesityWorld . 《肥胖世界》Obesity World - 同步传真肥胖及代谢国际新学术进展，为医学减重临床、教研人员搭建一座与国际接轨的桥梁，「每医健」旗下内容平台。 《柳叶刀糖尿病和内分泌学子刊》最新发表的一项突破性Meta分析揭示了减重与糖尿病缓解之间的精确关联：在超重或肥胖的2型糖尿病患者 中，体重下降与疾病缓解呈现强劲的剂量反应关系。这一关键发现与患者年龄、性别、种族背景、病程长短、初始糖化血红蛋白水平、体重指 数或减重方式均无关联。 研究团队对PubMed、Embase和临床试验注册库中截至2024年7月30日的全部相关随机对照试验进行了系统筛查，最终精选出22项高质量研 究，包含29个完全缓解和33个部分缓解评估指标。研究采用严格标准：完全缓解定义为干预一年后糖化血红蛋白低于6.0%或空腹血糖低于 5.6mmol/L且不使用任何降糖药物；部分缓解则为糖化血红蛋白低于6.5%或空腹血糖低于7.0mmol/L且不使用降糖药物。 数据分析结果令人震撼：干预一年后，不同减重幅度患者的完全缓解率呈现戏剧性差异——体重减轻 ...

Core Insights - The company is actively advancing the global expansion of its core product, Isupravaglutide α, which is intended for the treatment of Type 2 Diabetes (T2D) [1] - The company received BLA (Biologics License Application) approval for its core product in the Macau Special Administrative Region of the People's Republic of China in June 2025 [1] - The first prescription for the core product for T2D treatment was issued at the Huabao Medical Center in Macau on September 12, 2025, marking the official commercialization phase of the product in Macau [1]

Core Viewpoint - Taiji Group's subsidiary has received clinical trial approval for Semaglutide injection, a GLP-1 receptor agonist for type 2 diabetes management and weight control [1][2]. Group 1: Company Developments - Taiji Group's subsidiary, Chongqing Fuling Pharmaceutical Factory, has obtained the clinical trial approval notice from the National Medical Products Administration for Semaglutide injection [1]. - The approved indication for the clinical trial is for blood sugar control in adult patients with type 2 diabetes who have inadequate control despite treatment with metformin and/or sulfonylureas [1]. - The company has invested approximately RMB 44.1834 million in the research and development of this project [2]. Group 2: Industry Context - Semaglutide is a long-acting GLP-1 receptor agonist that stimulates insulin production, suppresses glucagon secretion, and reduces appetite, playing a significant role in treating type 2 diabetes and aiding weight management [1]. - The original product of Semaglutide injection was developed by Novo Nordisk, which reported total revenue of USD 29.296 billion for the product in 2024 [2]. - Currently, Novo Nordisk is the only company with the Semaglutide injection product approved for market in China [1].

Core Viewpoint - The article discusses the potential of multi-receptor agonists, specifically LY3437943, in improving health outcomes for patients with type 2 diabetes and obesity, highlighting its efficacy in blood sugar control and weight loss over a 12-week treatment period [5][10]. Group 1: Study Overview - LY3437943 is an innovative tri-agonist peptide designed to target GIP, GLP-1, and glucagon receptors, specifically for the treatment of type 2 diabetes and obesity [5]. - A 12-week study published in The Lancet evaluated the safety and pharmacological characteristics of LY3437943 in type 2 diabetes patients, showing significant improvements in blood sugar control and weight loss [5][10]. Group 2: Study Design and Methodology - The study was a randomized, double-blind, placebo-controlled phase 1b trial conducted from December 2019 to December 2020 across four research centers in the U.S., involving 72 eligible adult patients with type 2 diabetes [6]. - Patients were randomly assigned in a 9:3:1 ratio to receive different doses of LY3437943, a placebo, or a control group receiving 1.5 mg of dulaglutide, with treatment lasting 12 weeks [6]. Group 3: Safety and Efficacy Results - The primary assessment focused on the safety and tolerability of LY3437943, while secondary assessments looked at its pharmacodynamics and pharmacokinetics [7]. - Adverse events were reported in 63% of the LY3437943 group, 60% in the dulaglutide group, and 54% in the placebo group, with gastrointestinal symptoms being the most common adverse reactions [7]. - Pharmacokinetic analysis indicated a positive correlation between LY3437943's pharmacological parameters and dosage, with a half-life of approximately 6 days [8]. Group 4: Blood Sugar and Weight Loss Outcomes - After 12 weeks, average daily blood glucose levels significantly decreased in the high-dose LY3437943 groups compared to baseline, with reductions of 2.8 mmol/L, 3.1 mmol/L, and 2.9 mmol/L for the respective high-dose groups [8][10]. - Hemoglobin A1c levels also improved significantly in the high-dose groups, with reductions of 1.4%, 1.6%, and 1.2% for the respective groups [10]. - Weight loss was dose-dependent, with the highest dose group achieving an average weight reduction of 8.96 kg [10]. Group 5: Conclusion and Future Research - The findings suggest that LY3437943 exhibits safety characteristics comparable to existing incretin-based therapies while significantly improving blood glucose control and weight status over the 12-week treatment period, laying a solid foundation for phase 2 clinical studies in type 2 diabetes and obesity [10].

Core Viewpoint - The article discusses the development and clinical trial progress of GZR102, a fixed-dose combination long-acting weekly injection of basal insulin and GLP-1 receptor agonist, by Gan Li Pharmaceutical, aimed at improving treatment for type 2 diabetes mellitus (T2DM) patients [2][4]. Group 1: Product Development - Gan Li Pharmaceutical has initiated the first dosing of GZR102 in a Phase II clinical trial for adult T2DM patients in China [2]. - The trial compares the efficacy, safety, and tolerability of GZR102 administered weekly versus GZR18 administered biweekly, with a target enrollment of 90 patients [4]. - GZR102 aims to simplify T2DM treatment pathways while significantly reducing blood sugar levels and minimizing weight gain and hypoglycemia risks associated with basal insulin alone [4]. Group 2: Clinical Trial Details - The primary endpoint of the study is the change in glycated hemoglobin (HbA1c) from baseline after 24 weeks [4]. - The innovative formulation of GZR102 maximizes the synergistic effects of its two components, potentially enhancing glycemic control while reducing the daily insulin dosage [5]. Group 3: Market Potential - GZR102 represents a novel product in the diabetes combination therapy space, with no similar fixed-dose combination long-acting weekly injections currently available globally [4]. - The product's entry into Phase II clinical trials positions it as a potential preferred option in the diabetes treatment market in China, further enriching Gan Li Pharmaceutical's product portfolio [4].

Core Findings - The study confirms that the GLP-1/GIP dual receptor agonist Tirzepatide effectively reduces muscle fat deposition in type 2 diabetes patients while maintaining reasonable muscle mass changes [4][5] - After 52 weeks of treatment, patients showed significant weight loss and improved muscle fat infiltration, with muscle mass changes scientifically aligned with weight loss [4][5] - The research utilized data from the UK Biobank, involving nearly 3,000 real-world cases, providing a precise reference for clinical outcomes [4][5] Research Background - This milestone study originated from the MRI subgroup analysis of the SURPASS-3 clinical trial and was published in The Lancet Diabetes & Endocrinology in June 2025 [5] - The research team employed high-precision MRI technology to systematically compare the effects of Tirzepatide and insulin degludec on thigh muscle volume, fat infiltration, and standardized Z-scores after 52 weeks [5][7] Clinical Significance - Weight management is a core strategy in type 2 diabetes treatment, with over 10% weight loss potentially leading to disease remission and cardiovascular benefits [7] - Traditional weight loss methods often result in muscle loss, increasing the risk of sarcopenia in elderly patients [7] - Tirzepatide, as the first GIP/GLP-1 dual receptor agonist, has demonstrated superior weight loss and fat regulation effects, with this study providing authoritative data on its impact on muscle composition [7][8] Research Methodology - The study employed an international multicenter, randomized controlled trial design, including strictly defined type 2 diabetes patients [8] - Participants were divided into four groups: Tirzepatide 5mg/10mg/15mg weekly injection groups and a daily injection control group of insulin degludec [8] Key Research Highlights - Precise imaging assessments were conducted at baseline and after 52 weeks using MRI to quantitatively measure thigh muscle fat infiltration, lean muscle volume, and standardized Z-scores [9] - The introduction of UK Biobank data established a muscle-weight change model, enhancing the generalizability of the results [9] - Key findings indicated that weight loss does not equate to muscle loss, showcasing Tirzepatide's unique advantages [9][10] Clinical Breakthrough - The study innovatively utilized MRI technology to assess the effects of Tirzepatide on muscle composition in type 2 diabetes patients [13] - It revealed that significant weight loss (average 10.1%) was achieved while effectively reducing muscle fat infiltration, with muscle mass decline within physiological adaptation limits [13][14] Multiple Clinical Benefits - Tirzepatide demonstrated a unique "fat loss, muscle preservation" advantage, significantly reducing muscle fat infiltration by 0.36 percentage points [15] - The muscle mass reduction of 0.64 liters was proportionate to weight loss, outperforming muscle loss associated with simple dieting [15] - The study provided critical decision-making references for clinicians, particularly for patients needing enhanced weight management [15] Limitations and Future Directions - The study did not assess changes in muscle strength and daily activity capabilities [15] - There was a lack of strict control over lifestyle factors such as diet and exercise [15] - Long-term efficacy and safety beyond one year require further validation [15]