An Open-label, Randomized, Three-period, Crossover, Single-dose Study to Evaluate the Effect of a Low-fat Meal and a Standard Meal on the Pharmacokinetics of DBPR108 in Healthy Subjects

This is an open-label, randomized, three-period, crossover, single-dose study to evaluate the effects of a low-fat meal and a standard meal on the pharmacokinetics of DBPR108 and the safety and tolerability of DBPR108 under different fed states in healthy adult subjects.

开始日期2022-05-29

申办/合作机构

石药集团中奇制药技术（天津）有限公司

100 项与普卢格列汀相关的临床结果

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100 项与普卢格列汀相关的转化医学

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100 项与普卢格列汀相关的专利（医药）

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项与普卢格列汀相关的文献（医药）

2025-06-01·IRISH JOURNAL OF MEDICAL SCIENCE

Safety and efficacy of prusogliptin in type-2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials

Review

作者: Hamna Ahmed Khan ; Abdul Moeed ; Tooba Saqib ; Salim Surani ; Afia Salman ; Syed Muhammad Muneeb Akhtar ; Hoorain Jamil ; Muhammad Ahmed Ali Fahim ; Hajra Zainab Chaudry ; Laiba Zafar ; Abdul Hannan Siddiqui ; Laiba Sanober ; Alishba Adnan Janjua ; Ayesha Ali ; Muqaddas Parvez ; Hala Najeeb

BACKGROUND:

This study aims to conduct a systematic review and meta-analysis of the currently present literature analyzing the effectiveness and safety profile of prusogliptin, a novel dipeptidyl peptidase-IV (DPP-4) inhibitor, as compared to placebo in type 2 diabetes mellitus (T2DM) patients.

METHODS:

This systemic review and meta-analysis complied with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy based on various MeSH terms was run on: PubMed/Medline, SCOPUS, and Cochrane Central, which were then systematically searched from inception till March 2024 to select all relevant Randomized Control Trials (RCT).

RESULTS:

The analysis of the findings from three RCTs with 957 patients revealed that prusogliptin reduced Hemoglobin A1c (HbA1c)% levels in T2DM patients significantly [Mean Difference (MD): -0.62, 95% Confidence Interval (CI): -0.74 to -0.50, I² = 0%, p < 0.001] and led to more patients with a HbA1c% ≤ 7% [Odds Ratio (OR): 2.65, 95%CI: 1.94 to 3.61, I² = 0%, p < 0.00001]. However, prusogliptin led to a non-significant increase in weight when compared with placebo (MD: 0.22, 95% CI: -0.50 to 0.93, I² = 60%, p = 0.551). The safety profile of prusogliptin revealed a non-significant decrease in treatment-emergent adverse events (OR: 0.90, 95% CI: 0.59 to 1.38, I² = 43%, p = 0.64) and a non-significant increase in treatment-emergent serious adverse events (OR: 1.02, 95% CI: 0.43 to 2.44, I² = 0%, p = 0.96) and drug-related adverse events (OR: 1.07, 95%CI: 0.68 to 1.69, I² = 0%, p = 0.76).

CONCLUSION:

Prusogliptin has a favorable efficacy in attaining glycemic control in patients with T2DM. However, its safety profile yields uncertain outcomes. More literature is required for a definitive result.

2025-05-01·CLINICAL PHARMACOKINETICS

Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes

Article

作者: Lingli Yao ; Xiaoli Li ; Xiaofang Zhang ; Rui Jia ; Shan Jing ; Huanhuan Qi ; Kexu Yang ; Huan Zhou ; Wenfang Liu ; Jingyi Liu ; Yang Lin ; Tianhao Zhang ; Chunyan Lu ; Juan Wang

BACKGROUND AND OBJECTIVE:

DBPR108 (prusogliptin) is a novel, orally bioavailable dipeptidyl peptidase-4 (DPP-4) inhibitor. This study investigated the pharmacokinetics and pharmacodynamic characteristics of DBPR108 tablets in patients with type 2 diabetes.

METHODS:

In this randomized, parallel-group, open-label, phase I study, Chinese adults with type 2 diabetes, glycated hemoglobin of 7.0-9.5%, and body mass index of 19-35 kg/m² were randomized 1:1:1 to once-daily DBPR108 50-, 100-, or 200-mg tablet groups. The primary endpoints included pharmacokinetic and pharmacodynamic characteristics after a single dose and multiple doses of DBPR108.

RESULTS:

In total, 30 patients were randomized with 10 patients in each group. DBPR108 was quickly absorbed with median time to reach the maximum plasma concentration of 1.5-4 h at steady state. Exposure to DBPR108 at steady-state increased dose proportionally with mean maximum steady-state plasma DBPR108 concentration during dosage intervals of 119, 256, and 567 ng/mL in the 50-, 100-, and 200-mg groups, respectively. Accumulation ratio of DBPR108 ranged from 0.85 to 1.3, and steady state was reached after four continuous daily doses. After multiple doses of DBPR108, maximum inhibitory efficacy of DPP-4 increased with higher dose levels ranging from 62.1 to 89.4%. Active glucagon-like peptide-1 levels increased after DBPR108 administration. In addition, six patients experienced treatment-emergent adverse events without leading to treatment interruption or discontinuation.

CONCLUSIONS:

DBPR108 was well tolerated in Chinese patients with type 2 diabetes, and both the pharmacokinetic and pharmacodynamic profiles support once-daily dosage regimens of DBPR108 in future studies.

TRIAL REGISTRATION:

ClinicalTrials.gov (NCT05146869); registered 23 November 2021.

2025-03-01·DIABETES OBESITY & METABOLISM

Comparative efficacy and safety of dipeptidyl peptidase‐4 inhibitors in adults with type 2 diabetes mellitus: A network meta‐analysis

Review

作者: Zhai, Jiawei ; Wang, Gongquan ; Fu, Jia ; Du, Bing ; Li, Xiangjun ; Wang, Jiajia

Abstract:

Aims:

We have compiled updated evidence on the benefits and drawbacks of dipeptidyl peptidase‐4 (DPP‐4) inhibitors in treating type 2 diabetes mellitus.

Materials and Methods:

We systematically searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov (as of 20 May 2024). Effect estimates were calculated using network meta‐analysis under the frequentist framework. The P‐score established the ranking of competing treatments.

Results:

The authors incorporated 58 studies containing data from a substantial sample size of 21 332 patients. Based on evidence of high and moderate certainty, respectively, teneligliptin and vildagliptin were found to be superior to all other DPP‐4 inhibitors in lowering haemoglobin A1c (mean difference [MD] −0.81%, 95% CI −1.03, −0.60) and fasting blood glucose (MD −1.18 mmol/L, 95% CI −1.56, −0.81) compared to placebo. The absence of conclusive differences between interventions for serious adverse events was supported by evidence, which was interpreted with low to very low certainty.

Conclusions:

In adults with type 2 diabetes, teneligliptin was most effective for HbA1c control, and vildagliptin for fasting blood glucose. No significant differences in serious adverse events were noted among DPP‐4 inhibitors compared to placebo. Given the therapeutic significance of these findings, more studies are needed to explore this issue more thoroughly.

168

项与普卢格列汀相关的新闻（医药）

2026-10-08

·PRNewswire

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market to Reach USD 15,527.66 Million by 2032 - Credence Research

LONDON, Oct. 8, 2026 /PRNewswire/ -- The "Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market – Growth, Share, Opportunities & Competitive Analysis, 2026–2032" report has been added to the Credence Research Inc. offering. The global Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market was valued at USD 11,280.60 million in 2025 and is projected to reach USD 15,527.66 million by 2032, registering a CAGR of 5.47%. Demand is supported by the persistent global burden of type 2 diabetes, continued use of oral glucose-lowering therapies and the expanding availability of generics and fixed-dose combinations. DPP-4 inhibitors remain relevant for selected patients who benefit from simple oral dosing, low hypoglycemia risk and weight-neutral treatment profiles, although newer incretin and cardiometabolic therapies are increasing competitive pressure. Key Takeaways The market is projected to rise from USD 11,280.60 million in 2025 to USD 15,527.66 million by 2032 at a CAGR of 5.47%. Sitagliptin led the drug type segment with a 36.9% share in 2025, supported by long-standing prescribing familiarity, broad availability and generic participation. Retail pharmacies accounted for 44.8% of 2025 revenue, reflecting repeat-refill behavior in chronic outpatient diabetes management. North America led with a 37.8% share in 2025, followed by Europe at 26.1% and Asia Pacific at 23.4%. Fixed-dose combinations with metformin remain strategically important because they can reduce pill burden and support stepwise treatment intensification. Validated core participants include Merck & Co., AstraZeneca, Boehringer Ingelheim, Takeda Pharmaceutical, Novartis, Eli Lilly, Lupin, Sun Pharmaceutical and Dr. Reddy's Laboratories. Scope & Segmentation – Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market The report provides a comprehensive analysis of the global DPP-4 Inhibitors Market through 2032, covering drug molecules, formulation formats, treatment sequencing, combination strategies, dispensing channels and patient groups. The study evaluates how generic entry, payer formularies, fixed-dose combinations and competition from GLP-1, dual incretin and SGLT2 therapies are reshaping commercial strategies. It also examines regional access, chronic refill infrastructure and molecule-level considerations that influence prescribing. The DPP-4 Inhibitors Market is segmented based on drug type, formulation, therapy line, combination type, distribution channel, patient type and geography. By Drug Type, the market includes Sitagliptin, Saxagliptin, Linagliptin, Alogliptin and Others. By Formulation, the market includes Oral Tablets, Fixed-dose Combinations and Others. By Therapy Line, the market includes First-line Therapy, Second-line Therapy, Add-on Therapy and Others. By Combination Type, the market includes Monotherapy, Combination with Metformin, Combination with SGLT2 and Others. By Distribution Channel, the market includes Hospital Pharmacies, Retail Pharmacies, Online Pharmacies and Others. By Patient Type, the market includes Type 2 Diabetes Adults, Elderly Patients, Renal-impaired Patients and Others. By Geography, the market is analyzed across North America, Europe, Asia Pacific, Latin America and Middle East & Africa. Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. Why This Report Matters The report provides a focused view of a mature but resilient oral diabetes drug class undergoing a transition from branded growth toward access-led generic volume. It helps decision-makers assess molecule-level demand, fixed-dose combination opportunities, distribution dynamics and evolving therapy-line positioning. The study highlights the commercial impact of newer diabetes classes that offer weight-loss or broader cardiometabolic benefits. For pharmaceutical manufacturers, generic drug companies, distributors and investors, the report provides actionable intelligence for portfolio, pricing and market-access decisions. Market Overview • Industry Landscape and Value Chain Assessment • Supply-Side Evaluation • Demand-Side Evaluation • Stakeholder Mapping • Porter's Five Forces Review • PESTLE Environment Assessment • Market Forecast and Future Direction • Short-Term Forecast, 0–2 Years • Mid-Term Forecast, 3–5 Years • Long-Term Forecast, 5–10 Years • Market Entry and Expansion Strategy Market Insights • Patient and Prescriber Analysis • Therapy Sequencing Assessment • Generic Entry and Substitution Review • Fixed-Dose Combination Opportunity Assessment • Distribution and Refill Channel Review • Pricing and Reimbursement Analysis • Competitive Class Substitution Assessment • Regional Access and Diagnosis Review • Lifecycle Management and Portfolio Strategy Key Attributes Segmentation By Drug Type • Sitagliptin • Saxagliptin • Linagliptin • Alogliptin • Others By Formulation • Oral Tablets • Fixed-dose Combinations • Others By Therapy Line • First-line Therapy • Second-line Therapy • Add-on Therapy • Others By Combination Type • Monotherapy • Combination with Metformin • Combination with SGLT2 • Others By Distribution Channel • Hospital Pharmacies • Retail Pharmacies • Online Pharmacies • Others By Patient Type • Type 2 Diabetes Adults • Elderly Patients • Renal-impaired Patients • Others By Geography • North America • Europe • Asia Pacific • Latin America • Middle East & Africa Market Growth Driven by Chronic Type 2 Diabetes Demand and Oral Therapy Preference The persistent global burden of type 2 diabetes supports recurring demand for oral glucose-lowering medicines. DPP-4 inhibitors retain a role in selected patients because they offer simple daily administration, a generally low risk of hypoglycemia and a weight-neutral profile. These characteristics can be valuable in older patients, people managing multiple medicines and treatment plans where tolerability is prioritized. Generic entry is changing the revenue mix. Loss of exclusivity has reduced branded pricing power in several markets, yet lower-cost sitagliptin and other molecules can expand access and preserve prescription volume. Wider retail pharmacy availability and e-pharmacy distribution also support continuity for chronic therapy users. Fixed-dose combinations remain an important lifecycle strategy. Pairing DPP-4 inhibitors with metformin or other oral agents can simplify regimens and support patients who require stepwise treatment intensification without moving immediately to injectable therapy. Competitive Pressure from Newer Diabetes Therapies Reshapes the Market DPP-4 inhibitors face stronger competition from GLP-1 receptor agonists, dual incretin therapies and SGLT2 inhibitors. These newer classes can offer weight reduction or broader cardiovascular and renal benefits in selected patient populations, which can influence guideline positioning and payer preference. This pressure makes affordability, tolerability, oral convenience and combination availability increasingly important sources of differentiation. Manufacturers must manage mature brands carefully while generic suppliers compete on price, supply reliability and pharmacy coverage. Regional Growth Reflects Reimbursement Depth and Expanding Access North America led the market with a 37.8% share in 2025, supported by established diagnosis pathways, structured reimbursement and a mature retail refill infrastructure. Europe accounted for 26.1%, where reference pricing and cost-containment policies accelerate generic uptake while preserving steady outpatient use. Asia Pacific represented 23.4% of the market and offers substantial volume potential due to large diabetes populations, improving diagnosis and expanding pharmacy access. Latin America and Middle East & Africa remain smaller in revenue terms, with growth dependent on affordability, distributor reach and reimbursement development. Future Outlook The DPP-4 inhibitor market is expected to expand steadily rather than rapidly through 2032. Growth will be supported by chronic disease prevalence, generic access and fixed-dose combinations, while class share will remain under pressure from newer therapies with stronger weight and cardiometabolic profiles. Companies with broad generic portfolios, strong local distribution and combination-product capabilities will be better positioned to defend volume. Market opportunities will increasingly center on affordability, emerging-market access and simplified regimens rather than premium pricing. Competitive Landscape Competition is shifting from brand exclusivity toward formulary placement, generic substitution, combination availability and supply reliability. Merck remains closely associated with sitagliptin, while AstraZeneca, Boehringer Ingelheim, Takeda and Novartis have established DPP-4 portfolios or legacy brands. Eli Lilly remains relevant through its long-standing collaboration with Boehringer Ingelheim around linagliptin. Generic manufacturers including Lupin, Sun Pharmaceutical and Dr. Reddy's Laboratories strengthen price competition and expand access in large emerging markets. The strongest commercial positions increasingly depend on distribution coverage, procurement competitiveness and the ability to sustain reliable supply after patent expiry. Key Player Analysis • Merck & Co. • AstraZeneca • Boehringer Ingelheim • Takeda Pharmaceutical • Novartis • Eli Lilly and Company • Lupin • Sun Pharmaceutical • Dr. Reddy's Laboratories Recent Industry Developments In June 2025, Abbott and MSD Pharmaceuticals announced a distribution agreement in India covering sitagliptin, sitagliptin/metformin and the extended-release combination, expanding access to MSD's established DPP-4 portfolio. In January 2025, CSPC Pharmaceutical Group announced that China's National Medical Products Administration granted marketing approval for prusogliptin tablets, a new DPP-4 inhibitor for adults with type 2 diabetes. Report Coverage The research report offers an in-depth analysis based on Drug Type, Formulation, Therapy Line, Combination Type, Distribution Channel, Patient Type and Geography. It assesses market size, regional demand, competitive positioning, generic entry, fixed-dose combinations, reimbursement dynamics and the impact of alternative diabetes drug classes. The study provides strategic recommendations for branded manufacturers, generic companies, distributors and investors navigating a mature therapeutic category with changing treatment preferences. Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. Shape Your Report to Specific Countries or Regions and Enjoy 30% Off! Customize Now Related Reports – About Us Credence Research Inc is a global market intelligence and consulting firm founded in 2015. It delivers deep market insights, quantitative analysis, and strategic guidance to business leaders, investors, governments, NGOs, and non-profit groups worldwide. The company helps organizations evaluate markets, understand trends, reduce risk, and make data-driven decisions that support growth and competitive strategy. Credence Research is known for rigorous research methods and comprehensive analytics. The firm produces detailed reports covering market size, forecasts, growth drivers, trends, and competitive landscapes across many industries. Each report often includes frameworks like PESTLE and Porter's Five Forces to give a complete view of market dynamics and future potential. Credence Research also provides tailored consulting services, due diligence support, go-to-market planning, and pre-IPO research to strengthen client strategies and investment narratives. Its insights come from both primary and secondary research, expert interviews, and advanced data modelling. The firm's client base spans Europe, the Americas, Asia-Pacific, and the Middle East/Africa. To find out more, visit or follow us on X.com, LinkedIn and Facebook Contact Us – Credence Research Inc, Tower C-1105, S 25, Akash Tower, Vishal Nagar, Pimple Nilakh, Haveli, Pune – 411027, India USA: +1 6282 627 656 UK: +44 7453 598 606 Email: [email protected] Visit Our Website: SOURCE Credence Research Inc. 21% more press release views with Request a Demo

上市批准

2026-09-20

·原料药情报局

SYH2069 进 II 期，身后排着 5 个品种：石药的降糖减重"全家桶"

「点击蓝字，关注我们」原料药情报局 · 管线深扫描SYH2069 进 II 期，身后排着 5 个品种：石药的降糖减重"全家桶" 一纸临床公告背后：从 Fc 融合到月制剂，石药 GLP-1 的三条技术路线已经全部摆上桌面石药集团 1093.HK · 2026.09.16 自愿公告本文数据来源：石药集团港交所公告（2026年9月16日、6月18日、6月8日、3月20日、2月16日）· 石药集团2026年中期报告 · 天境生物公告 · 公开行业报道｜全文约 4,600 字 2026年9月16日，石药集团（1093.HK）发布自愿公告：SYH2069 注射液用于治疗成人 2 型糖尿病的 II 期临床试验（SYH2069-003）已在中国首个研究中心正式启动。单看是一条常规的临床推进。但把石药这一年多的公告串起来读，会发现 SYH2069 只是这家公司代谢管线的冰山一角——降糖减重赛道上，石药手里同时压着一条 NDA 双受理的准上市品种、三个不同技术路线的临床阶段新分子、一个卖掉海外权益换来 12 亿美元首付款的月制剂平台。这篇文章把这条"全家桶"管线拆给你看。一、公告主角 SYH2069：双靶点 + 偏向性设计 SYH2069 注射液是一款新型脂肪酸修饰多肽类长效 GLP-1R/GIPR 双靶点双偏向型激动剂——对标的是替尔泊肽（礼来）开辟的"GLP-1 + GIP"双靶机制赛道。先拆这串定语里的两个关键词：双靶点（GLP-1R + GIPR）：选择性激活两个受体，以葡萄糖依赖性方式促进胰岛素分泌，同时抑制食欲、延缓胃排空、增加饱腹感、减少热量摄入——降糖与减重协同。双偏向型（biased agonist）：这是石药在这条管线里最值得注意的技术选择。G 蛋白偶联受体下游有两条通路——cAMP 通路负责疗效信号，β-arrestin 募集则会导致受体内化和脱敏。SYH2069 被设计为选择性激活 cAMP 通路、避开 β-arrestin 募集，从而增强活性并延长药效持续时间。偏向性激动剂是当前 GPCR 药物设计的前沿方向——同一个受体，"激活"不等于"激活"，选择性地走疗效通路、不走脱敏通路，理论上能用同样的靶点做出更好的药。临床前研究显示 SYH2069 展现出良好的靶点活性和可控的安全性特征。时间线上，这个分子的推进节奏很快：时间进展 2025.12超重或肥胖适应症获 NMPA 临床试验批准，随后启动 I 期临床——初步展现了人体安全性、耐受性及药代/药效动力学特征 2026.042 型糖尿病适应症获 NMPA 临床试验批准 2026.09T2DM II 期临床（SYH2069-003）中国首个研究中心启动，受试者招募积极推进中资料来源：石药集团 2026年9月16日公告 II 期试验的设计也有信息量：多中心、随机、双盲、安慰剂及阳性对照、平行分组，评估不同给药方案下的有效性与安全性。设阳性对照，说明石药没打算只跟安慰剂比——上市前就要摸清与标准治疗的相对位置。二、把镜头拉远：石药降糖减重管线全景 SYH2069 之外，石药在这条赛道上还布了这些子：品种技术路线最新进展依达格鲁肽α （TG103）重组人源 GLP-1 Fc 融合蛋白，每周一次，生物制品 1 类NDA 双受理：减重（2025.10）+ T2DM（2026.6）；两项 III 期 TFL 定稿，头对头优于度拉糖肽SYH2069脂肪酸修饰长效多肽，GLP-1/GIP 双偏向激动剂减重 I 期完成初步数据；T2DM II 期启动（2026.9）SYH2082GLP-1/GIP 双偏向激动多肽月制剂（长效制剂平台+长半衰期修饰）中美双 IND：FDA（2026.2）+ NMPA（2026.3），肥胖/超重体重管理SYH9017司美格鲁肽月制剂，皮下注射形成凝胶贮库缓释2024.12 国内 IND；2026.6 获 FDA 临床批准（体重管理），中美双报SYH2092肥胖管线早期分子非临床阶段，入选 2026 年欧洲肥胖大会（ECO）摘要资料来源：石药集团历次公告及 2026 年中报仿制药与改良梯队同样在铺：普卢格列汀二甲双胍缓释片（DPP-4 复方，2026.1 NDA 受理）、西格列汀二甲双胍缓释片（2026.5 NDA 受理）、恩格列净二甲双胍缓释片（2026 年获注册批件）、普卢格列汀片联合达格列净和二甲双胍 III 期已完成末例入组（2026.3）——口服降糖基本盘与创新线并行。三、全家桶里最接近商业化的一张牌：依达格鲁肽α 如果说 SYH2069 是"未来"，那 TG103 就是"现在"。这个分子值得单独展开：依达格鲁肽α（商品名善美宁®，又称 TJ103/TG103）是重组人源 GLP-1 Fc 融合蛋白注射液，每周给药一次，按治疗用生物制品 1 类新药申报，开发主体为石药集团百克（山东）生物制药，原始权益来自天境生物（2018 年授权石药用于中国大陆的研发、注册、生产与商业化）。两项关键 III 期（单药 + 联合二甲双胍）已于 2026 年 2 月 TFL 定稿、结果符合预期，联合用药 III 期还拿到了 2026 年欧洲糖尿病研究协会（EASD）的简短口头报告席位。披露的临床要点：起效快、疗效持久：给药 4 周即明显起效，8 周 HbA1c 较基线降幅超 1%，疗效稳定持续至 52 周；基线 HbA1c 更高的患者降幅可达 2% 以上。头对头赢了度拉糖肽：在联合二甲双胍治疗基础上，与度拉糖肽相比展现出更好的长期血糖控制优势——Fc 融合路线打 Fc 融合路线，数据说话。耐受性差异化：胃肠道不良事件发生率及因不良事件终止治疗率低于已上市同类；剂量递增只需 4 周即达目标维持剂量，方案更简便。上市申请节奏：减重适应症 NDA 已于 2025 年 10 月获受理，T2DM 血糖控制 NDA 于 2026 年 6 月获受理——一个分子、两项适应症、双双在审。这是石药 GLP-1 矩阵里最先见分晓的品种。四、三条技术路线，卡三个生态位把四个临床阶段分子放在一起看，石药的布局逻辑非常清晰——不是在一个点上堆分子，而是用三条不同的技术路线覆盖三个竞争维度：路线代表品种给药频率对标逻辑Fc 融合蛋白依达格鲁肽α 每周一次度拉糖肽同路线，头对头争份额脂肪酸修饰双靶多肽SYH2069 长效替尔泊肽机制赛道+偏向性改良缓释制剂平台（月制剂）SYH9017 / SYH2082 每月一次给药频率降维打击，差异化竞争资料来源：石药集团历次公告整理；SYH2069 给药频率未披露，仅披露"长效" 三条路线的技术纵深不同：Fc 融合靠分子生物学（重组表达），脂肪酸修饰靠多肽化学（侧链偶联），月制剂靠递送技术（凝胶贮库 + 长半衰期修饰双层设计）。等于石药同时押注了"更好的分子"和"更好的递送"两个改进方向——前者解决药效上限，后者解决依从性下限。 SYH9017 的细节最能说明月制剂路线的打法：利用长效递送技术平台，以生物相容性辅料为基础，皮下注射后形成凝胶贮库实现缓释。国内临床研究显示，与已上市的司美格鲁肽周制剂相比，减重效果相当、安全性良好、半衰期明显延长——支持每月给药一次。2026 年 6 月 8 日该产品获 FDA 临床批准（体重管理适应症），是国内公开报道中用药间隔最长的 GLP-1 在研药物之一，也是国产药企首次将月制剂改良型新药推进美国临床。 ▎ 情报局观察 GLP-1 竞赛的评估维度正在换挡：从"减重幅度"转向口服便利性 + 给药频次 + 耐受性。礼来口服小分子 orforglipron 的 III 期（36mg 组体重降 8.2% vs 口服司美格鲁肽 5.3%）、阿斯利康 elecoglipron（75mg 组 36 周减重 11.8%，已启动全球 III 期）在攻"口服"；石药的月制剂在攻"频次"——方向不同，但都是在抢周制剂注射的未来市场。五、12 亿美元首付：月制剂路线已经被阿斯利康"验过货" 石药这条 GLP-1 管线最硬的背书，来自阿斯利康的支票簿。 2026 年 1 月，石药与阿斯利康签订战略合作与授权协议，利用缓释给药技术平台及多肽药物 AI 发现平台，开发创新长效多肽药物。阿斯利康获得每月一次注射用体重管理产品组合的全球独家权利（不含中国内地及港澳台）。对价结构：首付款 12 亿美元——2026 年 5 月 29 日已到账研发里程碑最高 35 亿美元——首笔 2,500 万美元已于 2026 年 7 月 10 日收到销售里程碑最高 138 亿美元 + 最高双位数比例的分层销售提成这笔交易创下国产创新药出海首付款纪录，而交易的底层资产正是月制剂技术平台。换句话说：石药留在手里的中国市场月制剂管线（SYH9017、SYH2082 等），和阿斯利康花 12 亿美元买走的是同一套技术能力——这套能力的成色，全球最顶尖的买方已经用真金白银标过价了。双方还在加码：2026 年 7 月，石药再与阿斯利康就 siRNA 平台达成第二笔合作（3,000 万美元首付，8 月 12 日已到账）；2026 年 8 月，双方签署合资合同，在石家庄建设新一代生物制剂生产基地——石药 51%、阿斯利康 49%，把 GMP 产能也绑进了同盟。六、赛道拥挤度：不是能不能做出来，是排在第几个必须承认，这条赛道的国产竞争已经白热化。仅 2026 年 6 月以来：翰森制药奥莱泊肽（GLP-1/GIP 双靶点）肥胖适应症 NDA 获 NMPA 受理——双靶点赛道上，翰森的申报节奏暂时领先石药。诺和诺德 zenagamtide（GLP-1/胰淀素双激动剂）II 期 36 周减重 14.6%，计划下半年启动 III 期。罗氏/Zealand 的 petrelintide（胰淀素类似物）42 周减重 10.7%。石药的相对位置：单靶周制剂（依达格鲁肽α）NDA 已在审，预计是国产 GLP-1 第二三梯队上市序列；双靶点（SYH2069）刚进 II 期，比头部慢了半程；但月制剂（SYH9017/SYH2082）在给药频率维度上是全球稀缺资产——周制剂和月制剂不是同一张牌桌，后者目前没有已上市竞品。七、对原料药与 CXO 产业链的三点信号多肽 API 的竞争焦点正在上移。司美格鲁肽 API 的价格战已经把"能合成 GLP-1"打成白菜价，下一步的溢价能力在修饰技术——脂肪酸侧链偶联（SYH2069 路线）、Fc 融合表达（TG103 路线）的工艺Know-how，比裸肽合成难得多。石药同时布局两条，等于给上游多功能修饰 CDMO 指了方向。月制剂打开的是辅料与制剂端的新市场。凝胶贮库缓释意味着新型生物相容性辅料、预充式注射器、超长效无菌制剂的验证体系——这不是传统多肽 API 厂的战场，是制剂 CDMO 和药用辅料企业的增量。石药的月制剂管线每往前走一步，这条供应链就多一分确定性。多肽产能过剩是结构性的，不是绝对的。裸肽过剩、修饰肽稀缺；普通注射剂过剩、缓释贮库稀缺。石药在石家庄与阿斯利康合建生物制剂基地（含多肽产线逻辑）说明头部玩家已经在为下一代产品结构配产能——跟着管线结构配产能，而不是跟着当下品种配产能，这个思路值得全行业对照自查。结语：从 2025 年 10 月依达格鲁肽α减重 NDA 受理算起，石药在 11 个月里完成了：一项 NDA 双适应症受理、三个新分子进入临床（含两个 FDA IND）、一次 12 亿美元的管线出海、一座与阿斯利康的合资工厂。SYH2069 的 II 期启动，只是这条时间线上最新的一格。对"原料药情报局"的读者，这家公司值得持续盯的点有两个：一是依达格鲁肽α的上市定价与放量节奏——它将检验石药代谢管线的商业化能力；二是 SYH2069 II 期的剂量-响应数据——偏向性设计能不能转化成临床优势，2027 年见分晓。三条技术路线、五个临床品种、一张海外支票——石药的 GLP-1，已经不是"在做了"，是"做全了"。原料药情报局专注原料药 · 中间体 · 合成生物学产业链研究本文为公开信息整理分析，不构成任何投资建议数据来源：石药集团港交所公告 · 石药集团 2026 年中报 · 天境生物公告 · 医药魔方等公开报道2026年9月 · 第 073 期往期推荐原料药供需对接项目产能医药资讯农化资讯医药中间体农药原药农药中间体营养保健食品饲料合成生物香精香料兽药资讯精细化工产品推荐新材料 IPO 园区推荐印度企业点点赞点分享点喜欢

2026-09-02

·石药集团

善报天下人：石药集团荣膺第十三届“中华慈善奖”

9月1日，第十三届“中华慈善奖”表彰大会在北京人民大会堂隆重举行。石药控股集团有限公司凭借在公益慈善领域的突出贡献，荣获本届“中华慈善奖”捐赠企业奖，石药集团执行总裁蔡鑫参加表彰大会。这一重磅荣誉，是国家民政部对石药集团多年积极履行社会责任、深耕公益事业、践行企业大爱担当的高度认可与充分褒奖。作为中国慈善领域设立最早、规格最高、影响最广的政府奖项，“中华慈善奖”旨在表彰全国范围内在慈善捐助、公益帮扶、乡村振兴、应急救灾、公益传播等领域作出卓越贡献的企业、个人及慈善项目，代表着中国公益慈善事业的最高标杆，社会影响力深远。此次获奖，充分彰显了石药集团持之以恒的公益初心与深耕社会民生的责任底色。自成立以来，石药集团始终秉持“做好药，为中国，善报天下人”的企业使命，将企业发展与社会责任深度绑定，坚持“产业报国、公益惠民”的发展理念，把慈善公益、民生帮扶、社会回馈贯穿企业高质量发展全过程。多年来，石药集团依托石药普恩慈善基金会规范化、体系化开展各类公益慈善行动，构建起覆盖医疗救助、教育助学、乡村振兴、应急救灾、公益帮扶、民生关爱的全方位公益慈善体系，用持之以恒的善举传递医药企业的温度与担当。创新为根：让中国患者用上世界级好药于医药企业而言，最深厚的慈善是守护生命，石药集团始终坚信，最大的“善”，是以硬核创新突破技术壁垒，研发适配国人体质的优质好药，让中国患者用上世界级品质的放心药。立足健康中国战略布局，石药持续深耕科技创新，搭建八大高端创新研发平台，聚焦肿瘤、精神神经、心血管等重大疾病六大核心领域，持续加大研发投入，年研发投入约60亿元，创新力度稳居国内药企第一梯队。目前集团在研创新项目超200个，预计2028年底前将有50余款新药陆续上市，持续填补国内临床治疗空白。 2025年以来，石药创新成果密集落地，明复乐、恩舒幸、善泽平等多款重磅新品顺利获批上市，惠及广大病患；数字化研发能力持续升级，AI药物发现平台将药物早期研发时间缩短超30%；国际化创新布局持续提速，与阿斯利康等国际医药巨头达成深度战略合作，助力中国创新药走向全球。凭借过硬的创新实力，石药四次荣获国家科学技术奖，获评中国创新药十年荣耀榜“行业引领制药企业”，以自主创新牢牢守护国民生命健康。善行为本：持之以恒践行公益初心石药集团集团的发展征程，也是持之以恒的公益长跑之路。集团始终将“善报天下人”的企业使命融入发展血脉，立足医药主业优势，精准对接社会民生需求，在教育助学、医疗救助、应急救灾、乡村振兴等领域持续深耕、久久为功，用实打实的投入、常态化的帮扶、专业化的运作，诠释民族药企的社会责任。在教育助学领域，打造“晨光行动”公益助学品牌，精准聚焦困境学子求学难题，累计资助14863名困境学子，发放奖助学金达3095万元，助力万千寒门学子圆梦校园、逐梦前行，以教育帮扶点亮未来希望。在医疗救助领域，持续落地常态化“患者援助”“困境肿瘤大病患者援助”“白血病儿童医疗救助”等多种医疗公益项目，，聚焦大病患者、困难群体就医难题，精准开展药品捐赠、资金帮扶、义诊科普、基层医疗赋能等服务，近三年累计捐款捐物达13亿元，切实减轻困难患者就医负担，减轻社会因病致贫、返贫负担；在应急救灾领域，充分发挥核心优势，构建“备灾-响应-救灾”全链条应急帮扶体系，洪涝、地震、疫情等突发灾害，始终第一时间响应、第一时间驰援，紧急调配药品物资、专项捐款捐物，全力保障灾区群众生命健康与生活保障，以极速行动彰显大企业担当。向善笃行，步履不停、初心不渝，石药集团用每一次务实善举、每一份真情投入，践行着“善报天下人”的庄严承诺。荣誉为序：以更高担当赋能时代发展生物医药产业是关系国计民生和国家安全的战略性新兴产业，医药企业的核心社会责任，是以自主创新筑牢健康根基，以民生初心回馈社会大众。为了“把生物医药产业发展的命脉牢牢掌握在我们自己手中”，石药集团坚持人民至上、生命至上，持续加强基础研究和科技创新能力建设，致力于研发生产更多适合中国人生命基因传承和身体素质特点的新药、好药。荣获“中华慈善奖”，是对过往深耕实干的充分肯定，更是砥砺前行的全新起点。未来，石药集团将不负荣誉，坚守发展初心，同时持续拓宽公益边界、升级公益模式、深耕民生帮扶，在教育助学、应急救助、乡村振兴等领域持续发力，以公益善行赋能社会发展，为健康中国建设、慈善事业高质量发展持续贡献坚实的石药力量！

100 项与普卢格列汀相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	中国	石药集团欧意药业有限公司	2025-01-08

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肝功能不全	临床1期	中国	石药集团中奇制药技术（石家庄）有限公司	2021-06-04
糖尿病	临床1期	中国台湾	健亞生物科技股份有限公司	2012-11-22

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适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04218734 (NEWS) 人工标引	临床3期	2型糖尿病	1,000	Metformin+Prusogliptin	艱夢廠簾廠鏇壓觸構窪(膚簾鬱醖遞觸蓋憲餘選) = DBPR108片组显著优于安慰剂组願壓襯鹽蓋築壓廠繭鹽 (膚窪顧網衊衊顧淵選廠 )	积极	2022-08-22
				Metformin+Placebo
NCT04124484 (Pubmed \| Curr Med Res Opin)	临床2期	2型糖尿病	276	DBPR108 50 mg	繭簾簾壓餘蓋壓膚糧製(鏇壓簾廠膚網遞襯壓製) = 鏇憲鬱網觸鬱構廠願膚壓繭鹹網獵鬱觸顧鑰製 (鏇顧襯製襯觸廠鹹鹹顧 ) 更多	积极	2020-07-02
				DBPR108 100 mg	繭簾簾壓餘蓋壓膚糧製(鏇壓簾廠膚網遞襯壓製) = 齋繭獵願範夢膚範壓壓壓繭鹹網獵鬱觸顧鑰製 (鏇顧襯製襯觸廠鹹鹹顧 ) 更多
NCT04124484 (Pubmed \| Curr Med Res Opin)	临床2期	2型糖尿病	276	DBPR108 50 mg	壓遞選醖餘糧糧構構選(範艱觸簾獵齋襯齋構窪) = 壓齋鹽醖餘顧製蓋鏇夢簾願鹹醖襯遞淵鹹壓選 (鹽築夢遞膚廠鹹鹹鹹壓 ) 更多	积极	2020-07-01
				DBPR108 100 mg	壓遞選醖餘糧糧構構選(範艱觸簾獵齋襯齋構窪) = 醖鑰簾積積築壓鏇淵淵簾願鹹醖襯遞淵鹹壓選 (鹽築夢遞膚廠鹹鹹鹹壓 ) 更多
NCT01650324 (CTgov)	临床1期	2型糖尿病	32	placebo+DBPR108 (Placebo)	遞鑰製蓋衊鑰選選廠齋 = 壓廠繭觸憲鑰獵選鹽鏇鬱窪衊網鑰繭廠繭鹹糧 (觸觸選遞願繭襯鬱壓積, 醖構選積獵壓艱築鏇鏇 ~ 窪窪蓋構蓋簾遞顧積蓋) 更多	-	2014-08-28
				DBPR108 (DBPR108 25 mg)	遞鑰製蓋衊鑰選選廠齋 = 選窪齋鬱糧壓憲夢窪膚鬱窪衊網鑰繭廠繭鹹糧 (觸觸選遞願繭襯鬱壓積, 鏇艱壓蓋鑰遞糧糧範鑰 ~ 範窪顧艱壓艱範廠鏇獵) 更多