A phase III, randomized, prospective, double-blind, parallel design, multi-arm, multicenter study to compare the efficacy and safety of alogliptin and empagliflozin combination therapy versus alogliptin alone and empagliflozin alone in metformin-treated participants with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise (ODISSEIA 2026).

开始日期2026-08-24

申办/合作机构

Tecnimede Sociedade Tecnico Medicinal SA

NCT07093476

/ Recruiting临床3期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin

Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.

开始日期2025-07-18

申办/合作机构

Celltrion, Inc.

JPRN-jRCTs031250234

/ Recruiting临床4期

Randomized trial to test the efficacy of SGLT2 inhibitor for biological aging.

开始日期2025-07-16

申办/合作机构-

100 项与苯甲酸阿格列汀相关的临床结果

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100 项与苯甲酸阿格列汀相关的转化医学

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100 项与苯甲酸阿格列汀相关的专利（医药）

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786

项与苯甲酸阿格列汀相关的文献（医药）

2026-09-01·BIOMEDICAL CHROMATOGRAPHY

Trace Analysis of Genotoxic Impurity 3‐Amino‐N‐Nitrosopiperidine in Alogliptin Benzoate by Ultra‐Sensitive Liquid Chromatography Tandem Mass Spectrometry

Article

作者: Gosar, Amit N. ; Gharat, Mithun M. ; Roy, Pallavi T. ; Shaikh, Tabrez A. ; Mirgane, Nitin A. ; Shendage, Suresh S.

ABSTRACT:

For many years, it is known as Nitrosamines are responsible for carcinogenicity in human. These nitroso‐impurities were found detected in plastics, food items, cigarette, insect killer, water and alcoholic beverages. In 2018 EMA and USFDA claimed the presence of N‐nitrosodimethylamine in valsartan used for the treatment of hypertension. Consequently, to assess the adverse effects of nitrosamine generation during storage, in the course of production, or through contaminated supply chains, regulators have issued many guidelines. Hence, there is a crucial need for accurate evaluation technique to measure nitroso‐impurities in pharmaceutical products.According to the Carcinogenic Potency Categorization Approach, the allowable intake is 400 ng/day, which translates to an allowable limit of 16 ppm for a 25 mg daily dose. A study was then performed at 1.5 ppm relative to sample concentration, which is less than 10% of this limit. The main aim of this development to optimize and prove suitability of a new liquid chromatography–tandem mass spectrometry method for quantitatively analyzing 3‐amino‐N‐nitrosopiperidine (NTPA) in Alogliptin Benzoate (AGP), achieving detectable response of 0.03 ppm and quantifiable response value of 0.1 ppm relative to sample concentration. Current method was found to be linear with the coefficient of regression of 0.9979. Also, spiking study was performed by the calculating percentage spiked NTPA in the drug, which ranged from 96.67% to 100.14%. The results confirmed that the methodology was reliable, precise, robust and reproducible to quantify NTPA at 1.5 ppm in samples of 2.75 mg/mL concentration.

2026-09-01·Endocrinology, diabetes & metabolism

Dipeptidyl Peptidase‐4 Inhibitors Associated Heart Failure Events in Adult Patients With Type‐2 Diabetes Mellitus Treated With Dipeptidyl Peptidase‐4 Inhibitors: A Systematic Review and Meta‐Analysis

Review

作者: Nepal, Shishir ; Nepal, Shiva Prasad

ABSTRACT:

Introduction:

DPP‐4 inhibitors use has been reported to cause heart failure events in patients with type‐2 diabetes. The FDA had also issued warnings concerning increased risk of heart failure events for alogliptin, saxagliptin and their combination with metformin.

Methods:

Randomized controlled trials (RCTs) involving adult patients with type‐2 diabetes patients with or without history of cardio‐vascular disorders were included in the review. Cohort studies, case–control studies and other non‐RCTs, and studies involving paediatric patients were excluded. Data bases searched were PubMed/Medline, DOAJ, MDPI, Google Scholar and clinicaltrails.gov . The search was conducted in late January of 2026. Risk of bias was assessed using RoB‐2 tool for RCTs. Individual study outcomes were tabulated and summary measure was synthesized by meta‐analysis under random effect model; GRADE certainty of evidence was used; sub‐group analysis based on individual DPP‐4 inhibitors, follow‐up duration and placebo or other controls was done; systematic review was done under PRISMA 2020 Guidelines.

Results:

The meta‐analysis was done under random effect computation model for all 29 included studies. The analysis for total of pooled 67,873 patients showed statistically insignificant association between the use of DPP‐4 inhibitors and heart failure with Risk Ratio (RR) = 1.06, 95% Confidence Interval (CI) 0.94–1.12. Sub‐group analysis found significant association of saxagliptin use with increased heart failure risk.

Conclusion:

Results should be interpreted with caution because of several limitations of the study.

Trial Registration:

PROSPERO, CRD420261288081

2026-09-01·DIABETES OBESITY & METABOLISM

Comparative Effects of Antidiabetic Drugs on Body Composition: A Systematic Review and Network Meta‐Analysis

Review

作者: Heshmat, Ramin ; Jadidi, Paria ; Mastouri, Dena ; MansourZadeh, Mohammad Javad ; Rakhsha, Seyedeh Samira ; Shahinfar, Hossein ; Shafiee, Gita ; Hosseini, Seyed Alireza ; Ebrahimi‐Mousavi, Sara ; Mirzababaei, Atieh ; Aali, Yasaman ; Kosari, Ali

ABSTRACT:

Background:

Antidiabetic drugs differ in their effects on body composition, which may influence metabolic and functional outcomes. This systematic review and network meta‐analysis aimed to quantify and compare effects of major antidiabetic drugs on key body composition parameters.

Methods:

PubMed, Web of Science and Scopus were searched from inception to March 2025 for randomized controlled trials. Network meta‐analyses used a frequentist random‐effects framework to estimate mean differences (MDs) and 95% confidence intervals (CIs) for changes in fat mass (FM) and lean body mass (LBM).

Results:

Forty‐one trials involving 2906 participants were included. For FM among Glucagon‐like peptide‐1 (GLP‐1) and dual GLP‐1 and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists, tirzepatide showed the greatest reduction compared with placebo (MD −10.70 kg; 95% CI: −13.42 to −7.99), followed by liraglutide plus exercise. Semaglutide and liraglutide produced moderate reductions. In contrast, insulin glargine and alogliptin were associated with FM gain relative to metformin and exenatide. For LBM, tirzepatide (MD −4.40 kg; 95% CI: −7.58 to −1.22) and liraglutide (MD −1.54 kg; 95% CI: −2.55 to −0.52) were associated with significant reductions. Sodium–glucose cotransporter‐2 (SGL2) inhibitors caused minor losses, whereas metformin, insulin regimens and dipeptidyl peptidase‐4 (DPP4) inhibitors showed neutral effects.

Conclusion:

GLP‐1 and dual GIP/GLP‐1 receptor agonists produced the greatest FM reduction but also decreased lean mass. Exercise mitigated liraglutide‐related LBM loss. SGLT2 inhibitors showed modest effects, while metformin, insulin, DPP4 inhibitors and sulfonylureas had minimal impact. Further research on dose, duration and lifestyle influences is warranted.

284

项与苯甲酸阿格列汀相关的新闻（医药）

2026-10-12

·今日头条

华东医药，再生医美第一股，押注创新药！

2026 年，我国老牌药企华东医药的日子似乎并不好过。一来，多个仿制药品种在新一轮集采中丢标；二来，曾被寄予厚望、视为增长新引擎的医美业务，持续失血，2026上半年收入同比下滑超40%。这种情况下，华东医药又能依靠什么重新掌握经营主动呢？四款产品集采丢标仿制药业务承压集采，简单讲就是医保部门牵头，把全国或全省公立医院的采购需求打包，形成超大订单直接向药企招标，属于医药领域的“超级团购”。集采的核心是以量换价，目标也通常为仿制药。对于有仿制药业务的药企而言，产品进入集采名单，虽然价格会降低，但销量却有保障。反之，倘若生产的药品失去集采准入资格，即在集采中“丢标”，那么其院内市场份额会快速萎缩，营收下滑。纵观历年行业案例，多数药企集采丢标后，相关主力产品都会出现销量、利润双降的局面，这也是整个仿制药行业共同面临的经营风险。 2026年8月初，第十二批全国药品集中采购落下帷幕。本次集采中，华东医药“喜忧参半”。喜的是公司共有3款产品成功中选，忧的是4款核心品种遗憾落标。成功中标的产品分别为环孢素软胶囊、他克莫司胶囊、美沙拉秦肠溶片，三款产品2025年合计营收约20.76亿元，占公司全年总营收的4.76%。丢标的产品分别是艾沙康唑注射剂、吡格列酮二甲双胍片、吲哚布芬片以及苯甲酸阿格列汀片。这四款落选品种2025年合计销售收入高达46.34亿元，占当年总营收的10.62%。对比来看，本次集采落选品种对公司医药工业板块的冲击力度达到了中选品种的两倍以上。这就意味着，华东医药的传统仿制药业务收入即将开始承压。截至9月28日，公司市值接近500亿。事实上，本轮丢标并非个例，此前华东医药也时常受到集采影响。在2020年，公司的王牌降糖药阿卡波糖，就曾意外在集采中流标，年销售额从巅峰时的超30亿降至10亿级别。还有中成药百令胶囊，纳入集采后一度降价超30%，叠加佐力药业的激烈竞争，销售额不复此前规模。可以说，接连遭遇集采冲击，华东医药早已深刻意识到单靠仿制药的老路已经走不通。那么，应对仿制药集采的不确定性，公司又做了哪些努力呢？医美引擎熄火创新药接棒彼时，华东医药将医美、创新药这两大方向视为发展重点。首先出彩的是医美。自2018年始，华东医药一路并购，先后拿下英国、韩国、瑞士等多家海外优质医美企业，不断丰富产品矩阵。现在公司的海外医美主体之一英国Sinclair，便是当时斥资15亿并购而来。医美，确实不负众望。 2020年-2023年，该板块营收从3.19亿快速增长至21.92亿（只统计单独划分到医美分部的收入），“少女针”伊妍仕也一度成为现象级产品。但自2024年开始，医美收入首次出现下滑，为20.41亿，2025年进一步降至约14亿。2026上半年，下滑态势再次持续，医美收入5.21亿，同比降低约47%，并且毛利率也同比下滑了约9个百分点至70%多。从数据来看，医美业务已是华东医药业绩的最大负贡献项。幸运的是，当年与医美一同布局的创新药已经开始接棒。 2025年华东医药创新产品收入23.40亿，同比增长64%，占医药工业营收比重约16%；2026上半年该板块收入16.84 亿，同比增幅达52%，占医药工业营收比重则是进一步提升至21%出头。从产品层面来看，公司的创新产品主要集中在肿瘤、自免、内分泌三个领域。肿瘤领域，华东医药已获批产品覆盖卵巢癌、非小细胞肺癌、肝细胞癌、乳腺癌等多个癌种。其中，代表性产品爱拉赫，是全球首个且目前唯一获批用于铂耐药卵巢癌的FRα靶向ADC药物。自免药物，公司产品已达10余款，适应症涵盖移植免疫、银屑病、特应性皮炎、类风湿关节炎等。相比肿瘤、自免，内分泌领域才是华东医药的舒适区。公司深耕糖尿病用药领域二十余年，已形成产品管线全面布局，在传统口服降糖药、P-4抑制剂、胰岛素类似物、GLP-1类药物等均有布局。围绕GLP-1减重及代谢产品，华东医药单靶点、双靶点、三靶点药物全覆盖，已上市利拉鲁肽注射液，对症体重管理及2型糖尿病。就在9月27日，公司宣布，口服小分子GLP-1产品HDM1002用于超重或肥胖人群体重管理的中国Ⅲ期临床研究取得积极顶线结果。具体到疗效来看，此产品400mg组52周可减重12.2%，这一水平与礼来、恒瑞医药的竞品相比处于同一量级，后两者效果分别为72周减重11.2%、50周减重11.1%。据华东医药透露，HDM1002体重管理适应症计划于2026年第四季度递交NDA申请，商业化准备同步有序开展。总的来说，公司在创新药领域已经取得不错进展。其创新药研发中心成立6年来，累计取得12个创新产品上市许可，如今正在推进96项创新药管线项目。按照上半年的情况推测，2026年华东医药的创新产品收入或许将超32亿，较2025年有超10亿的增量，在一定程度上对冲仿制药集采丢标的影响。或许，正如华东医药曾在关于第十二批全国药品集采的公告里提到的： “本次集采落地执行后，公司仿制药核心品种由集中采购带来的阶段性经营压力有望得到充分释放，全面迈入创新药加速发展的崭新阶段。” 以上分析仅代表个人观点，不构成任何具体的投资建议，投资者需结合市场变化及自身风险承受能力独自决策。股市有风险，入市需谨慎。

带量采购财报并购核酸药物申请上市

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

2026-10-08

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15家浙江原料药企：2026中报业绩和发展战略

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。全球原料药市场仍在扩张。Precedence Research预计，2026年全球原料药市场规模达2522亿美元，2023—2032年复合增速约6%。专利悬崖周期性到来，仿制药放量带动上游原料药需求。中国是这条供应链上的核心枢纽，2024年化学原料药规上营收5783亿元，约占全球35.5%。浙江是其中的重要一极，仅台州一地，化学原料药出口就占全省三分之一、全国十分之一。本文选取15家浙江原料药上市企业，以2026年中报为切口，看谁在承压，谁有新出路。 01 业绩分化，涨多跌少 15家企业上半年合计营收约228亿元，归母净利润约21亿元。营收端涨多跌少，利润端压力明显更重。业绩增速上，海昇药业以39.96%领跑，美诺华26.79%，天宇股份13.23%，东亚药业12.09%；普洛药业和奥翔药业小幅下滑。利润端，8家净利润同比下滑，海翔药业、东亚药业由盈转亏，正增长的只剩司太立、美诺华、海昇药业、海森药业、本立科技5家。普洛药业半年度营收48.23亿元，是15家中唯一站上40亿的。原料药中间体收入同比下降20.88%，不过毛利率逆势提升3.88个百分点至17.58%，“做精原料”的主动收缩正在改写产品结构。CDMO业务是另一条线，报告期内6个项目获批，司美格鲁肽注射液III期临床进展顺利。浙江医药上半年营收43.86亿元，净利润6.06亿元居首。业务横跨生命营养品和医药制造，维生素类产品周期性波动影响显著。国邦医药2026H1收入稳健增长，营收31.42亿，归母净利润3.41亿，利润受汇率及产品价格周期拖累而阶段性承压，但核心产品放量、市占率提升的趋势未变，经营性现金流大幅改善。动保产品价格一旦回暖，叠加特色原料药与新产品持续放量，业绩具备修复空间。美诺华营收8.59亿元，净利润0.64亿元，实现“双增”。制剂与原料药收入增长是主要动力，"医药中间体—原料药—制剂"的垂直一体化开始兑现：集采接续采购中10个品种拟中选，第十二批国采阿格列汀口服常释剂型拟中选。海昇药业营收1.41亿元，增长39.96%，净利润增长55.05%，是15家中增速最亮眼的。体量虽小弹性最大，在兽药原料药和医药原料药两个领域同步发力。从研发投入来看，15家企业研发费用合计约13亿元。普洛药业2.79亿元居首，浙江医药2.46亿元紧随，海昇药业0.05亿元最少。8家同比扩大投入，花园生物增幅39.02%最高，本立科技24.73%次之。值得注意的反差是：花园生物净利润下滑18.34%，研发投入反而大幅加码。 02 一体化都在提，但走法各不相同如此业绩之下，各企业针对未来的战略，个人最直观的感受是：“原料药+制剂一体化”几乎成了标配，用制剂端的利润对冲原料药的价格波动。但共识之下，各家的走法差别不小。司太立押得最“重”。它不做泛泛的一体化，而是锚定碘造影剂一条赛道，做"造影剂全产业链"，核心原料药自主供应。造影剂品种集中、注册门槛高、全球玩家有限，全链条一旦跑通，后来者很难切入。普洛药业拆成两条腿：一边是原料药+制剂一体化，一边是CDMO战略升级。上半年CDMO营收14.12亿元，同比增长14.2%，毛利率42.6%，未来三年内待交付的商业化在手订单超73亿元。API业务则主动砍掉低毛利品种，营收降了两成，毛利率反升近4个百分点。这种收缩规模换利润的动作，在15家里算果断的。国邦医药的视野更宽。横向多品种复制，纵向往上游原料和下游制剂延伸，配合2035年"200个核心产品、200亿销售规模"的目标，走的其实是平台型路线，对标全球配套工厂的角色。天宇股份和奥锐特代表了另一种思路：在优势品种上做深，再横向拓展。天宇以沙坦类为核心，非沙坦类原料药上半年增速35%，制剂业务首次盈利。奥锐特则覆盖呼吸、心血管、抗感染等六大领域，重心放在“首仿”和集采参与上，走的是“复杂原料药+制剂”的高壁垒路线。仙琚制药的选择更聚焦。它在甾体激素这一条线上深耕，目标是“全球甾体激素药物主要供应商”。海昇药业体量最小，但战略最“纯粹”。它只做原料药和中间体，同时在兽药和医药两个领域发力。营收和净利润增速双双居首，某种程度上说明：在细分领域做到足够专注，小体量也能跑出弹性。把15家的战略摊开看，差别不在"做不做一体化"，而在往哪延伸——CDMO、制剂、动保、新材料，方向各不相同。至于哪种方向能接住企业已有的能力，现在下结论还早，但研发投入的流向已经先一步给出了答案。浙江这批企业的探索，无论成败，都为行业提供了参照。周期总会过去。但对这15家来说，低谷期把钱和人投向哪里，决定了下一轮上行时能吃到多少。参考资料：各企业财报、半年度报告及公开资料立即扫码加入药事纵横交流群

100 项与苯甲酸阿格列汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06553	苯甲酸阿格列汀	A10BH04	DB06203

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	日本	Teijin Pharma Ltd.	2010-04-06
2型糖尿病	日本	Takeda Pharmaceutical Co., Ltd.	2010-04-06

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
急性冠状动脉综合征	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	奥地利	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	巴西	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	保加利亚	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	智利	Takeda Pharmaceutical Co., Ltd.	2009-09-01

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临床结果

适应症

分期

评价

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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


NCT02856113 (2015-000208-25, Pubmed \| Diabetes Ther)	临床3期	2型糖尿病	152	Alogliptin 25 mg QD	獵襯鏇構顧鏇鏇觸鹹齋(製鏇範簾餘鏇築膚鬱製) = 壓構製網壓醖積繭構廠憲簾製構顧積繭壓鹹餘 (蓋遞築製醖糧淵製糧願, -0.63 ~ 0.83)	不佳	2025-03-04
1340-P (ADA2024)	N/A	糖尿病	-	SGLT2i	齋壓鹹衊淵蓋衊鑰觸範(憲艱範壓網膚鑰餘鑰糧) = 遞築壓簾鹽膚鏇製願淵醖鬱憲鹹淵選觸鏇簾鏇 (糧窪觸網憲鏇廠鹽簾糧, 16.6 ~ 19.7)	积极	2024-06-14
				DPP4i	齋壓鹹衊淵蓋衊鑰觸範(憲艱範壓網膚鑰餘鑰糧) = 夢鹹鑰選鑰遞選鹽淵鏇醖鬱憲鹹淵選觸鏇簾鏇 (糧窪觸網憲鏇廠鹽簾糧, 19.1 ~ 21.4)
NCT05782192 (Pubmed)	临床3期	2型糖尿病	-	Fotagliptin	遞製獵鹹壓選窪淵襯廠(壓築製積範觸鹽廠範壓) = 鑰獵獵壓鏇衊鬱鹽鹹選觸繭壓鹹餘齋鑰選餘衊 (襯範選鏇餘製鑰範鹽齋 ) 更多	积极	2023-10-09
				Alogliptin	遞製獵鹹壓選窪淵襯廠(壓築製積範觸鹽廠範壓) = 淵製壓網膚廠齋遞鏇鏇觸繭壓鹹餘齋鑰選餘衊 (襯範選鏇餘製鑰範鹽齋 ) 更多
NCT02856113 (2015-000208-25, CTgov)	临床3期	2型糖尿病	152	Placebo (Placebo)	糧鹹鹹襯餘鑰衊構簾網(淵壓遞蓋淵製餘構鹹積) = 壓積窪網觸顧範壓願蓋鹹膚鬱築憲膚繭構遞鹹 (顧襯範範鏇蓋鹽齋憲遞, 0.2809) 更多	-	2022-10-19
				Alogliptin Benzoate (Alogliptin 25 mg)	糧鹹鹹襯餘鑰衊構簾網(淵壓遞蓋淵製餘構鹹積) = 齋餘淵憲壓觸積淵顧艱鹹膚鬱築憲膚繭構遞鹹 (顧襯範範鏇蓋鹽齋憲遞, 0.2879) 更多
NCT03794336 (ACADEMIC, Pubmed \| Diabetes Obes Metab) 人工标引	临床4期	2型糖尿病 \| 冠状动脉疾病	1,088	aspirin+alogliptin	積廠顧願糧網觸壓鹹憲(鏇顧夢獵願積鹽壓遞窪) = 鏇鏇構繭廠糧築襯構憲餘範廠積選鏇鑰繭製鹽 (鑰夢廠艱艱艱蓋製製廠, 0.4) 更多	积极	2022-02-03
				aspirin+acarbose	積廠顧願糧網觸壓鹹憲(鏇顧夢獵願積鹽壓遞窪) = 淵築蓋窪築壓網鬱選淵餘範廠積選鏇鑰繭製鹽 (鑰夢廠艱艱艱蓋製製廠, 0.5) 更多
NCT03794336 (EASD2021)	临床4期	心血管疾病 \| 2型糖尿病 \| 冠状动脉疾病	-	Alogliptin 25 mg q.d.	鹹憲衊襯獵糧築願蓋夢(淵鬱遞鏇製積觸網顧蓋) = Significantly lesser GI adverse events were observed with alogliptin than acarbose (8.9% vs 33.6%, P <0.0001) 糧製鏇築餘膚憲築繭鬱 (醖鬱範壓膚構遞鹽齋齋 ) 更多	积极	2021-09-29
				Acarbose 100 mg t.i.d.
NCT03231709 (TRINITY, Pubmed \| Curr Med Res Opin)	临床4期	2型糖尿病	-	Trelagliptin	憲艱膚獵淵醖糧鏇壓夢(願網範淵構觸構廠網餘) = 構膚醖簾構夢構蓋積鹽觸齋顧餘壓淵齋鹽夢鬱 (範憲鹽淵遞選襯衊膚構 )	-	2019-12-02
				Alogliptin	憲艱膚獵淵醖糧鏇壓夢(願網範淵構觸構廠網餘) = 鏇顧構壓餘簾顧蓋構築觸齋顧餘壓淵齋鹽夢鬱 (範憲鹽淵遞選襯衊膚構 )
NCT03501277 (CTgov)	临床1期	-	72	alogliptin+pioglitazone+SYR-322-4833 BL (Regimen A)	築遞艱餘積範選遞淵餘(艱齋遞醖積衊衊鹽憲遞) = 糧選簾簾範壓壓齋網窪繭繭鑰醖糧憲顧齋獵繭 (夢網糧繭願夢鹹顧襯構, 42.87) 更多	-	2019-08-08
				Alogliptin+pioglitazone (Regimen B)	築遞艱餘積範選遞淵餘(艱齋遞醖積衊衊鹽憲遞) = 壓壓艱膚膚顧構衊鬱廠繭繭鑰醖糧憲顧齋獵繭 (夢網糧繭願夢鹹顧襯構, 44.71) 更多
NCT03231709 (TRINITY, CTgov)	临床4期	2型糖尿病	60	Trelagliptin+Alogliptin (Trelagliptin 100 mg + Alogliptin 25 mg)	簾遞壓鹹鹹構顧夢選壓 = 糧淵鹹憲鑰繭選襯醖蓋鹽糧廠醖膚齋淵鏇製襯 (夢鬱觸鑰廠網遞鬱遞壓, 網範艱廠築選構壓鏇憲 ~ 願蓋繭窪鹹築觸範繭鬱) 更多	-	2019-05-10
				Trelagliptin+Alogliptin (Alogliptin 25 mg + Trelagliptin 100 mg)	簾遞壓鹹鹹構顧夢選壓 = 顧膚糧鏇鑰簾遞艱蓋鏇鹽糧廠醖膚齋淵鏇製襯 (夢鬱觸鑰廠網遞鬱遞壓, 齋願夢獵醖壓簾夢壓鬱 ~ 願醖蓋鹽糧鬱網憲憲鬱) 更多
NCT02771093 (TRACK, CTgov)	临床4期	2型糖尿病	27	Trelagliptin (Trelagliptin 100 mg)	願憲遞積糧壓夢膚壓積(醖鹽壓積構憲鑰夢選構) = 鬱蓋淵膚製觸鬱壓製觸觸餘廠構選艱觸觸窪顧 (繭齋衊醖廠製壓鏇餘鏇, 餘簾選壓範網壓築鬱鏇 ~ 構築構襯獵膚艱選壓顧) 更多	-	2018-12-10
				Alogliptin (Alogliptin 25 mg)	願憲遞積糧壓夢膚壓積(醖鹽壓積構憲鑰夢選構) = 顧窪廠築願製顧齋獵窪觸餘廠構選艱觸觸窪顧 (繭齋衊醖廠製壓鏇餘鏇, 願繭憲遞醖積蓋鏇襯鑰 ~ 窪餘願襯衊窪廠襯糧簾) 更多