A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture

The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.

开始日期2025-06-01

申办/合作机构

齐鲁制药有限公司

CTR20244889

/ CompletedN/A

评估受试制剂阿巴帕肽注射液与参比制剂阿巴帕肽注射液（Tymlos®）作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究

主要研究目的研究空腹状态下皮下注射受试制剂阿巴帕肽注射液与参比制剂阿巴帕肽注射液（Tymlos®）在健康成年受试者体内的药代动力学，评价空腹状态下皮下注射两种制剂的生物等效性。次要研究目的研究受试制剂阿巴帕肽注射液在健康受试者中的安全性。

开始日期2025-01-02

申办/合作机构

齐鲁制药有限公司

NCT04626141

/ Withdrawn临床4期IIT

Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).

开始日期2024-06-01

申办/合作机构

Geisinger Clinic

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100 项与阿巴帕肽相关的临床结果

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100 项与阿巴帕肽相关的转化医学

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100 项与阿巴帕肽相关的专利（医药）

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359

项与阿巴帕肽相关的文献（医药）

2026-05-01·Biomaterials advances

A dual-active biological scaffold with in situ loaded Abaloparatide and bone marrow-derived mesenchymal stem cells synergistically regulatory T cell to promote bone regeneration

Article

作者: Chen, Zhihong ; Jia, Mingyu ; Jiang, Haoran ; Zhang, Yukang ; Wu, Min ; Zhou, Huajian ; Liu, Yangyang

Bone defect repair remains a significant challenge faced in clinical practice. Bone tissue engineering has emerged as an effective approach for bone defect repair due to its ample donor source and remarkable repair efficacy. In this study, we combined Abaloparatide (ABL) with bone marrow-derived mesenchymal stem cells (BMSCs) and utilized methacrylated gelatin (GelMA) as a matrix to successfully develop a bio-scaffold with dual activity (ABL@GelMA/BMSCs). BMSCs regulate the bone microenvironment by secreting cytokines, which promote bone repair through a paracrine mechanism. The addition of ABL not only facilitated the osteogenic differentiation and paracrine function of BMSCs but also significantly enhanced the bone induction capability of the scaffold, as evidenced by the marked upregulation of osteogenic markers (ALP, RUNX2, OCN). Furthermore, this bio-scaffold was able to upregulate the Foxp3 gene, inducing Foxp3+ regulatory T cells, thereby modulating the local immune microenvironment to promote bone formation. After implantation of this bio-scaffold into a critical-sized cranial defect model, histological results demonstrated a higher bone mineral density (BMD), and CT reconstruction indicated good healing of the defect. In summary, this bio-scaffold exhibits a powerful capacity for bone defect repair while improving the bone microenvironment through the synergistic modulation of regulatory T cells, providing a new strategy for bone defect repair.

2025-12-01·ANNALS OF SURGERY

Major Pancreatic Resection Increases Bone Mineral Density Loss, Osteoporosis, and Fractures

Article

作者: Gorgov, Eliyahu ; Khalilieh, Saed ; Lavu, Harish ; Hammelef, Emma ; Nevler, Avinoam ; Yeo, Theresa P. ; Zohar, Nitzan ; Iyer, Amrita ; Bowne, Wilbur ; Yeo, Charles J.

Objective::

To assess whether long-term survivors of pancreatic surgery show increased risk to develop impaired bone mineral density, osteoporosis, and vitamin D deficiency.

Background::

Pancreatic resection poses a risk for malabsorption of fat-soluble vitamins and other micronutrients essential for bone mineralization. Here, we evaluated the long-term effects of pancreatic resection on bone mineral density (BMD) and its clinical sequelae.

Methods::

This was a 2-pronged analysis of postpancreatectomy patients with a follow-up period >3 years comprising (1) a large, propensity score matched, cohort study based on a multinational federated research network (FRN) and (2) a retrospective single institution review of clinical and radiographic patient data. In the FRN analysis, an initial cohort of 8423 postpancreatectomy patients were identified and propensity score matched with normal controls. The primary endpoint was the 10-year risk of developing osteoporotic pathologic fractures and secondary endpoints included diagnosis of osteoporosis, vitamin D deficiency, and related therapies. The single institution retrospective analysis identified 224 patients who underwent pancreatic resection between 2005 and 2019. BMD was quantified in CT images acquired before and after surgery. BMD trends and related factors were assessed in a time-series mixed-effect linear regression model.

Results::

A total of 8080 propensity score-matched pairs were included in the FRN analysis. The analysis revealed a 2.4-fold increase in pathologic fractures ( P <0.0001) and 1.4- to 1.5-fold increase in osteoporosis/osteomalacia ( P <0.0001) and vitamin D deficiency ( P <0.0001) in postpancreatectomy patients. Vitamin D supplements were more common in the pancreatectomy group (OR=1.4, 95% CI: 1.28–1.53, P <0.0001), as were specific osteoporosis/osteomalacia treatments such as calcitonin, denosumab, romosozumab, abaloparatide, and teriparatide (OR=2.24, 95% CI: 1.69–2.95, P <0.0001). Retrospective analysis of CT imaging revealed that BMD declined more rapidly following pancreatic resection compared with normal historical controls ( P =0.015). Older age, pancreatic cancer, and pancreaticoduodenectomy were associated with increased rates of BMD loss ( P <0.05, each).

Conclusions::

After pancreatic resection, patients are at higher risk for BMD loss and subsequent fractures. As the cohort of pancreatic resection survivorship grows, attention will need to be paid to focused prevention efforts to reduce BMD loss, osteoporosis, and fractures in these vulnerable patients, with specific attention to the pancreatic cancer population.

2025-12-01·World Neurosurgery

Association of Osteoporosis and Bone-Strengthening Medications with Postoperative Outcomes Following Transforaminal Lumbar Interbody Fusion

Article

作者: Khalid, Syed I ; Wang, Ryan ; Ghenbot, Yohannes ; Massaad, Elie ; Ozturk, Ali K ; Abou-Mrad, Tatiana ; Shin, John H ; Arena, John D ; Golubovsky, Joshua L

BACKGROUND:

Osteoporosis increases the risk of postoperative complications and reoperation following spinal fusion due to reduced bone quality. Bone-strengthening medications are frequently employed to mitigate these risks. This study evaluates the impact of osteoporosis and osteoporosis medications on the incidence of additional spine surgeries and postoperative complications following lumbar fusion.

METHODS:

We conducted a retrospective cohort study using a national database of patients who underwent transforaminal lumbar interbody fusion between 2010 and April 2023. Patients were exactly matched 1:1 for age, gender, and comorbidities. Osteoporosis medications included bisphosphonates (alendronate, ibandronate, and risedronate), parathyroid hormone analogs (teriparatide and abaloparatide), and monoclonal antibodies (denosumab and romosozumab). Logistic regression and Kaplan-Meier survival compared rates of additional spine surgeries and postoperative complications and assessed the effect of osteoporosis medications.

RESULTS:

After matching, 24,145 patients with and without osteoporosis were identified. Osteoporosis patients had a higher incidence of all-cause need for additional spine surgery (odds ratio [OR] = 1.40; 95% confidence interval [CI]: 1.28-1.53). Although medication effects did not reach statistical significance, teriparatide (OR = 1.06; 95% CI: 0.41-2.21), abaloparatide (OR = 3.04; 95% CI: 0.71-8.95), and denosumab (OR = 1.35; 95% CI: 0.33-3.70) demonstrated moderate change in risk for reoperation. Osteoporosis patients had higher rates of urinary tract infections (OR = 1.18; 95% CI: 1.08-1.29), pneumonia (OR = 1.25; 95% CI: 1.07-1.45), and deep vein thrombosis (OR = 1.40; 95% CI: 1.16-1.69).

CONCLUSIONS:

Osteoporosis is linked to higher reoperation and medical complications following lumbar fusion. Although osteoporosis medications did not significantly alter reoperation risk, their potential role in perioperative optimization requires further investigation.

105

项与阿巴帕肽相关的新闻（医药）

2026-01-15

·丁香园风湿时间

抗骨质疏松只知道地舒单抗？传统方案与新兴疗法超全总结

骨质疏松从来不是小病。在风湿免疫、内分泌、老年医学和骨科门诊，我们常见骨密度长期隐匿下降，最终以脆性骨折集中「爆雷」，带来功能丧失、再骨折和过早死亡等后果。到 2025 年，治疗已不再局限于「钙 + 维生素 D + 双膦酸盐」，多条通路的新药与序贯/联合策略推动治疗向个体化发展 [1]。一当前治疗格局：从经典到最新 01 抗骨吸收治疗（Antiresorptives）（1）双膦酸盐 [2] 双膦酸盐仍为多数情形下首选，代表药物包括阿仑膦酸盐、利塞膦酸盐、伊班膦酸盐和唑来膦酸等。其通过与骨羟基磷灰石结合，干扰破骨细胞的黏附、分化与存活，从而抑制骨吸收。口服制剂对胃肠耐受性有要求；对依从性差或有口服禁忌者，可选静脉唑来膦酸。长期用药需关注下颌骨坏死（MRONJ）和不典型股骨骨折（AFF），在用药 3~5 年后按个体风险评估是否考虑「drug holiday」。（2）地舒单抗（Denosumab）地舒单抗是抗-RANKL 人源化单抗，每 6 个月皮下注射一次，给药方便且降骨折风险显著，适用于不能耐受口服双膦酸盐或肾功能不全患者。地舒单抗不掺入骨基质，其作用可逆，停药后可能出现快速的骨量丢失与反跳性骨折，因此务必在停药前预先安排序贯抗骨吸收治疗以巩固效果，并需按期注射以避免「漏针」。使用时还需监测血钙，肾功能不全患者尤其需注意低钙的风险。（3）选择性雌激素受体调节剂（SERMs）代表药物雷洛昔芬，可在骨组织发挥类雌激素作用，降低椎体骨折风险的同时可降低乳腺癌风险，但其会增加静脉血栓风险并可能加重潮热等症状，适用时需权衡利弊，主要考虑于需兼顾乳腺肿瘤风险的绝经后女性。（4）激素替代治疗（HRT） HRT 在围绝经期或新绝经且合并明显更年期症状的女性既可缓解症状又能保护骨密度，但因可能增加乳腺癌、心血管事件与 VTE 风险，须严格个体化评估，不宜作为单纯骨保护的常规首选。（5）降钙素（Calcitonin）作用较弱，整体疗效不及上述药物，临床上多为无法耐受其他药物时的备选。 02 促成骨治疗（Anabolics）[3] 促成骨药物通过激活成骨通路直接增加新骨形成。特立帕肽（teriparatide，PTH 1-34）与阿巴帕肽（abaloparatide）均为间断给药的 PTH/PTHrP 类药，能在数月内显著提升成骨标志物并增加 BMD，适用于严重骨质疏松、既往脆性骨折或糖皮质激素所致骨质疏松等高危人群。临床上应将总疗程限定在 24 个月以内，疗程结束后必须立即序贯抗骨吸收药以巩固骨量增益并维持骨折风险降低。使用促成骨药需监测血钙并评估患者是否能配合随后的长期巩固治疗。 03 双重作用药物 Romosozumab[4] 为抗 sclerostin 单抗，具有同时促进成骨和抑制骨吸收的「双重作用」，在短期内对腰椎与髋部 BMD 的提升速度与幅度均较显著，适合骨折风险「非常高」的患者起始使用（例如近期脆性骨折或多发既往骨折、T ≤ −3.0 等）。Romosozumab 疗程通常限制为 12 个月，停用后需无缝接抗骨吸收药以维持获益。总体耐受性良好，但存在心血管事件增加的信号，既往 1 年内发生心肌梗死或脑卒中的患者禁用，心血管高危患者需谨慎评估。 04 联合与序贯治疗（1）联合治疗（同时用两种）理论上可利用促成骨与抗吸收药的互补机制以获得更快、更大 BMD 增益。临床研究显示【特立帕肽＋地舒】可在短期内显著提高腰椎与髋部 BMD，但【特立帕肽＋阿仑膦酸】未见叠加效果甚至可能抑制成骨反应。由于成本与管理复杂，联合治疗宜限于极高危或特殊病例。（2）序贯治疗（先后衔接用药）临床常用「先攻后守」策略：先用促成骨或 Romosozumab 快速建骨，随后紧接抗骨吸收药以维持增益。注意转换时机：长期口服双膦酸后再上促成骨，成骨反应可能减弱；由地舒直接转换为促成骨时髋部 BMD 可能短期下降，需个体化设计并密切监测。对近期骨折或 FRAX 高者，先促成骨 /Romosozumab 再接抗吸收药是当前证据支持的主要路径。 05 支持治疗钙以饮食为主，目标 1000-1200 mg/日；维生素 D 800-1000 IU/日（建议缺乏者补充，治疗前及治疗中应监测血清 25 羟维生素 D 水平）。避免常规大剂量钙补，且需结合心血管风险综合评估。运动以负重和抗阻训练为主，配合平衡训练与跌倒危险因素干预，按功能状态制定个体化方案。二炎症控制类生物制剂对骨的潜在益处炎症与骨丢失密切相关：促炎细胞因子（TNF-α、IL-1、IL-6、IL-17 等）可上调 RANKL，促进破骨。对风湿病人群而言，抗炎治疗常能改善骨转换标志物并在一定程度上稳定或小幅提升 BMD，但目前证据不足以将这些药物作为专门的防骨折药 [5]。 01 TNF-α 抑制剂（阿达木单抗、依那西普、英夫利昔单抗）可抑制炎症驱动的破骨过程。在类风湿关节炎等炎症性疾病中，使用 TNF 抑制剂后常见骨转换标志物下降和腰髋 BMD 稳定或略升。然而尚无确凿证据显示其能独立替代抗骨吸收或促成骨治疗以预防脆性骨折。 02 IL-6 抑制剂（托珠单抗）阻断 IL-6 信号可降低骨吸收相关标志物（如 CTX），临床上在活动期类风湿患者中常见腰髋 BMD 稳定或小幅增加，ACPA 阳性亚组效应更明显。当前证据仍以「炎症控制后附带获益」为主，独立降低骨折的证据不足。 03 T 细胞共刺激阻断（阿巴西普）通过抑制 T 细胞活化，阻断炎症级联的上游环节，间接影响 RANKL。真实世界队列提示阿巴西普对 BMD 的保护或优于部分对照，可能是合并骨质疏松风险的 RA 患者的合理治疗考量之一。 04 B 细胞清除抗体（利妥昔单抗） B 细胞对骨代谢的作用复杂，既能产生促破骨因子（如 RANKL），也能产生抗吸收因子（如 OPG）。达到良好炎症控制者可见 RANKL 下降与 BMD 稳定，但病情波动时效果不一致，主要收益仍来自对原发炎症的控制。 05 IL-17 抑制剂（赛库奇珠单抗）对脊柱关节病相关的局灶性骨破坏有保护潜力，系统性对抗骨质疏松的证据有限，临床上多表现为 BMD 稳定，作用更偏向控制局部炎性损害。 06 IL-23 抑制剂（ustekinumab、guselkumab、risankizumab）通过下游抑制 Th17/IL-17 轴间接控制炎症，针对全身骨代谢的临床数据稀少，护骨效果多被视为炎症控制的二次结果。 07 JAK 抑制剂（tofacitinib、baricitinib、upadacitinib、filgotinib）[6] JAK 抑制剂可同时阻断多种促炎细胞因子的信号。基础研究提示可能有利于成骨，但临床数据混杂：部分研究显示骨转换标志物改善，药物监测数据（如 VigiBase）亦提示骨折报告率的安全信号，需警惕并继续观察真实世界结局。 08 IL-1β（canakinumab）可降低骨吸收标志物，但临床证据有限，需更多研究确认对 BMD/骨折的实际益处。综上，对于风湿免疫病患者，有效控制原发病的炎症活动是保护骨健康的基础。在炎症控制达标后，若患者仍属骨折高危人群，应依据通用的骨质疏松治疗指南启动或优化抗骨质疏松治疗，而非仅依赖生物制剂的『附带』护骨作用。三正在开发的新型治疗 01 Wnt 通路调节剂：Sclerostin 与 DKK1 抑制剂 [7] Sclerostin 抑制剂除了罗莫苏单抗外，blosozumab 在临床早期也显示出希望，在一项 120 例的 II 期试验中，皮下给药 1 年使腰椎 BMD 增加 17.7%、全髋 6.7%，但其后开发被终止，具体原因未披露。 DKK1 也是 Wnt 的内源性抑制子，阻断其可促进成骨。但需注意，全身性增强 Wnt 信号存在潜在致瘤等安全顾虑。 02 Strontium ranelate[8] 口服可降低绝经后妇女骨折风险，兼具抑骨吸收与促成骨作用，但与心血管事件、VTE 和罕见严重过敏反应相关，因在多国未获批，临床应用极为有限。 03 Cathepsin K 抑制剂 [9] 以 odanacatib 为代表，LOFT III 试验显示每周给药可降低各类骨折并增加 BMD，但延长期观察到卒中事件增多，导致开发终止，其它同类药物亦因安全性问题未推进。 04 Calcilytics 口服小分子模拟间歇 PTH 的促成骨效应，动物与早期研究有积极信号（成骨标志物与 BMD 提升），但 II 期试验未显示显著 BMD 提高，开发受挫。 05 基于 PTH 的新策略在特立帕肽/阿巴帕肽基础上开发的新方向包括骨锚定（PTH-CBD）与长效前药（TransCon-PTH）等，目标是提高疗效与给药便利性 [10]。这些方案仍在临床验证阶段。 06 其他早期候选药物包括 AChE 抑制剂、降钙素受体激动剂、天然产物（如 tiliroside）、NLRP3/TLR4 等炎症相关靶点，以及 FAP、FGF21、SIRT3、P2X7、基因/细胞疗法等，多数证据来自动物或早期研究，作用与适应症尚不明确，安全性为主要限制。 07 临床开发亮点若干地舒单抗生物类似药已进入 II/III 期试验（如 CT-P41、RGB-14-P、QL1206、Bmab1000、AVT03、TVB-009 等），双特异性或新机制抗体（如同时抑制 sclerostin + DKK1 的 AGA2118）及改善给药方式的候选（如口服 PTH 类似物 EB613）在研。总体上，生物相似药可提升可及性，其它新药仍需更多抗骨折与安全数据支持。四总结当前骨质疏松治疗的核心不再是「有没有药」，而是把「风险识别 → 药物档位选择 → 序贯/接力设计 → 规范监测」形成临床流程。风湿科患者天然高风险，我们的价值就在于早期识别极高危患者、及时给予促成骨或双重作用起始并妥善安排后续巩固，从而最大限度减少脆性骨折的发生。 Take-home message 风险分层后再用药：极高危先促成骨或罗莫尤单抗，疗程后立即接抗吸收药巩固。药物安全性：Romosozumab 前评估心血管史；PTH 类/地舒单抗监测血钙；长期双膦酸盐注意 MRONJ 与 AFF。疗效监测：DXA 按药物调整频率；骨转换标志物可作为早期反应指标。地舒单抗停药管理：提前安排双膦酸盐接力，按时给药，防反跳性骨丢失和椎体骨折。基础治疗不可少：保证充足钙 + 维 D，常规推荐负重/抗阻训练。 ✩ 本文仅供医疗卫生等专业人士参考投稿邮箱：huanghaihua@dxy.cn 编辑：黄海花题图来源：站酷海洛参考资料： [1] Inderjeeth C, Inderjeeth DC. Novel therapies in osteoporosis - Clinical update - 2025. Best Pract Res Clin Rheumatol. Dec 2025;39(4):102100. doi:10.1016/j.berh.2025.102100 [2] Watts NB, Camacho PM, Lewiecki EM, et al. American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis-2020 Update. Endocr Pract. Apr 2021;27(4):379-380. doi:10.1016/j.eprac.2021.02.001 [3] Inderjeeth CA, Inderjeeth DC. The use of anabolic agents in the treatment of osteoporosis: a clinical update. Curr Opin Endocrinol Diabetes Obes. Aug 1 2024;31(4):157-163. doi:10.1097/med.0000000000000867 [4] McClung MR. Role of bone-forming agents in the management of osteoporosis. Aging Clin Exp Res. Apr 2021;33(4):775-791. doi:10.1007/s40520-020-01708-8 [5] Kim Y, Kim GT. Positive Effects of Biologics on Osteoporosis in Rheumatoid Arthritis. J Rheum Dis. Jan 1 2023;30(1):3-17. doi:10.4078/jrd.22.0046 [6] Martinez de la Torre A, Clausen AB, Burden AM, et al. Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase. Drug Saf. Feb 2025;48(2):191-201. doi:10.1007/s40264-024-01490-w [7] Recker RR, Benson CT, Matsumoto T, et al. A randomized, double-blind phase 2 clinical trial of blosozumab, a sclerostin antibody, in postmenopausal women with low bone mineral density. J Bone Miner Res. Feb 2015;30(2):216-24. doi:10.1002/jbmr.2351 [8] Meunier PJ, Roux C, Seeman E, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med. Jan 29 2004;350(5):459-68. doi:10.1056/NEJMoa022436 [9] McClung MR, O'Donoghue ML, Papapoulos SE, et al. Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study. Lancet Diabetes Endocrinol. Dec 2019;7(12):899-911. doi:10.1016/s2213-8587(19)30346-8 [10] Clarke BL, Khan AA, Rubin MR, et al. Efficacy and Safety of TransCon PTH in Adults With Hypoparathyroidism: 52-Week Results From the Phase 3 PaTHway Trial. J Clin Endocrinol Metab. Mar 17 2025;110(4):951-960. doi:10.1210/clinem/dgae693

2026-01-12

·汇聚南药

国内多肽药物相关产业分布情况3.0

随着GLP-1药物在全球市场的爆发性增长，多肽药物已成为国内生物医药领域最炙手可热的赛道之一。在这一背景下，中国多肽药物企业呈现出明显的区域集聚现象，并不断发展壮大。从长三角到粤港澳，从合成多肽到基因重组，中国多肽药物产业地图正在迅速扩张与重塑。根据网络信息显示国内目前涉及多肽药物整个产业链的企业已经超过1000家；分为合成多肽、基因重组多肽和动植物提取多肽三类；从AI驱动研发到口服递送突破，从长三角集群到新兴区域崛起，中国多肽药物产业正迎来“黄金五年”。产业链重构多肽药物产业链正在经历价值重构，中国企业在全球供应链中的地位显著提升。上游原料领域，国内企业已突破高端氨基酸合成技术壁垒。凯莱英通过生物催化法实现Fmoc保护基试剂的规模化生产，纯度达99.8%，成本较进口产品降低35%。这种技术突破直接推动多肽CDMO行业格局变化，2025年本土企业订单占比从2020年的18%跃升至42%。中游制造环节，CDMO企业正从“代工生产”向“技术赋能”转型。药明康德推出的多肽-小分子杂合药物开发平台，可同时实现多肽修饰、非天然氨基酸插入等复杂操作，将客户研发周期缩短50%。产能即估值已成为行业新逻辑。符合FDA标准的大规模产线稀缺，预计2026年起将出现“产能为王”的并购潮，掌握绿色合成专利、连续流工艺的企业将享受“技术+产能”双击溢价。表：中国多肽原料药主要企业及特色区域格局新变化多肽药物企业的分布呈现更为明显的区域集聚与梯度发展特征，且不同技术路径的企业分布差异进一步凸显。合成多肽药物企业仍是最主要的力量，主要分布在广东、江苏、上海等省市。长三角地区作为多肽药物产业的重要聚集地，依托成熟的生物医药产业带，形成了以上海、南京、苏州、杭州为核心的研发与生产基地，覆盖合成多肽、基因重组多肽及原料药全产业链。珠江三角洲地区产业集聚度进一步提升，合成多肽和基因重组多肽企业集中，尤其在深圳、广州等地，已形成从研发到生产的完整产业链。代表企业包括翰宇药业、丽珠集团、信立泰、联邦生物、健康元等。京津冀地区的研发中心地位进一步巩固，北京聚集了多家头部企业，依托高校和科研院所资源，持续推动技术创新。新兴区域表现活跃，海南作为医药产业的新兴热点，聚集了双成药业、中和药业等多家多肽企业。湖南常德加快探索“飞地研发·常德转化”模式，与深圳瑞德林生物技术有限公司签订战略协议，项目总投资3.5亿元，致力于打造年产250吨的多肽类活性原料基地。各省多肽相关企业分布情况小编根据往年整理的国内多肽药物研发企业分布情况，结合2025年的产业变化更新了国内多肽药物重点企业分布情况。涉及企业约200余家，具体分布如下：北京：质肽生物、盛诺基医药、甘李药业、东方百泰、爱泰浦生物、赛升药业、悦康药业、华润双鹤、北京诺博特、北京康明海慧、拜西欧斯、鸿绪生物、质肽生物、深势科技、北京四环（惠升生物）、双鹭药业、中科国纳康达、诺诚健华、诺尼瑞、艾赛普上海：仁会生物、盟科药业、银诺医药、主流源、贺普药业、民为生物、硕迪生物、复星医药、上海汉明波、上海盟科、上海世领、天竞生物、智肽生物、维昇药业、上海医工院、诚益生物、锐格医药、拓臻生物、普递瑞、上药第一生化药业、璞汇至臻、艾博兹医药江苏：豪森药业、普洛药业、前沿生物、海辰药业、派格生物、江苏普莱、同宜医药、信达生物、奥赛康、博瑞医药、恒瑞医药、诺泰生物、闻泰医药、南京杰肽、万邦生化、常山生化、吉锐生物、扬子江、奥锐特、南京诺唯赞、天吉生物、南京赛诺生物、星洲生物、特瑞药业、正大天晴、吉泰肽业、阿尔脉生物、江苏海普、新百药业、修实生物、美药星、立新制药、拓创生物、安吉生物、先声药业、东瑞制药、亿帆医药部分多肽企业分布情况（双击可放大）广东：领晟医疗、图微安创、中奥生物、肽盛生物、元思生肽、泰尔康、藤栢医药、莱博瑞辰、东阳光、众生睿创、广州中奥生物、翰宇药业、磷基生物、丽珠集团、信立泰、联邦生物、健康元、深圳晶泰、新声药业、誉衡生物、深圳健元、祥根生物、奥礼生物、百极优棠、一品红、必贝特、海普瑞、中科新进、呈元科技、赛烽医药浙江：瀛康生物、道尔生物、先为达、汉鼎医药、贝达药业、鸿运华宁、华东医药、德睿智药、纽安津、禾泰健宇、争光实业、三生蔓迪、海正药业、新博思、国光药业、海翔药业、诺澳生物、九源基因、苏泊尔、普洛康裕、中肽生化四川：奥达生物、惠泰生物、圣诺生物、纽瑞特、佩德生物、好医生药业、科隆化学、同晟生物、什邡市三高生化、成都先导、成都地奥制药、海思科、天台山制药、国为生物、成都倍特安徽：合肥国肽、国平药业、丰原药业、安科生物福建：海王福药制药有、基诺厚普海南：双成药业、中和药业、普利制药陕西：麦科奥特、慧康科肽、利君制药江西：青峰药业重庆：派金生物、莱美药业、北大医药、太极集团、宸安生物河北：石药集团、常山药业（凯捷健）、菲尼斯生物、智同生物、博海生物河南：开封明仁药业、大明药物湖北：武汉武药、武汉摩尔、湖北荆祥、人福药业、华龙生物、仙肽药业、健翔湖南：五洲通药业、九典制药、一格制药、中晟全肽、千金药业山西：康宝生物、同达药业天津：星联肽生物、凯莱英、峰鑫泽、红日药业山东：齐鲁制药、绿叶制药、新时代药业、齐都药业、鲁南药业、罗欣药业、辰欣药业、瑞阳制药云南：昆药集团、南诏药业、积大制药贵州：银河起源生物、铭肽吉林：金赛药业（金派格药业）、长春高新、天诚药业、精优药业、生物制品研究所、普华制药、普莱医药、翔通药业、国药一心、长春海外制药、敖东药业、通化东宝黑龙江：吉象隆、哈三联、誉衡药业辽宁：拜澳泰克、阿拉宁、三生制药多肽产能情况 GLP-1药物，尤其是司美格鲁肽和替尔泊肽，因其销售额的快速增长，正推动多肽原料药需求的爆发。预计2030年中国多肽原料药市场规模将达652.5亿元。有专家指出，国际市场上多肽原料药供应主要依赖于中国。国内相关企业正在快速扩展产能。成都圣诺："年产 395 千克多肽原料药生产线项目" 已顺利投产，自有资金建设的 106、107、108 车间陆续投入运营，预计年总产能将达 1.25 吨 / 年，较原 400kg / 年提升 212%。杭州诺泰：具体产能构成如下：601车间：2025年1月投产，产能5吨/年，重点生产司美格鲁肽、替尔泊肽等GLP-1类药物，单批次产量达10公斤级。602车间：2025年上半年建成，新增产能5吨/年，覆盖胸腺法新、醋酸兰瑞肽等多品种，其中司美格鲁肽和替尔泊肽分别规划500公斤/年产能。武汉子公司：扩建司美格鲁肽固相合成产能至250kg/年，重组多肽液相合成产能250kg/年。翰宇药业：截至2025年12月，翰宇药业多肽原料药总产能可达5吨以上，且司美格鲁肽、替尔泊肽、利拉鲁肽等产品共线生产。健元医药：现有产能：已建成10条符合欧盟、FDA要求的多肽原料药生产线，年产能达2000公斤。扩建规划：2025年启动扩建项目，新增3栋生产车间（A14、A15、A16），预计2026年9月完工后，总产能将提升至8260公斤/年。中肽生化：目前的多肽年产能为500千克。其生产基地分布在中美两地，拥有19条独立合成产线、5条切割产线和19条独立纯化产线，可支持克级至千克级的多肽生产，单批次最大产能为20千克。湃肽生物：目前的替尔泊肽产能为150公斤/年，规划产能为350公斤/年。博瑞生物：2024年6月投资7000万改建，项目建设后，形成年产BGM0504产品600kg、替尔泊肽100kg、司美格鲁肽100kg、蓝铜肽1200kg的生产能力。多瑞药业：2025年7月投资2亿改建，建成后预计实现年新增年产100kg兰瑞肽、2000kg司美格鲁肽、100kg替尔泊肽、100kg比伐卢定、100kg奥曲肽、10kg特立帕肽、50kg阿巴帕肽、200kg阿托西班50kg普卡那肽、50kg利那洛肽、30kg的pegcetacoplan、100kg的Amycretin110K9 HDM1005，共计3000kg/年的多肽生产线的生产能力。沣润药业：2025年11月投资2.55亿，项目建成后，计划形成年产多肽类原料药500kg(其中司美格鲁肽160kg、比伐芦定40kg、醋酸特利加压素6kg、胸腺法新14k9、普尔泊肽120k9、醋酸奥曲肽10kg、胸腺五肽110k9、醋酸阿托西班40kg)、核苷类化药(富马酸丙酚替诺福韦)100k9、小容量注射剂(司美格鲁肽注射液)1000万支、片剂(恩替卡韦分散片)4000万片的生产规模。铭肽生物：2025年5月投资2000万改扩建，项目建设完成后厂区形成年产乙酰基六肽-8:100 千克、棕榈酰四肽-7:20 千克、九肽-1:50 千克客户定制多肽 130 千克、二肽-2:100 千克、司美格鲁肽:50 千克、替尔泊肽:60 千克、瑞他鲁肽:20千克。基诺厚普：2024年底投资1.21亿建设周期24个月，建成后产能可达司美格鲁肽426kg/a、替尔泊肽50kg/a，以上原料药将制成注射液出售，年产5856万支。常州制药厂：项目拟投资1.2亿，建成后形成年产380kg原料药的生产能力其中发酵法司美格鲁肽280kg/a，固相合成司美格鲁肽60kg/a，普尔泊肽40kg/a。同达制药：2025年7月投资3200万建设中试车间，建成后形成试产品司美格鲁肽原料药50公斤、醋酸亮丙瑞林原料药20公斤、替尔泊原料药20公斤。表：国内司美格鲁肽原料药现有产能及规划产能情况在多肽原料药行业快速发展的阶段，众多产业链服务及仪器设备商也尝到了行业红利，像乔枫实业、安徽松羽、勃拉精密、尤尼菲克等均在积极拓展多肽领域业务。拥有核心技术和产能优势的CRO/CDMO公司将在这一过程中获得显著的发展机遇。然而随着多肽产能的快速扩充，国内产能已经开始大批量投放市场；企业也要留意司美格鲁肽的原料产能过剩。趋势资本市场上，2025 年以来，中国肽类创新药领域至少发生 20 起融资事件，融资总额突破 120 亿元人民币，其中 12 起属于亿元级及以上，涵盖 Pre-A 至 IPO 多个阶段。全球市场方面，Cyprumed 与默沙东达成 4.93 亿美元的口服多肽递送平台合作协议，显示出国际巨头对多肽药物的强烈兴趣。这种资本热潮反映了市场对多肽药物前景的高度认可。规模化生产方面，现阶段多肽合成方法以化学合成为主，随着GLP-1类药物的爆发，行业开始优化生产工艺，呈现化学合成法与生物合成法融合发展的趋势。在后GLP-1时代，复杂结构的多肽数量正在成倍增加，但传统合成技术显然无法满足所有类别多肽的合成需求。此外，GLP-1及下一代GLP-1产品的需求会在未来几年快速放量，下游对多肽药物的产能需求正逐渐演变为吨量级别，但现阶段多种多肽原料药生产工艺还不成熟，大量环节有待探索、验证，且多肽药物产能构建周期较长，终端产品品类繁多，多肽的合成与规模化扩展仍面临痛点。技术趋势，多肽药物正朝着长效化和多靶点方向发展，这一趋势在最新的研发中表现得尤为明显。在解决稳定性问题的众多策略中，环肽技术展现出了独特的优势。相比线性肽，环肽不仅稳定性更好，亲和力也更强，透膜性也更佳。环肽通过封闭肽链两端，增强稳定性与膜通透性，有效抑制酶降解；在治疗领域上GLP-1类药物正向非酒精性脂肪性肝炎等新适应症拓展；靶向多肽偶联药物(PDC)在抗肿瘤领域的临床试验数量呈现出爆发式增长，成为了抗肿瘤药物研发的新热点。随着技术的不断进步，口服多肽药物正在取得突破性进展。AI等新兴技术将在多肽药物研发中发挥越来越重要的作用。AI可以用于多肽序列设计、结构预测、活性预测等多个方面，提高研发效率，降低研发成本。展望：未来五年，多肽赛道将再造 “创新药+原料药”双千亿市场，中国有望从“跟随者”转为“规则共建者”。然而，行业也面临诸多挑战与风险。建议采取 “三不一要”策略应对风险：不赌单品、不拼价格、不碰高污染产能；要布局新一代递送平台和适应症梯队。未来五年，中国多肽药物产业将从“规模扩张”转向“质量提升”，在这场产业变革中，只有把握核心技术与战略布局的企业才能成为真正的“规则共建者”。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 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并购

2026-01-12

·BioSpace

B-FLEXION Life Sciences to Acquire Remaining 57% Interest in Radius Health

Transaction follows three years of accelerated growth and successful operations under B‑FLEXION and Patient Square's ownership. BOSTON , Jan. 12, 2026 /PRNewswire/ -- Radius Health ("Radius" or "the Company"), a specialty biopharmaceutical company dedicated to bone health and related therapeutic areas, including through its lead product TYMLOS® (abaloparatide) injection, announced today that B‑FLEXION Life Sciences has agreed to purchase shares of the Company currently held by affiliates of Patient Square Capital ("Patient Square") and Webster Equity Partners. B‑FLEXION and Patient Square acquired Radius in August 2022 in a take‑private transaction. "Over the past three years, Radius has undergone a significant transformation, sharpening our focus on commercialization and delivering sustained growth," said Scott Briggs, Chief Executive Officer of Radius Health. "We are grateful for the support our partners have provided, which has enabled us to deliver TYMLOS® to an increasing number of patients living with osteoporosis." "We are extremely proud of the momentum of what has become a strong, profitable business within our portfolio," said Nithya Desikan, Operating Partner at B-FLEXION Life Sciences and Member of the Board at Radius. "The team has built incredible commercial capabilities, and we look forward to continuing the success of TYMLOS® as it provides meaningful impact to the patients and families we serve." "We are proud of the transformation achieved at Radius over the past three years by Scott and his team expanding the impact of an important medicine," said Jim Momtazee, Managing Partner of Patient Square. "With our initial investment thesis playing out as expected and with a bright future ahead, it is a good time to deliver returns for our investors and consolidate ownership of the Company for its next stage of growth." The transaction is expected to close by the end of the first quarter of 2026. Centerview Partners LLC acted as financial advisor to Radius. About Radius Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, a parathyroid hormone related peptide, is approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women and men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture) or patients who have failed or are intolerant to other available osteoporosis therapy. For additional information, please visit . About B-FLEXION Life Sciences B-FLEXION Life Sciences is an investment manager and part of the wider B-FLEXION group, the private, entrepreneurial investment firm that has offices across Europe and the United States and which seeds, acquires and builds investment partnerships across a number of focused fields. Through B-FLEXION Life Sciences it also makes principal investments in operating businesses across biotech, therapeutics, diagnostics, physician practice management, and more. It is an active owner, applying the experience and skills of its investment and operations team to work closely with management at its portfolio companies with the shared goals of bringing safe and effective treatments to market while also moving towards and through key value inflection points. About Patient Square Capital Patient Square Capital is a dedicated health care investment firm with over $15 billion in assets under management. The firm aims to achieve strong investment returns by partnering with growth-oriented companies and top-tier management teams whose products, services, and technologies improve health. Patient Square utilizes deep industry expertise, a broad network of relationships, and a partnership approach to make investments in companies that will grow and thrive. Patient Square invests in businesses that strive to improve patient lives, strengthen communities, and create a healthier world. For more information, visit . About Webster Equity Partners Founded in 2003, Webster is a private equity firm that focuses on high impact growth strategies that seek to deliver optimal outcomes for our investors, portfolio companies and the communities that we serve. Our mission is to deliver superior returns to our partners through the investment in and development of purpose driven patient-centric healthcare organizations dedicated to providing best of class clinical care and service to their patients. Media Prosek Partners pro-PatientSquareCapital@prosek.com View original content: SOURCE Radius Health

并购上市批准

100 项与阿巴帕肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10885	阿巴帕肽	H05AA	DB05084

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
骨质疏松症	日本	Teijin Ltd.	2022-08-31
绝经期后骨质疏松	美国	Radius Health, Inc.	2017-04-28

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
原发性骨质疏松症	临床3期	美国	Radius Health, Inc.	2018-05-03
原发性骨质疏松症	临床3期	意大利	Radius Health, Inc.	2018-05-03
原发性骨质疏松症	临床3期	波兰	Radius Health, Inc.	2018-05-03
骨折	临床3期	美国	Radius Health, Inc.	2011-04-01
骨折	临床3期	阿根廷	Radius Health, Inc.	2011-04-01
骨折	临床3期	巴西	Radius Health, Inc.	2011-04-01
骨折	临床3期	捷克	Radius Health, Inc.	2011-04-01
骨折	临床3期	丹麦	Radius Health, Inc.	2011-04-01
骨折	临床3期	爱沙尼亚	Radius Health, Inc.	2011-04-01
骨折	临床3期	中国香港	Radius Health, Inc.	2011-04-01

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临床结果

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


NCT01343004 (ACTIVE, Pubmed \| Menopause)	临床3期	骨质疏松性骨折	-	Abaloparatide	範製餘鬱鏇製遞鬱餘餘(壓衊網願鬱築鬱醖窪簾) = 8.9% 鹽餘壓鬱蓋襯淵廠繭糧 (蓋選壓積選醖獵遞夢鹽 ) 更多	积极	2025-05-01
				Placebo
NCT04760782 (CTgov)	临床2期	骨折	22	Hard collar immobilization+Abaloparatide (Treatment Group)	糧醖鑰範築構選願鑰鬱(顧齋鹽築窪廠鑰觸簾製) = 襯廠襯築遞遞築襯製遞鹽襯醖築獵膚醖觸鏇鏇 (餘壓鬱鏇艱糧壓鬱製遞, 鑰繭壓鬱鑰鹽鹽鏇窪觸 ~ 衊鏇製膚鑰築衊顧夢窪) 更多	-	2024-09-19
				Hard collar immobilization (Historical Control Group)	糧醖鑰範築構選願鑰鬱(顧齋鹽築窪廠鑰觸簾製) = 遞鑰選鑰選憲顧鑰淵鹹鹽襯醖築獵膚醖觸鏇鏇 (餘壓鬱鏇艱糧壓鬱製遞, 遞憲艱築鹽鏇窪顧齋艱 ~ 簾鹽範糧醖簾鬱齋製構) 更多
NCT03512262 (ATOM, ENDO2024)	临床3期	骨硬化 PINP \| CTX	228	Abaloparatide 80 µg	夢觸襯鬱齋選醖繭選蓋(餘餘積網繭艱膚糧鏇淵) = 獵範憲鑰構鑰遞糧糧簾遞鏇簾築餘願網顧簾壓 (窪選淵簾窪蓋窪壓製構 ) 更多	积极	2024-06-01
Biospace 人工标引	N/A	骨质疏松症	43,352	TYMLOS (abaloparatide)	構網淵憲鹽築壓鹽鑰糧(遞醖遞築鬱範糧窪鏇範) = 齋範範鑰艱選遞積窪醖夢襯鬱鹹製糧鹹選鹽築 (簾艱膚製網夢選顧鑰積 ) 更多	积极	2024-04-16
				Teriparatide	構網淵憲鹽築壓鹽鑰糧(遞醖遞築鬱範糧窪鏇範) = 選顧構遞淵選選獵醖願夢襯鬱鹹製糧鹹選鹽築 (簾艱膚製網夢選顧鑰積 ) 更多
WCO_IOF_ESCEO2024	N/A	-	-	Abaloparatide	構構築範蓋醖鹹廠構顧(憲膚鑰餘鏇淵簾壓齋醖): HR = 0.83 (95% CI, 0.7 ~ 0.98), P-Value = 0.03	积极	2024-04-11
				Teriparatide
NCT04366726 (CTgov)	临床1期	绝经期后骨质疏松	22	abaloparatide-sMTS	鑰憲夢願糧夢窪網網簾(憲鹽範齋觸願衊顧鏇廠) = 膚廠膚鹽繭夢醖夢鬱餘獵簾簾選艱選鑰蓋鏇齋 (艱膚齋願鏇願觸繭築網, 41.8) 更多	-	2023-11-22
WCO_IOF_ESCEO2023	N/A	绝经期后骨质疏松	-	Abaloparatide	遞鹹構廠夢鹹廠製選製(壓蓋範鬱製鹽艱憲觸鹽) = 夢鹽繭壓艱範鑰鑰憲築繭築蓋糧窪願艱衊遞憲 (廠夢蓋衊築醖範壓構遞 ) 更多	积极	2023-05-04
				Teriparatide	遞鹹構廠夢鹹廠製選製(壓蓋範鬱製鹽艱憲觸鹽) = 艱構糧觸膚構觸艱網鏇繭築蓋糧窪願艱衊遞憲 (廠夢蓋衊築醖範壓構遞 ) 更多
NCT03512262 (ATOM, CTgov)	临床3期	原发性骨质疏松症 \| 骨质疏松症	228	Abaloparatide (Abaloparatide)	膚艱鏇齋繭繭觸鹽鏇顧(蓋膚遞壓願鹽鑰觸醖鑰) = 鏇鏇範觸鏇鹹鑰衊醖積襯製鹽糧糧齋範積鏇齋 (憲襯壓構夢構襯願蓋壓, 0.5353) 更多	-	2023-04-07
				Placebo (Placebo)	膚艱鏇齋繭繭觸鹽鏇顧(蓋膚遞壓願鹽鑰觸醖鑰) = 餘製窪壓憲願衊夢繭積襯製鹽糧糧齋範積鏇齋 (憲襯壓構夢構襯願蓋壓, 0.7235) 更多
NCT04064411 (CTgov)	临床3期	绝经期后骨质疏松	511	abaloparatide (Abaloparatide-SC)	構觸簾選膚遞鹹選醖壓(鏇鏇夢壓窪繭鹹鏇襯襯) = 糧壓蓋網淵範糧蓋鹹觸獵選蓋憲壓繭網糧積齋 (廠網簾鹹蓋鬱鑰網鹽簾, 0.4755) 更多	-	2023-02-15
				abaloparatide solid microstructured transdermal system (Abaloparatide-sMTS)	構觸簾選膚遞鹹選醖壓(鏇鏇夢壓窪繭鹹鏇襯襯) = 餘膚窪鹽積願窪憲艱築獵選蓋憲壓繭網糧積齋 (廠網簾鹹蓋鬱鑰網鹽簾, 0.4605) 更多
PSAT156 (ENDO2022)	N/A	骨质疏松症	146	Abaloparatide therapy	繭鑰鬱鹹餘壓醖鏇憲艱(艱憲鹹構構鬱製艱膚餘) = One reported fracture during the evaluation period 艱齋衊夢膚廠選簾鬱夢 (鏇網淵鑰糧窪築鏇築衊 ) 更多	积极	2022-11-01