A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 Mg (Triptorelin Mesylate Injection, 11.25 Mg) in Patients with Advanced Prostate Cancer (KATANA E3M)

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 26 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 11.25 mg formulation will be given to the patients by separate SC injections 12 weeks apart in an unblinded manner. The first dose of FP-014, 11.25 mg, will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 11.25 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 84 (Visit 13/Week 12) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 12-week observation period (Day 168/Week 24/ Visit 22).
Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 11.25 mg administration, immediately thereafter and at specified time points through Day 168 (Week 24) to determine pharmacokinetic (PK) (triptorelin) and pharmacodynamic (PD) (testosterone, PSA, and LH) profiles.

开始日期2025-07-01

申办/合作机构

逸达生物科技股份有限公司

[+1]

NCT06795191

/ Not yet recruiting临床3期

A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 Mg (Triptorelin Mesylate Injection, 22.5 Mg) in Patients with Advanced Prostate Cancer (KATANA E6M)

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.

开始日期2025-06-01

申办/合作机构

逸达生物科技股份有限公司

[+1]

NCT06763926

/ Not yet recruiting临床4期IIT

Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial

This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in oocyte donors undergoing ovarian stimulation.

开始日期2025-03-15

申办/合作机构-

100 项与双羟萘酸曲普瑞林相关的临床结果

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100 项与双羟萘酸曲普瑞林相关的转化医学

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100 项与双羟萘酸曲普瑞林相关的专利（医药）

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2,076

项与双羟萘酸曲普瑞林相关的文献（医药）

2025-02-25·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Central precocious puberty in a toddler with hypothalamic hamartoma

Article

作者: Büyükyılmaz, Gönül ; Turhan, Banu ; Boyraz, Mehmet

Abstract:

Objectives:

Hypothalamic hamartoma (HH) is a rare condition that causes epilepsy and central precocious puberty (CPP) at an early age. In this report, we describe a child with CPP secondary to HH and discuss the current literature.

Case presentation:

A 26-month-old girl was brought to our hospital for evaluation of breast enlargement. Her parents were first-degree relatives. Her breast development was categorized as Tanner stage 3, and her bone age was 7 years/4 months. Laboratory investigations were consistent with CPP. Brain magnetic resonance imaging (MRI) revealed a smooth, spherical lesion in the hypothalamus, located in the tuber cinereum and measuring 11 × 9 × 10 mm. The lesion was identified as a HH. The patient was started on gonadotropin-releasing hormone analogue therapy, specifically 200 μg/kg/month of leuprolide acetate (3.75 mg depot) administered intramuscularly every 28 days. During the 2-year follow-up, her breast development remained at Tanner stage 3, and she did not develop axillary or pubic hair. Her bone age was 7 years/6 months (chronological age; 4 years/2 months). 2-year follow-up MRI showed no change in the size or contours of the HH compared with the initial diagnosis. No side effects from the medical treatment were observed during the follow-up period.

Conclusions:

In patients under the age of 4 years showing signs of CPP, HH should be considered as diagnosis. All patients receiving medical treatment should be closely monitored.

2025-01-15·Clinical and experimental pediatrics

Efficacy of leuprolide acetate versus triptorelin pamoate administered every 3 months for treatment of central precocious puberty

Article

作者: Thaneetrakool, Thanaporn ; Numsriskulrat, Nattakarn ; Wacharasindhu, Suttipong ; Srilanchakon, Khomsak ; Aroonparkmongkol, Suphab ; Supornsilchai, Vichit

Background: Central precocious puberty (CPP) is typically treated with gonadotropin-releasing hormone (GnRH) agonists. Although numerous GnRH agonist variants are available, limited research has compared the efficacy of leuprolide acetate and triptorelin pamoate administered at 3-month intervals.Purpose: This study aimed to assess the efficacy of CPP treatment with triptorelin pamoate and leuprolide acetate administered at 3-month intervals.Methods: This retrospective cohort study included 116 girls with CPP: 71 treated with leuprolide acetate every 3 months and 45 treated with triptorelin pamoate every 3 months. Anthropometric measurements were compared before and after therapy. At 6 months after the therapy, luteinizing hormone (LH) suppression was evaluated.Results: When administered every 3 months, leuprolide acetate and triptorelin pamoate significantly suppressed LH. The predicted adult height (PAH) and degree of bone age advancement at the end of treatment were comparable.Conclusion: Treatment with leuprolide acetate and triptorelin pamoate every 3 months did not have significantly different effects on LH suppression or PAH.

2024-12-01·ADVANCES IN THERAPY

A Phase 3, Open-Label, Single-Arm Trial of the Efficacy and Safety of Triptorelin 6-Month Formulation in Chinese Children with Central Precocious Puberty

Article

作者: Huang, Frank ; Xu, Xu ; Shi, Xiaofeng ; Li, Guimei ; Wei, Haiyan ; Cabri, Patrick ; Cheng, Xinran ; Yu, Xiao ; Yang, Yu ; Zhou, Li ; Luo, Xiaoping ; Zhong, Yan ; Luo, Feihong ; Zhang, Yining ; Gong, Chunxiu ; Yao, Hui

INTRODUCTION:

This phase 3 study assessed the efficacy, safety, and pharmacokinetics of the 6-month prolonged release (PR) formulation in Chinese children with central precocious puberty (CPP).

METHODS:

In this open-label study (NCT05029622), Chinese children (girls < 9 years, boys < 10 years) received two doses of triptorelin pamoate 22.5 mg (day 1 and month 6). Primary endpoint was the proportion at month 6 with luteinizing hormone (LH) suppression (stimulated peak LH ≤ 5 IU/L after gonadotropin-releasing hormone stimulation). Secondary endpoints included safety assessments, hormone level changes, and clinical parameters from baseline.

RESULTS:

Overall, 66 children completed the study (93.9% girls; median age 8.0 [range 5-9] years). At month 6, all patients had LH suppression; this was maintained at month 12 in 98.5% of patients. Mean basal and peak LH and follicle-stimulating hormone levels were suppressed throughout follow-up. All patients at months 3 to 12 had sex hormone suppression to prepubertal levels. Stable or reduced breast development was seen for 98.4% and 93.5% of girls at month 6 and 12, respectively; all boys had regression or stable genital development until month 12. Compared with baseline (9.82 cm/year), mean growth velocity was 5.88 cm/year at month 6 and 5.17 cm/year at month 12. Mean bone age/chronological age ratio decreased from 1.27 at baseline to 1.23 and 1.21 at month 6 and 12, respectively. In girls, 64.5% showed decreased uterine length at month 6 and 12 versus baseline, while 75.0% of boys showed stable testicular volume versus baseline. Thirteen patients (19.7%) had 22 drug-related treatment emergent adverse events (TEAEs); no grade ≥ 3 TEAEs were reported.

CONCLUSION:

The efficacy and safety profile of triptorelin 6-month PR in Chinese children with CPP was consistent with data previously reported in non-Chinese children with CPP, supporting this as a viable treatment option for Chinese children with CPP.

TRIAL REGISTRATION:

Trial registration: ClinicalTrials.gov identifier, NCT05029622.

项与双羟萘酸曲普瑞林相关的新闻（医药）

2025-03-28

·药闻康策

这5个抗肿瘤药品种或将纳入第11批国采！

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策前言近一个月内，已有包括湖北、甘肃、安徽、宁夏等在内的多省发布相关通知，推进第10批国采的落地工作。按照此前国家医保局的要求，第10批国采将于今年4月正式落地执行。此外，国家层面于上半年开展第11批药品集采亦是大概率事件。作为市场规模超千亿元人民币的重要领域，抗肿瘤药*市场已有32个品种被纳入历次集采。2023年整体抗肿瘤药物市场内外资企业格局如何？又有哪些品种初步符合新一批国采条件并有望被纳入？其市场表现如何？补充说明*本分析所述的药品范围（按照药物解剖学、治疗学及化学分类法ATC编码）：L01抗肿瘤药；L02抑制细胞生长的激素疗法。*中国医疗机构：包括两个医院渠道（城市医院、县域医院）和两个基层医疗机构渠道（社区卫生中心、乡镇卫生院）。千亿抗肿瘤市场，TOP10企业内资占七席根据法伯全渠道数据显示，2023年我国总体医疗机构抗肿瘤药物市场规模达到1087亿元，同比增长5%。分渠道来看，2021-2023年城市医院和县域医院渠道合计占据该药物市场超99%的份额，而两类基层医疗机构渠道的占比微乎其微。此外，2023年处在城市区域内的城市医院和社区卫生中心渠道均实现了增长（图1）。图1-2021-2023年总体医疗机构抗肿瘤药市场总规模及渠道分布数据来源：法伯全渠道数据抗肿瘤药物是指治疗各类肿瘤疾病的药物，主要包括化学治疗药物、靶向治疗药物和抑制细胞生长的激素疗法等。根据法伯全渠道数据显示，2023年我国总体医疗机构抗肿瘤药TOP15分子中包括3个激素类抗肿瘤药，分别为排名第三的亮丙瑞林、第五的戈舍瑞林和第十三的依西美坦。在TOP分子中，贝伐珠单抗的市场规模最大，替雷珠单抗近年来的增速最快（图2）。图2-2023年总体医疗机构抗肿瘤药市场TOP15分子及增速表现数据来源：法伯全渠道数据值得关注的是，在抗肿瘤药领域，近年来内资企业的整体市场份额要优于外资。法伯数据显示，到2023年，总体医疗机构销售额排名前十的企业中包括七家内资企业，其中齐鲁制药、恒瑞医药和正大天晴位列前五。分渠道来看，全部四个销售渠道均由内资主导，尤其是在社区卫生中心占比更高（图3）。图3-2023年总体医疗机构抗肿瘤药市场内外资分布及TOP10企业数据来源：法伯全渠道数据5个抗肿瘤药品种有望纳入新一批VBP根据法伯整理，在既往的第1-10批VBP中，抗肿瘤药物市场已有32个品种被纳入，涉及到的原研厂家主要包括阿斯利康、强生、辉瑞等。根据法伯全渠道数据显示，这些集采品种2023年在我国总体医疗机构抗肿瘤药市场合计占比达20.2%（图4）。图4-抗肿瘤药市场VBP品种及2023年在总体医疗机构销售额占比数据来源：法伯全渠道数据而随着第10批国采进入落地执行的倒计时，目前已经初步符合纳入第11批集采条件的品种成为行业内讨论的话题，当中也包括抗肿瘤药物。根据易联招采统计数据显示，截止到2025年3月21日，尚未纳入国采且原研企业+过评企业数量≥7家的品种共有113个，已初步具备纳入新一批国采的条件。而根据法伯进一步整理，这113个品种中包括5个抗肿瘤药物品种，分别为：奥拉帕利口服常释剂、恩扎卢胺口服常释剂、甲氨蝶呤注射剂、阿糖胞苷注射剂、曲普瑞林注射剂（表1）。表1-尚未纳入VBP且竞争格局数量≥7家的抗肿瘤药品种来源：易联招采；法伯全渠道数据*注：1. 竞争格局符合条件不一定会纳入国采，一切信息以官方为准；2. 统计截止日期2025.3.21，仅供参考。根据法伯全渠道数据显示，2023年上述抗肿瘤药品种在我国总体医疗机构的销售额合计超过33亿元，市场占比较小，为3.0%。从2021-2023年的整体市场表现来看，奥拉帕利口服常释剂在抗肿瘤药物市场的份额最大，恩扎卢胺口服常释剂近年来增速最快（图5）。图5-2023年总体医疗机构抗肿瘤药市场集采品种占比及第11批集采候选品种增速表现数据来源：法伯全渠道数据抗肿瘤集采候选品种多渠道发展格局关注5个抗肿瘤药VBP候选品种的分渠道市场格局，根据法伯全渠道数据显示，曲普瑞林注射剂、恩扎卢胺口服常释剂以及阿糖胞苷注射剂超过90%的销售额分布在城市医院，而奥拉帕利口服常释剂和甲氨蝶呤注射剂则由城市医院和县域医院渠道共同主导（图6）。图6-2023年抗肿瘤药第11批集采候选品种销售额渠道分布数据来源：法伯全渠道数据奥拉帕利阿斯利康原研，齐鲁制药首仿奥拉帕利由阿斯利康原研（商品名：利普卓），是全球首创的PARP抑制剂，也是首个阻断同源重组修复（HRR）缺陷的细胞/肿瘤中DNA损伤修复通路 (DDR) 的靶向治疗，目前已在多个国家获批用于多个肿瘤类型。2017年7月，阿斯利康与默沙东宣布联合开发和推广奥拉帕利；2018年该药物于国内获批上市。根据法伯全渠道数据显示，2021-2023年我国总体医疗机构奥拉帕利销售额复合增长22.7%，且在城市医院的销售占比逐渐提高，到2023年市场规模超过12亿元（图7）。图7-2021-2023年总体医疗机构奥拉帕利市场规模及渠道分布数据来源：法伯全渠道数据2023年5月，齐鲁制药奥拉帕利片（商品名：齐帕尼）获批上市，系国内首仿。2024年8月，齐帕尼正式在国内开售。公开信息显示，在齐鲁制药之后，还有包括科伦制药、石药集团、南京方生和医药、中美华东制药等在内的8家仿制药企旗下相关药物过评，截止至2025年3月21日，已经与原研共同形成“8+1”的竞争格局，至于最终能否进入国采采购品种目录，值得期待。曲普瑞林原研益普生持续主导市场曲谱瑞林由益普生原研（商品名：达菲林），是全球第一个多肽微球产品，于1986年首次上市，2003年进入中国市场，2004年辉凌制药的曲普瑞林（商品名：达必佳）在国内获批。公开信息显示，原研益普生的达菲林在国内市场主要有3个月缓释剂型（双羟萘酸曲普瑞林）、1个月缓释剂型和日剂型（醋酸曲普瑞林）可用，均已进入2019年医保乙类药品目录。虽然相关仿制药已上市多年，但目前曲普瑞林市场依旧由益普生主导。根据法伯全渠道数据显示，2021-2023年我国总体医疗机构曲普瑞林市场复合增长-5.9%，原研益普生的份额持续提升，到2023年达73.9%（图8）。图8-2021-2023年总体医疗机构曲普瑞林市场企业竞争格局数据来源：法伯全渠道数据根据易联招采截止至今年3月21日统计数据显示，目前曲普瑞林注射剂已有包括长春金赛药业、重庆莱美药业、哈尔滨三联药业等在内的6家仿制药企过评，初步满足纳入新一批国采的门槛，仿制药业能否借助集采抢占由原研占据的市场份额，值得关注。恩扎卢胺安斯泰来原研，豪森药业获批首仿公开信息显示，恩扎卢胺为雄激素受体抑制剂，由安斯泰来和美国Medivation联合开发（商品名：安可坦）。2012.8恩扎卢胺首次获美国FDA批准上市，用于治疗晚期去势抵抗前列腺癌。2016.8辉瑞以140亿美元收购Medivation，将该品种收入囊中。2019.11获国家药监局批准，用于雄激素剥夺治疗（ADT）失败后无症状或有轻微症状且未接受化疗的转移性去势抵抗性前列腺癌（mCRPC）成年患者。2020通过国家医保谈判，降价78%进入医保乙类目录，挂网价为69.6元（40mg）。2021.8豪森药业的恩扎卢胺软胶囊首仿（商品名：普来坦）获国家药监局批准上市。根据法伯全渠道数据显示，2021-2023年我国总体医疗机构恩扎卢胺市场复合增长显著，达74.3%，其中主要份额由原研安斯泰来占据，豪森药业首仿上市后逐渐开始抢占原研份额，到2023年豪森普来坦占比达18%（图9）。图9-2021-2023年总体医疗机构恩扎卢胺市场企业竞争格局数据来源：法伯全渠道数据甲氨蝶呤/阿糖胞苷均为辉瑞原研另外两款初步满足第11批国采竞争格局的品种，甲氨蝶呤注射剂和阿糖胞苷注射剂原研均为辉瑞。法伯数据显示，甲氨蝶呤有口服常释剂和注射剂两种剂型，其中前者2023年在我国总体医疗机构甲氨蝶呤市场占比达55.9%，且主要份额由上海医药集团占据，注射剂型则主要由原研辉瑞占据。阿糖胞苷2023年市场规模超2亿元，目前市场基本由原研占据。根据易联招采统计数据显示，截止至今年3月21日，甲氨蝶呤和阿糖胞苷的注射剂型的竞争格局均大于七家，若最终真的纳入，相关细分市场或将被新入局的内资企业“搅动”。(来源：法伯科技）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

上市批准带量采购核酸药物申请上市

2025-02-26

·摩熵医药

2024年微球制剂市场分析：17.1%的增速！中国微球制剂市场迎来爆发期！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。微球制剂作为一种新型药物递送技术，在全球医药领域备受关注。近年来，中国微球制剂市场展现出强劲的增长态势，不仅市场规模增速远超全球平均水平，国产制剂的占比也显著提升。本文基于摩熵咨询最新发布的《基于剂型改良的复杂注射剂分析-微球篇》研究报告部分精华内容，将从整体市场规模、具体药物市场分析以及未来发展趋势三个方面，全面解读中国微球制剂行业的现状与前景。本文旨在为业内人士提供数据支持与趋势洞察，助力行业发展。 01 中国微球制剂药物市场规模市场规模增速远超全球截至2024年10月，国内有19款微球产品上市，其中有4款造影剂，主要用于肿瘤、糖尿病和精神分裂。图片来源：摩熵咨询《基于剂型改良的复杂注射剂分析-微球篇》 2017- 2019 年，全球微球制剂市场规模从 72 亿美元上升至 78 亿美元，2017-2019年CAGR为 4.3%。 2015-2023年，中国微球制剂销售额从25亿元增长到79亿元，2015-2019年CAGR为13.4%，2019-2023年CAGR为17.1%。 2015-2023年，国产微球制剂销售额占比呈逐步提高的趋势，从2015年的34.6%增长至2023年的49.7%；自2018年起，国产销售额占比一直稳定在45%以上。由此可见，中国微球制剂市场规模的增长速度远高于全球市场。随着国内企业加紧微球制剂的研发布局，未来中国微球制剂市场的规模有望继续保持高速增长。 02 中国微球药物市场分析亮丙瑞林的销售额占比最高曲普瑞林次之据摩熵医药销售数据统计，2023年，亮丙瑞林国内总销售额为53.92亿元，占总销售额的68.5%，曲普瑞林次之，总销售额为18.36亿元，占比23.3%。数据来源：摩熵医药销售数据库 01 亮丙瑞林微球制剂市场分析：国内销售额持续增长，2023年达到53亿元亮丙瑞林主要用于治疗前列腺癌、乳腺癌和中枢性性早熟，亮丙瑞林制剂2019-2023年国内销售额保持持续增长趋势，从2019年的27.44亿元增长到2023年的53.92亿元，CAGR为18.4%。截至2024年10月，国内市场上销售亮丙瑞林制剂的企业有北京博恩特、丽珠制药和日本武田，2023年销售额占比分别为29.5%、41.9%和28.7%。近五年，丽珠制药的注射用醋酸亮丙瑞林微球的销售额占比最高，销售额占比基本维持在40%左右。 02 曲普瑞林微球制剂市场分析：国内销售额持续增长，2023年达到18亿元 2019-2023年，曲普瑞林制剂的国内销售额持续增长，从2019年的11.49亿元增长到2023年的18.36亿元，CAGR为12.4% 。不同曲普瑞林制剂中，法国益普生的注射用醋酸曲普瑞林的销售额占比最高，2023年销售额占比为56.2%，然而，近5年其销售额占比呈现缓慢下滑趋势。唯一一款国产曲普瑞林制剂为丽珠制药的注射用醋酸曲普瑞林微球，于2023年5月获批上市，随着国产制剂成功推入市场，后续曲普瑞林市场规模有望进一步增长，并加速该品种的国产替代进程。 03 奥曲肽微球制剂市场分析：销售额趋于稳定 2020年，奥曲肽微球的销售额快速增长，从2019年的2.42亿元增长到4.56亿元，2020年后，奥曲肽微球在国内销售额趋于稳定，保持在4亿元以上；截至2024年10月，国内奥曲肽微球市场上的在售产品有诺华的善龙和齐鲁制药的佑远，诺华市场占比在99%以上。 04 利培酮微球制剂市场分析：销售额快速增长截至2024年10月，国内市场上销售利培酮微球的企业有杨森和绿叶制药，自绿叶制药的瑞欣妥推入市场后，销售额一路走高，2023年销售额达到4718万元，目前市场占比已超过99%。 03 微球制剂的未来发展趋势 01 微球制剂行业已经进入加速发展期中国微球制剂市场的发展经历了三个阶段。2000年-2008年为市场导入期，期间日本武田注射用亮丙瑞林微球、Ferring注射用曲普瑞林及Novartis注射用醋酸奥曲肽微球相继进入中国市场。2009年-2014年为微球制剂行业的初步发展期，丽珠制药和博奥特的产品获批上市并被纳入国家医保，同时《中国药典》2010年版收录了相关指导原则。2015年至今为加速发展期，2015年版《中国药典》进一步明确了微球制剂的要求，AstraZeneca和绿叶制药等公司推出了创新产品，丽珠集团也开启了新的合作模式。这一阶段标志着中国微球制剂技术的快速发展和创新。 02 微球产业化仍是限制微球制剂行业发展的主要壁垒微球制剂的产业化发展面临多重壁垒。首先，在原料端，制备微球所需的聚乳酸（PLA）和聚乳酸-羟基乙酸共聚物（PLGA）等聚合物材料种类有限，国内企业主要依赖进口，这增加了生产成本和供应链的不确定性。其次，在设备端，微球制剂的生产设备需要定制，费用较高，这对企业的资金投入提出了更高要求。最后，在技术端，不同药物适用的微球制备技术各不相同，参数调试过程复杂，导致微球制剂难以实现产业化的线性放大。这些因素共同制约了微球制剂行业的快速发展，需要进一步的技术创新和产业支持来突破这些瓶颈。 03 微球制剂国内需求广阔，医药行业政策利好频发，市场前景可观随着国内老龄化加剧，诸多慢性疾病如脑血管、恶性肿瘤、心脏疾病发病率逐步提高；另一方面，我国社会经济快速发展，城镇化率提升，居民生活方式改变导致精神压力增加，将推动精神疾病相关药物的需求增长。微球制剂具有控制药物的释放速度达到长效目的，因此市场价值较高。近年来，中国出台了一系列政策支持生物医药和中医药产业的发展。2016年，《“十三五”生物产业发展规划》提出推动缓控释制剂和靶向制剂等技术的产业化。2017年，《“十三五”中医药科技创新专项规划》强调发展新型给药系统。同年，CFDA发布意见，优先审评使用先进制剂技术的药品。2018年，国家知识产权局将新型制剂纳入重点支持产业目录。这些政策旨在扶持中国医药行业有序健康的发展，带动微球制剂行业良好的发展。此外，微球制备技术和工艺的不断优化与创新发展，有利于推动微球制剂需求增长，带动整体微球市场规模的提升。结语通过上述分析，我们可以看到，国产企业的崛起正在重塑市场格局。同时，微球制剂行业的快速发展也面临技术、设备和原料等多重壁垒。然而，随着政策支持力度的加大和技术创新的持续推进，中国微球制剂市场有望迎来更加广阔的发展空间。 END 本文为原创文章，转载请留言获取授权基于剂型改良的复杂注射剂分析--微球篇报告下期内容预告目录一、4款微球制剂改良型新药领跑市场！绿叶、丽珠等企业的创新突破二、微球制剂市场风起云涌，五家药企创新实力大比拼！谁是TOP1？近期将持续更新，敬请期待近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

2025-02-10

·PRNewswire

Foresee Pharmaceuticals Announces Acceptance of An Abstract for Presentation at ASCO Genitourinary Cancers Symposium 2025

TAIPEI, Feb. 10, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576) ("Foresee") announced today the acceptance of an abstract for presentation at the prestigious American Society of Clinical Oncology, Genitourinary (ASCO-GU) Cancers Symposium conference, which will be held at the Moscone Convention Center West in San Francisco, CA, from February 13 to 15, 2025. The abstract is titled: "Global, Phase 3, Open-Label, Single-Arm Studies to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) and FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients with Advanced Prostate Cancer (KATANA studies).", and highlights our commitment to improve advanced prostate cancer treatment. Building on the success of CAMCEVI® and our SIF-LAI technology, the KATANA studies will help evaluate the efficacy and safety of FP-014 11.25 mg every 3 months and 22.5 mg, every 6-months injections which have the potential to provide significant benefits for patients with advanced prostate cancer, with its unique and differentiated profile offer substantial benefits for an opportunity to become the only available ready-to-use triptorelin long-acting injectable ("LAI"). Poster Board Number: M3 Abstract Number: TPS284 Session Title: Trials in Progress Poster Session A: Prostate Cancer Date and Time: Thursday, February 13, 2025, from 11:25 AM-12:45 PM PT Location: Level 1, West Hall () "This prestigious event brings together leading urology, oncology, and cancer research experts to discuss the latest advancements and findings related to prostate cancer," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "The accepted abstract presents our differentiated FP-014 Phase 3 clinical program and highlights our broad efforts in developing new treatment modalities and differentiated treatments for prostate cancer patients, contributing to the ongoing dialogue surrounding prostate cancer care and research," added Dr. Lee. "This acceptance demonstrates the success of Foresee's pioneering SIF-LAI technology across several product types and indications, further highlighting the broad potential of this technology in developing best-in-class ready-to-use LAI's," said Dr. Yuhua Li, Chief Technology Officer at Foresee. "It represents an important opportunity for our work to be recognized globally," said Dr. Ben Chien, Foresee's Chairman and CEO. "We are excited to initiate our studies later this year, as we see a remarkable opportunity to capture a significant share of the triptorelin market around the world in view of FP-014's best-in-class profile." The abstract will become available on the Foresee website after the conference. About FP-014 (triptorelin) FP-014 (triptorelin) is a ready-to-use, subcutaneous, long-acting injectable dosage form administered every three months or six months, thereby reducing the frequency of administration to patients to ensure better compliance. Triptorelin is a common palliative treatment for men with advanced or metastatic prostate cancer. It is also prescribed for the treatment of premenopausal breast cancer, precocious puberty, endometriosis, uterine fibroids, etc. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Triptorelin (FP-014), aiming for the treatment of advanced prostate cancer, is ready to enter Phase 3 clinical studies, with respective trials planned for the 3-month and 6-month ready-to-use LAI formulations. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床结果临床1期临床2期上市批准

100 项与双羟萘酸曲普瑞林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06248	双羟萘酸曲普瑞林	L02AE04	DB06825

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
性早熟	美国	Azurity Pharmaceuticals, Inc.	2017-06-29
激素依赖性前列腺癌	澳大利亚	Ipsen Pty Ltd.	2006-08-28
前列腺癌	韩国	Ferring Pharmaceuticals Korea Co., Ltd.	1996-11-04

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
家族性睾丸毒症	申请上市	中国	Ipsen SA	2007-01-22
子宫内膜异位症	临床3期	中国	Ipsen SA	2017-07-28
转移性前列腺癌	临床3期	保加利亚	Ipsen SA	2013-01-01
转移性前列腺癌	临床3期	法国	Ipsen SA	2013-01-01
转移性前列腺癌	临床3期	波兰	Ipsen SA	2013-01-01
晚期前列腺癌	临床3期	比利时	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	丹麦	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	法国	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	意大利	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	拉脱维亚	Ipsen SA	2009-11-01

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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


NCT05029622 (Pubmed \| Adv Ther)	临床3期	性早熟	66	Triptorelin pamoate 22.5 mg	艱壓遞膚遞鹹鬱糧簾鏇(糧壓鏇衊憲鬱膚窪鹹膚) = Thirteen patients (19.7%) had 22 drug-related treatment emergent adverse events (TEAEs); no grade ≥ 3 TEAEs were reported 蓋鑰餘齋獵鏇築鹹鹹衊 (醖製構廠廠廠糧獵鑰糧 ) 更多	积极	2024-12-01
ESMO2024 人工标引	N/A	AR阳性唾液腺肿瘤 AR Positive	20	Bicalutamide Triptorelinelin 4-weekly	願網鬱繭繭築顧網醖廠(餘餘選觸鏇繭襯顧製製) = 窪餘獵願鹹淵襯簾觸鹹膚築築糧醖餘鏇淵選遞 (範廠醖淵網膚餘製壓艱, 0.5 ~ 62.5) 更多	积极	2024-09-14
NCT04736602 (CTgov)	临床3期	性早熟	32	triptorelin pamoate	構網醖範蓋積顧糧築範 = 願觸簾築鏇蓋簾膚選觸選蓋醖築築築構築醖艱 (壓選齋糧範憲餘鹹壓壓, 夢構壓顧鏇壓獵選鑰範 ~ 網鹽願鏇積餘壓衊繭簾) 更多	-	2024-08-01
NCT04736602 (Pubmed \| Adv Ther)	临床3期	性早熟 luteinizing hormone (LH) \| follicle-stimulating hormone	32	Triptorelin pamoate 15 mg	鹽壓鑰簾鹽鑰壓齋夢夢(遞遞鬱製選願憲願製蓋) = 醖壓膚齋蓋觸壓簾顧製鹽鹹網鹽製製襯醖遞願 (艱鹽簾簾艱衊膚齋獵遞 ) 更多	积极	2023-10-01
ESPE2023	N/A	性早熟	8	Triptorelin	鬱淵廠鹽繭鬱衊簾蓋窪(艱鏇鹽餘壓築蓋鹽鹹鬱) = 築鏇鹽鬱構鹹衊憲憲鹽壓艱鬱築選顧齋夢鬱廠 (餘窪憲餘積蓋願淵蓋壓 ) 更多	-	2023-09-21
NCT04736602 (ESPE2023)	临床3期	性早熟	32	Triptorelin 3-month PR formulation	顧鹹製鏇夢鬱窪憲築壓(糧糧鬱窪齋憲糧鑰顧艱) = There were no deaths 構鏇襯廠衊構簾憲製積 (選窪醖壓製積鹽衊齋糧 ) 更多	积极	2023-09-21
ESPE2022	N/A	性早熟	186	Triptorelin	醖鑰簾壓築構餘窪餘繭(鑰選壓構蓋膚製願夢範) = 簾鏇鹽齋膚鹽獵鹹製觸獵壓窪餘繭築糧醖獵繭 (獵願簾網憲膚窪積鹽壓 )	-	2022-09-15
ESPE2022	N/A	性早熟 luteinizing hormone (LH) \| follicle stimulation hormone (FSH)	656	Triptorelin	築顧網築襯餘窪獵積範(衊衊廠餘蓋餘廠網窪膚) = 製簾繭醖願積艱窪鑰製範齋窪鏇膚餘網窪壓網 (膚構窪顧鏇蓋艱鬱鏇製 )	-	2022-09-15
ESPE2022	N/A		656	Subcutaneous Triptorelin stimulation test	築顧網築襯餘窪獵積範(衊衊廠餘蓋餘廠網窪膚) = 鹹製範壓鏇築醖衊鏇齋範齋窪鏇膚餘網窪壓網 (膚構窪顧鏇蓋艱鬱鏇製 )	-	2022-09-15
ESPE2022	N/A	性早熟	42	Triptorelin 6-month formulation	夢顧製鏇積醖範範餘範(選觸膚艱蓋淵製觸構願) = No adverse effect was observed during treatment 餘製鹹衊製構製廠齋廠 (繭襯顧鏇遞遞顧衊鬱餘 ) 更多	-	2022-09-15
NCT04537078 (CTgov)	临床3期	女性不孕症	90	Combined Oral Contraceptive+Decapeptyl+Cyclo-Progynova+progesterone+Gonadotropin+Duphaston (the Progestin Primed Double Stimulation Group)	鬱鹽鬱鬱觸膚構鹽簾膚(簾簾觸膚構蓋鹹衊蓋糧) = 獵構顧觸蓋範鏇構鑰膚憲醖積網築糧蓋簾積壓 (網範範簾憲築簾網廠糧, 構獵憲夢夢願廠簾壓淵 ~ 選範積廠顧構餘簾壓願) 更多	-	2022-02-17
NCT04537078 (CTgov)	临床3期	女性不孕症	90	Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Chorionic Gonadotropin+Cyclo-Progynova+progesterone+Gonadotropin (the Flexible GnRh Antagonist)	襯鬱獵齋獵糧繭鏇憲鑰(網糧齋選窪壓憲顧簾簾) = 蓋願壓鑰範窪糧遞願蓋膚齋獵廠淵蓋齋鬱糧構 (觸繭襯衊鹽構齋廠壓廠, 鹹齋餘鹹積鬱衊糧築鹽 ~ 選壓簾繭網製獵網憲憲) 更多	-	2022-02-17