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]

NCT06475781

/ Recruiting临床2期

A Multinational Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Mirivadelgat, an Aldehyde Dehydrogenase 2 Activator, in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

The goal of this clinical trial is to see if mirivadelgat will work in patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs.
Researchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being.
Participants will:
Take mirivadelgat or a placebo once a day for 12 weeks
Visit the clinic once every 4 weeks for checkups and tests
Receive phone calls every one or two weeks to check on how things are going

开始日期2025-03-01

申办/合作机构

逸达生物科技股份有限公司

[+1]

100 项与逸达生物科技股份有限公司相关的临床结果

登录后查看更多信息

0 项与逸达生物科技股份有限公司相关的专利（医药）

登录后查看更多信息

项与逸达生物科技股份有限公司相关的文献（医药）

2023-11-21·European heart journal

4-Hydroxynonenal impairs miRNA maturation in heart failure via Dicer post-translational modification

Article

作者: Mori, Marcelo A ; Ferreira, Julio C B ; Ramalho, Lisley S ; Campos, Juliane C ; Campolo, Nicolás ; MacRae, Ian J ; Durán, Rosario ; Alves, Ariane N ; Arantes, Guilherme M ; Chen, Che-Hong ; Leyva, Alejandro ; Candido, Darlan S ; Mochly-Rosen, Daria ; Bozi, Luiz H M ; Albuquerque, Ruda P ; Zambelli, Vanessa O ; Cunha-Neto, Edécio ; Radi, Rafael ; Bartesaghi, Silvina ; Mastrogiovanni, Mauricio ; Jesus, Itamar C G ; Kiyuna, Ligia A ; Bechara, Luiz R G ; Yang, Wenjin ; Ferreira, Ludmila R P ; Krum, Barbara

Abstract:

Background and Aims:

Developing novel therapies to battle the global public health burden of heart failure remains challenging. This study investigates the underlying mechanisms and potential treatment for 4-hydroxynonenal (4-HNE) deleterious effects in heart failure.

Methods:

Biochemical, functional, and histochemical measurements were applied to identify 4-HNE adducts in rat and human failing hearts. In vitro studies were performed to validate 4-HNE targets.

Results:

4-HNE, a reactive aldehyde by-product of mitochondrial dysfunction in heart failure, covalently inhibits Dicer, an RNase III endonuclease essential for microRNA (miRNA) biogenesis. 4-HNE inhibition of Dicer impairs miRNA processing. Mechanistically, 4-HNE binds to recombinant human Dicer through an intermolecular interaction that disrupts both activity and stability of Dicer in a concentration- and time-dependent manner. Dithiothreitol neutralization of 4-HNE or replacing 4-HNE-targeted residues in Dicer prevents 4-HNE inhibition of Dicer in vitro. Interestingly, end-stage human failing hearts from three different heart failure aetiologies display defective 4-HNE clearance, decreased Dicer activity, and miRNA biogenesis impairment. Notably, boosting 4-HNE clearance through pharmacological re-activation of mitochondrial aldehyde dehydrogenase 2 (ALDH2) using Alda-1 or its improved orally bioavailable derivative AD-9308 restores Dicer activity. ALDH2 is a major enzyme responsible for 4-HNE removal. Importantly, this response is accompanied by improved miRNA maturation and cardiac function/remodelling in a pre-clinical model of heart failure.

Conclusions:

4-HNE inhibition of Dicer directly impairs miRNA biogenesis in heart failure. Strikingly, decreasing cardiac 4-HNE levels through pharmacological ALDH2 activation is sufficient to re-establish Dicer activity and miRNA biogenesis; thereby representing potential treatment for patients with heart failure.

2021-01-01·Clinical Drug Investigation

First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects

Article

作者: Diamant, Zuzana ; Mao, John ; Abd-Elaziz, Khalid ; Chien, Benjamin ; Li, Yuhua ; Pan, Sandy ; Lau, David ; Voors-Pette, Christine ; Lee, Yisheng ; Wang, Kang-Ling

BACKGROUND AND OBJECTIVES:

Matrix metalloproteinases (MMPs) are proteases with different biological and pathological activities, and many have been linked to several diseases. Targeting individual MMPs may offer a safer therapeutic potential for several diseases. We assessed the safety, tolerability, and pharmacokinetics of FP-025, a novel, highly selective oral matrix metalloproteinase-12 inhibitor, in healthy subjects.

METHODS:

Two randomized, double-blind, placebo-controlled studies were conducted. Study I was a first-in-man study, evaluating eight single ascending doses (SADs) (50-800 mg) in two formulations: i.e., neat FP-025 in capsule (API-in-Capsule) and in an amorphous solid dispersion (ASD-in-Capsule) formulation. In Study II, three multiple ascending doses (MADs) (100, 200, and 400 mg, twice daily) of FP-025 (ASD-in-Capsule) were administered for 8 days, including a food-effect evaluation.

RESULTS:

Ninety-six subjects were dosed. Both formulations were well tolerated with one adverse event (AE) reported in the 800 mg API-in-Capsule SAD group and seven AEs throughout the MAD groups. The exposure to FP-025 was low with the API-in-Capsule formulation; it increased dose-dependently with the ASD-in-Capsule formulation, with which exposure to FP-025 increased in a greater-than-dose-proportional manner at lower doses (≤ 100 mg) but less proportionally at higher doses. The elimination half-life (t_1/2) was between 6 (Study I) and 8 h (Study II). Accumulation of FP-025 was approximately 1.7-fold in the MAD study. Food intake delayed the rate of absorption, but without effect in the extent of absorption or bioavailability.

CONCLUSION:

FP-025 was well tolerated and showed a favorable pharmacokinetic profile following ASD-in-Capsule dosing. Efficacy studies in target patient populations, including asthma, chronic obstructive pulmonary disease (COPD), and pulmonary fibrosis, are warranted.

TRIAL REGISTRATION NUMBER:

www.clinicaltrials.gov : NCT02238834 (Study I); NCT03304964 (Study II). Trial registration date: Study I was registered on 12 September 2014 while study II was registered on 9 October 2017.

2020-01-01·World journal of urology

A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients

Article

作者: Mao, John ; Jievaltas, Mindaugas ; DeGuenther, Mark ; Li, Yuhua ; Simpson, Kelle ; Patockova, Jitka ; Huang, Shih-Tsung ; Chien, Ben ; Hu, Chu-Hsuan ; Lee, Yisheng ; Mincik, Ivan ; Student, Vladimir ; Shore, Neal

OBJECTIVES:

To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer.

PATIENTS AND METHODS:

In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336.

RESULTS:

Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported.

CONCLUSIONS:

LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.

项与逸达生物科技股份有限公司相关的新闻（医药）

2025-02-21

·genscigroup.com

半年只需一次皮下注射！金赛肿瘤又一创新产品申报上市

近日，金赛药业宣布旗下亮丙瑞林注射乳剂上市申请已获得国家药品监督管理局受理。该产品是一种促性腺激素释放激素激动剂（GnRHa）类长效制剂，拟用于晚期前列腺癌的雄激素去势治疗（ADT）。该产品在晚期前列腺癌患者中开展的两项关键临床研究均达到了预设疗效终点，有望证实本品对治疗前列腺癌患者获益明确。本品已在美国、加拿大、欧盟和中国台湾地区获批上市，此次申报上市将大大提高亮丙瑞林注射乳剂在晚期前列腺癌患者中的使用便捷性，更好的满足临床需求。亮丙瑞林注射乳剂（曾用名为“甲磺酸亮丙瑞林混悬注射液”或“LMIS 50 mg”，商品名为CAMCEVI®）采用储库型原位凝胶技术，给药方式为皮下注射，注射后形成固体植入物，随时间缓慢降解释放药物达到缓释效果，实现在体内持续6个月亮丙瑞林的释放，使其长期占据促性腺激素释放激素受体，使垂体靶细胞相应受体脱敏，进而抑制垂体-性腺轴分泌促黄体生成素、卵泡刺激素和性腺激素作用，可极大的改善患者的用药依从性。亮丙瑞林注射乳剂是金赛药业与逸达生物科技股份有限公司合作的一款长效制剂，金赛药业享有该产品中国区（除台湾）权益。本品采用即用型单支预充式注射器包装，产品规格为42 mg（以亮丙瑞林计，相当于48 mg甲磺酸亮丙瑞林），使用前无需复溶，为医护人员和患者提供更加便利和安全的用药方式。前列腺癌是老年男性泌尿生殖系统常见的恶性肿瘤之一，其发病率和死亡率分别位列全球男性恶性肿瘤发病和死亡的第2位和第5位；根据中国国家癌症中心的数据，在中国男性中分别居第6位和第7位，已超过膀胱癌成为我国男性泌尿生殖系统发病率最高的恶性肿瘤；相关研究提示2019年中国年龄标准化发病率（ASIR）为18.72/10万，预计到2030年ASIR为25.54/10万，ASIR呈现显著上升的趋势，前列腺癌的疾病负担将进一步增加。前列腺癌的发病与睾酮水平（即雄性激素）密切相关，降低睾酮水平可延缓前列腺癌的疾病进程。ADT是前列腺癌的标准治疗方法之一，GnRHa是去势治疗的重要手段，在临床中广泛应用。声明： 1.本新闻旨在分享研发前沿资讯，仅供医疗卫生专业人士参阅，非广告用途。 2.金赛药业不推荐任何未被批准的药品、适应症的使用。

上市批准临床研究

2025-02-20

·金赛药业

半年只需一次皮下注射！金赛肿瘤又一重磅产品申报上市

近日，金赛药业宣布旗下亮丙瑞林注射乳剂上市申请已获得国家药品监督管理局受理。该产品是一种促性腺激素释放激素激动剂（GnRHa）类长效制剂，拟用于晚期前列腺癌的雄激素去势治疗（ADT）。该产品在晚期前列腺癌患者中开展的两项关键临床研究均达到了预设疗效终点，且安全性良好，证实了本品对治疗前列腺癌患者获益明确。本品已在美国、加拿大、欧盟和中国台湾地区获批上市，此次申报上市将大大提高亮丙瑞林注射乳剂在晚期前列腺癌患者中的使用便捷性，更好的满足临床需求。亮丙瑞林注射乳剂（曾用名为“甲磺酸亮丙瑞林混悬注射液”或“LMIS 50 mg”，商品名为CAMCEVI®）采用储库型原位凝胶技术，给药方式为皮下注射，注射后形成固体植入物，随时间缓慢降解释放药物达到缓释效果，实现在体内持续6个月亮丙瑞林的释放，使其长期占据促性腺激素释放激素受体，使垂体靶细胞相应受体脱敏，进而抑制垂体-性腺轴分泌促黄体生成素、卵泡刺激素和性腺激素作用，可极大的改善患者的用药依从性。亮丙瑞林注射乳剂是金赛药业与逸达生物科技股份有限公司合作的一款长效制剂，金赛药业享有该产品中国区权益。本品采用即用型单支预充式注射器包装，产品规格为42 mg（以亮丙瑞林计，相当于48 mg甲磺酸亮丙瑞林），使用前无需复溶，为医护人员和患者提供更加便利和安全的用药方式。前列腺癌是老年男性泌尿生殖系统常见的恶性肿瘤之一，其发病率和死亡率分别位列全球男性恶性肿瘤发病和死亡的第2位和第5位；根据中国国家癌症中心的数据，在中国男性中分别居第6位和第7位，已超过膀胱癌成为我国男性泌尿生殖系统发病率最高的恶性肿瘤；相关研究提示2019年中国年龄标准化发病率（ASIR）为18.72/10万，预计到2030年ASIR为25.54/10万，ASIR呈现显著上升的趋势，前列腺癌的疾病负担将进一步增加。前列腺癌的发病与睾酮水平（即雄性激素）密切相关，降低睾酮水平可延缓前列腺癌的疾病进程。ADT是前列腺癌的标准治疗方法之一，GnRHa是去势治疗的重要手段，在临床中广泛应用。声明： 1.本新闻旨在分享研发前沿资讯，仅供医疗卫生专业人士参阅，非广告用途。 2.金赛药业不推荐任何未被批准的药品、适应症的使用。 ·END·

上市批准临床研究

2025-02-19

·抗体圈

半年打一针！金赛药业联合研发的抗癌药申报上市啦

2月18日，中国国家药监局药品审评中心（CDE）官网有新消息：Accord BioPharma 和长春金赛药业联合申报的一款新药 —— 亮丙瑞林注射乳剂，它的上市申请被受理了。这款药可不简单，它是亮丙瑞林 42 毫克注射乳剂，商品名叫 Camcevi，是 6 个月预充式皮下制剂。啥意思呢？就是患者每 6 个月打一针就行，而且药就在预先填充好的注射器里，不用再自己混合调配，特别方便。截图来源：CDE官网这个药已经在美国、加拿大、欧盟，还有中国台湾地区获批上市了，主要用来治疗前列腺癌。按照这次申报上市的注册分类来推测，它在中国申报的治疗病症大概率也是前列腺癌。亮丙瑞林其实是一种促性腺激素释放激素（GnRH）激动剂。这类激动剂能治疗的病还挺多，像女性的子宫内膜异位症、有月经过多、肚子疼、腰疼还贫血症状的子宫肌瘤，还有绝经前雌激素受体阳性的乳腺癌；男性的前列腺癌；以及儿童中枢性性早熟症等等。 2022 年 4 月的时候，Accord BioPharma 和逸达生物科技股份有限公司合作，在美国推出了 Camcevi 42mg 注射乳剂。这个药在 2021 年 5 月就已经获得美国 FDA 批准，用来治疗成人晚期前列腺癌。之前有研究显示，137 名成年人在第 0 天和第 24 周打了 42mg 的 Camcevi，从第 4 周一直到第 48 周，药都能持续把体内的睾丸激素抑制到阉割水平，效果很不错。早在 2020 年，长春高新和逸达生物就达成了合作，逸达生物把两个规格的甲磺酸亮丙瑞林产品在中国地区的权益转让给了金赛药业。为啥要做长效缓释制剂呢？因为这样患者不用频繁跑医院打针，能更好地按要求治疗，也给医生和患者都省了不少时间。现在临床上已经有 3 个月缓释期的亮丙瑞林长效缓释制剂产品了，而这次两家合作的甲磺酸亮丙瑞林产品用了新一代的原位凝胶技术平台，缓释期最长能达到 6 个月。截图来源：中国药物临床试验登记与信息公示平台从中国药物临床试验登记与信息公示平台上能看到，逸达生物和金赛药业针对亮丙瑞林注射乳剂做了至少 3 项 3 期临床研究，研究的病症包括晚期前列腺癌、儿童中枢性性早熟，还有绝经前乳腺癌。其中，针对晚期前列腺癌的 3 期临床研究已经完成了。以后，这款药要是成功在中国上市，说不定能给很多患者带来新希望！参考资料： [1]中国国家药监局药品审评中心（CDE）官网.Retrieved Feb 18，2025, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c [2]Accord BioPharma, in Partnership with Foresee Pharmaceuticals, Launches CAMCEVI™ (Leuprolide) Injection Emulsion in the U.S. for the Treatment of Advanced Prostate Cancer in Adults.Retrieved Apr 4，2022, from https://www.prnewswire.com/news-releases/accord-biopharma-in-partnership-with-foresee-pharmaceuticals-launches-camcevi-leuprolide-injection-emulsion-in-the-us-for-the-treatment-of-advanced-prostate-cancer-in-adults-301516986.html [3]长春高新技术产业（集团）股份有限公司关于子公司取得台湾逸达公司甲磺酸亮丙瑞林产品相关权益的公告 .Retrieved Nov 18，2020, from http://static.cninfo.com.cn/finalpage/2020-11-18/1208756885.PDF [4]逸达生物官网. From https://www.foreseepharma.com/tw/rd/overview 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期上市批准申请上市临床结果

100 项与逸达生物科技股份有限公司相关的药物交易

登录后查看更多信息

100 项与逸达生物科技股份有限公司相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2025年04月24日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

临床前

临床申请批准

临床1期

临床2期

临床3期

批准上市

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

甲磺酸亮丙瑞林 ( GnRHR )	晚期前列腺癌更多	批准上市
Aderamastat ( MMP12 )	炎症更多	临床2期
FP-045 ( ALDH2 )	肺性高血压更多	临床2期
FP-020 ( MMP12 )	哮喘更多	临床1期
双羟萘酸曲普瑞林 ( GnRHR )	前列腺癌更多	早期临床1期