逸达生物宣布FDA批准CAMCEVI ETM用于治疗晚期前列腺癌-动脉网

Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer

CISION 等信源发布 2025-08-29 11:26



可切换为仅中文







TAIPEI

台北

，

Aug. 28, 2025

2025年8月28日

/PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ('Foresee') announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI) formulation administered every 3 months), as a treatment for advanced prostate cancer..

/PRNewswire/ -- 前景制药（6576.TWO），('前景') 今日宣布，美国食品药品监督管理局 (FDA) 已批准CAMCEVI ETM（甲磺酸亮丙瑞林21毫克，每3个月使用一次的即用型长效注射剂 (LAI)）的新药申请 (NDA)，用于治疗晚期前列腺癌。

'The approval of CAMCEVI ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients,' said Dr.

“CAMCEVI ETM（21 毫克）的获批是我们改善护理标准和患者生活使命的重要一步，”博士表示。

Ben Chien

本·钱恩

, founder, Chairman, and CEO of Foresee. 'It is also a key step in our efforts to build Foresee as a profitable and growing business. We want to thank the team and all stakeholders for their tireless work, which has made this approval possible.

预见公司的创始人、董事长兼首席执行官表示：“这也是我们努力将预见公司建设成为一家盈利且不断增长的企业过程中迈出的关键一步。我们要感谢团队和所有利益相关者为此付出的不懈努力，正是他们的工作使得这一批准成为可能。

The FDA approval was based on the successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with CAMCEVI ETM was demonstrated to be effective, safe, and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint.

FDA的批准是基于一项成功的III期临床研究，该研究共纳入了144名晚期前列腺癌患者，研究表明CAMCEVI ETM治疗有效、安全且耐受性良好，97.9%的受试者达到了主要疗效终点。

As it was the case for CAMCEVI 42 mg, we anticipate the commercial launch to take place after obtaining a J-code. The commercial market access strategy established by our partner will seek to find a balance between near term uptake and the optimization of mid/long term growth.

与CAMCEVI 42 mg的情况一样，我们预计商业发布将在获得J代码后进行。我们的合作伙伴制定的商业市场准入策略将寻求在短期内的吸收和中长期增长的优化之间取得平衡。

CAMCEVI ETM is exclusively licensed to Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. for commercialization in the U.S.

CAMCEVI ETM 由 Intas Pharmaceuticals, Ltd. 的美国专业部门 Accord BioPharma, Inc. 独家授权，用于在美国的商业化。

About Foresee Pharmaceuticals Co. Ltd.

关于 Foresee Pharmaceuticals Co. Ltd.

Foresee is a

预见是一个

Taiwan

台湾

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..

是一家总部位于美国的生物制药公司，于台北交易所上市（TPEx: 6576）。Foresee的研发工作集中在两个关键领域：一是其独特的稳定注射制剂（SIF）长效注射（LAI）技术及衍生的针对专业市场的药物产品；二是其变革性的临床前和临床阶段的首创新化学实体（NCE）项目，专注于罕见且严重、具有高度未满足需求的疾病领域。

Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S.,

Foresee的产品组合包括晚期和早期项目。用于治疗晚期前列腺癌的CAMCEVI 42 mg现已在美国获得批准，

Canada

加拿大

, EU,

，欧盟，

Taiwan

台湾

，

Israel

以色列

, and the UK and was launched in the U.S. in

，并在英国和美国推出

April 2022

2022年4月

. Additionally, CAMCEVI ETM was approved by the U.S. FDA on

此外，CAMCEVI ETM 已获得美国 FDA 批准。

August 25, 2025

2025年8月25日

, while the EU regulatory review for the 3-month version of CAMCEVI is still ongoing. 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 .

，而CAMCEVI 3个月版本的欧盟监管审查仍在进行中。对于CAMCEVI 6个月LAI制剂的第二个适应症——中枢性性早熟（CPP），Caspian III期临床研究正在进行中。CAMCEVI 6个月LAI制剂还在绝经前乳腺癌的III期临床试验中开发。

China

中国

in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, successfully completed a Phase 2 proof-of-concept study in allergic asthmatic patients. Future development of aderamastat will be in rare immune-fibrotic diseases, including cardiac sarcoidosis.

与合作伙伴共同成功完成。Aderamastat（FP-025）是一种高选择性口服MMP-12抑制剂，针对炎症和纤维化疾病，在过敏性哮喘患者中成功完成了2期概念验证研究。Aderamastat的未来开发将集中在罕见的免疫纤维化疾病，包括心脏结节病。

Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted in severe asthma and COPD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second quarter of 2025.

Linvemastat（FP-020）是一种后续口服MMP-12抑制剂，已在健康志愿者中完成了一项一期研究，其开发目标是重症哮喘和慢性阻塞性肺病（COPD）。Mirivadelgat（FP-045）是一种高选择性的口服小分子变构激活剂，作用于线粒体酶ALDH2，针对肺动脉高压-间质性肺病（PH-ILD）患者的二期WINDWARD研究于2025年第二季度启动。

。

www.foreseepharma.com

foreseepharma.com

SOURCE Foresee Pharmaceuticals Co., Ltd.

来源：前景制药公司

WANT YOUR COMPANY'S NEWS

想要贵公司的新闻

FEATURED ON PRNEWSWIRE.COM?

刊登在PRNEWSWIRE.COM上？

440k+

44万+

Newsrooms &