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April 25, 2025
2025年4月25日
/PRNewswire/ --
/PRNewswire/ --
Taiwan
台湾
-based Formosa Pharmaceuticals ('Formosa', 6838.TW) announced that the company has entered into an exclusive licensing agreement with Laboratorios Saval ('Saval'), a Chilean-based pharmaceutical company operating in Central and
总部位于台湾的福尔摩沙制药公司(Formosa Pharmaceuticals,6838.TW)宣布,已与智利制药公司Laboratorios Saval(Saval)达成独家授权协议,该公司在中南美洲运营。
South America
南美洲
, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. Saval, a family-owned pharmaceutical company founded in 1938, boasts its own internal R&D and GMP manufacturing facilities, while holding international strategic partners.
,以获得0.05%氯倍他索丙酸酯眼科混悬液(APP13007)商业化的独家权利,这是一种已上市的创新疗法,用于治疗眼部手术后的术后炎症和疼痛。Saval是一家成立于1938年的家族制药公司,拥有自己的内部研发和GMP生产设施,同时持有国际战略合作伙伴关系。
Clobetasol propionate ophthalmic suspension, 0.05% (APP13007), approved by the U.S. Food and Drug Administration (FDA) in March, 2024, was launched in .
2024年3月,由美国食品和药物管理局(FDA)批准的0.05%氯倍他索丙酮酸酯眼用混悬液(APP13007)上市。
the United States
美国
in September. The licensing agreement includes upfront payment and milestones, with additional considerations throughout the term of the agreement.
九月。许可协议包括预付款和里程碑,以及在协议期限内的额外考量。
APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT
APP13007 的活性成分是超强效皮质类固醇丙酸氯倍他索,并且源自福尔摩沙制药公司的专有 APNT 技术。
®
®
nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain. In a recent US survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were highlighted as key drivers to prescribing APP13007. APP13007 anticipates having significant potential in Saval's territories, whose ophthalmic corticosteroid market is estimated at almost USD .
纳米颗粒制剂平台。这种新型制剂能够实现方便且直接的给药方案(每日两次,持续14天),同时快速且持久地缓解炎症和疼痛。在最近一项针对100名眼科医生的美国调查中,术后疼痛的快速缓解(约80%的患者在术后四天内无痛)以及较低的不良事件发生率(<2%)被强调为开具APP13007处方的关键驱动因素。APP13007预计在Saval的市场中具有巨大的潜力,其眼科皮质类固醇市场的规模估计接近XX亿美元。
$7.5 million
750万美元
, currently led by treatments with a less convenient dosing regimen (4 to 6 times daily).
,目前的治疗方案较为不便,需要每天服药4到6次。
'We are pleased that Saval has identified APP13007 as a worthy therapy to include in their ophthalmology core business unit. Saval's vast network throughout
“我们很高兴Saval认为APP13007是一种值得纳入其眼科核心业务部门的疗法。Saval在整个
Latin America
拉丁美洲
will guarantee that patients recovering from ocular surgery will have access to APP13007.' said Erick Co, President and CEO of Formosa Pharmaceuticals.
“将确保眼部手术康复患者能够获得APP13007。”台湾微脂体公司总裁兼首席执行官柯艾立克表示。
'At Saval we are committed to providing patients with affordable and high-quality products in a broad range of therapeutic areas throughout
“在萨瓦尔,我们致力于在广泛的治疗领域为患者提供价格合理且高质量的产品。
Latin America
拉丁美洲
. Ophthalmology is part of our core and APP13007 will provide physicians and patients with an innovative and valuable addition to the available treatment options. We are pleased to partner with Formosa Pharmaceuticals and look forward to working together for Latin American patients and physicians' said Nicolás Donoso, CEO of Laboratorios Saval..
“.眼科是我们核心的一部分,APP13007将为医生和患者提供一个创新且有价值的治疗选择。我们很高兴与台湾微脂体公司合作,并期待为拉丁美洲的患者和医生共同努力,”Laboratorios Saval首席执行官Nicolás Donoso表示。
About Formosa Pharmaceuticals, Inc.
关于台湾微脂体股份有限公司
Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT
台湾微脂体股份有限公司(6838.TW)是一家临床阶段的生物技术公司,主要专注于眼科和肿瘤学领域。该公司拥有专有的纳米颗粒制剂技术(APNT)。
®
®
), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in safety, delivery, and penetration to target tissues. For more details about Formosa Pharma and APNT.
),通过它开发了APP13007,提高了用于局部、口服和吸入给药的活性药物成分(API)的溶解性和生物利用度。所得到的制剂具有高度的均匀性、纯度和稳定性,从而允许利用那些否则可能在安全性、递送和渗透到目标组织方面面临难以克服的挑战的难溶性或极强效药物成分。欲了解有关台湾微脂体公司(Formosa Pharma)和APNT的更多信息。
®
®
, visit
,访问
www.formosapharma.com
www.formosapharma.com
.
。
About Saval Corporation:
关于沙瓦尔公司:
Laboratorios Saval S.A. is based in
萨瓦尔实验室股份公司位于
Santiago, Chile
智利圣地亚哥
and currently is present in 14 countries in Central and
目前在中欧和
South America
南美洲
. For more than 85 years, Saval has provided patients and physicians with affordable and high-quality products in multiple therapeutic areas. For more information, please refer to
八十五年来,萨瓦尔一直在多个治疗领域为患者和医生提供价格合理且高品质的产品。欲了解更多信息,请参阅
www.savalcorp.com
www.savalcorp.com
.
。
SOURCE Formosa Pharmaceuticals Inc.,
来源:台湾微光制药公司,
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