Latanoprost/Timolol Maleate

4月16日，兆科眼科发布公告，公司已与Interpharma Public Company Limited就于泰国商业化NVK002（一种控制近视加深的创新疗法）；BRIMOCHOL™PF（一种治疗老花眼的创新药物）；以及六款针对青光眼的仿制药（贝美前列素、贝美素噻吗洛尔、拉坦前列素、拉坦噻吗、曲伏前列素及曲伏噻吗）分别订立三份分销及供应协议。根据协议条款，兆科眼科将授予Interpharma于泰国进口、分销、推广、营销及销售该等产品的独家权利。Interpharma将代表兆科眼科取得相关的当地药物注册。该等已签订的协议将让兆科眼科可获得不可退还、不可抵扣的预付款项及按照若干成就获得额外里程碑付款。NVK002是一种用于控制儿童及青少年近视加深的试验性新型外用眼部溶液。NVK002是一项专利配方，成功解决低浓度阿托品的不稳性，此技术在全球均受到知识产权保护。NVK002不含防腐剂，预计保存期逾24个月。BRIMOCHOL™PF为不含防腐剂的每日一次瞳孔调节滴眼液，用于矫正因老花眼而丧失近距离视力的疗法。BRIMOCHOL™PF为固定剂量卡巴胆碱（胆碱制剂）及酒石酸溴莫尼丁（α2－受体促效剂）复方。BRIMOCHOL™PF令瞳孔收缩，产生「针孔效应」，仅让在中央聚焦的光线进入眼球，从而使中短距离的影像更锐利。贝美前列素为一种前列腺素类似物（PGA），用于治疗开角型青光眼及高眼压症。兆科眼科已开发出不含防腐剂的单一剂量贝美前列素滴眼液，为艾伯维旗下Lumigan的仿制药，亦为获中国批准的首款不含防腐剂的单一剂量贝美前列素滴眼液。贝美素噻吗洛尔为一种固定剂量组合滴眼液，含PGA及β受体拮抗剂，可降低眼压。该滴眼液为单药应答不佳或不足的原发性开角型青光及高眼压患者的替代疗法。该药具有多重降眼压途径，可以使对仅含PGA或β受体拮抗剂的滴眼液应答不足的患者实现目标眼压。拉坦前列素为一种PGA单一疗法滴眼液，用于治疗开角型青光眼及高眼压症。根据灼识的资料，拉坦前列素为中国用于治疗开角型青光眼的最常用PGA处方药之一。拉坦噻吗为一种组合PGA及β受体拮抗剂滴眼液，可降低眼压。拉坦噻吗滴眼液为耐药性开角型青光眼的替代疗法。该药具有双重作用机制，可以使对仅含PGA或β受体拮抗剂的滴眼液应答不足的患者实现目标眼压。曲伏前列素为一种PGA单一疗法滴眼液，用于治疗开角型青光眼及高眼压症。根据灼识的资料，曲伏前列素为中国用于治疗开角型青光眼的最常用PGA处方药。曲伏噻吗为一种组合PGA及β受体拮抗剂滴眼液，可降低开角型青光眼或高眼压症成年患者的眼压。曲伏噻吗滴眼液为单药无法达到理想眼压降低效果的开角型青光眼患者的替代疗法。该药具有双重作用机制，可以使对仅含PGA或β受体拮抗剂的滴眼液应答不足的患者的眼压进一步降低。Interpharma由一个拥有丰富药业经验的医疗专业人士团体成立。该团体由全球领先制药公司的前董事、医师、药剂师、营养师及医疗技术人员组成。Interpharma拥有丰富而悠久的药业经验，在医院营养保健品方面名列第一。

Formosa Pharmaceuticals has signed an exclusive licensing agreement with DÁVI Farmacêutica (DÁVI) in Portugal, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05 percent (APP13007), a marketed innovative medicine for the treatment of inflammation and pain following ocular surgery. DÁVI is a trusted partner of Pharmathen Global Holding B.v., AZAD Pharma AG, NTC S.r.l. and Pfizer through the marketing and promotion of Xalacom (Latanoprost + Timolol) and Xalatan (Latanoprost) for more than 12 years. DÁVI is one of the key players in the Portuguese Market, with over 100 years' history in the distribution and promotion of branded ophthalmology products. Clobetasol propionate ophthalmic suspension, 0.05 percent (APP13007), approved by the US Food and Drug Administration (FDA) in March 2024, was recently launched in the United States in September 2024. The DÁVI licensing agreement includes upfront, commercialization milestones, and sales milestones, with additional considerations throughout the term of the agreement. APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT 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 survey of 100 ophthalmic surgeons, rapid resolution of pain (~80 percent pain-free four days post-surgery) and low incidence of adverse events (<2 percent) were highlighted as key drivers to prescribing APP13007. APP13007 anticipates significant potential in Portugal, which has around 90,000 cataract surgeries, annually, as reported by Eurostat. "This partnership with DÁVI Farmacêutica, marks our first entry into a competitive EU market, opening the door for growth into other EU territories. DÁVI's experience and commitment to novel ophthalmic therapies is steadily apparent and Formosa Pharma appreciates their recognition of APP13007 as a worthy offering to patients recovering from ocular surgery," said Erick Co, President and CEO, Formosa Pharmaceuticals. Rui Alves, Business Development Manager of DÁVI Farmacêutica, stated, "We are excited at DÁVI to be partnering with Formosa and have the opportunity to offer this cutting-edge drug and technology to our ophthalmologists and patients, reinforcing our strong position in the market and the commitment to enhance the well-being of our people."