默克行权，和誉医药匹米替尼全球权益落地

2023年12月，和誉医药与默克就CSF-1R抑制剂匹米替尼订立独家许可协议（“该协议”）。根据该协议条款，默克最初获得匹米替尼在中国内地、中国香港、中国澳门及中国台湾所有适应症进行商业化的独家授权，并拥有全球商业化权利的独家选择权。默克现已行使前述选择权，因此拥有全球商业化匹米替尼的独家授权。和誉医药已于2024年2月收到了一次性、不可退还的首付款7,000万美元，并已有权额外收取行权费8,500万美元。此外，默克亦可选择在若干条件下共同开发匹米替尼的其他适应症。和誉医药可收取最多6.055亿美元的款项，包括首付款、开发及商业化里程碑付款，以及实际年净销售额的两位数比例销售提成。

匹米替尼是由和誉医药独立研发的一种新型、口服、高选择性且高效的小分子CSF-1R抑制剂。匹米替尼在全球III期MANEUVER研究中针对腱鞘巨细胞瘤（“TGCT”）的积极顶线结果已于2024年11月成功发布。在该研究中，MANEUVER研究达到了主要终点，匹米替尼组第25周的客观缓解率（“ORR”）达54.0%，而安慰剂组为3.2%（p<0.0001）。每日一次口服匹米替尼的耐受性良好，因治疗相关不良事件而终止治疗的比例非常低，且没有观察到胆汁淤积性肝毒性的证据。

和誉医药董事长兼首席执行官徐耀昌博士表示：“匹米替尼代表了新兴CSF-1R抑制剂中的一项突破性进展，它展现了卓越的临床疗效和安全性，使其成为全球TGCT患者的创新治疗选择。我们期待与默克团队深化合作，加快匹米替尼的注册进程，从而尽快造福全球患者。”

“今天标志着我们与和誉医药合作达成一个重要里程碑，我们共同努力为全球TGCT患者提供潜在的同类最佳疗法，”默克医药健康的首席市场官Andrew Paterson说，“这一合作凸显了我们为需要这些疗法的罕见肿瘤患者推进新治疗选择的承诺。通过这一重要进展，我们旨在变革现有治疗格局，为如今治疗选择非常有限的TGCT患者带来希望。” 

Merck Exercised the Option for the Global Rights of Abbisko Therapeutics's Pimicotinib

On April 1 2025, Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics”) announced that Merck has exercised the global commercialization option for pimicotinib(ABSK021), with an option exercise fee of USD85.0 million, under the licensing agreement signed in December 2023. The development represents further deepening of the collaboration, underscoring the unwavering commitment and confidence that both parties possess for the ongoing advancement of pimicotinib.

In December 2023, Abbisko   Therapeutics entered into an exclusive licensing agreement (the “Agreement”) with Merck regarding pimicotinib, a CSF-1R inhibitor. Under the terms of the Agreement, Merck initially had an exclusive license to commercialize pimicotinib for all indications in the Chinese mainland, Hong Kong, Macau and Taiwan with an exclusive option for global commercial rights of pimicotinib. Merck now has exercised such option and has the exclusive license to commercialize pimicotinib worldwide. Abbisko Therapeutics has already received the one-time, non-refundable upfront payment of USD70.0 million in February 2024, and is now entitled to receive the additional option exercise fee of USD 85.0 million. Additionally, Merck has the option to co-develop pimicotinib for additional indications under certain conditions. In total, Abbisko Therapeutics is eligible to receive up to USD605.5 million in payments, including upfront, development, and commercial milestones, as well as double-digit percentage royalties on annual net sales.

Pimicotinib is a novel, orally administered, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics. Pimicotinib’s positive topline results from the Global Phase III MANEUVER Study in tenosynovial giant cell tumor (“TGCT”) were successfully released in November 2024, where MANEUVER met the primary endpoint with an objective response rate (“ORR”) at Week 25 of 54.0% for pimicotinib compared with 3.2% for placebo (p<0.0001), and treatment with oral, once-daily pimicotinib was well-tolerated with very low rates of discontinuation due to treatment-related adverse events, and with no evidence of cholestatic hepatotoxicity. 

Yao-Chang Xu, Chairman and CEO of Abbisko Therapeutics, said, “Pimicotinib represents a key advancement within the emerging class of CSF-1R inhibitors, demonstrating a meaningful clinical efficacy and safety profile that positions it as an innovative treatment option for worldwide TGCT patients. We look forward to deepening our collaboration with the Merck team to expedite the registration process of pimicotinib to bring benefits to patients as quickly as possible."

“Today marks a significant milestone in our partnership with Abbisko as we work together to deliver a potentially best-in-class therapy for patients with TGCT around the world,” said Andrew Paterson, Chief Marketing Officer for the Healthcare business sector of Merck. “This collaboration underscores our commitment to advancing new treatment options in rare oncology for patients who need them. With this important step forward, we aim to transform the treatment landscape and offer hope to those living with TGCT, who today have very limited treatment options.”