Merck Inks $605.5M Deal for Abbisko's Novel CSF-1R Inhibitor Pimicotinib

On December 4, 2023, Abbisko announced that it had entered into an exclusive licensing agreement with Merck KGaA, a leading technology company headquartered in Darmstadt, Germany, for its self-developed CSF-1R small molecule inhibitor, Pimicotinib (ABSK021). Under the terms of the agreement, Merck will obtain the license to commercialize Pimicotinib for all indications in mainland China, Taiwan, Hong Kong, and Macao, while Abbisko will retain the exclusive right to develop Pimicotinib within the licensed region. Additionally, after meeting certain exercise conditions and paying additional consideration, Merck has the option to acquire the global commercialization rights for Pimicotinib, as well as the rights to co-develop other indications of Pimicotinib under specific conditions.

According to the terms of the agreement, Abbisko will receive$70 millionA one-time, non-refundable upfront payment. If Merck exercises the global commercialization option, Abbisko will also receive an additional exercise fee; together with R&D milestone payments and sales milestone payments, the total potential payments may reach up to$605.5 millionIn addition, Merck will also pay Abbisko sales royalties of up to double-digit percentages.

Dr. Yaochang Xu, founder and CEO of Abbisko, stated that this collaboration between Abbisko and Merck is an important milestone in advancing the global commercialization process of Pimicotinib, providing a new model for the future commercial pathway of the company’s pipeline. We are delighted to collaborate with Merck, a leading multinational pharmaceutical company, to jointly accelerate the global approval and commercialization of Pimicotinib, aiming to bring new treatment options to patients as soon as possible.

"Through our collaboration with Abbisko, we have the opportunity to provide a first-in-class treatment option for patient groups in China who severely lack therapeutic choices, and this may also benefit patients in more countries and regions," said Andrew Paterson, Global Chief Marketing Officer of Merck's healthcare business. "Pimicotinib offers an opportunity to address significant unmet medical needs and allows Merck to expand its commercial footprint in oncology treatment in China, the world's second-largest pharmaceutical market."

The Pimicotinib (ABSK021) licensed this time is a novel oral, highly selective, and highly active CSF-1R small molecule inhibitor independently developed by Abbisko. It has received Breakthrough Therapy Designation and Priority Medicine Designation in China, the United States, and Europe for the treatment of unresectable tenosynovial giant cell tumor, and a global multi-center Phase III clinical trial has been launched simultaneously in China, the United States, Canada, and Europe.

On November 3, 2023, Abbisko announced a further update on the one-year long-term follow-up data of TGCT patients from the Phase Ib clinical trial of Pimicotinib at the CTOS Annual Meeting. In the 50 mg QD cohort, Pimicotinib achieved an ORR of 87.5% (28/32, including 3 CRs), demonstrating excellent efficacy. Pimicotinib had previously completed the dose-escalation phase of the Phase Ia clinical trial in the United States.

Currently, there are no approved drugs for the treatment of this disease in China. In the United States, only one drug has been approved for marketing. However, due to its potential hepatotoxicity, patients can only access it through a restricted program under the Risk Evaluation and Mitigation Strategy (REMS). The clinical treatment needs of TGCT patients in China, the United States, and Europe remain unmet.

In addition to the indication for tenosynovial giant cell tumor, Abbisko is also actively exploring the clinical potential of Pimicotinib in various solid tumors. It has received NMPA approval to conduct Phase II clinical trials for chronic graft-versus-host disease and advanced pancreatic cancer. As of the publication date of this article, no highly selective CSF-1R inhibitor has been approved for marketing in China.

Abbisko (HKEX: 02256) is an innovative drug research and development company based in China with a global outlook. The company's founders and management team have many years of top-tier multinational pharmaceutical R&D and management experience and have participated in the development of multiple clinical and marketed new drugs. Abbisko focuses on the development of novel oncology drugs, with small molecule precision oncology treatments and small molecule cancer immunotherapy drugs as its core. Attentive to the needs of patients and the pharmaceutical market, and adhering to international new drug development concepts and standards, Abbisko is committed to developing potential first-in-class or best-in-class innovative drugs targeting novel and high-potential drug targets, aiming to improve the quality of life for patients in China and around the world.

Since its establishment in 2016, Abbisko has built a product pipeline consisting of 15 candidate drugs, comprehensively covering the fields of precision oncology and cancer immunotherapy.