​US$70 million Arrived! Abbisko Therapeutics Announced it Received Upfront Payment Pursuant to the Licensing Agreement for Pimicotinib (ABSK021) with Merck

On 6 Feb. 2024, Shanghai—Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics”) announced that it had received the upfront payment of US$70 million upon the entry into a licensing agreement for pimicotinib（ABSK021）with Merck in December 2023, a leading science and technology company headquartered in Darmstadt, Germany. It marks the successful completion of the first step in this collaboration. The receipt of this upfront payment will further bolster Abbisko Therapeutics's cash reserves and facilitate its subsequent pipeline R&D and internationalization strategy.

On December 1, 2023, Abbisko Therapeutics entered into a license agreement (the “License Agreement”) with Merck. Under the terms of the License Agreement, Abbisko Therapeutics has granted Merck an exclusive license to commercialize products comprising or containing pimicotinib (ABSK021) for all indications in the Chinese mainland, Hong Kong, Macau and Taiwan, and an exclusive option for global commercial rights of pimicotinib, (the “Global Commercialization Option”). In addition, Merck has the option to co-develop pimicotinib in additional indications under certain conditions.

Pursuant to the terms of the license agreement, Abbisko has received a one-time, non-refundable upfront payment of US$ 70 million. In the event that Merck exercises the global commercialization option, Merck will pay Abbisko an additional option exercising fee. The aggregate amounts of upfront payment, option exercising payment, and payment for development and commercialization milestones will total US$ 605.5 million. Abbisko will also receive double-digit percentage (%) royalties on annual net sales.

Pimicotinib is a novel, orally available, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics. It has been granted the Break Through Designation（BTD） and PRIME designation by China NMPA, U.S. FDA, and EMA, Fast Track Designation (FTD) by U.S. FDA, and Orphan Drug Designation (ODD) by EMA for the treatment of TGCT patients who are not amenable to surgery. The study is the first global Phase III clinical trial of TGCT conducted simultaneously in China, the U.S., Canada and Europe.

Upon 1-year follow-up in a Phase Ib trial for TGCT, pimicotinib demonstrated an ORR of 87.5% (28/32, including 3 CR) in the 50 mg QD cohort，which was presented at the 2023 CTOS. Pimicotinib has completed a Phase I dose-escalation trial in the U.S.

In addition to TGCT, Abbisko is actively exploring the potential of pimicotinib in treating other indications including many types of solid tumors in clinic, and it has obtained approval from China NMPA to conduct Phase II clinical studies in chronic graft-versus-host disease (cGVHD) and advanced pancreatic cancer. Up until today, no highly selective CSF-1R inhibitors have been approved in China.