Merck and Heyu Pharmaceuticals have reached an agreement to jointly promote the commercial cooperation of Pimicotinib, a Phase III clinical investigational product

Pimicotinib (ABSK021) for the treatment of giant cell tumor of the tendon sheath (TGCT) is currently in phase III clinical trials worldwide.

Merck will obtain the commercial license of Heyu Pharmaceuticals in mainland China, Taiwan, China, Hong Kong and Macao, China, and have the option of other markets in the world.

Pimicotinib has obtained breakthrough therapy recognition from the China National Medical Products Administration and the US Food and Drug Administration, as well as priority drug qualification recognition from the European Medicines Agency, for the treatment of giant cell tumors of the tendon sheath.

Darmstadt, Germany, December 4, 2023. Merck announced today that it has reached a licensing agreement with Shanghai Heyu Biopharmaceutical Co., Ltd. in China for Pimicotinib (ABSK021). Pimicotinib is currently undergoing phase III clinical trial evaluation for giant cell tumor of the tendon sheath (TGCT). Tenosyl giant cell tumor is a benign tumor that occurs in joints and can cause joint swelling, pain, stiffness, and limited joint movement. This disease can seriously affect the quality of life of patients, and currently treatment options are very limited. The agreement will grant Merck the commercial license of Pimicotinib in mainland China, Taiwan, China, Hong Kong and Macao, China, and have the option of other markets in the world.

Andrew Paterson, Marketing Officer for Merck's Healthcare Business, stated:

Through cooperation with Heyu Pharmaceutical, we have the opportunity to provide treatment options for patients in China who are severely lacking in treatment options, and may benefit patients from more countries and regions. Pimicotinib provides an opportunity to address significant unmet medical needs and expand Merck's commercial footprint in cancer treatment in China.

PimicotinibIt is a highly selective, colony stimulating factor for oral administration-1Receptor（CSF-1R）Powerful small molecule inhibitors are currently being used globally to treat giant cell tumors of the tendon sheathIIIPhase of clinical trial evaluation. There are no drugs approved for treating this disease in China, and only one drug has been approved in the United States.

In recent timesIbIn clinical trials,pimicotinibShowing sustained anti-tumor activity with clinical significance, according to the independent review committee's evaluation criteria for solid tumor efficacyv1.1（RECIST 1.1）Judgment, acceptance50mg QDThe overall response rate of dose patients during one-year follow-up is87.5%（28/32, including3Patients who have experienced relief. The ongoing randomized, double-blind, placebo-controlled studyIIIperiodMANEUVERClinical trials are currently being evaluatedPimicotinib 50 mg QDThe efficacy and safety of dose therapy for unresectable giant cell tumors of the tendon sheath.

Dr. Xu Yaochang, founder and CEO of Heyu Pharmaceuticals, stated:

This collaboration with Merck is an important milestone in advancing the global commercialization of Pimicotinib, providing a new model for the company's future pipeline commercialization path. We are pleased to collaborate with a multinational pharmaceutical company to accelerate the global approval process and commercialization of pimicotinib, striving to bring new treatment options to patients as soon as possible.

According to the terms of the agreement, Merck will obtain the commercialization license of pimicotinib in mainland China, Taiwan, China, Hong Kong and Macao, China, and enjoy the commercialization option in the rest of the world. Heyu Pharmaceutical will continue to develop Pimicotinib. In addition, under specific conditions, Merck has the right to jointly develop other indications for pimicotinib. Merck will pay a prepayment of $70 million to Heyu Pharmaceuticals, and after exercising commercial options in other global markets, Merck will pay additional option fees to Heyu Pharmaceuticals. After achieving specific research and commercial milestones, Heyu Pharmaceuticals will receive additional payments and receive double-digit tiered royalties from Merck's net sales.

AboutPimicotinib（Absk 021）

Pimicotinib is a new oral, highly selective, and highly active CSF-1R small molecule inhibitor independently developed by Heyu Pharmaceuticals. We have obtained breakthrough therapy certification from the China National Medical Products Administration and the US Food and Drug Administration, as well as priority drug qualification certification from the European Medicines Agency, for the treatment of inoperable giant cell tumors of the tendon sheath.

Pimicotinib has completed a Phase Ia dose escalation trial in the United States, and a global Phase III MANEUVER clinical study for the treatment of giant cell tumors of the tendon sheath is currently underway in China, the United States, Canada, and Europe.

In addition to giant cell tumors of the tendon sheath, Heyu Medical Treatment is actively exploring the potential of pimicotinib in treating other indications, including many types of solid tumors. Heyu Pharmaceutical has also been approved by the State Drug Administration of China to conduct phase II clinical studies on chronic graft-versus-host disease and advanced pancreatic cancer.