Tendon sheath giant cell tumor (TGCT) is a locally invasive disease that can seriously affect the quality of life of patients, causing joint pain, stiffness, swelling, and limited mobility. The working age population is a high-risk group. If left untreated or recurrent, it may lead to irreversible damage to bones, joints, and surrounding tissues. Patients have a huge and unmet clinical need for well tolerated and effective systemic treatment options. Recently, there has been good news in this drug field in China, as the first innovative drug for TGCT treatment has been approved for market by the National Medical Products Administration.
According to the website of the National Medical Products Administration on December 22, through the priority review and approval process, Merck Serono (Beijing) Pharmaceutical Co., Ltd. has been approved to launch its Class 1 innovative drug, Pembrolizumab Hydrochloride Capsules (trade name: Beijiemai), for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients who may experience functional limitations or serious complications due to surgical resection.
It is reported that Beijiemai is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor developed by Heyu Pharmaceuticals. In December 2023, Heyu Pharmaceutical entered into a * * * license agreement with Merck, which initially granted Merck the right to commercialize pimitini in mainland China, Hong Kong, Macao and Taiwan, China. In February 2024, according to the terms of the authorization contract with Merck, Heyu Pharmaceutical received a one-time, non refundable down payment of $70 million. Based on the smooth progress of the pipeline, in April 2025, Heyu Pharmaceuticals announced that Merck would exercise its global commercialization option for pemetrexed. In May, Heyu Pharmaceuticals received a global commercial option exercise fee of $85 million from Merck.
Officials from Heyu Pharmaceutical stated that this approval is a decisive moment in the development of Heyu Pharmaceutical, marking the company's growth from a pioneer in scientific innovation to a company that can bring breakthrough therapies to patients. It is reported that the approval of Beijiemai this time is based on the research results of Global Phase III MANEUVER. Data shows that in the systematic treatment of TGCT, Beijimai demonstrated an objective response rate (ORR) based on the RECIST v1.1 standard evaluation, accompanied by significant improvement in clinical outcomes. The above results have been announced at the 2025 American Society of Clinical Oncology Annual Meeting. In addition, the long-term follow-up data released at the 2025 European Society of Oncology (ESMO) conference showed that at a median follow-up time of 14.3 months, according to the RECIST v1.1 criteria, the ORR of patients treated with beclomethasone since the start of the study continued to increase to 76.2%.
Tendon sheath giant cell tumor is a rare locally invasive tumor that mainly affects joints, tendon sheaths, and bursae, and can lead to severe local lesions and functional impairments. Industry insiders say that giant cell tumors of the tendon sheath can cause pain, joint stiffness, and limited mobility in patients, affecting their daily living abilities and even preventing them from participating in family and social activities, causing a dual burden on their physical and mental health. Patients urgently need more treatment options that can alleviate symptoms and shrink tumors. The approval of Beijiemai for marketing is of great significance to patients.
It is reported that since its establishment, Heyu Pharmaceutical has continuously strengthened innovation and research and development. Now, it has strategically built a strong product pipeline consisting of 22 candidate drugs, of which 12 are in the clinical development stage. From a financial perspective, in the first half of 2025, Heyu Pharmaceutical achieved a revenue of 657 million yuan, a year-on-year increase of 20%; Profit of 328 million yuan, a year-on-year increase of 59%; Adjusted net profit of 336 million yuan, a year-on-year increase of 56%; Cash reserves (including deposits and cash equivalents) exceeded 2.3 billion yuan.