Revolutionizing Cancer Care: Innovent and HUTCHMED's Combo Therapy Approved

Endometrial cancer, a significant global health challenge, has received a boost with the conditional approval of a novel combination therapy by the National Medical Products Administration (NMPA) of China. Innovent Biologics, Inc. and HUTCHMED (China) Limited jointly announced the approval of TYVYT® (sintilimab injection) in combination with ELUNATE® (fruquintinib) for the treatment of advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors. This approval is a milestone in the fight against endometrial cancer, offering hope for improved patient outcomes.

The approval is based on data from the FRUSICA-1 study, which demonstrated the combination's promising efficacy and manageable safety profile. The study showed an objective response rate (ORR) of 35.6% and a disease control rate (DCR) of 88.5% with the combination therapy. Moreover, the median time to tumor response was just 1.6 months, indicating rapid onset of efficacy. The median progression-free survival (PFS) and overall survival (OS) reached 9.5 months and 21.3 months, respectively.

The combination of sintilimab and fruquintinib leverages the synergistic effects of targeted therapy and immunotherapy, addressing a critical gap in treatments available for patients with limited responses to traditional therapies. Prof. Xiaohua Wu, Director of the Department of Gynecologic Oncology at Fudan University Affiliated Cancer Hospital and Principal Investigator of the FRUSICA-1 study, expressed optimism about the approval, stating that it brings us closer to improving survival and enhancing quality of life for patients living with advanced endometrial cancer.

Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, emphasized the potential of fruquintinib to be used with other therapeutic agents to improve patient outcomes. He also highlighted the ongoing efforts to extend the clinical benefit of fruquintinib to a broader patient population. Dr. Hui Zhou, Senior Vice President of Innovent, reiterated the commitment to driving forward treatment solutions through innovation and cooperation.

The approval of sintilimab and fruquintinib combination therapy is a significant advancement in the global endometrial cancer treatment landscape. This innovative combination not only offers a novel treatment option but also underscores the importance of strategic partnerships between biopharmaceutical companies in expediting regulatory approvals and market access.



As the market continues to evolve, investors should closely monitor the impact of this approval on the market share and financial performance of Innovent and HUTCHMED. The promising efficacy and manageable safety profile of the combination therapy may attract more patients and healthcare providers, potentially enhancing the companies' competitiveness in the global endometrial cancer treatment market.



The conditional approval of fruquintinib plus sintilimab for advanced endometrial cancer has significant implications for the development of targeted therapies and immunotherapy combinations in other cancer types. The successful approval of this combination therapy may pave the way for further research and development of similar combinations, potentially leading to improved survival and quality of life for patients.

In conclusion, the NMPA's conditional approval of the sintilimab-fruquintinib combination therapy marks a significant milestone in the fight against endometrial cancer. This innovative combination offers hope for improved patient outcomes and highlights the importance of strategic partnerships between biopharmaceutical companies. As the market continues to evolve, investors should closely monitor the impact of this approval on the market share and financial performance of Innovent and HUTCHMED.