#China #Suzhou #renal cancer #Sintilimab #Fruquintinib

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China

On June 4, 2025, Innovent Biologics, a prominent biopharmaceutical firm headquartered in Hong Kong, along with HUTCHMED, announced a landmark achievement: the acceptance of their New Drug Application (NDA) by the China National Medical Products Administration (NMPA). This NDA pertains to the combination of sintilimab and fruquintinib, aimed at providing a new treatment avenue for patients suffering from locally advanced or metastatic renal cell carcinoma (RCC) who have previously failed treatment with one tyrosine kinase inhibitor (TKI).

Significance of the NDA Acceptance

The acceptance of the NDA is particularly noteworthy in the context of renal cell carcinoma, a serious form of kidney cancer that has been challenging to treat. According to recent statistics, about 74,000 patients in China were newly diagnosed with kidney cancer in 2022, making it a critical public health issue. Patients facing advanced RCC often have limited options after their first line of treatment. With this NDA, Innovent and HUTCHMED are poised to offer a promising combination therapy that can potentially enhance patient outcomes in this difficult scenario.

Clinical Background and Study Insights

The FDA approval is substantiated by data derived from the FRUSICA-2 study, a randomized, open-label, active-controlled trial. This trial assessed the efficacy and safety of fruquintinib in conjunction with sintilimab in comparison to standard treatments such as axitinib or everolimus monotherapy. The results showed that the combined therapy significantly improves progression-free survival (PFS) as evaluated by blinded independent central review (BICR) according to RECIST 1.1 criteria. Beyond PFS, the study also yielded favorable results in terms of secondary endpoints, which included the objective response rate (ORR) and duration of response (DoR). Importantly, the safety profile was deemed tolerable, with no new adverse safety signals emerging from the trial.

The FRUSICA-2 study is set to be presented at an upcoming scientific conference, with additional details accessible through clinicaltrials.gov under identifier NCT05522231. The outstanding performance of this combination suggests a robust therapeutic option that could alter the treatment landscape for renal cancer patients in China.

Insights from Industry Leaders

Dr. Hui Zhou, Senior Vice President at Innovent, emphasized that the NDA acceptance reflects a significant stride in enhancing treatment options for patients battling advanced renal cell carcinoma. He noted that this acceptance marks sintilimab's tenth indication, reinforcing its standing as a cornerstone in the immuno-oncology arena.

Dr. Michael Shi, Head of RD and Chief Medical Officer of HUTCHMED, highlighted the critical challenges kidney cancer patient face in China, particularly with the limited therapeutic avenues available post-first line treatments. He reiterated the dedication of HUTCHMED to make this beneficial combination therapy accessible to patients and further iterated their commitment to research that seeks to unlock the full potential of this therapy while advancing additional treatments in their pipeline.

Research in Context

Significantly, it’s critical to note that in December 2024, the combination therapy of sintilimab and fruquintinib garnered conditional approval from the NMPA for treating advanced mismatch repair proficient (pMMR) endometrial cancer, indicating the broadening scope of this partnership and their commitment to tackling diverse malignancies.

Understanding Renal Cell Carcinoma

Globally, it's estimated that around 435,000 new cases of kidney cancer were diagnosed in 2022, highlighting chronic issues related to early detection and treatment challenges, particularly in regions like China. Renal cell carcinoma accounts for approximately 90% of all kidney tumors, emphasizing the significance of advancing treatment options such as this new combination therapy.

Conclusion

The joint effort between Innovent and HUTCHMED to combine sintilimab and fruquintinib signifies a transformative approach in battling advanced renal cell carcinoma. With the NDA acceptance, stakeholders eagerly anticipate further advancements and strategic implementations of this therapy, which holds great promise for patients in need of effective treatment solutions. As the biopharmaceutical landscape continues to evolve, such collaborations reinforce the ongoing pursuit of innovative health solutions for chronic diseases, showcasing the potential to reshape patient care positively.