Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the New Drug Application (NDA) for the combination of sintilimab and fruquintinib for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA).

The NDA is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma. The study has met its primary endpoint of progression free survival (PFS), as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. The combination also demonstrated improvements in secondary endpoints including objective response rate (ORR) and duration of response (DoR). The safety profile was tolerable and no new safety signals were observed. Data from FRUSICA-2 will be submitted for presentation at an upcoming scientific conference. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231.

Dr Hui Zhou, Senior Vice President of Innovent, stated: "The second NDA acceptance of sintilimab and fruquintinib combination represents a significant step toward providing a more effective treatment option for patients with second line advanced renal cell carcinoma in China. Our PD-1 inhibitor, sintilimab (TYVYT^®), has solidified its position as a cornerstone of immuno-oncology (IO) therapy with this NDA as its 10^th indication, marking a meaningful milestone in lifecycle management and clinical value optimization."

Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, stated: "Kidney cancer continues to pose significant challenges in China, with limited treatment options for patients who fail first-line therapies. Submitting this NDA for the fruquintinib and sintilimab combination for advanced renal cell carcinoma marks an important step in our efforts to address this unmet need. We are dedicated to making this combination therapy available to patients with renal cell carcinoma. At the same time, through ongoing research, we remain focused on exploring the full potential of this combination, as well as advancing our broader pipeline across multiple cancer types, to provide more patients with new and effective treatment options."

In December 2024, the combination of sintilimab and fruquintinib received conditional approval from the China NMPA for the treatment of patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study (NCT03903705).