Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, 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 advanced endometrial cancer with pMMR^[1] or non-MSI-H^[2] tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration ("NMPA").

The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy. The primary endpoint was independent review committee (IRC) assessed objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DoR), progression free survival (PFS), overall survival (OS), as well as pharmacokinetic (PK) assessments. Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference. Additional details may be found at clinicaltrials.gov, using identifier NCT03903705.

Dr. Hui Zhou, Senior Vice President of Innovent, stated, " TYVYT^® (sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for endometrial cancer patients in China. We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT^® in China."

Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, stated, "This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab. It also represents an important step closer to reshaping the treatment landscape for this challenging disease in China. Endometrial cancer remains one of the most common gynecological malignancies. We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."

The NMPA granted Breakthrough Therapy designation to the combination of sintilimab and fruquintinib for this potential indication in July 2023. The NMPA granted this designation to this combination as a new treatment that could target a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates substantial advantages over existing therapies.