The board of directors of Innovent Biologics, Inc. announced that the National Medical Products Administration ("NDA") of China has accepted the New Drug Application ("NDA") and granted priority review designation for the combination of sintilimab and fruquintinib for the treatment of patients with advanced endometrial cancer ("EMC") with Mismatch Repair proficient ("pMMR") or non-Microsatellite instability-high ("non-MSI-H") tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation. The NDA is supported by data from FRUSICA-1, the EMC registration cohort of a multi-center, open-label Phase 2 clinical study investigating sintilimab in combination with fruquintinib in EMC 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. EMC is a type of cancer that begins in the uterus.

Globally, an estimated 417,000 people were diagnosed with EMC, causing approximately 97,000 deaths in 2020i. In China, an estimated 82,000 people were diagnosis with EMC, causing approximately 17,000 deaths in 2020ii. Although early-stage EMC can be surgically resected, recurrent and/or metastatic EMC remains an area of high unmet need with poor outcomes and limited treatment optionsiii, iv, v. TYVYT®?

(sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for EMC patients in China. For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who progressed after EGFR-TKI (tyrosine kinase inhibitor) therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous NSCLC; For the first-linetreatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; and For the first- line treatment of unresectable locally Advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Besides, the combination of sintilIMab and fruquintinab for the treatment of patients with advance endometrial cancer with pMMR or non-MSI-H tumors that have failed prior systemic Therapy but are not candidates for curatives surgery or radiation has been accepted and granted priority review by the NMPA.

In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 clinical study of sintilimab monotherapy as second-line treatment of esophageal squamous NSCLC with disease progression following platinum-based doublet chemotherapy; and Phase 3 clinical study of sintilIMab monotherapy as second- line treatment for squamous NSCLC with Disease progression following platinum-based doubleT.