Innovent Biologics, Inc. and Eli Lilly and Company (Lilly) announced that the innovative PD-1 inhibitor sintilimab has been successfully included in the updated National Reimbursement Drug List ("NRDL") for all approved indications, according to the latest announcement from the China National Healthcare Security Administration ("NHSA"). The updated NRDL will officially take effect on January 1, 2022. A total of four approved indications for sintilimab are now included in the updated NRDL: Three indications for sintilimab have been included in the NRDL for the first time, as follows: in combination with pemetrexed and platinum chemotherapy for the first-line treatment of advanced or recurrent nonsquamous non-small cell lung cancer (nsq NSCLC) without sensitizing EGFR mutations or ALK rearrangements; in combination with gemcitabine and platinum chemotherapy for the first-line treatment of advanced or recurrent squamous non-small cell lung cancer (sq NSCLC); and in combination with BYVASDA® (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC).

An indication for relapsed or refractory classic Hodgkin's lymphoma (cHL) after two lines or later of systemic chemotherapy, which was first included in the NRDL in 2019, has been successfully renewed this year. Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 /PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.

Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including: The treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy. In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer.

In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer. In combination with BYVASDA® (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma. Additionally, Innovent currently has two regulatory submissions under review in China for sintilimab, for the first-line treatment of esophageal squamous cell carcinoma, and the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Additionally, three clinical studies of sintilimab have met their primary endpoints: Phase 2 study as second-line treatment of esophageal squamous cell carcinoma. Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy. Phase 3 study in combination with BYVASDA® (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated nonsquamous NSCLC following EGFR-TKI treatment In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.