Innovent Biologics, Inc. pleased to see that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for CYRAMZA® (ramucirumab) in patients with hepatocellular carcinoma (HCC, also known as liver cancer), who have an alpha fetoprotein of =400 ng/mL and have been treated with sorafenib. In March 2022, CYRAMZA (ramucirumab) was approved by the NMPA in combination with paclitaxel for second-line treatment in patients with advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma, making it the first and only targeted drug approved for the second-line treatment of advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma in China. CYRAMZA (ramucirumab) has been discovered and developed by Lilly.

In March 2022, Innovent and Lilly expanded their strategic partnership in oncology, which includes an agreement for Innovent to obtain the sole commercialization rights of CYRAMZA (ramucirumab) once approved in China, which positions Innovent to be fully responsible for the pricing, importation, marketing, distribution and detailing of this product. With this further expanded oncology product portfolio, Innovent intends to use its experienced oncology commercial team to leverage its broad commercial coverage in hospitals and pharmacies at various tiers and to provide integrated patient solutions with strong synergies to cancer patients in China. This new approval was based on the results of the REACH-2 study, a global randomized, double-blind, placebo-controlled Phase 3 clinical trial.

The REACH-2 study is the first Phase 3 clinical trial in HCC to obtain positive results in a biomarker-enriched population known for poor prognosis. On the primary endpoint of overall survival (OS), treatment with CYRAMZA significantly improved the OS of patients compared to placebo (HR: 0.71; 95% CI: 0.53-0.95; P=0.020). The median OS was 8.5 months with CYRAMZA, compared to 7.3 months with placebo.

On the secondary endpoint of progression-free survival (PFS), median PFS was significantly improved with CYRAMZA (2.8 months vs. 1.6 months for placebo (HR: 0.45; 95% CI: 0.34-0.60; P<0.0001)). Objective response rate (ORR) was numerically higher with CYRAMZA compared to placebo (4.6% vs.

1.1%). Disease control rate (DCR) was higher with CYRAMZA than with placebo (59.9% vs. 38.9%).

CYRAMZA was well-tolerated in Chinese patients and the overall patient population. The safety and efficacy profile of CYRAMZA in the Chinese population was consistent with that observed in previously reported global studies. About CYRAMZA (ramucirumab): CYRAMZA is an antiangiogenic therapy.

It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds specifically to VEGFR-2, thereby blocking the binding of the receptor ligands (VEGF-A, VEGF-C, and VEGF-D) – which may slow tumor growth. In recent years, studies have shown that the VEGF pathway is an important signaling pathway involved in tumor angiogenesis, and it is also the main target pathway in targeted therapy of liver cancer. From the existing research results, the single drug use of compounds targeting the VEGF pathway can bring survival benefits to patients and is a very promising treatment method in the treatment of liver cancer.

In March 2022, CYRAMZA® (ramucirumab) in combination with paclitaxel was approved by the National Medical Products Administration (NMPA) for second-line treatment in patients with advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma. In October 2022, CYRAMZA (ramucirumab) was approved by the NMPA for patients with Hepatocellular Carcinoma (HCC) who have an alpha fetoprotein (AFP) of =400 ng/mL and have been treated with sorafenib.