On May 9, 2023, Cornerstone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616) announced that it would terminate its license agreement with EQRx regarding Shuglizumab and nofazinlimab, and would regain the development and commercialization rights of tumor immunotherapy drugs PD-L1 antibody Shuglizumab and PD-1 antibody nofazinlimab outside Greater China. Both sides will be committed to a smooth transition of rights and interests. The termination of this agreement will not affect the down payment and milestone payment that Cornerstone Pharmaceutical has received from EQRx.
At present, the application for market approval of Shuglizumab for first-line treatment of metastatic non-small cell lung cancer (NSCLC) is under review by the European Medicines Agency (EMA) and the Medicines and Healthcare Products Agency (MHRA) in the UK. After completing the equity transition, Cornerstone Pharmaceutical will be responsible for promoting the registration application process for the above two items of Shuglizumab.
Cornerstone Pharmaceutical is pleased to regain the development and commercialization rights of Shuglizumab and Nofazinlimab outside Greater China, and firmly believes that these two products have huge market opportunities outside Greater China. Shuglizumab has achieved success in five registered clinical studies, with indications covering stage III NSCLC, stage IV NSCLC, lymphoma, gastric cancer, and esophageal cancer. The phase III international multicenter registration study of Nofazinlimab combined with lenvatinib for first-line treatment of advanced hepatocellular carcinoma is currently underway, and the results of this study will be used to support Nofazinlimab's global and multi regional new drug marketing applications. The research data of Shuglizumab and Nofazinlimab have been presented at international academic conferences multiple times. Multiple research data on Shuglizumab have been published in top international journals such as The Lancet Oncology and Journal of Clinical Oncology.
Based on the encouraging clinical trial data obtained from these two drugs in clinical trials, Cornerstone Pharmaceutical has sufficient confidence in the overseas market expansion of Shuglizumab and Nofazinlimab, and will continue to communicate with regulatory departments such as the US Food and Drug Administration (FDA), EMA, and MHRA.
At the same time, Cornerstone Pharmaceutical will actively seek partners for the development and commercialization of Shuglizumab and Nofazinlimab outside of Greater China.
About Shuglizumab
Shugli monoclonal antibody is an anti PD-L1 monoclonal antibody developed by Cornerstone Pharmaceutical. The development of Shugli monoclonal antibody is based on OmniRat, which was authorized and imported by Ligand Company in the United States ® Genetically modified animal platform. This platform can generate all human antibodies in one stop. As a fully human full-length anti PD-L1 monoclonal antibody, Shugli monoclonal antibody is a natural G-type immunoglobulin 4 (IgG4) monoclonal antibody drug that is closest to the human body. Shuglizumab has a lower risk of immunogenicity and related toxicity in patients, which gives it a unique advantage compared to similar drugs.
At present, the National Drug Administration (NMPA) of China has approved Shuglizumab (trade name: Zojiemet) ®) 2 indications for the treatment of non resectable stage III non-small cell lung cancer patients who have not progressed after synchronous or sequential radiotherapy and chemotherapy, as well as first-line combined chemotherapy for metastatic squamous and non-small cell lung cancer patients.
Shuglizumab is used for the treatment of relapsed and refractory extranodal NK/T cell lymphoma (R/R ENKTL), local advanced or metastatic gastric/esophageal junction adenocarcinoma that cannot be surgically resected in combination with chemotherapy on the first line, and local advanced or recurrent or metastatic esophageal squamous cell carcinoma that cannot be surgically resected in combination with chemotherapy on the first line. The application for a marketing license for the indications has been accepted by NMPA and is currently under review.
About nofazinlimab
Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1), which is currently being developed for immunotherapy in tumors. Nofazinlimab has high affinity with PD-1 in humans, macaques, and mice, which can block the interaction between PD-1 and PD-L1 and PD-L2 ligands.
Nofazinlimab was awarded Orphan Drug Design (ODD) by the US Food and Drug Administration (FDA) in July 2020 for the treatment of hepatocellular carcinoma.
In March 2022, the international multicenter phase III registration study CS1003-305 of nifazinlimab combined with lenvatinib for first-line treatment of advanced hepatocellular carcinoma patients successfully achieved the predetermined patient enrollment goal.
