CStone Pharmaceuticals announced licensing strategic partnership and exclusive agreement with Shenyang Sunshine Pharmaceutical Co. Ltd. for an anti-PD-1 antibody Nofazinlimab (Anti-PD-1 Antibody) in mainland China. Nofazinlimab is an Anti-PD-1 antibody developed by CStone.

It's international multi-regional Phase 3 study CS1003-305, evaluating the efficacy and safety of nofazinlimab in combination with lenvatinib in first-line treatment for advanced HCC patients, has successfully achieved its prespecified patient enrollment target in March 2022. The topline results are expected to be disclosed in the first quarter of 2024. The study results will be used to support the new drug applications of nofazinlimab in countries and regions including China, the United States, and Europe.

Multiple research results of nofazinlimab have been published in international academic conferences and renowned journals. Preliminary data from the first-in-human trial, CS1003-101, were initially presented at the 2020 European Society for Medical Oncology (ESMO) Annual Conference and were subsequently published in full in the prestigious international oncology journal, the British Journal of Cancer, in September 2023. The data indicates that nofazinlimab monotherapy was well tolerated and demonstrated preliminary anti-tumor activity in multiple tumor types, no DLT was observed.

Additionally, data from the Phase Ib study (CS1003-102-1b) of nofazinlimab in combination with lenvatinib as a first-line treatment for unresectable advanced HCC patients in China were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The results showed an objective response rate (ORR) of 45%, with a median duration of response (DoR) not yet reached at the data cutoff, ranging from 4.2 to 18.7+ months. The median progression-free survival (PFS) was 10.4 months, and the safety and tolerability were favorable.

Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed in solid tumors. Nofazinlimab shows comparable high binding affinities to the PD-1 of humans, cynomolgus monkey, and mouse, and can block the interaction of PD-1 with its ligands PD-L1 and PD-L2. The U.S. FDA has granted nofazinlimab Orphan Drug Designation (ODD) in July 2020 for the treatment of patients with HCC.

In March 2022, the Phase 3 international multi-regional registrational study CS1003-305, evaluating the efficacy and safety of nofazinlimab in combination with lenvatinib in first-line treatment for advanced HCC patients, has already achieved the prespecified patient enrollment target. Liver cancer is a common malignant tumor of digestive system worldwide. According to GLOBOCAN 2020 (Global Cancer Incidence, Mortality and Prevalence) data of the International Agency for Research on Cancer (IARC), a specialized agency of the World Health Organization, global new cases of liver cancer is more than 900,000, and death cases are more than 830,000 per year.

The number of death cases is close to the number of new cases. Liver cancer is the second leading cause of cancer- related death and its incidence is increasing globally. HCC is the most common form of liver cancer and accounts for 90% of cases.

Systemic antitumor therapy plays an important role in the treatment of advanced HCC. Despite the expanding implementation of surgical and locoregional therapies worldwide, estimates suggest that 50?60% of patients with HCC will ultimately be treated with systemic therapies. A median survival for symptomatic advanced-stage HCC cases treated with systemic therapies is 1?1.5 years.

Poor prognosis of HCC is attributed primarily to tumor presentation at an advanced stage when there is no effective treatment to achieve the long-term survival of patients.