China-based 3SBio Inc., (HKG: 1530) has announced a strategic partnership and exclusive licensing agreement with compatriot firm CStone Pharmaceuticals (HKG: 2616), focusing on CStone’s anti-programmed death-1 (PD-1) antibody, nofazinlimab. This partnership signifies a significant expansion in the immuno-oncology space for both companies.
Financial Terms and Agreement Details
Under the terms of the agreement, 3SBio will pay CStone an upfront payment of RMB 60 million (USD 8.2 million), along with commitments to development and registration milestone payments close to RMB 100 million (USD 13.7 million). Additionally, 3SBio will be eligible for sales-based milestones and tiered royalties on any future sales of nofazinlimab. This deal grants 3SBio exclusive rights to develop, register, manufacture, and commercialize nofazinlimab in mainland China, while CStone retains rights outside of mainland China and continues to seek partners globally.
Global Phase III Study and Manufacturing Commitments
CStone will continue its work on a global pivotal Phase III study assessing nofazinlimab combined with lenvatinib as a first-line treatment for advanced hepatocellular carcinoma (HCC). 3SBio’s contract development and manufacturing organization (CDMO) facilities will be utilized to exclusively handle commercial manufacturing of the product in China mainland.
Phase III Study (CS1003-305) and ASCO Presentation
The Phase III study (CS1003-305) is a multi-regional trial comparing the combination of nofazinlimab plus lenvatinib versus placebo plus lenvatinib in HCC patients, with patient enrollment fully completed. Topline results are expected to be disclosed in Q1 2024. Data from the Phase Ib study (CS1003-102-1b) for the same drug combination and indication in Chinese patients were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, showing an objective response rate (ORR) of 45%, a median duration of response (DoR) not yet reached at the data cutoff, ranging from 4.2 to 18.7+ months, and a median progression-free survival (PFS) of 10.4 months. The safety and tolerability profiles were favorable.-Fineline Info & Tech
