Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced an update to the licensing agreement initially struck with PT Kalbe Genexine Biologics (KGbio) in September 2019 regarding Henlius’s programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The Indonesian firm was initially granted rights to develop and commercialize the drug in certain Southeast Asian countries. Under the updated deal, KGbio is now permitted to commercialize the drug in agreed Middle East and North Africa countries and regions, including Bahrain, Egypt, Jordan, Kuwait, Oman, Palestine, Qatar, Saudi Arabia, the United Arab Emirates, Morocco, Algeria, and Tunisia, excluding Türkiye and Israel. The licensed field includes extensive-stage small cell lung cancer (ES-SCLC) and another indication as per a separate agreement. The updated deal is effective immediately and is valid for 10 years upon the first approval of serplulimab in the new territories, with an option for automatic renewal every five years after expiration.
Financial Terms and Milestones
KGbio will pay Henlius USD 7 million upfront and up to USD 8 million in future regulatory milestones. The USD 650 million sales milestone payment agreed in 2019 now covers both license deals. Additionally, KGbio is committed to paying royalties based on 15% to 20% of the net sales.
Serplulimab’s Approvals and Indications
Serplulimab has been approved for the treatment of microsatellite highly unstable (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), and ES-SCLC. The expansion of the licensing agreement with KGbio signifies Henlius’s commitment to increasing global access to its PD-1 inhibitor, potentially benefiting patients in the Middle East, North Africa, and beyond.-Fineline Info & Tech
