Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced that its partner, PT Kalbe Genexine Biologics (KGbio), through its subsidiary PT Kalbio Global Medika, has received a GMP inspection completion letter from the Badan Pengawas Obat dan Makanan (BPOM), a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Indonesia. This milestone indicates that Henlius’s facilities in Xuhui District, Shanghai, have successfully passed the GMP compliance inspection for its PD-1 inhibitor, HanSiZhuang (serplulimab).
First Overseas Regulatory Approval for Serplulimab
This achievement marks the first time that a programmed death-1 (PD-1) inhibitor has successfully completed an on-site inspection by an overseas regulatory authority. Serplulimab has already received approval for the treatment of various cancers, including microsatellite highly unstable (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC).
Expanding Market Presence in Southeast Asia
Henlius initially granted KGbio exclusive development and commercial rights to serplulimab in Southeast Asia in September 2019. This licensing agreement was further expanded in August 2023, with an additional payment of USD 15 million, enhancing Henlius’s market presence in the region and paving the way for broader access to this innovative cancer therapy.-Fineline Info & Tech
