First International Shipment of HANSIZHUANG Launched

SHANGHAI, Jan. 25, 2024 /PRNewswire/ -- On January 25, a truck carrying anti-PD-1 mAb Zerpidio^® (serplulimab, Chinese trade name: HANSIZHUANG) slowly left Henlius' Songjiang First Plant. These products, bearing Henlius' mission of benefiting patients worldwide with high-quality biopharmaceuticals, will ultimately set sail for Indonesia. The shipment opens a new chapter for serplulimab to benefit patients around the world.

On December 28, 2023, the subsidiary of PT Kalbe Genexine Biologics (KGbio) received the relevant registration certificates issued by the BPOM for the approval of serplulimab in Indonesia under the trade name Zerpidio^® for the treatment of extensive stage small cell lung cancer. Since 2019, Henlius has been collaborating with KGbio in 22 emerging market countries across Southeast Asia and MENA countries. The two parties are actively working towards obtaining approvals in more countries, aiming to bring advanced and efficient treatment options to local patients.

Lung cancer (LC) is one of the most common malignancies around the world. According to GLOBOCAN, there were near 35,000 new LC cases and 31,000 deaths in Indonesia in 2020, and LC is the leading cause of cancer death. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Around 30%–40% patients are in limited stage and most patients are in extensive stage when diagnosed. Their clinical condition deteriorates rapidly, and the overall prognosis is poor. In the past 20 years, chemotherapy such as etoposide combined carboplatin/cisplatin was still the standard of care for ES-SCLC, but almost all patients in extensive stage relapse within one year ^[1]. The advent of immune checkpoint inhibitors has brought new hope to patients with SCLC. The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022 and became the world's first anti-PD-1 mAb for the first-line treatment of SCLC. The shipment of HANSIZHUNAG to Indonesia will bring new hope to local patients.

At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting over 51,000 Chinese patients.