Zhangjiang Innovations Shine: Two Medical Products from Shengqi Medical and Henlius Receive Approvals

Recently,Zhangjiang Science City Company: Shanghai Henlius Biotech, Inc.Hansizhuang (H drug), a self-developed anti-PD-1 monoclonal antibody^®(Serplulimab, European brand name: Hetronifly)^®), respectively approved by Singapore's Health Sciences Authority (HSA) and Malaysia's National Pharmaceutical Regulatory Agency (NPRA) for the treatment of extensive-stage small cell lung cancer (ES-SCLC), marketed under the brand name Zerpidio.^®. This approval marks another significant expansion in the Southeast Asian market for the product, following its previous approvals in Indonesia, Cambodia, and Thailand. The commercialization of Drug H in Southeast Asia is handled by KGbio, a subsidiary of PT Kalbe Farma Tbk., an Indonesian pharmaceutical company. KGbio has been granted exclusive rights to develop and commercialize Drug H for certain indications and therapies across the ten ASEAN countries.

(Image Source: Shanghai Henlius Biotech, Inc.)

Apart from the Southeast Asian market, the globalization layout of H drug is also accelerating its expansion into multiple regions. Up to now, H drug has been approved in China for the treatment of sqNSCLC, ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). In February 2025, H drug was approved by the EU for first-line treatment of ES-SCLC, becoming the first and only anti-PD-1 monoclonal antibody approved for this indication in the EU, achieving a key breakthrough for domestically produced innovative drugs in the mainstream biopharmaceutical markets of Europe and America. Currently, the company is conducting a head-to-head bridging trial in the United States comparing H drug with the first-line standard treatment atezolizumab for ES-SCLC to support its U.S. marketing application. In addition, H drug for the treatment of SCLC has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA), the European Commission (EC), and Swissmedic, and has also been granted orphan drug designation by the South Korean Ministry of Food and Drug Safety (MFDS) for ES-SCLC.