Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 63 |
| INN | Serplulimab |
| Status | Approved |
| Drug code(s) | HLX10 |
| Brand name | HETRONIFLY®, HANSIZHUANG |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Colorectal cancer, Hepatocellular Carcinoma, Triple Negative Breast Cancer, Hepatitis B, Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer, Esophageal Squamous Cell Carcinoma, Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | May 15, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2022 |
| Date of first US approval | |
| INN, US product name | Serplulimab |
| US or EU approved indications | None |
| Company | Shanghai Henlius Biotech Co. Ltd. |
| Licensee/Partner | Intas Pharmaceuticals |
| Comments about company or candidate | September 21, 2024 I Intas Pharmaceuticals Limited (“Intas”) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HETRONIFLY® (serplulimab, approved as Hansizhuang in China), in European markets. October 2023: Intas Pharmaceuticals has signed an exclusive licensing agreement with Shanghai Henlius Biotech to develop and commercialise serplulimab in Europe and India. Mar 31, 2023: Henlius also plans to submit a BLA for HANSIZHUANG in the U.S. in 2024. March 23, 2023: Shanghai Henlius Biotech, Inc., announced that the European Medicines Agency (EMA) has validated the application for its self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), in combination with chemotherapy (carboplatin and etoposide), for the first-line treatment of adults with extensive-stage small cell lung cancer. Jan 2023: Syneos Health announced a strategic partnership with Fosun Pharma USA Inc., the US-based subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. As part of the partnership, Syneos Health will provide Full-Service Commercial support through its Syneos One® team for the launch of Serplulimab, a novel anti-PD-1 antibody for extensive stage small cell lung cancer (ES-SCLC), in the US. Serplulimab is currently in a final bridging study stage for the ES-SCLC indication. April 2022: The FDA granted orphan drug designation to serplulimab for treatment of small cell lung cancer. March 25, 2022 I Shanghai Henlius Biotech, Inc. announced that its first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments; supp approval in Oct 2022 for NSCLC April 22, 2021 I Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy, has been accepted by the National Medical Products Administration (NMPA) and proposed to be granted priority review. March 11, 2021 I Shanghai Henlius Biotech, Inc. announced the first patient was dosed in a Phase II/III clinical trial (NCT04547166) of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, in combination with HLX04 (bevacizumab) and chemotherapy for the first-line treatment of metastatic colorectal cancer NCT04301739 in triple neg breast cancer not yet recruiting when first posted on March 10, 2020. NCT04133259 Phase 2 in HepB not yet recruiting. NCT04063163 Phase 3 in small cell lung cancer recruiting as of Aug 2019; NCT04033354 Phase 3 in NSCLC recruiting as of July 2019. NCT03958890 Phase 3 study in Esophageal Squamous Cell Carcinoma recruiting as of May 2019. NCT03952403 Phase 3 study in NSCLC not yet recruiting as of May 17, 2019. June 2018: Recently, Henlius has received acceptance notifications from China Drug Administration (CDA) for its investigational new drug (IND) applications of a combination therapy that contains 2 monoclonal antibodies, i.e. HLX10, a Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection, and HLX04 (a biosimilar mAb), a Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection, for the treatment of advanced solid tumors. HLX10 is a novel mAb developed by Henlius, and has complete proprietary intellectual property. The product is a humanized monoclonal antibody targets the PD-1 on the surface of T cells. The therapeutic areas may include gastrointestinal stromal tumor, renal cell carcinoma, colon cancer, thyroid cancer, gastric cancer and prostate cancer. HLX06 has submited the IND application to CDE in July 2017. Established between Fosun and Chinese returnees from the US, Henlius is mainly focused on developing follow-on versions to some best-selling biologics. |
| Full address of company | 11/F, B8 Building, No.188 Yizhou Rd, Xuhui District, Shanghai Asia China https://www.henlius.com/en/contact-information.html |
Immune checkpoint target
| Anticipated events | Pos opinion in EU - anticipate approval by end of Nov, BLA submission to FDA in 2024 |
| Factor(s) contributing to discontinuation | None |