HENLIUS has announced that its self-developed Serplulimab Injection, marketed as HANSIZHUANG in China and HETRONIFLY in the EU, has received a positive review opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. The committee recommended approval for two indications: the use of HANSIZHUANG in combination with fluoropyrimidine and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma; and its use in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer.
The CHMP's opinion will be submitted to the European Commission, which is expected to make a final decision within the next two months. If approved by the EC, the centralized marketing authorization for HANSIZHUANG will be effective in all European Union member states, as well as in Iceland, Liechtenstein, and Norway within the European Economic Area.
This positive opinion was primarily based on two randomized, double-blind, multicenter phase 3 clinical studies. The results demonstrated that HANSIZHUANG combined with chemotherapy showed significant benefits compared to chemotherapy alone in both treatment groups, meeting the pre-specified primary endpoints and exhibiting a favorable safety and tolerability profile.
In December 2023, the group received several GMP certificates from the Dutch Health and Youth Care Inspectorate, confirming that the production lines for HANSIZHUANG comply with EU GMP standards. HANSIZHUANG is an innovative anti-PD-1 monoclonal antibody developed by the company. It has already received marketing approval in China for several indications and in the EU for use in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer. The drug has also been approved in numerous other countries and has received orphan drug designations from regulatory authorities in the United States, Switzerland, and South Korea.
Additionally, the company is progressing with multiple global clinical trials for HANSIZHUANG and related combination therapies, covering a wide range of indications including lung cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer. In October 2023, HENLIUS entered into a licensing agreement with Intas Pharmaceuticals Ltd., granting Intas exclusive rights to commercialize HANSIZHUANG in specified European regions and India. According to data from IQVIA, global sales of PD-1 targeted monoclonal antibody drugs are projected to reach approximately $48.503 billion in 2025.
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