Henlius Gains CHMP Approval for HANSIZHUANG in Treating Extensive-Stage Small Cell Lung Cancer

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of HANSIZHUANG (serplulimab) as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). This anti-PD-1 monoclonal antibody (mAb), independently developed by Henlius, is on track to become the first and only anti-PD-1 monoclonal antibody available in Europe for this indication. Henlius had previously entered into an exclusive licensing agreement with Intas Pharmaceuticals Limited for the drug's development and commercialization in over 50 countries across Europe and India. If approval is granted, HANSIZHUANG will be marketed by Accord Healthcare Ltd, a subsidiary of Intas, in Europe.

Dr. Jason Zhu, Executive Director and CEO of Henlius, emphasized that the CHMP's positive opinion is a significant milestone, validating their patient-centered R&D approach and commitment to global strategy. Paul Tredwell, Executive Vice President of EMENA at Accord, expressed his excitement over the CHMP's opinion, stating that it represents a critical step in providing new treatment options for ES-SCLC patients who currently face limited choices and poor prognoses.

Lung cancer remains the most diagnosed and deadliest cancer globally, with over 2.48 million new cases reported in 2022. Small cell lung cancer (SCLC) comprises 15%-20% of these cases and is characterized by high malignancy, early metastasis, and rapid disease progression. Due to its prevalence, SCLC is classified as an orphan disease in Europe. In December 2022, the European Commission granted HANSIZHUANG orphan drug designation for the treatment of SCLC, and the EMA validated its marketing authorization application in March 2023.

The CHMP's positive opinion is based on results from the ASTRUM-005 clinical study, a randomized, double-blind, placebo-controlled international multi-center trial that evaluated the efficacy and safety of serplulimab combined with chemotherapy compared to a placebo plus chemotherapy in ES-SCLC patients. The trial included 585 participants from multiple countries, with 31.5% being Caucasians. The findings were first presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of the American Medical Association (JAMA), marking a significant milestone in SCLC immunotherapy research.

Henlius is committed to expanding its global presence, with HANSIZHUANG already approved in China, Indonesia, Cambodia, and Thailand, benefiting approximately 80,000 patients. The company is also conducting extensive research on immuno-oncology combination therapies worldwide. In China, HANSIZHUANG has received approval for treating various cancers, including microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC).

Henlius' comprehensive strategy includes ongoing clinical trials for additional indications. For instance, their marketing application for the first-line treatment of non-squamous NSCLC (nsNSCLC) is under review by the National Medical Products Administration (NMPA). They are also conducting a phase 3 international multi-center clinical trial of HANSIZHUANG in combination with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). Additionally, a bridging head-to-head trial is underway in the U.S. comparing HANSIZHUANG with Atezolizumab, the standard of care for first-line treatment of ES-SCLC, to facilitate its entry into the U.S. market.

The global expansion of HANSIZHUANG is accelerating, with approvals in China and Southeast Asia and licenses granted to over 70 countries and regions, including the U.S., Europe, the Middle East, and North Africa. Henlius has also secured EU GMP Certificates for its production facilities, confirming compliance with EU standards. The first overseas shipment of HANSIZHUANG was completed in early 2024, making it the first Chinese anti-PD-1 mAb to enter Southeast Asia.

Henlius remains dedicated to addressing unmet clinical needs and delivering high-quality biologics to patients worldwide. The company continues to focus on innovation and patient-centric approaches to expand its global footprint and enhance treatment options for cancer patients globally.