Key Takeaways
- Small cell lung cancer patients in Europe may soon have access to HANSIZHUANG (serplulimab), the first anti-PD-1 monoclonal antibody for first-line treatment of extensive-stage SCLC, following a positive CHMP opinion.
- The CHMP’s recommendation is based on the results of the ASTRUM-005 clinical trial, which demonstrated the efficacy of HANSIZHUANG plus chemotherapy as a promising new treatment option for patients with ES-SCLC.
- With approvals in China and Southeast Asia and a marketing application under review in Europe, Henlius is expanding the global reach of HANSIZHUANG, aiming to improve treatment options for SCLC patients worldwide.
Shanghai Henlius Biotech, Inc. 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 HANSIZHUANG (serplulimab), an independently developed anti-PD-1 monoclonal antibody (mAb), as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). If approved, HANSIZHUANG will become the first and only anti-PD-1 mAb available in Europe for this indication.
In 2023, Henlius entered into an exclusive license agreement with Intas Pharmaceuticals Limited for the development and commercialization of HANSIZHUANG across more than 50 countries, including Europe and India. With the CHMP’s positive opinion, Henlius and Intas are one step closer to bringing serplulimab to the European market. Upon approval, HANSIZHUANG will be marketed by Accord Healthcare, a subsidiary of Intas, in Europe. The drug has already been approved in China, Indonesia, Cambodia, and Thailand, benefiting over 80,000 patients.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, expressed excitement over the CHMP’s decision, stating: “The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products and validates Henlius’ patient-centered R&D approach and commitment to a global strategy. We look forward to the formal approval of this treatment in Europe, bringing more options and hope to patients worldwide.”
Paul Tredwell, Executive Vice President of EMENA at Accord, also commented: “I am thrilled with the CHMP’s positive opinion. This not only strengthens our partnership with Henlius but also means serplulimab is on track to become a vital part of the treatment landscape for patients with extensive-stage small cell lung cancer, who currently face limited options and poor prognoses.”
HANSIZHUANG Granted Orphan Drug Status After Positive CHMP Opinion
According to GLOBOCAN 2022, lung cancer is the most diagnosed cancer globally, with over 2.48 million new cases in 2022, accounting for 12.4% of all new cancer cases. Small cell lung cancer (SCLC) represents 15-20% of all lung cancers and is characterized by high malignancy, early metastasis, and rapid disease progression. SCLC is divided into limited-stage and extensive-stage, with the latter representing 60-70% of cases at diagnosis. Due to its aggressive nature, SCLC is associated with a very poor prognosis. In recognition of its orphan status in Europe, HANSIZHUANG was granted orphan drug designation by the European Commission (EC) in December 2022 for the treatment of SCLC, and its marketing authorization application (MAA) was validated by EMA in March 2023.
The CHMP’s positive opinion is based on data from the ASTRUM-005 clinical trial, a randomized, double-blind, placebo-controlled international study evaluating the efficacy of serplulimab plus chemotherapy compared to placebo plus chemotherapy as a first-line treatment for ES-SCLC. The trial involved 128 sites across countries such as China, Poland, Turkey, and Georgia, with a total enrollment of 585 patients, 31.5% of whom were Caucasian. The results of this trial were first presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and later published in the Journal of the American Medical Association (JAMA). These results showed that serplulimab, combined with chemotherapy, offers a promising new treatment for ES-SCLC, leading to its approval in China and several Southeast Asian countries.
HANSIZHUANG is the first innovative monoclonal antibody developed by Henlius, focusing on cancers with high global incidence such as lung and gastrointestinal tumors. In China, it has already been approved by the National Medical Products Administration (NMPA) for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Additionally, Henlius is conducting more than 10 clinical trials globally for various combination therapies in immuno-oncology.
Henlius Expands Global Reach with HANSIZHUANG, Advancing Lung Cancer Treatments and Preparing for U.S. Market Approval
Henlius has strategically expanded its efforts in the treatment of lung cancer, with HANSIZHUANG covering first-line treatments for both sqNSCLC and ES-SCLC. A marketing application for non-squamous NSCLC (nsNSCLC) has also been submitted to the NMPA. Henlius is currently conducting a phase 3 international trial combining HANSIZHUANG with chemotherapy and radiotherapy for limited-stage small cell lung cancer (LS-SCLC). Furthermore, Henlius is running a head-to-head trial in the U.S. comparing HANSIZHUANG with standard-of-care atezolizumab for the first-line treatment of ES-SCLC, with the goal of securing U.S. market approval.
HANSIZHUANG’s global expansion is gaining momentum. In 2023, Henlius received European Union (EU) Good Manufacturing Practice (GMP) certificates for its production facilities, and the first overseas shipment of HANSIZHUANG was completed in early 2024. This marked the product’s entry into Southeast Asia, becoming the first Chinese anti-PD-1 mAb to reach the region.
Looking ahead, Henlius remains committed to addressing unmet medical needs and delivering high-quality biologics to patients worldwide. The company continues to prioritize patient care and expand the global footprint of its innovative therapies, ensuring that more people around the world benefit from cutting-edge treatments like HANSIZHUANG.
Resource: Shanghai Henlius Biotech, September 21, 2024
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