EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab)-Media

EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab)

2023-03-23

HANSIZHUANG (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC) -

The EC and the FDA previously granted Orphan Drug Designations (ODDs) for HANSIZHUANG in SCLC -

HANSIZHUANG is approved in China for microsatellite instability-high (MSI-H) solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), benefiting more than 19,000 Chinese patients -

Shanghai, China, March 23, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) 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 (ES-SCLC). The European Commission (EC) previously granted Orphan Drug Designation (ODD) to HANSIZHUANG for the treatment of small cell lung cancer (SCLC).

“HANSIZHUANG is Henlius’ first innovative mAb, as well as the first and only anti-PD-1 therapy approved for treatment of SCLC, which has benefited 13,000 SCLC patients in China. Since launched in March 2022, it has been approved for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer and ES-SCLC in China,” said Jason Zhu, President of Henlius. “HANSIZHUANG is steadily making its way from China to Europe and the U.S. Previously, we had Zercepac^® approved in more than 30 countries including the European Union. We hope HANSIZHUANG will further open that market and spur global expansion as we seek to benefit more patients.”

Enhance the global presence

The regulatory application is based on data from ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre phase 3 clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. The study has set up a total of 128 sites in various countries including China, Poland, Turkey, and Georgia, and enrolled 585 subjects, among whom 31.5% were White. The results of ASTRUM-005 were presented in oral for the first time at the 2022 ASCO annual meeting and was then published in the Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world, which made ASTRUM-005 the first study published on JAMA in SCLC immunotherapy, demonstrating the high level of academic acclaim on a global scale.

In 2022, HANSIZHUANG was also granted ODD by the Food and Drug Administration (FDA) for the treatment of SCLC. The ODD granted by the FDA is beneficial for the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the United States (U.S.). Based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion results of the FDA's Class C consultation meeting, Henlius has initiated a bridging head-to-head trial in U.S. patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG, which propels the product towards U.S. market approval further.

More are on the horizon

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius and has since seen benefits in 19,000 patients in China. Its synergy with in-house products of the company and innovative therapies are being actively promoted and 14 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. In addition to the launched indications of sqNSCLC and ES-SCLC, Henlius also explored to treat patients with non-squamous non-small cell lung cancer (nsNSCLC) and limited-stage small cell lung cancer (LS-SCLC). Recently, the first patient has been dosed in an international multi-centre phase 3 clinical trial of HANSIZHUANG (serplulimab) in patients with LS-SCLC in the U.S. In the field of gastrointestinal cancer, HANSIZHUANG has been approved for the treatment of MSI-H solid tumours, which could benefit patients with MSI-H colorectal cancer and MSI-H gastric cancer. It was also recommended for the first-line treatment of esophageal cancer (category IA) in the 2022 China Guidelines for Radiotherapy of Esophageal Cancer and its NDA for the first-line treatment of esophageal squamous cell carcinoma (ESCC) was accepted by the NMPA based on the data of ASTRUM-007, which was published in Nature Medicine (IF: 87.241). In addition, PD-1 inhibitors are less explored in neoadjuvant/adjuvant therapies for gastric cancer, and Henlius has led the way with a phase 3 clinical study, striving to benefit gastric cancer patients from the early line of immunotherapy.

Through overseas development of HANSIZHUANG, Henlius will accelerate the pace of global internationalisation and deliver more high-quality, affordable treatment options to patients.

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the EMA, respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 14 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,500 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA, IF: 157.3), Nature Medicine (IF: 87.241), and the British Journal of Cancer (IF: 9.075), respectively. Furthermore, HANSIZHUANG was respectively recommended for the first-line treatment of ES-SCLC in the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) and the treatment of esophageal cancer (category IA) in the 2022 China Guidelines for Radiotherapy of Esophageal Cancer. Serplulimab was also granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.