– HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of ES-SCLC
– HETRONIFLY® (serplulimab) is expected to be the first anti-PD-1 monoclonal antibody available in Europe for the first-line treatment of ES-SCLC
AHMEDABAD, India, Sept. 22, 2024 /PRNewswire/ – 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 granting approval of HETRONIFLY® (serplulimab, approved in China as Hansizhuang) in the European markets.
Serplulimab, an injection of a recombinant humanized anti-PD-1 monoclonal antibody (mAb), is the first innovative monoclonal antibody developed by Henlius. The US Food and Drug Administration (FDA) and the European Commission have granted it orphan drug designation for the treatment of small cell lung cancer (SCLC).
Serplulimab will be commercialized by Intas through its subsidiary Accord Healthcare Ltd (Accord) in more than 30 countries in Europe. As a key player in the global oncology market, Accord has a long-standing commitment to oncology with proven commercial capabilities and currently supplies approximately one in three injectable oncology products in Europe. This positive opinion from the CHMP represents a further step for Henlius and Intas towards making serplulimab available to patients in Europe.
Dr. Jason Zhu, Executive Director und Chief Executive Officer von Henlius, explained: “The positive opinion from the CHMP is an important milestone in our efforts to accelerate the global distribution of our products and confirms Henlius’ patient-focused R&D approach and commitment to a global strategy. We look forward to the formal approval of this treatment in Europe, which will bring more treatment options and hope to patients there and around the world.”
Paul Tredwell, Executive Vice President von EMENA bei Accord, said: “I am very pleased with the positive opinion from the CHMP. This not only strengthens our current partnership with Henlius, but also means that serplulimab is on track to become part of the treatment landscape for patients with advanced-stage small cell lung cancer, who currently have limited options and a poor prognosis.
Alex Falgas, Senior Vice President of Business Development bei Accord said „The CHMP’s positive opinion on serplulimab is a pivotal moment in our mission to bring world-class cancer treatments to patients in Europe. This strengthens our oncology portfolio and underscores Accord’s commitment to alleviating the global burden of cancer and increasing access to innovative therapies for those in need.”
According to GLOBOCAN 2022, lung cancer is the most commonly diagnosed cancer worldwide and the one with the highest mortality rate. In 2022, there were more than 2.48 million new cases of lung cancer worldwide, accounting for 12.4% of all new cancer cases. (1) Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancer cases and is associated with early metastasis, rapid disease progression, and extremely poor prognosis.
The CHMP’s positive opinion is based primarily on ASTRUM-005, a randomized, double-blind, placebo-controlled international multicenter clinical trial evaluating the efficacy and side effect profile of the PD-1 inhibitor serplulimab plus chemotherapy compared to placebo plus chemotherapy as first-line treatment was studied in patients with ES-SCLC.
References:
(1) Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834
Information about Henlius Henlius (2696.HK) is a global biopharmaceutical company with a vision to provide high quality, affordable and innovative biologic medicines to patients around the world, with a focus on oncology, autoimmune diseases and eye diseases. To date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide and 3 regulatory applications have been accepted for review in China and the EU, respectively. Since its founding in 2010, Henlius has built an integrated biopharmaceutical platform whose core competencies are high efficiency and innovation, embedded throughout the entire product lifecycle including R&D, manufacturing and commercialization. The company has a global innovation center and commercial manufacturing facilities in Shanghai that are GMP certified by China, the EU and the US.
Henlius has proactively built a diversified and high-quality product pipeline with over 50 molecules and continues to explore immuno-oncology combination therapies using the company’s HANSIZHUANG (anti-PD-1 mAb) as the backbone. In addition to the launched products HANLIKANG (rituximab), the first biosimilar developed in China, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the USA, Zercepac® in Europe), a mAb biosimilar developed in China, which is available in China, Europe and the USA approved, HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumors, non-small cell squamous cell carcinoma (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). This makes it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. In addition, Henlius has conducted more than 30 clinical trials for 16 products and expanded its presence in major and emerging markets.
Information about Intas Intas is one of the world’s leading multinational companies for the development, manufacturing and marketing of pharmaceutical formulations. The company has established a network of subsidiaries under the Accord name for marketing and sales in the highly regulated markets of the EU, USA, Canada, South Africa, Australia, Asia Pacific, CIS and MENA. Intas is present in more than 85 countries worldwide, with more than 69% of revenues coming from global operations, particularly from the highly regulated EU and US markets.
The company currently ranks 6th (according to IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market and is the largest privately held Indian generics company. While Intas is a leader in key therapeutic segments such as CNS, cardiovascular, diabetology, plasma therapy, cell and gene therapy, gastroenterology, urology and oncology in India, the company is prominent in the EU and US for its product range in oncology and other hospital-based therapeutic segments.
Intas’ success and growth is a direct influence of Intas’ extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, eleven of which are located in India and the remaining in the UK, Greece and Mexico. The facilities are accredited by leading global regulatory bodies such as the US FDA, EMA, MHRA, TGA and others. Every year the company invests 6 to 7% of its sales in research and development. Currently, Intas has more than 10,000 product registrations worldwide and a strategic pipeline of more than 300 high-quality FTF/FTM, biosimilars and NDDS products.