Henlius and Intas Receive Positive CHMP Opinion for HETRONIFLY® (Approved as HANSIZHUANG in China) in European Markets as First-Line Treatment for Adult Patients with Extensive-Stage Small Cell Lung Cancer USA - Français USA - English USA - español USA - Deutsch

– HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody approved for the first-line treatment of extensive-stage SCLC

– HETRONIFLY® (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for the first-line treatment of extensive-stage SCLC.

AHMEDABAD, India, Sept. 22, 2024 /PRNewswire/ — Intas Pharmaceuticals Limited (“Intas”) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of HETRONIFLY® (serplulimab, approved as Hansizhuang in China), in the European markets.

Serplulimab, an injectable recombinant humanized anti-PD-1 monoclonal antibody (mAb), is Henlius’ first innovative monoclonal antibody and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of small cell lung cancer (SCLC).

Serplulimab will be marketed by Intas, through its subsidiary Accord Healthcare Ltd (Accord), in more than 30 countries across Europe. As a key player in the global oncology market, Accord has a long-standing commitment to the field, with proven commercial capabilities, and currently supplies approximately one in three injectable oncology medicines in Europe. This positive CHMP opinion marks a further milestone for Henlius and Intas in making serplulimab available to patients in Europe.

Dr. Jason Zhu, Executive Director and CEO, Henlius, states: “The positive CHMP opinion represents an important milestone in our efforts to accelerate the global reach of our products, and further validates Henlius’ patient-centric approach to R&D and commitment to a global strategy. We now look forward to formal approval of this treatment in Europe, which will bring more treatment options and hope to patients in this region and around the world.”

Paul Tredwell, Executive Vice President, EMENA, Accord, said: “I am delighted with the positive opinion from the CHMP. This not only strengthens our existing partnership with Henlius, but also means that serplulimab is well on its way to becoming part of the treatment landscape for patients with extensive-stage small cell lung cancer, who currently have limited options and face a poor prognosis.

Alex Falgas, Senior Vice President, Business Development, Accord, states: « The CHMP’s positive opinion on serplulimab is a pivotal moment in our mission to deliver world-class cancer treatments to patients in Europe. It strengthens our oncology portfolio and Accord’s commitment to reducing the global cancer burden by ensuring greater access to innovative therapies for those who need them.”

According to GLOBOCAN 2022, lung cancer is the most diagnosed and deadly cancer worldwide. More than 2.48 million new cases of lung cancer were reported worldwide in 2022, accounting for 12.4% of all new cancer cases. [1] Small cell lung cancer (SCLC) accounts for 15–20% of total lung cancer cases and is associated with early metastasis, rapid disease progression, and extremely poor prognosis.

The CHMP’s positive opinion is mainly based on ASTRUM-005, an international, multicentre, randomised, double-blind, placebo-controlled clinical study that evaluated the efficacy and adverse effects of the PD-1 inhibitor serplulimab in combination with chemotherapy compared with placebo in combination with chemotherapy as first-line treatment in patients with small cell lung cancer.

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

About Henlius
Henlius (2696.HK) is a global biopharmaceutical company focused on bringing high-quality, affordable and innovative biologics to patients worldwide, with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, six products have been launched in China, three have been approved for overseas marketing, 24 indications are approved worldwide and three marketing applications have been accepted for review in China and the EU, respectively. Since its establishment in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high efficiency and integrated innovation throughout the product lifecycle, including R&D, manufacturing and market launch. The company has established a global innovation center and commercial manufacturing facilities based in Shanghai and certified by China, EU and US GMP.

Henlius has proactively built a diversified and high-quality product portfolio covering more than 50 molecules and continued to explore combination therapies in immuno-oncology with HANSIZHUANG (anti-PD-1 monoclonal antibody) as its lead product. In addition to the launched products, HANLIKANG (rituximab), the first biosimilar developed in China, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the United States, Zercepac® in Europe), a biosimilar monoclonal antibody developed in China and approved in China, Europe and the United States, HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, non-small cell lung cancer, extensive-stage small cell lung cancer and esophageal squamous cell carcinoma, making it the world’s first anti-PD-1 monoclonal antibody for the first-line treatment of SCLC. Additionally, Henlius has conducted more than 30 clinical studies for 16 products, strengthening its presence in major as well as emerging markets.

About Intas
Intas is one of the world’s leading multinational pharmaceutical formulation development, manufacturing and marketing companies. The company has established a network of subsidiaries under the name of Agreement 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 over 85 countries worldwide and over 69% of its turnover comes from global trade, particularly in the highly regulated markets of the EU and USA.

Currently ranked 6th (as per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, the company is also the largest privately held generic pharmaceutical company in India. While Intas has established itself in key therapeutic segments such as CNS, Cardiovascular, Diabetes, Plasma Therapy, Cell & Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its product portfolio in Oncology and other hospital-based therapeutic segments in the EU and the US.

Intas’ success and growth is directly linked to its extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing sites, eleven of which are in India and the remaining in the UK, Greece and Mexico. The facilities are accredited by major international regulatory bodies such as FDA, EMA, MHRA, TGA and others. The company invests 6-7% of its turnover in R&D every year. Currently, Intas has registered over 10,000 products worldwide and has a strategic pipeline of over 300 high-value products (FTF/FTM, Biosimilars and NDDS).