EMA’s Human Medicines Committee Recommends Approval of Henlius’ Hansizhuang

EMA’s Human Medicines Committee Recommends Approval of Henlius’ Hansizhuang

By, Admin 24 September 2024

EMA’s human medicines committee recommends approval of Henlius’ Hansizhuang to treat extensive-stage small cell lung cancer

Overview

Shanghai Henlius Biotech, Inc., a global biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of Hansizhuang (serplulimab), Henlius’ independently developed anti-PD-1 monoclonal antibody (mAb), as a first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).

Exclusive license Agreement: Henlius & Intas

  • In 2023, Henlius entered into an exclusive license agreement with Intas Pharmaceuticals Limited (Intas) for the development and commercialisation a total of more than 50 countries in Europe and India. 
  • This positive opinion from CHMP marks another step closer for both companies to providing serplulimab for patients in Europe. 
  • If approved, serplulimab will be marketed by Intas’ subsidiary, Accord Healthcare Ltd, in Europe.

Statement from the CEO: Henlius

Dr. Jason Zhu, executive director and chief executive officer of Henlius, stated: “The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius’ patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide.”

From the EVP: at Accord

Paul Tredwell, executive vice president of EMENA at Accord, said, ""I am thrilled with the CHMP's positive opinion. This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis.”

Lung Cancer

  • According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world.
  • There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases. 
  • Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer, which is featured by high malignancy, early metastasis, and rapid disease progression, with extremely poor prognosis. 
  • SCLC is divided into limited-stage and extensive-stage, with approximately 30%-40% of patients diagnosed at the limited stage and the rest at the extensive stage. 
  • With a prevalence of 1-5 per 10,000 people in the European community, SCLC has an orphan disease designation.  
  • In December 2022, Hansizhuang was granted orphan drug designation by the European Commission (EC) for the treatment of SCLC, and in March 2023, EMA validated the marketing authorisation application (MAA) of Hansizhuang for ES-SCLC.

About ASTRUM-005

  • The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre 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 Caucasians. 
  • The ASTRUM-005 clinical trial results were firstly presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of the American Medical Association (JAMA), making it the first study published on JAMA in SCLC immunotherapy. 
  • Based on the ASTRUM-005 study, Hansizhuang has been approved in China and Southeast Asian countries for first-line treatment of ES-SCLC, making it the world’s first anti-PD-1 mAb approved for first-line treatment of SCLC.

About Hansizhuang

  •  Hansizhuang, Henlius’ first innovative mAb developed in-house, focuses on high-incidence cancers such as lung cancer and gastrointestinal tumours. 
  • In China, it has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC). 
  • The company is also conducting more than 10 clinical studies on immuno-oncology combination therapies worldwide.

Henlius for lung Cancer

  • Notably, Henlius covers the full range of first-line treatment of lung cancer. 
  • In addition to sqNSCLC and ES-SCLC, Hansizhuang’s marketing application for first-line treatment of non-squamous NSCLC (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). 
  • Additionally, the company is conducting a phase 3 international multi-centre clinical trial of Hansizhuang combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). 
  • Henlius is also running a bridging head-to-head trial in the U.S. to compare Hansizhuang with standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC, which is expected to propel the product towards US market approval further.

Global Expansion of Hansizhuang

  • The global expansion of Hansizhuang is accelerating. 
  • It has already been approved in several countries, including China, Indonesia, Cambodia, and Thailand, and has been licensed to over 70 countries and regions, including the US, Europe, Southeast Asia, the Middle East, and North Africa. 
  • On December 2023, Henlius received the European Union (EU) GMP Certificates for the production lines of Hansizhuang, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for Hansizhuang and meet the EU GMP standards.
  • The first overseas shipment of Hansizhuang was completed in Q1 2024, making it the first Chinese anti-PD-1 mAb to enter Southeast Asian, offering new treatment options for more global patients.

Looking ahead, Henlius will continue to prioritize patient needs, address unmet clinical demands, and accelerate efforts to deliver high-quality biologics from China to patients worldwide.

About Henlius

Henlius is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases.

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