Shanghai, November 1, 2022 – Henlius (2696.HK) announced that the supplemental new drug application (sNDA) for 汉斯状 (generic name: sorliplizumab injection), its first independently developed innovative biologic anti-PD-1 monoclonal antibody, has been approved by the National Medical Products Administration (NMPA) of China. The drug is indicated for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with carboplatin and albumin-bound paclitaxel, providing a new therapeutic option for patients with lung squamous cell carcinoma. Previously, 汉斯状 had been approved for the treatment of microsatellite instability-high (MSI-H) solid tumors, and its extensive indication layout is set to benefit more patients.
Basis for Approval
This approval is primarily supported by ASTRUM-004, a randomized, double-blind, international multicenter Phase III clinical trial. The study established research centers across multiple global regions including China, Poland (EU) and Türkiye, with Caucasian patients accounting for over 30% of the enrolled population. Robust international clinical trial data are expected to support overseas marketing applications and lay a solid foundation for global clinical use.
Clinical results demonstrated that 汉斯状 combined with carboplatin and albumin-bound paclitaxel achieved significant clinical benefits in patients with previously untreated locally advanced or metastatic sqNSCLC, meeting the predefined primary endpoint, and exhibited favorable safety and tolerability profiles.
Disease Background
Lung cancer is one of the most prevalent cancers worldwide and the malignant tumor with the highest incidence and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there were 828,000 new lung cancer cases and 657,000 related deaths in China.
Non-small cell lung cancer (NSCLC) accounts for approximately 80%–85% of all lung cancer cases, and about 50% of NSCLC patients are diagnosed with unresectable locally advanced or metastatic disease at initial presentation. Advanced sqNSCLC makes up roughly 30% of advanced NSCLC cases, for which platinum-based doublet chemotherapy has long been the standard treatment with unsatisfactory efficacy and a short median overall survival (often less than 1 year). Thus, a huge unmet medical need remains in this field.
In recent years, immune checkpoint inhibitors have achieved remarkable clinical breakthroughs and substantial progress in NSCLC treatment. Notably, anti-PD-1 monoclonal antibody combined with carboplatin and albumin-bound paclitaxel for advanced or metastatic sqNSCLC has been recommended by authoritative global and Chinese guidelines including the NCCN and CSCO guidelines, ushering advanced NSCLC into the era of immunotherapy.
The approval of 汉斯状 will deliver a new treatment option for this pathological subtype, expand the clinical application of immunotherapy in lung cancer, and further drive the innovative development of lung cancer treatment.
Sustained Innovation & Focus on First-Line Lung Cancer Therapy
As Henlius’ first innovative monoclonal antibody, 汉斯状 boasts an extensive indication portfolio and over 10 global clinical trials of combination immunotherapies, covering high-incidence cancers such as lung cancer, hepatocellular carcinoma, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer. With more than 3,100 subjects enrolled globally, it is also one of the anti-PD-1 monoclonal antibodies with rich international clinical data, accelerating its global commercialization process.
In the lung cancer sector, 汉斯状 achieves full coverage of first-line treatment. Beyond sqNSCLC, clinical trials are also underway for non-squamous non-small cell lung cancer (nsqNSCLC) and small cell lung cancer (SCLC).
