复宏汉霖创新PD-1抑制剂斯鲁利单抗一线治疗鳞状非小细胞肺癌国际多中心临床试验达到主要终点，上市注册申请获NMPA受理

The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for First-Line Treatment of sqNSCLC Accepted by China’s NMPA, Phase 3 MRCT Met its Primary Endpoint

Shanghai, China, September 16th, 2021 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of Serplulimab Injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with carboplatin and albumin-bound paclitaxel for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) has been accepted by China’s National Medical Products Administration (NMPA).

The NDA is based on the results from a randomised, double-blind, global multi-centre Phase 3 clinical trial in patients with locally advanced or metastatic squamous non-small cell lung cancer patients to compare Serplulimab Injection in combination with chemotherapy versus chemotherapy in respect of efficacy and safety. The study results demonstrated that Serplulimab can significantly extend the progression-free survival (PFS) of patients with good safety. In April 2021, the NMPA accepted and officially granted priority review for the NDA of Serplulimab Injection for the treatment of unresectable or metastatic microsatellite instability-high solid tumours that fail to respond to the standard therapy.

Prof. Caicun Zhou, the leading principal investigator and Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University Medical School, said, “This is the largest sqNSCLC MRCT (Multi-Regional Clinical Trials) led by Chinese researchers, with more than 500 subjects enrolled globally. The study results demonstrated that the predefined primary study endpoint had been reached, providing evidence of safety and efficacy. This milestone takes us one step closer to bringing a much-needed treatment option to patients living with sqNSCLC. We are hoping that approval of Serplulimab comes soon.”

“Serplulimab Injection is an innovative anti-PD-1 mAb independently developed by Henlius, and sqNSCLC is its second listed indication after MSI-H,” said Mr. Jason Zhu, Chief Medical Officer and Senior Vice President of Henlius. “Underpinned by the patient-centric strategy, we focus on addressing the clinical needs of high-incidence cancers worldwide and in China. We remain committed to implementing our ‘Combo+Global’ differentiation strategy with Serplulimab as the backbone, promoting immuno-oncology combination therapies and MRCT, speeding up the development of products in lung cancer and gastrointestinal cancer, and bringing a more hopeful future to patients worldwide.”

Henlius (2696.HK) 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. Up to date, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDAs) of 3 products accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has proactively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康® (rituximab), the first China-developed biosimilar, 汉曲优® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远® (adalimumab), the Company’s first product indicated for autoimmune diseases, the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX04 (bevacizumab), HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What’s more, Henlius has conducted over 20 clinical studies for 11 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.