The 24^th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) is held online and in-person from 25^th to 29^th September 2021. In this meeting, Henlius releases phase 2 study results of serplulimab (HLX10, novel anti-PD-1 antibody), in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumours in an oral presentation. In April, the New Drug Application (NDA) of serplulimab for the treatment of MSI-H solid tumours was accepted by the National Medical Products Administration (NMPA) and granted priority review, which is expected to be approved in the first half of 2022. What's more, the NDA of serplulimab for the treatment of squamous non-small cell lung cancer is also under review.

With the "Combo+Global" strategy, serplulimab has been approved for clinical trials in China, the United States, the European Union, as well as other countries and regions. To evaluate the safety and efficacy of serplulimab, Henlius has conducted 10 immuno-oncology therapy clinical studies covering cancers with high incidence rates, including lung cancer, esophageal cancer, hepatocellular cancer, gastric cancer, head and neck cancer, etc. Up to date, about 2300 patients have been enrolled worldwide, proving that the quality of serplulimab has built trust in foreign markets.

Details of this study are as follows:

This single-arm, open-label, multi-centre, phase 2 study aimed to evaluate the efficacy, safety, and tolerability of HLX10 in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumours who have progressed on or been intolerant to standard therapies. Eligible patients were recruited to receive 3 mg/kg HLX10 every two weeks intravenously for up to 2 years until disease progression, unacceptable toxicity, or patient withdrawal. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1.

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.