SHANGHAI, China I March 11, 2021 I Shanghai Henlius Biotech, Inc. (2696.HK) announced the first patient was dosed in a Phase II/III clinical trial (NCT04547166) of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, in combination with HLX04 (bevacizumab) and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC). Currently, there are few studies exploring immuno-oncology combination therapies in this patient population in China and this study is in a leading position in this area. Professor Ruihua Xu of Sun Yat-Sen University Cancer Center is the leading principal investigator of this study.

Immuno-oncology mAbs combination therapies based on proprietary products, expecting to benefit first-line mCRC patients

CRC is the second common malignancy and the fifth leading cause of cancer deaths in China. There are about 521,000 new diagnosed cases in 2018[1] and the incidence increases with age. Metastasis happens frequently in colorectal cancers and the majority of patients with colorectal cancer are diagnosed at advanced stages[2]. The most common sites for metastasis are liver, lung and abdominal cavity, among which liver metastasis is most frequently seen, and about 50% of mCRC patients suffer from liver metastasis[3]. Currently, colorectal cancer treatment may include some combination of surgery, radiation therapy, chemotherapy and targeted therapy. Combining bevacizumab with chemotherapy is the standard first-line treatment for mCRC, which can significantly improve survival rates. The New Drug Application (NDA) of HLX04 has been accepted by the National Medical Products Administration (NMPA), potentially for the treatment of advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer.

Studies have indicated that anti-PD-1 mAbs are effective in treating mCRC[4]. The exploration of HLX10 in combination with HLX04 in the first-line of mCRC treatment aims to benefit patients with immuno-oncology mAbs combination therapy as early as possible, further delaying the disease progression and improving the survival status of patients with mCRC. Moreover, HLX10 in combination with HLX04 is the first domestic mAbs combination therapy approved for clinical trials in China, which has been carried out late-stage clinical studies in non-small cell lung cancer and hepatocellular carcinoma previously.

Nine immuno-oncology mAbs combination therapies trials ongoing, “Combo+Global” differentiation advantages significant

HLX10 is a novel anti-PD-1 mAb independently developed by Henlius and has the potential to treat a variety of solid tumours. A differentiated strategy of “Combo + Global” is adopted by Henlius in the development of HLX10. Henlius fully leverages proprietary extensive pipeline across different categories of targets including tumour-specific target, angiogenesis target, immunotherapeutic target, etc. to conduct immune combination therapies. At present, HLX10 has been approved for clinical trials in Chinese mainland, the United States and Taiwan China successively. Two monotherapies and nine immuo-oncology combination therapies clinical trials with HLX10 are ongoing in Henlius pipeline. Many of them are global multi-centre clinical trials with a variety of solid tumours that cover lung cancer, gastric cancer, cervical cancer, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma and head and neck carcinoma etc. What’s more, HLX10 on MSI-H/dMMR solid tumours has entered Phase 2 clinical trial, Henlius is expected to submit NDA based on its data on HLX10.

With the continuous development of “Combo+Global” strategy of HLX10 and diversified pipeline of innovative drug candidates of Company, Henlius is actively accelerating innovation transformation, improving innovation efficiency, and committing to bringing high-quality and affordable innovative biologics to patients around the world.

About NCT04547166
This is a multi-centre, randomised, double-blind, parallel-controlled, three-stage phase II/III study, aimed to evaluate HLX10 combined with HLX04 and chemotherapy (XELOX) versus placebo combined with Avastin® and chemotherapy (XELOX), as first-line treatment for metastatic colorectal cancer (mCRC). Stage 1 is a single-arm safety run-in study primarily aimed to evaluate the safety and tolerability of HLX10 combined with HLX04 and chemotherapy as first-line treatment in mCRC patients. Stage 2 is a multicentre, randomised, double-blind, parallel-controlled phase II study whose primary objective is to compare the efficacy between two treatment groups through the evaluation of progression-free survival (PFS). Secondary objectives include the evaluation of other efficacy endpoints, pharmacokinetic profiles, safety, and tolerability. Stage 3 is a phase III study that will be conducted based on the phase II primary efficacy results, and it follows the study design and has the same primary and secondary objectives as phase II study.

About Henlius

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. 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 centers and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).

Henlius has pro-actively 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 HLX10 (anti-PD-1 mAb) as backbone. Up to date, Henlius has launched three mAbs developed independently: 汉利康® (HLX01, rituximab), the first China-developed biosimilar, 汉曲优® (HLX02, trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远® (HLX03, adalimumab), the Company’s first product indicated for autoimmune diseases. In addition, the New Drug Applications of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review, and Henlius has conducted over 20 clinical studies for 10 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.