Shanghai, China, 11th May, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the Company has entered into a license agreement with Suzhou NeuPharma Co., Ltd. (NeuPharma) in respect of a small-molecule inhibitor of BRAF V600E HLX208 (RX208). NeuPharma will grant Henlius an exclusive license to research, develop, produce, commercialize and sublicense the product in China (including Hong Kong, Macau and Taiwan regions). This collaboration is an important part of Henlius’ strategies to accelerate diversified innovation with a variety of drug targets and modalities to further enhance current pipeline.
BRAF V600E inhibitors can be used in the treatment of colorectal cancer, melanoma, and certain rare diseases including Erdheim-Chester Disease (ECD). Studies have shown that BRAF V600E inhibitor in combination with anti-EGFR monoclonal antibody can effectively improve the survival and prognosis of patients with colorectal cancer. The licensed product has a proprietary new chemical structure different from other marketed BRAF inhibitors, and it exhibited excellent anti-tumor efficacy and safety in preclinical studies. This product is currently in Phase 1 clinical study, and early clinical data have also suggested preliminary efficacy and minimal side effects in patients with cancer. It has the potential to become the Best-in-Class BRAF V600E inhibitor, and may have a synergy with Henlius’ proprietary EGFR or PD-1 targeted antibodies to enhance a high-quality, innovative and differentiated product portfolio for the treatment of various cancer types.
Henlius has accumulated rich experiences in global clinical trials and product commercialization in the field of oncology over the years. Its clinical development platform strictly complies with GCP standards and has passed several GCP inspections by the NMPA and the European Medicines Agency. Henlius will accelerate the clinical development and commercialization of this licensed product to full speed, leveraging its therapeutic potential in multiple cancer types to develop innovative and effective therapies for the patients. Looking forward, Henlius will further strengthen the in-licensing and collaboration on external high-quality innovative assets, to expand and upgrade its product pipeline and bring more affordable therapies to patients around the world.
About BRAF V600E Mutation
BRAF protein is an important upstream regulator of the MAPK/ERK signaling pathway, and the V600E mutation of BRAF can activate the downstream MEK protein, which induces the proliferation and invasion of tumor cells. The V600E mutation frequently occurs in colorectal cancer, thyroid cancer, melanoma and other types of cancers, which often predicts poor prognosis. Among those cancers, colorectal cancer is the second most common cancer in China, with a 5-15% BRAF V600E mutation rate.
NeuPharma is a clinical-stage biopharmaceutical company dedicated to the research and development of innovative anti-cancer medicines. The company was founded by a group of well-trained and experienced professionals in pharmaceutical industry. Through its proprietary drug discovery platform, NeuPharma has discovered and advanced several drug candidates into clinical trials.
 Thiel A, Ristimäki A. Toward a Molecular Classification of Colorectal Cancer: The Role of BRAF. Front Oncol. 2013 Nov 15;3:281.