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ND Application of Henlius (Committed to the Patient Affordable Innovation) for Another Innovative McAb

07-11 2017

Recently, Henlius - Shanghai Fosun Pharmaceutical (Group) Co., Ltd 's (“Fosun Pharma”; Stock Code: 600196.SH, 02196.HK) platform for innovation of biological drugs has applied for Investigational New Drug (IND) to China Food and Drug Administration – the independently developed "Recombinant Anti-PD-1 Humanized Monoclonal Antibody (McAb) Injection". In the first half of 2017, Henlius has completed the IND application for two innovative McAb projects.


PD-1-targeted antibody drugs are applicable to cancer immunotherapy, which attack the tumor cells by stimulating the own immune system of patients. Since 2014, US FDA has approved the indications to be extended from melanoma to non-small cell lung carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, Hodgkin's lymphoma and Merkel's cell carcinoma. Such drugs are broad-spectrum anti-carcinogenic drugs of Class I which are not distinguished based on the tumor source. A paper recently published in the Journal of Science has also demonstrated the "broad-spectrum anti-carcinogenic action", and a number of pharmaceutical enterprises at home and abroad have joined the R&D of PD-1-targeted antibody drugs.


At present, the recombinant anti-PD-1 humanized McAb injection marketed in the world includes Opdivo and Keytruda, and no recombinant anti-PD-1 humanized McAb injection has been marketed in China (excluding Hong Kong, Macao and Taiwan) yet. According to the IMS MIDASTM information, the annual global sales of recombinant anti-PD-1 humanized McAb injection was approximately US$ 5.3 billion in 2016.


Fosun Pharma always takes independent innovation as the source power for enterprise development, and has been continuously improving the drug R&D innovation system of "combining generic drugs with innovative drugs". In recent years, Fosun Pharma has continuously increased the investment in the R&D of chemical innovative drugs and biological drugs, forming the internationalized R&D layout and the strong R&D ability. Dr. Scott Liu, President and CEO of Henlius, said, "What Henlius highlights is 'Patient Affordable Innovation', and Henlius shoulders the great mission to 'improve patients’ lives by timely providing them with quality and affordable protein therapeutics through technical innovation and operational excellence'. Henlius will focus on supply of biological drugs of high quality and competitive price by constant exploration and development, committed to be the most admired biotech company providing innovative and affordable medicines to all patients."