henlius, biologics platform of fosun pharma receives fda approval for drug clinical test again-凯发k8娱乐app下载

henlius, biologics platform of fosun pharma receives fda approval for drug clinical test again-凯发k8娱乐app下载

2017-09-30

henlius, biologics platform of fosun pharma receives fda approval for drug clinical test again


henlius, the biologics platform of fosun pharma, announced recently that it has received fda approval for drug clinical test for hlx10 - recombinant humanized anti-pd-1 monoclonal antibody injection (the “new drug”), a new drug independently developed by its subsidiary taiwan henlius. in early this month, another innovative monoclonal antibody drug developed by henlius - recombinant humanized vegfr2 monoclonal antibody injection (hlx06) was just approved for clinical test in the united states. 

 

hlx10 is a representative new drug in the monoclonal antibody product line of henlius. the new drug targets at the pd-1 and is designed to treat the solid tumor by stimulating the immune system of the patient to attack the tumor cells. henlius submitted ind application to china food and drug administration for the new drug in july this year. following hlx06 and hlx07, the new drug is the third innovative monoclonal antibody drug for which clinical test application has been carried out in three regions (usa, mainland china, taiwan), further driving the development of the monoclonal antibody product line of henlius.

 

it is reported that the recombinant humanized anti-pd-1 monoclonal antibody injection products offered in global market include opdivo and keytruda while no recombinant humanized anti-pd-1 monoclonal antibody injection has launched in china. according to the data of ims midastm, the global sales amount of anti-pd-1 monoclonal antibody injection in 2016 was approximately usd 5.3 billion. as of august 2017, fosun pharma has invested rmb 37 million for the r&d of the new drug.

 

innovative monoclonal antibody product line of henlius

as the first product in the innovative monoclonal antibody product line of henlius, hlx07 - recombinant humanized anti-egfr monoclonal antibody injection was approved for clinical test in mainland china, taiwan and usa in october 2016. and phase i clinical test of hlx07 has been carried out in taiwan. it will be used to treat various diseases in the future, including colorectal cancer and head and neck cancer.

 

hlx06 - recombinant humanized anti-vegfr2 monoclonal antibody injection is a monoclonal antibody targeted drug developed by the innovative monoclonal antibody r&d platform of henlius with independent intellectual property. the mechanism of action of this product is different from ramucirumab. as an innovative “first in class” drug, it will be used to treat the solid tumor in the future. in addition, it is reported that there are other several ongoing projects in the innovative product line of henlius, such as the innovative monoclonal antibody products targeting at pdgfrα and pd--l1, hlx08 and hlx20, which are in the preclinical study stage.


henlius is committed to offering patients with affordable innovative drugs, and takes independent innovation as the source power for enterprise development. based on the concept of “patient affordable innovation”, henlius adopts many innovative technologies to reduce the cost while ensuring high quality: 1) adopting cell line with high level expression. the antibody output of ordinary cell line is 1g/liter, while the output of the cell line modified by henlius can reach 2-3g/liter. the improvement of yield per unit volume naturally leads to cost reduction. 2) adopting the advanced large-scale (2000l) one-off production technology which first came out in 2008 to reduce the facility construction and operation cost and improve the operation efficiency and flexibility. 3) in-house development of cell culture medium by r&d team, with the production outsourced to foreign companies, rendering a much lower cost when compared with the purchase of imported cell culture medium. 4) design of advanced facilities which allow for production of multiple product lines. henlius has completed the application for eight products for the moment. the comprehensive development of multiple products has increased the utilization rate of the facilities, diluted the fixed cost and helped to create economies of scale.

 

in addition, henlius has made a strategic planning that is good for both attack and defense in the development of innovative monoclonal antibody: to make down-to-earth and modified innovation. that is, to develop monoclonal antibody for the clinically proven targets, in order to reduce the product development risk and cost, monoclonal antibodies have been developed for the clinically proven targets. if the newly developed monoclonal antibody has no significant difference with the drugs in the market in terms of clinical performance and safety, it can enter the markets of china and other emerging markets quickly thanks to its price advantage. if the new product is better than the existing drugs in efficacy or safety, we can cooperate with the internationally leading pharmaceutical manufacturers to carry out international multi-center clinical tests, in order to offer the product in the markets of europe and usa, thus benefiting the patients around the world.

 

looking forward, as the biologics platform of fosun pharma, henlius will be dedicated to improving patients’ lives by timely providing with high- quality and affordable protein therapeutics through technical innovation and operational excellence, focus on supply of biological drugs of high quality in competitive price, strive to be the most respected biotech company.