henlius biotech’s anti-pd-1 antibody receives approval for taiwan clinical trials
recently, shanghai fosun pharmaceutical (group) co., ltd (referred to “fosun pharma”) announced that hlx10-recombinant humanized anti-pd-1 monoclonal antibody injection (the “new drug”) received the approval letter from “taiwan food and drug administration, ministry of health and welfare” (“tfda”) for clinical trials of solid tumors treatment, which was researched by henlix biotech inc. ("henlix biotech"), a holding subsidiary of shanghai henlius biotech., inc. ("henlius biotech"), the biologics platform of fosun pharma.
hlx10 is an iconic monoclonal antibody in innovative product line of henlius biotech. in july 2017, hlx10 was submitted for investigational new drug (“ind”) to china food and drug administration (“cfda”). meanwhile, subsequent to hlx06 and hlx07, hlx10 received the approval from food and drug administration, u.s. (“fda”) for clinical trials of solid tumors treatment in september 2017, officially becoming henlius biotech’s third innovative monoclonal antibody approved by fda for clinical trials.
until 19 december 2017, opdivo and keytruda are two recombinant humanized anti-pd-1 monoclonal antibody injections launched in the global market with no similar products with the same targeted therapy launched in china (excluding hong kong, macau and taiwan). according to the latest data from ims health, a leading provider of information, strategic consultation services for healthcare industry, global sales revenue of recombinant humanized anti-pd-1 monoclonal antibody injections was approximately usd 5.3 billion in 2016. until november 2017, fosun pharma has invested rmb 41 million on r&d for the “new drug”.
“affordable innovation has always been our primary concern,” said dr. scott liu, president and ceo of henlius biotech. based on this, henlius biotech lowers costs with high quality-assurance by adopting a variety of innovative technologies:
(1) adoption of the improved high-titer cell lines: normally, an average yield for a cell line of monoclonal antibody is about 1 gram per liter, while the average yield for henlius biotech’s improved cell line is 2-3 grams per liter. the enhancement of yield in unit volume leads to the natural cost reduction.
(2) application of the advanced large-scale (2000l) single-use production technology, which was newly introduced in 2008: this brings lower costs in building manufacturing plants and operating as well as improving operational efficiency and production flexibility.
(3) self-developed cell culture media by r&d team being out-sourced to foreign companies for mass production: this leads to the significantly reduced cost compared with direct purchase of imported media.
(4) advanced plant design with multi-product lines setup: the development of multiple products has increased the plant utilization rate, diluted fixed costs and developed scale economies effect. until now, henlius biotech has completed the declaration for 9 products.
in addition, with the belief of “affordable innovation for patients”, henlius biotech sticks to the strategy of combination therapy. as most european and american pharmaceutical companies incurred high r&d costs for antibodies, the unaffordable price has always been the greatest challenge in combination therapy field. henlius biotech creates a comparative cost advantage through applying a variety of innovative technologies to reduce production costs, where two to three antibodies used in combination therapy have comparable price to an imported monoclonal antibody in the market. this substantial comparative advantage in price can significantly improve the accessibility of the combination therapy, benefiting for more patients in the future.
as fosun pharma biologics platform, henlius biotech will continue to pursue technical innovation and operational excellence in drug discovery and development to improve patients’ lives by timely providing them with quality and affordable protein therapeutics, and strive to be the most admired biotech company in the world. fosun pharma always regards innovation as the driving force for its business growth and continuously optimizes its pharmaceutical r&d system that integrates biosimilars and innovative drugs. in recent years, fosun pharma has been continuing to increase r&d investment and has formed an international layout for r&d with relative strong capabilities.