The 8th Annual BioPharma Industry Awards Ceremony was concurrently taking place with 2018 Phar East Asia Pharma & Biotech Festival at Singapore on 1stMarch 2018. At the awards ceremony, Shanghai Henlius Biotech, Inc. (Hereinafter referred to as Henlius) had the honor to win “Asia Biotech of 2017” due to its promising and outstanding performance in the past few years. Several important milestones in the company’s history had been hailed in the ceremony and they can be chalked up as major accomplishments. Being awarded as “Asia Biotech of 2017” does not only accredit Henlius on the account of its impressive performance but also the company’s potential influence upon Asian, and even global biopharmaceutical market.
So far, Henlius has accomplished IND filings of 9 products with 16 clinical indications. Three of these products have entered phase III clinical trials. The achievements that Henlius managed to get in 2017 were in not doubt, brilliant and spectacular. Firstly, Henlius first product HLX01 (Rituximab) filed its first new drug application (NDA) to CFDA in Oct 2017. The application was soon accepted and assigned by CFDA into their priority evaluation list. Secondarily, Henlius second biosimilar product HLX02, which is a Trastuzumab Biosimilar, is conducting a global phase III trial and the clinical trial approvals have successively been obtained in Ukraine, Poland and Philippines last year. HLX02 is also the first Chinese biosimilar product that gets study approvals outside of China. Moreover, the company’s third biosimilar product HLX03, once again, makes Henlius a pioneer in Chinese biosimilar drug development area by being the very first few Adalimumab biosimilars that enter phase III clinical trials for treatment of psoriasis.
Apart from monoclonal antibody (mAb) biosimilars, Henlius also puts in tremendous amount of time and effort developing its innovative product pipeline. HLX07(anti-EGFR mAb), the first novel mAb by Henlius, is approved to conduct clinical trials in Mainland China, Taiwan China and the United States. A phase I study of HLX07 is currently being conducted in Taiwan China. HLX06 (anti-VEGFR2 mAb), Henlius’ second innovative mAb, also received IND approvals in the same areas. The approvals from US and Taiwan China were gained in September and November 2017 respectively and its phase I study in Taiwan China has already initiated.At the same year, phase I first in human study of HLX10 which is a novel PD-1 inhibitor, was officially approved by the FDA and TFDA(study in Taiwan China is currently recruiting patients). HLX10 is said to have a large potential to be applied widely in cancer immunotherapy in the future.
About Biopharma Industry Awards
BioPharma Asia Convention is one of the leading communication platforms for investors, stakeholder, pharmaceutical and biotechnology companies. The Biopharma Industry Awards aims to accredit the most potential entities, either organizations or individuals, for their dedicating achievements in Asia's burgeoning biopharmaceutical industry; to recognize and reward creativity and initiative; to stimulate passions and create a healthy environment for biopharmaceutical and biotechnological value chain.ng efforts and the drive of core value “Quality, Speed and Innovation’’, Henlius has created a high-tech platform for research, development and industrialization of monoclonal antibodies and is now possessing multiple competitive pipelines. What is also worth mentioned here is that Henlius has always been applied globally recognized compliance standards in drug manufacturing process and it has successfully broken the technology barriers that major international pharmaceutical companies placed on monoclonal antibodies. In the global gigantic monoclonal antibody market, the game players are only those big pharmaceutical companies.