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Important News! Henlius Combination Therapy Received Approval to Conduct Clinical Trials in China


Recently, Henlius has received an approval from National Medical Products Administration (NMPA) for its combination therapy with HLX10 (recombinant humanized anti-PD-1 monoclonal antibody injection) and HLX04 (recombinant anti-VEGF humanized monoclonal antibody injection) to treat advanced solid tumors.

“Henlius is committed to developing high-quality biologics to build a robust monoclonal antibody portfolio and proactively leveraging this portfolio to explore the combination therapy of monoclonal antibody (mAb) products in order to lead and promote the development of combination therapy in China.” said Dr. Scott Liu, the President and Chief Executive Officer of Henlius.

About HLX10

Since June 2017, Henlius submitted clinical trial applications for HLX10 to the Food and Drug Administrations in mainland China, Taiwan China and the United States respectively. As of March 2018, HLX10 was approved to conduct clinical trials for solid tumors in all the three locations with its phase I study being conducted successfully in Taiwan China.

About Combination Therapy

Combination of immune checkpoint blockage such as anti-PD-1/L1 with 1 or 2 monoclonal antibodies to achieve synergistic antitumor activity is one of the latest trends in tumor treatment.HLX10 (anti-PD-1 antibody) and HLX20 (anti-PD-L1 antibody) are both strategic products of Henlius novel mAb portfolio, with the potential use as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. 

The high treatment expense is the potential issue for combination therapy. The cost of manufacturing biological products remains high in many pharmaceutical companies in Europe and the United States, resulting in approximately over $100,000 USD per year for a single course of immunotherapy, and over $200,000 USD per year for combination immunotherapy. The high expenses is a huge financial burden to the patients even in the developed countries. In contrast, Henlius’ advantage in terms of pricing becomes significant. Henlius manages to reduce the manufacturing costs to make all of its products more cost-effective. Henlius believes that its combination therapy which contains 2-3 mAbs will be no more expensive than a single imported mAb, leading to the greater patients’ affordability and accessibility.

Moving forward, with the existing signature products HLX10 and HLX20, Henlius will be dedicating to fully utilize its robust product portfolio to come up with more affordable and efficacious combination therapies for more patients.

About Henlius

Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in December 2009, with its R&D footprint in Shanghai, Taipei and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, bio-better and novel monoclonal antibody, to treat tumor and autoimmune disease.

As of now, Henlius has completed IND/CTA filings of 12 products and 1 combination therapy with 20 indications and obtained 25 successful IND/CTA filings (15 approvals from China; 3 from the United States; 3 from Taiwan; 1 from the European Union; 1 from Ukraine; 1 from Philippines and 1 from Australia).