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The 2nd Combination Immunotherapy of Henlius Received Notification of Acceptance


Henlius recently has received notification of acceptance from the China National Medical Products Administration (NMPA) for its investigational new drug (IND) application of HLX10, a recombinant humanized anti-PD-1 monoclonal antibody (mAb) injection, in combination with HLX07, a Recombinant Humanized Anti-EGFR mAb Injection, for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.

HLX07, which targets EGFR, is a cetuximab biobetter developed by Henlius with independent intellectual property rights. HLX07 is bioengineered with the potential for the treatment of various solid tumors, such as colorectal cancer and head and neck cancer. As of October 2016, HLX07 has been approved to conduct clinical trials in mainland China, Taiwan China and the United States. HLX10, which targets PD-1 receptor with the potential to use in immunotherapy for oncology, is a bio-innovative (novel biologic) also developed by Henlius with independent intellectual property rights. As of March 2018, HLX10 also received IND approvals in the same regions as of HLX07.

In September 2018, the combination immunotherapy of HLX10 and HLX04 (Recombinant anti-VEGF Humanized mAb Injection) received clinical approval from NMPA to treat advanced solid tumors, making it one of the few combination immunotherapies approved to conduct clinical trial in China. Furthermore, this combination therapy clinical trial has dosed the first subject in mainland China.

About Combo Therapy

Combination immunotherapy employing immune checkpoint inhibitors such as anti-PD-1/L1 with 1 or 2 target monoclonal antibodies to enhance the immune system and achieve synergistic antitumor activity has recently demonstrated improved safety and efficacy in oncology. HLX10 (anti-PD-1 mAb) and HLX20 (anti-PD-L1 mAb) are both Henlius novel biologics with the potential use in the treatment of various solid tumor and hematologic cancers as monotherapy or combined with other therapies.

The high treatment cost is the potential issue for combination immunotherapy. Through operational excellence, Henlius manages the research, development and manufacturing costs to ensure a robust combination therapy through our portfolio. Henlius believes its combination immunotherapy may possibly be priced similar to a single immunotherapy from other companies, leading to the greater patients’ affordability and accessibility for these effective treatments.

About Henlius

Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in February 2010, with its R&D footprint in Shanghai, Taipei, China 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 auto-immune disease.

Until now, Henlius has completed IND/CTA filings of 13 products and 2 combination therapies with 23 indications and obtained 29 successful IND/CTA approvals (19 approvals from China; 3 from the United States; 3 from Taiwan,China; each 1 from the European Union, Ukraine, Philippines and Australia). The first product of Henlius HLX01(rituximab injection) has granted approval by the China National Medical Products Administration (NMPA) as the first approved biosimilar in China and another important product of Henlius HLX03 has its New Drug Application under review.