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Sanofi’s partner JHL Biotech accepted for clinical trial in China

JHL Biotech said Wednesday its Clinical Trial Application (CTA) for use of its first product in pipleine, JHL1101 in Phase 1 and Phase 3 clinical trials in Non-Hodgkin’s Lymphoma patients has been accepted by the China Food and Drug Administration (CFDA).

JHL1101 is a proposed rituximab biosimilar that JHL is pursuing as part of its strategic biologics alliance with Sanofi, and it is the first product in JHL’s pipeline.

ituximab is used to treat Rheumatoid Arthritis (RA) and Non-Hodgkin’s Lymphoma (NHL). In China, rituximab is used to treat NHL. Each year, about 4.3 million Chinese are diagnosed with cancer, and about 80,000 of these diagnoses are NHL.

JHL is the only Greater China-based biosimilars developer to have received European Union and Taiwanese regulatory approval to conduct clinical trials of the proposed rituximab biosimilar JHL1101 versus European MabThera in anti-tumor necrosis factor (TNF) inadequate responder patients with moderate to severe rheumatoid arthritis.

Racho Jordanov, JHL’s co-founder and CEO, said this is JHL’s first step towards making an important oncology therapy more accessible and affordable to Chinese patients. “I am exceptionally proud of our fantastic team for making JHL1101 a reality,” he said.

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