August 30, 2019, Shanghai, China - HaiHe Biopharma, a biopharmaceutical company focusing on the discovery, development and commercialization of innovative anti-tumor drugs,, announced that the first patient has been dosed in the Phase Ib clinical trial (AL3810-101) of the company's innovative drug Lucitanib combined with Toripalimab.

The purpose of this study was to evaluate the safety and tolerance of Lucitanib combined with Toripalimab in the treatment of advanced solid tumors. The principal investigator of this clinical trial is Professor Li Jin, Director of the Department of Oncology, Oriental Hospital affiliated to Tongji University.

Lucitanib (Code: AL3810) is a three-target oral small molecule kinase inhibitor targeting FGFR1–3, VEGFR1–3 and PDGFRα/β, which is jointly studied by Shanghai Institute of Materia Medica, Chinese Academy of Sciences and its partners. HaiHe Biopharma is responsible for the clinical development, production and commercialization of the drug in China. Preclinical studies have shown that the compound Lucitanib has a strong antitumor activity in vitro and in various animal tumor models. Clinical studies conducted in Europe have shown itsefficacy on alignant tumors including breast cancer and NSCLC etc. with manageable safety.

In March 2018, the New Drug Application (“NDA”) for JS001, a recombinant humanized anti-PD-1 monoclonal antibody for injection, was accepted by the NMPA. On 17 December 2018, Junshi Biosciences’ anti-PD-1 therapy toripalimab was conditionally granted marketing approval for use in the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy by the NMPA, which is the first commercialized product of Junshi Biosciences. In the pivotal clinical trial, patients were observed with the ORR of 17.3% and the DCR of 57.5%, and the one-year overall survival rate is 69.3%. The NDA approval of toripalimab witnessed the pivotal step from pre-revenue biotech start-up to a commercial-stage biopharmaceutical company.

Haihe Biopharma is an innovation-driven biotechnology company in China focusing on the discovery, development, production and commercialization of innovative anti-tumor drugs. Haihe brings life-saving therapies to cancer patients worldwide. It also has a research and management team with a global perspective, and is proactively mapping out the international development of innovative drugs. The Company currently has thirteen key drug candidates. As of today, Haihe Biopharma has received 21 IND or clinical trial approvals in four countries and regions. 

Junshi Bioscieces is an innovation-driven biopharmaceutical company which is dedicated to the discovery and development of innovative drugs and their clinical research and commercialization on a global scale. Our mission is to provide patients with treatment options that work better and cost less. Based on the core platform technology of protein engineering, Junshi Biosciences stands at the frontier of R&D of macromolecular drugs. With distinguished capability of innovative drug discovery, advanced biotechnological R&D, large-scale production capacity on the full industry chain and rapidly expanding drug candidate portfolio of tremendous market potential, Junshi Biosciences has a leading edge in the PRC in the emerging field of immuno-oncology and for the treatment of autoimmune and metabolic diseases. Junshi Biosciences is the first PRC company to obtain NDA approval from the NMPA for anti-PD-1 monoclonal antibody, and also the first PRC company to receive IND approvals from the NMPA for anti-PCSK9 monoclonal antibody and anti-BLyS monoclonal antibody. Our vision is to become a pioneer in the area of translational medicine by developing first-in-class and best-in-class drugs through original innovation. With enrichment of our product pipelines and exploration of drug combination therapies, Junshi Biosciences has expanded its innovation to the R&D of more types of drugs, including small molecule drugs and antibody drug conjugates (or ADCs), as well as to the exploration of the next-generation innovative therapies for cancer and autoimmune diseases.

Please visit the company website for more information: http://www.junshipharma.com