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On June 28, A CMAB008 International Exclusive Commercial License Agreement was reached between Kexing Biopharm and Taizhou Mabtech Pharmaceutics Co., Ltd. to grant Kexing Biopharm an exclusive commercial license of CMAB008 infliximab generic drug in all countries and regions of the world except the Chinese mainland, Japan, Europe and North America.

CMAB008, a recombinant chimeric anti-TNF-alpha monoclonal antibody, is an infliximab biosimilar for the treatment of rheumatoid arthritis, adult and pediatric Crohn's disease, fistulizing Crohn's disease, ankylosing spondylitis, psoriasis and adult ulcerative colitis. It is expected to be approved for marketing in the Chinese mainland in 2021.

Remicade®, the originator infliximab, is the first TNF-α monoclonal antibody marketed in the United States, while infliximab biosimilars are still under application for marketing in China. Among them, CMAB008 was the first to apply and is expected to be the first infliximab biosimilar marketed in China.

Kexing Biopharm said that the antibody drugs in the commercial stage were introduced in this cooperation to enrich product lines and further improve the market layout, offering more treatment options for unmet clinical needs and satisfying the needs of doctors and patients. Meanwhile, the cooperation lays a foundation for overseas sales of self-developed products or introduced products in the future. It helps to increase overseas marketing channels, expand sales scale and enhance the international influence of Kexing Biopharm.

During the active involvement of Kexing Biopharm in overseas market layout in recent years, its sales network keeps expanding overseas. At present, Kexing Biopharm has cooperated with more than 30 countries and has been recognized in the industry for its international business capacity. Under the synergy of products sales at home and abroad, Kexing Biopharm is accelerating the introduction of upcoming or marketed products, as well as early to mid-term product technologies with high market expectations, and enriching the pipelines of products on sale or under research. On April 26, a cooperation agreement on the antitumor drug HC007 was reached between Kexing Biopharm and Haichang Biotech to grant Kexing Biopharm a development and commercial license of the drug in all regions except the United States.

Kexing Biopharm, as a leader of recombinant protein drugs in China, has the vision to become a leader of high-quality biopharmaceuticals. It believes that Chinese medicine must take root and blossom both at home and abroad. After years of international market expansion, Kexing Biopharm has accumulated a series of mature and effective experiences in international business. Given this, it will make full use of its comprehensive strength, aiming to make Chinese high-quality biopharmaceuticals step into the global market and serve global patients.

About CMAB008

CMAB008 (infliximab), a recombinant chimeric anti-TNF-alpha monoclonal antibody, is a brand-new candidate of infliximab for the treatment of moderate-severe active rheumatoid arthritis. It is expected to be one of the best-in-class chimeric anti-TNF-alpha antibodies in China. CMAB008 is the first chimeric anti-TNF-alpha antibody approved by the National Medical Products Administration and developed by a domestic company for clinical trials in China.

According to the completed phase III head-to-head clinical trials, CMAB008 has similar safety and efficacy to marketed infliximab products.