CFDA released the 2016 Annual Report of Release of Biological Products written by the National Institutes for Food and Drug Control of China on July 4, which has made statistics of biological products included in release management. The applications for biological products other than those included in release management are also being conducted in full swing, however, most Chinese pharmaceutical enterprises, due to a lack of powerful strength, are focusing on the biosimilars of import biological products. I have recently noticed that the applications for biosimilars of the blockbuster variety Rituxan of Roche are extremely fierce in China, with more than a dozen enterprises having conducted relevant application. The Chinese "Rituxan" is expected to be marketed in the next few years.

The only anti-CD20 monoclonal antibody marketed in China

CD20 is a transmembrane phosphoprotein that is expressed on the surface of B lymphocytes. Besides the expression in normal B cells, CD20 is also expressed in tumor cells of B-cell lineage lymphoma and leukemia, etc., and in B cells involved in immune diseases and inflammatory diseases, and the anti-CD20 monoclonal antibody is a monoclonal antibody targeting CD20. Anti-CD20 monoclonal antibodies have developed to the third generation, however, the first-generation anti-CD20 monoclonal antibodies represented by Rituxan (rituximab) is still leading in the sales as the second and third generations have not been obtained breakthroughs in the treatment of DLBCL, the largest subdomain of B-cell lymphomas.

As a chimeric murine/human monoclonal antibody originally developed by IDEC Pharmaceuticals (currently under Biogen), Rituxan was approved the marketing by FDA in 1997, with the present indications approved by FDA including: Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Wegener's granulomatosis (WG) and Microscopic Polyangiitis (MPA), and the first is worth mentioning here: Rituxan is the world’s first monoclonal antibody approved for treating NHL, with the combination of Rituxan and the chemotherapeutic drug CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone) and the combination of Rituxan and CVP (cyclophosphamide, vincristine, and prednisone) separately being the standard regimen for diffuse large B-cell lymphoma and follicular lymphoma.

Having entered China since 1999, Rituxan is the only anti-CD20 monoclonal antibody marketed in China, with the indications approved in China mainly including CD20-positive follicular NHL and diffuse large B-cell NHL.

CP Guojian Pharm and Innovent Biologics expected to take the lead in occupying the Chinese market

There are more than a dozen Chinese pharmaceutical enterprises applying for anti-CD20 monoclonal antibody, including Henlius (subsidiary of Fosun Pharmaceutical), Innovent Biologics, Hisun Pharmaceutical, and Livzon Group, etc.

Main pharmaceutical enterprises applying for anti-CD20 monoclonal antibody

Wherein, according to the acceptance numbers in the above table, CP Guojian Pharma is the fastest in the application progress, having completed Phase III clinical trial, however, it withdrew the new drug application in the clinical self-inspection in 2016; the second is the Rituxan biosimilar applied by Innovent Biologics which has been started the Phase III clinical efficacy contrast test from November 2016.

The potential market size of about RMB 3 billion

The 2016 global sales of Rituxan were about USD 7.2 billion, with the compound annual growth rate in last 5 years of 2%, ranking 5^th among global pharmaceutical product sales, and according to IMS data, the total sales of Rituxan in Chinese hospitals were about RMB 1.2 billion in 2015. Certain professional in the industry forecast that the anti-CD20 monoclonal antibody market of China could reach about RMB 30 billion in the future, wherein, the potential market size of Chinese anti-CD20 monoclonal antibodies could reach about RMB 2 billion. Which Chinese enterprise will produce the first Chinese "Rituxan"? We will stay focused.

About the author: Caicai, a Master of Pharmacy from Shanghai Jiaotong University, ever worked in an institute for scientific and technical information, currently a practitioner of the drug administration system, good at interpreting industry regulations and latest drug research dynamics, etc.