The second domestic Kexing Pharmaceutical 36000IU specification of erythropoietin was approved

Shanghai Securities News China Securities Network News Kexing Pharmaceutical recently issued an announcement that its applicant, Erythropoietin 36000IU, has been approved and issued by the State Food and Drug Administration of the "Notice of Approval of Drug Supplement application". This means that one of the core drugs of Kexing Pharmaceutical, human erythropoietin injection (36000IU/1ml/branch specification) will be officially used to treat anemia caused by chemotherapy for non-bone marrow malignancies, and the company will become the second enterprise to have this specification of human erythropoietin drugs.

It is understood that there are three kinds of domestic treatment measures for cancerous anemia: human erythropoietin injection therapy, blood transfusion treatment or iron and vitamin supplementation, of which human erythropoietin treatment has a significant effect in alleviating cancerous anemia. There are also a number of authoritative guidelines at home and abroad, including ASCO/ASH guidelines (American Clinical Oncology Association and American Blood Association), NCCN guidelines (National Comprehensive Network of The United States), and CSCO guidelines (Chinese Clinical Oncology Association) all recommend the use of erythropoietin for the treatment of "anemia caused by chemotherapy for non-bone marrow malignancies". Large-sized 36000IU people only need to inject erythropoietin once a week, which significantly reduces the frequency of medication, and can greatly improve patients' medication compliance under the premise of equivalent efficacy. Before Kexing Pharmaceutical, there was only one human erythropoietin 36000IU on the market in China. At present, the National Medical Insurance Bureau has included human erythropolybin in the treatment of tumor-related anemia into the scope of medical insurance reimbursement.

In the domestic human erythropoietin market, the market share of recombinant human erythropoietin injection (iprudin) of Kexing Pharmaceutical ranks among the top three, and it is also one of the fist products of Kexing Pharmaceutical. From 2017 to 2020, the sales revenue of Kexing Pharmaceutical's restructured human erythropoietin in China was 209 million yuan, 329 million yuan, 424 million yuan and 501 million yuan, respectively, and its market share was also continuously improving, from 2017 to 2020, it was 9.36%, 11.27%, 12.51% and 13.19% respectively.

At the same time, human erythrin products (iprin) have obvious export advantages in similar domestic products, and have been exported to more than 30 countries such as Brazil, the Philippines and Indonesia. As the benchmark of erythropoietin, Kexing Pharmaceutical's iprudin has been clinically used for more than 20 years, and its safety and efficacy have been proven by extensive clinical use, and it is a first-line clinical drug.

Kexing Pharmaceutical said in the announcement that the new indications and new specifications of human erythropoietin injection have obtained supplementary application approvals, which is conducive to expanding the market share of the drug in the field of oncology. In addition, the human granulocyte stimulating factor developed by Cosh Pharmaceutical is also applied to cancer chemotherapy and other reasons leading to neutropenia, coupled with the recent introduction of new products by the company, such as albumin paclitaxel and bevacizumab, Cohin Pharmaceutical has formed a series of product portfolios in the field of oncology. The layout of multiple measures will further enhance the company's market competitiveness and play a positive role in the future operation and development of Kexing. (Tan Pengpeng)