Beijing News (Reporter Liu Xu) On the evening of February 19, Qilu Pharmaceutical announced that its anti-tumor drug, Azacitidine for Injection, had been approved for marketing by the National Medical Products Administration and was deemed to have passed the consistency evaluation.
Azacitidine is a cytidine nucleoside analog that exerts its antitumor effect by inducing DNA demethylation, restoring the normal function of tumor suppressor genes that are hypermethylated, and exerting direct cytotoxic effects on abnormal hematopoietic cells in the bone marrow. It belongs to the class of demethylating antitumor drugs. It is indicated for the treatment of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) with 20%-30% bone marrow blasts, and chronic myelomonocytic leukemia (CMML). Azacitidine has become one of the first-line treatments for myelodysplastic syndromes and acute myeloid leukemia, especially suitable for elderly patients who are not candidates for high-intensity chemotherapy or hematopoietic stem cell transplantation.
Azacitidine for Injection, originally developed by U.S.-based Celgene Corporation, was approved for marketing in China in 2017 and included in the National Reimbursement Drug List in 2018. In 2019, Huiyu Pharmaceutical and Zhengdatianqing simultaneously obtained the first domestic generic approval for this drug. According to the official website of the National Medical Products Administration, currently, six enterprises (excluding Qilu Pharmaceutical) hold the approval for Azacitidine for Injection. Data from Menet shows that in recent years, sales of Azacitidine for Injection in terminal public medical institutions in China—namely, urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions)—have grown rapidly. After surpassing 300 million yuan in 2021, sales reached a new high in 2022, with a year-on-year increase of nearly 15%.
Proofread by Baoqing Liu