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Pharmaceutical Network Market AnalysisOn the evening of February 19, Qilu Pharmaceutical announced that the anti-tumor drug Azacitidine for Injection had been approved for marketing by the National Medical Products Administration (NMPA) and was deemed to have passed the consistency evaluation. Azacitidine is indicated for the treatment of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) with 20%-30% bone marrow blasts, and chronic myelomonocytic leukemia (CMML). It has become one of the first-line drugs for treating myelodysplastic syndromes and acute myeloid leukemia, especially suitable for elderly patients who are not suitable for high-intensity chemotherapy and hematopoietic stem cell transplantation.
Data show that azacitidine is a cytidine nucleoside analog, which can restore the normal function of tumor suppressor genes that are excessively methylated by causing DNA demethylation. It also exerts direct cytotoxic effects on abnormal hematopoietic cells in the bone marrow, thereby achieving an anti-tumor effect. It belongs to the class of demethylating anti-tumor drugs.
The sales scale of injectable Azacitidine in China is growing rapidly. Data shows that in recent years, the sales of injectable Azacitidine in Chinese urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) have increased rapidly. After exceeding 300 million yuan in 2021, it reached a new high in 2022, with a year-on-year increase of nearly 15%.
It is reported that the original research company of Azacitidine is Celgene Corporation, with the trade name Vidaza. It was approved for marketing in China in 2017, entered the National Medical Insurance Catalog in 2018, and in 2019, Huiyu Pharmaceutical and Zhengdatianqing simultaneously obtained the first domestic generic approval for this drug.
The industry indicates that, from a long-term perspective, the market capacity for azacitidine is large and it also has development potential in the future; facing the huge market for injectable azacitidine, many pharmaceutical companies in China have "come to attention."
For example, in February 2018, BeiGene announced that it had obtained exclusive distribution rights from Celgene to sell the drug exclusively in China. In September 2019, both Zhengda Tianqing and Huiyu Pharmaceutical's Azacitidine for Injection were approved for production simultaneously. Additionally, currently in China, there are pharmaceutical companies such as Shandong XSD Pharmaceutical, Yangtze River Pharmaceutical, and Jiangsu Hansoh Pharmaceutical that hold production licenses. In the field of generic drug development, companies like Jianjin Pharmaceutical and Ruiyang Pharmaceutical have submitted applications for the generic version of Azacitidine for Injection, all of which are under review.
Industry insiders indicate that, with the "crowding" of enterprises, the future of this niche market may face increasingly fierce competition. Other sources suggest that, as a variety that has risen through centralized procurement, the price competition for injectable azacitidine is also receiving significant industry attention.
It is reported that Azacitidine for Injection is a procurement variety in the third batch of national drug centralized procurement in China. Huiyu Pharmaceutical won the bid at a price of 260 yuan per bottle, covering 16 provinces including Tianjin, Hebei, Shanghai, Fujian, Guangdong, and Sichuan. Data shows that in 2022, the sales volume of Huiyu Pharmaceutical's Azacitidine for Injection increased significantly, achieving revenue of 125 million yuan, a year-on-year increase of 19.46%.
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