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On April 24, Huahai Pharmaceutical announced that the company's busulfan injection was approved for imitation of Class 4 production, which was deemed to have passed the evaluation, becoming the second enterprise to pass the evaluation of the product. According to data from Minenet, the terminal sales scale of busulfan injection in China's public medical institutions has exceeded 200 million yuan in recent years, with a year-on-year increase of 12.54% in 2022, and Otsuka Pharmaceutical has the largest market share. Since the beginning of this year, Huahai Pharmaceutical has 8 products approved for marketing.
Source: One-click search on Minenet
Busulfan injection is developed by Otsuka Pharmaceutical Co., Ltd. and is suitable for use in combination with cyclophosphamide as a pretreatment regimen for hematopoietic progenitor cell transplantation in chronic myeloid leukemia allogeneic cells.
In recent years, the terminal sales scale of busulfan injection in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (hereinafter referred to as China's public medical institutions) has exceeded 200 million yuan, with a year-on-year increase of 12.54% in 2022, and Otsuka Pharmaceutical has the largest market share.
Approval of busulfan injection
Source: Minenet China Listed Drugs (MID) Database
According to the data of Minenet, there are 5 companies with production approvals for busulfan injection, Jianjin Pharmaceutical and Zhejiang Huahai Pharmaceutical have been evaluated, China Resources Shuanghe Pharmaceutical's supplementary application for consistency evaluation is under review, and Zhongrun Pharmaceutical|Sichuan Meida Kangjiale Pharmaceutical is under review for generic 4 types of production, which is deemed to have passed the evaluation after approval.
Since the beginning of this year, Huahai Pharmaceutical's products have been approved
Source: Minenet China Declaration Progress (MED) database
Prior to this, Huahai Pharmaceutical successively issued announcements that the company's empagliflozin tablets and torsemide tablets were approved for production as generic Class 4 products. Since the beginning of this year, 8 products have been approved for marketing, covering multiple therapeutic categories such as cardiovascular and cerebrovascular system drugs, digestive system and metabolic drugs, and nervous system drugs.
Source: Company announcements, Minenet database
Note: The statistical scope of "Drug Terminal Competition Pattern of China's Public Medical Institutions" by Minenet is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics, and the above sales are calculated based on the average retail price of products at the terminal. If there is any omission, please correct it!