Yuan Dong, Humanwell and Over 10 Domestic Pharma Companies Race for First-to-File Generic of $1.2B Sugammadex Sodium Injection

Recently, the CDE official website showed that the sugammadex sodium injection of Yichang Humanwell Pharmaceutical Co., Ltd. has been accepted for production in category 4. Prior to this, the company had one acceptance number for production under review. Data from MiNe Network shows that the global sales of this product in 2020 were close to 1.2 billion US dollars; although the sales in Chinese public medical institutions terminals in 2020 were less than 200 million yuan, its potential is astonishing. In the first half of 2021, the year-on-year growth exceeded 200%, and only MSD was selling.

Data show that Sugammadex Sodium Injection, developed by MSD and Organon, is the world's first specifically binding neuromuscular blockade reversal agent, used to reverse neuromuscular blockade induced by rocuronium or vecuronium.

Source: MiNei Network One-Click Search

Data from MiNe Network shows that the global sales of this product approached $1.2 billion in 2020; although terminal sales in China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) were less than 200 million yuan in 2020, its potential is astonishing, with year-on-year growth exceeding 200% in the first half of 2021. Currently, only MSD is selling the product.

Source: MiNeiNet MED2.0 China Drug Evaluation Database

It is worth mentioning that the compound patent of sugammadex in China expired in November 2020, and no generic drug has been approved for marketing in China yet. Currently, more than 10 companies, including Yangtze River Pharmaceutical Group, Hunan Kelun Pharmaceutical, Nanjing Chia Tai Tianqing Pharmaceutical, Chengdu Yundong Biopharmaceutical, and Yichang Humanwell Pharmaceutical Co., Ltd., have submitted applications for the production of generic drugs classified as Category 4 for the injection of sugammadex sodium under review and approval. Once approved, these drugs will be considered to have passed the evaluation.

Source: CDE official website, MiNeiNet database