Qilu Pharmaceutical's Sugammadex Sodium Injection Nears First Generic Approval in China

Recently, according to the official website of the NMPA, Qilu Pharmaceutical's sugammadex sodium injection has entered the administrative approval stage and is expected to be approved shortly, securing the first generic approval for this blockbuster drug.

Source: NMPA Official Website

Sugammadex sodium, hailed as a major drug discovery in the field of anesthesia over the past 20 years, has grown into a blockbuster drug since its market launch. Due to certain technical barriers (40 chiral centers) and the special regulatory nature of narcotic and psychotropic drugs, in China, apart from the approved import of the originator product, although 19 companies have filed registration applications for this drug, no version produced in China has been approved to date.

The First Selective Muscle Relaxant Antagonist

Sugammadex sodium is the first marketed selective neuromuscular blocking antagonist. Discovered by Organon Biosciences and developed by MSD, it was approved in the European Union in July 2008, and subsequently received marketing approval in Japan in 2010, the United States in 2015, and China in 2017, under the brand name Bridion.

Figure 1.1 Chemical structure of sugammadex sodium (two forms) & 40 chiral centers

(Image source: FDA official website)

Since its market launch, this drug has grown into a blockbuster, with sales demonstrating sustained and rapid growth over the past five years, reaching $1.189 billion in 2020.

Source: Insight Database (http://db.dxy.cn/v5/home/)

From the perspective of clinical indications, the clinical use of sugammadex sodium primarily "targets" the neuromuscular blocking agents rocuronium bromide and vecuronium bromide. These two agents are aminosteroid competitive neuromuscular blocking agents (key facilitators of successful general anesthesia surgery) and are clinically indicated for endotracheal intubation, providing skeletal muscle relaxation during surgical general anesthesia, and assisting with controlled ventilation.

In clinical practice, the dosage of neuromuscular blocking agents must be adjusted according to each patient's response, as overdose carries certain side effects and risks. Therefore, there is an urgent clinical need for "reversal agents" for the aforementioned two drugs. Neostigmine, which has been on the market for many years, can alleviate these issues to a certain extent but carries a risk of adverse reactions. In contrast, sugammadex sodium, introduced later, is uniquely capable of specifically reversing rocuronium and vecuronium even during deep neuromuscular blockade, demonstrating significantly superior efficacy compared to neostigmine.

Meanwhile, sugammadex sodium is more suitable for the following patient populations: 1) those with a difficult airway, particularly in "cannot intubate, cannot oxygenate" scenarios; 2) pediatric patients, predominantly those aged 2 years and above; 3) obstetric patients, with over 10 years of clinical use of sugammadex and no teratogenicity observed in animal models; and 4) patients with perioperative respiratory insufficiency.

White-Hot Competition: 19 Companies Race for First Generic Approval

According to the Insight database, a cumulative total of 19 companies have submitted marketing authorization applications for generic sugammadex sodium. The generic sugammadex sodium products from Xinghao Pharmaceutical/Dongyangguang and Hengrui Medicine were successively rejected in May and September of this year and failed to gain approval.

Kelun Pharmaceutical, the market leader in intravenous infusions, was the first to submit a marketing authorization application for sugammadex sodium. The company filed its application in November 2018 and is currently addressing the second round of supplementary information requests. Closely following are Yangtze River Pharmaceutical, Nanjing Chia Tai Tianqing, Yuanda Bio-Pharmaceutical, and Humanwell Healthcare. Today, Jiangsu Desano Pharmaceutical submitted its marketing authorization application, joining the competition.

Competitive Landscape of Sugammadex Sodium in China (Insight)

Source: Insight Database (http://db.dxy.cn/v5/home/)

Note: The original text has been abridged.