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On July 3rd, global pharmaceutical giant Eli Lilly announced that its innovative drug Tirzepatide Injection (trade name: Mounjaro®) has been approved by China's National Medical Products Administration (NMPA) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adult patients with obesity. This groundbreaking progress makes tirzepatide the world’s first and currently the only prescription drug for this indication, marking a "zero breakthrough" in the field of pharmaceutical treatment for OSA in China and bringing a new treatment option to tens of millions of patients.

"The Silent Crisis Affecting 176 Million Patients: The Unresolved Dilemma in OSA Diagnosis and Treatment"

Obstructive Sleep Apnea (OSA), a highly prevalent yet underrecognized sleep-disordered breathing condition, is characterized by recurrent upper airway collapse during sleep. This leads to apneas or hypopneas, accompanied by sudden drops in blood oxygen levels and sleep fragmentation. Patients often present with symptoms such as nighttime snoring, daytime sleepiness, and fatigue, but its harms extend far beyond "sleep issues" — clinical studies have confirmed that OSA is closely associated with cardiometabolic diseases including hypertension, coronary heart disease, and diabetes. It also increases the risk of cognitive decline and all-cause mortality.

Latest data from The Lancet shows that the total number of OSA patients in China has reached 176 million, ranking first in the world. Among them, 65.52 million are moderate to severe cases, and 41% of these moderate to severe patients are obese. However, due to the general public’s lack of awareness about the disease, the consultation rate of OSA patients in China is less than 10%, with a large number of cases remaining "undiagnosed and untreated" for a long time.

On the treatment front, traditional approaches have long faced bottlenecks: while device-based therapies led by positive airway pressure (PAP) show certain efficacy, patients’ long-term adherence rate is only 30%. Many obese patients abandon treatment due to issues like mask discomfort and noise interference. Surgical treatment, restricted by strict indications and postoperative recurrence risks, is difficult to apply widely. The approval of tirzepatide marks the first time a convenient pharmaceutical treatment option has been available for this group of patients.

From Metabolic Regulation to Respiratory Improvement: Tirzepatide’s "Versatile" Mechanism

As the world’s first GLP-1R/GIPR dual agonist, tirzepatide’s innovation lies in simultaneously activating the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. This achieves the dual physiological effects of "appetite suppression + metabolic regulation." Beyond effective weight management, this mechanism directly alleviates upper airway obstruction in OSA patients by reducing soft tissue edema and fat accumulation in the upper airway, forming a synergistic therapeutic effect of "weight loss + respiratory improvement."

In fact, tirzepatide has demonstrated extensive clinical value in China. Previously, it was successively approved for the treatment of type 2 diabetes and long-term weight management. With the approval of this OSA indication, it has rapidly covered three major areas—metabolic diseases, weight management, and sleep-disordered breathing—within just over a year, becoming a core pillar of Eli Lilly’s metabolic disease pipeline layout in China.

Behind the Accelerated Approval of Innovative Drugs: "China Speed" Driven by Patient Needs

The rapid approval of tirzepatide this time benefits from the "green channel" support provided by China’s drug regulatory authorities for clinically urgently needed drugs. As a key variety included in the Third Batch of Encouraged Generic Drugs Catalog, its clinical trial and approval processes have been significantly optimized. It took only 3 years from the initiation of clinical research to the final approval, nearly halving the time compared with traditional processes.

"This achievement demonstrates China's high attention to innovative drugs and its patient-centric regulatory wisdom," said Huzur Devletsah, General Manager of Eli Lilly China. She added that the comprehensive layout of tirzepatide is a key strategic pillar for Eli Lilly's deep cultivation in the Chinese market. Data shows that the global sales of this drug reached $16.4 billion in 2024, of which the weight loss indication contributed $4.9 billion, reflecting significant market potential.