On April 14, 2026, Hangzhou Sino-American Huadong Pharmaceutical Jiangdong Co., Ltd. (hereinafter referred to as "Jiangdong Company"), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company"), received the "Acceptance Notice" issued by the National Medical Products Administration (NMPA), in which the marketing authorization application for Smegglutide injection (research code: HDM1702) submitted by Jiangdong Company was accepted.

The indication for this application is: This product is suitable for long-term weight management in adult patients based on diet control and increased physical activity, with an initial body mass index (BMI) meeting the following criteria: ≥30kg/m2 ( obese), or ≥27kg/m2 to <30kg/m2 ( overweight) and having at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

Regarding Smegglutide injection

Smegglutide injection is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with 94% sequence homology to human GLP-1. Clinically, it is mainly used for glycemic control in patients with type 2 diabetes and for long-term weight management in obese or overweight patients. Smegglutide lowers blood glucose by stimulating insulin secretion and reducing glucagon secretion. Furthermore, the mechanism of smegglutide's blood glucose-lowering effect also involves a slight delay in early postprandial gastric emptying. Simultaneously, smegglutide can reduce appetite and food intake, induce weight loss, and significantly reduce the risk of major adverse cardiovascular events (MACE) in obese patients.

The original manufacturer of semaglutide injection is Novo Nordisk A/S. Its diabetes indication was approved by the U.S. Food and Drug Administration (FDA) in December 2017, and by the European Medicines Agency (EMA) in February 2018, under the brand name Ozempic®. It was approved by the China National Medical Products Administration (NMPA) in April 2021, under the brand name Novogene®. The weight management indication of the original semaglutide injection was approved by the FDA in June 2021, by the EMA in January 2022, under the brand name Wegovy®, and by the NMPA in June 2024, under the brand name Novogene®. According to Novo Nordisk's 2025 financial report, Wegovy®'s global sales in 2025 amounted to DKK 79.106 billion (approximately RMB 84.129 billion), of which sales in mainland China, Hong Kong and Taiwan amounted to DKK 796 million (approximately RMB 847 million).

In March 2025, the company's marketing application for the hypoglycemic indication of semaglutide injection was accepted by the NMPA. In January 2026, the company completed a Phase III clinical trial for the weight management indication of semaglutide injection. This study evaluated the safety and efficacy of semaglutide injection compared to the original semaglutide injection in obese subjects in China. The results of the percentage weight loss relative to baseline after 44 weeks of treatment in obese patients showed that the company's semaglutide injection was comparable in efficacy to the original semaglutide injection, achieving equivalence and demonstrating good safety.

Impact on listed companies

Obesity is a chronic, relapsing, and progressive disease. In China, a nationwide cross-sectional study published in 2023 showed that the prevalence of obesity among adult men was 18.2% and among adult women was 9.4%, more than four times the rate twenty years ago (from 3.1% to 14.1%), making it a growing public health challenge. Obesity is associated with an increased risk of various comorbidities, including hypertension, type 2 diabetes, hyperlipidemia, obstructive sleep apnea, cardiovascular disease, and some cancers. Weight loss can significantly improve individual health and quality of life.

Currently, the main methods for weight loss are lifestyle intervention, medication, and surgery. Among these, lifestyle intervention, which involves reducing dietary calorie intake and increasing physical activity, is the preferred treatment for obesity. However, only about 20% of patients achieve their weight loss goals through this method. Meanwhile, bariatric surgery has low acceptance in China, and its high cost is a major reason why its promotion is difficult.

Weight loss drugs can provide additional weight reduction, but the variety of weight loss drugs available in China is currently limited, indicating a significant unmet clinical need in the weight loss field. GLP-1 products have effects such as weight loss, blood sugar control, and cardiovascular benefits, and are a relatively mature and safe target. Around the GLP-1 target, the company has built a comprehensive and differentiated product pipeline, including long-acting and multi-target global innovative drugs and biosimilars, including oral and injectable formulations. The acceptance of the marketing application for the remanufacture indication of semaglutide injection is another important milestone in the development of this product, and will contribute to further enhancing the company's core competitiveness in the field of endocrine therapy in the long term.

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