Hainan Puli Pharmaceutical Co., Ltd. (hereinafter referred to as "Puli Pharmaceutical" or the "Company") and its controlled subsidiary, Anhui Puli Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Puli"), successfully submitted the Drug Master File (DMF) for the active pharmaceutical ingredient (API) Semaglutide to the U.S. Food and Drug Administration (hereinafter referred to as the "FDA") on February 28, 2025.
(I) Product Name: 司美格鲁肽 (Semaglutide)
(II) English Name: Semaglutide
(III) Dosage Form: Pharmaceutical Active Pharmaceutical Ingredient (API)
(IV) DMF Number: 041314
(V) Packaging Specification: 1.00 kg/bag/drum, or as per customer requirements
(VI) Holder: Anhui Puli Pharmaceutical Co., Ltd.
Semaglutide is a novel, long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA). It was first approved for marketing in the United States in December 2017 and subsequently in China in April 2021. To date, it has been approved for use in more than 50 countries and regions worldwide.
Semaglutide is primarily indicated for the treatment of type 2 diabetes mellitus and obesity. In addition to its approved indications for glycemic control and weight management, semaglutide has demonstrated multifaceted cardiovascular protective effects, including vascular endothelial protection, blood pressure reduction, lipid profile improvement, inflammation alleviation, and microcirculation enhancement, all with favorable tolerability. Furthermore, semaglutide has been shown to reduce albuminuria in patients with type 2 diabetes, exert renoprotective effects, and lower the risk of composite renal endpoint events, thereby contributing to the prevention and treatment of diabetic kidney disease. Semaglutide also improves insulin resistance in the liver and brain, offering hepatoprotective effects, reducing hepatic fat content, enhancing cognitive function, and providing neuroprotection. As such, it represents a therapeutic option for non-alcoholic fatty liver disease (NAFLD) and neurodegenerative disorders.
Looking back at 2024, semaglutide achieved a number of milestone advancements, including the approval of a new indication for reducing the risk of major adverse cardiovascular events, positive results from a Phase III trial in peripheral arterial disease, successful outcomes in Part 1 of a Phase III trial in metabolic dysfunction-associated steatohepatitis (MASH), and successful Phase III weight-management results for the oral 25 mg and 7.2 mg dosage strengths.
According to Novo Nordisk's 2024 financial results, semaglutide sales remained the focal point of the company's performance report. Specifically, the injectable semaglutide for diabetes (Ozempic®) generated sales of DKK 120.342 billion (approximately USD 17.466 billion) in 2024, representing a year-on-year increase of 26%. The oral semaglutide tablet (Rybelsus®) recorded sales of DKK 23.301 billion (approximately USD 3.382 billion), also up 26% year-on-year. The weight-management injectable semaglutide (Wegovy®) generated revenue of DKK 58.206 billion (approximately USD 8.448 billion), an 86% increase year-on-year. Collectively, the three semaglutide products generated total annual revenue of DKK 201.849 billion, equivalent to approximately USD 29.296 billion, compared to DKK 145.811 billion (USD 21.201 billion) in 2023. The sales gap between semaglutide and Keytruda® (pembrolizumab) has narrowed to a marginal difference, with Keytruda generating USD 29.482 billion in 2024, suggesting that semaglutide is well-positioned to become the next global "blockbuster" best-selling drug.
Anhui Puli has proactively positioned itself in the development of Semaglutide API and its related excipient, SNAC. Through years of dedicated effort, the current progress is as follows:
Semaglutide API:Production of the registration batch has been completed, and the DMF has been submitted to the U.S. FDA (DMF No. 041314). The Company is also continuously advancing the registration of Semaglutide API in other global markets.
SNAC Excipient:Production of the registration batch has been completed, and the Company is now capable of commercial-scale production.
United States: The DMF has been submitted to the U.S. FDA (DMF No. 039651).
China: The excipient filing has been submitted to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), with the registration number F20240000398. The Company is also continuously advancing the registration of the SNAC pharmaceutical excipient in other global markets.
Anhui Poly Pharm Co., Ltd., a wholly-owned subsidiary of Poly Pharmaceutical, has recently completed the construction of its Semaglutide API project and commenced production as scheduled. The DMF for Semaglutide API has been submitted to the U.S. FDA, and the DMF for the excipient SNAC was previously submitted to the U.S. FDA in 2024. Leveraging its strengths in global regulatory registration and manufacturing internationalization, the Company will utilize its international-standard high-capacity production facilities to support the research and development of products in the weight-management sector.
Anhui Poly Pharm Co., Ltd. is a professional supplier of active pharmaceutical ingredients (APIs), dedicated to providing high-quality, specialty APIs and services to the global pharmaceutical, healthcare, and cosmetic industries through both chemical synthesis and biosynthetic approaches.
Premium Quality – Crafted by Poly.
Welcome for enquiry, cooperation！
