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Poly Pharmaceuticals’ High-End Pediatric Medicine Open the US Market, Zhejiang Poly's Azithromycin Dry Powder Suspension (Precision Dosing) Becomes the First Chinese Product to Receive FDA Approval!

In the United States, stringent requirements for precision dosing of pediatric medications are in place, while China faces significant challenges in this regard. According to publicly available data, the global pediatric drug market has been steadily expanding, with the market size increasing year by year. In 2018, the global pediatric drug market was valued at approximately $97.3 billion, and in 2019, including vaccines, it reached an estimated $122 billion. Projections suggest that by 2025, this market will reach $141 billion. However, issues related to precise and safe pediatric medication and the shortage of specialized pediatric drugs cannot be ignored.


1.Lack of Accurate Pediatric Medication Information: A substantial number of drug leaflets lack information on pediatric use or provide inaccurate dosing instructions. This often leads doctors to make dosage adjustments based on their experience, which can pose safety risks.


2.Challenges in Pediatric Drug Trials: Conducting clinical trials for pediatric drugs, especially antibiotics, is a complex task. Many parents strongly resist enrolling their children in clinical trials or using antibiotics due to emotional concerns.


The United States currently has the largest pediatric drug market globally and one of the most robust regulatory frameworks in the pharmaceutical industry. It initiated legislation related to pediatric medications early on, which has established clear guidelines for research and the strictest standards for pediatric drug usage. Many of these experiences are valuable for other countries to learn from. Taking Azithromycin Dry Powder Suspension as an example (see image below), the US requires precise dosing for all pediatric patients by providing medication in a bottled form equipped with a precise dosing device. In contrast, China's instructions for children weighing over 15 kilograms lack accurate dosage descriptions, leading to the use of bagged forms, jeopardizing the safety and efficacy of pediatric medication.


Before obtaining FDA marketing approval, Zhejiang Poly Pharmaceutical, a wholly-owned subsidiary of Hainan Poly, successfully completed a consistency evaluation in January 2023. This marked the first approval for the sale of domestically produced bottled dry powder suspensions (equipped with precise dosing devices) in China. Compared to conventional bagged dry powder suspensions, this development significantly enhances the precision of pediatric medication, subsequently improving drug efficacy and safety. This achievement holds significant importance for advancing precise pediatric medication practices in China.

Here are the detailed specifications of the medication:

• Drug Name: Azithromycin Dry Powder Suspension

• Dosage Form: Dry Powder Suspension

• Specifications: ① 100mg/5ml, 15ml; ② 200mg/5ml, 15ml; ③ 200mg/5ml, 30ml;

• Manufacturer: Zhejiang Poly Pharmaceutical Co., Ltd. (a wholly-owned subsidiary of Hainan Poly)

Indications: Acute otitis media and community-acquired pneumonia in children (6 months and older); pharyngitis/tonsillitis in children (2 years and older).

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