Language

English 中文

Beimei Pharma and EMP Pharma reached an exclusive license and supply agreement for an innovative oral solution in China

2020-09-25

Beimei Pharma and EMP Pharma reached an exclusive license and supply agreement for an innovative oral solution in China

 


On August 25, 2020, Shenzhen Beimei Pharmaceutical Co., Ltd. (hereinafter referred to as “Beimei Pharma”) and EMP Pharmaceuticals BV of the Netherlands (hereinafter referred to as “EMP Pharma”) signed an exclusive license and supply agreement on an innovative formulation (hereinafter referred to as “this product”) in China, Beimei Pharma is responsible for the registration and commercialization of this product in Mainland China.

This product is a hormone replacement drug, used for the replacement therapy of related hormone hypofunction. It is a product in urgent clinical demand in China, and the main patient population are children. The drug has a narrow therapeutic window, hence homogeneity and dose accuracy is particularly important to ensure precise administration to patients. At present, the only drugs of the same kind that have been marketed in China are in tablet form. Targeted in the most important patient population of children, this innovative oral solution formulation (this product) developed by EMP Pharma has the superior characteristics of exceptional dose accuracy, excellent content uniformity, stable formula, and the solution is free of alcohol, sugar and colors, and has outstanding taste masking technology with good taste, making it the first choice for certain groups of patients -including children and patients with dysphagia.

This product has been launched in European countries such as Germany, the United Kingdom, France, the Netherlands, Belgium, Greece, Austria, and has been listed as a reference preparation for products with same molecule; and has been submitted for a registration approval to the FDA as 505B(2). In China, it will be applied for listing as an exclusive innovative formulation.

The drug molecule has global annual sales of up to US$4.5 billion (30.5 billion RMB) as of 2019. The sales of the tablet in the same molecule launched in China reached 445 million RMB, and it maintains in a steady growth, with a considerable market scale. This molecule currently has no dosage form suitable for children. The successful launch of this product in China will meet the pediatric needs . 

About EMP Pharma

EMP Pharma is a pharmaceutical development company that is in cooperation of PharmaMatch, the Netherlands and Pharma-Data, Greece. The headquarter is located in Amsterdam, the Netherlands. Since starting it’s activities in 2007, EMP has distinguished itself as a specialist in the international market for pharmaceutical products. EMP is committed to developing generic-plus, added-value generics and niche formulations. Its product is patent protected in the EU and USA .

About Beimei Pharma

Beimei Pharma is focused in the field of pediatric prescription drugs, and aims to become a new-styled pharmaceutical company integrated with R&D, in-licensing, production and sales. It takes independent R&D and the in-licensing of domestic and international pediatric products as its strategic direction. The current product pipeline covers the respiratory, anti-infection (antibacterial), neuroscience, gastroenterology and others. Beimei Pharma is committed to providing Chinese pediatric patients with convenient, accurate, excellent-taste and high-quality products.