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Announcement on Acceptance of Application For Sevelamer Carbonate Powder for Oral Suspension

2022-04-01

Shenzhen Beimei Pharmaceutical Co., LTD. (hereinafter referred to as "Beimei Pharmaceutical") has officially received the acceptance letter issued by the Drug Evaluation Center of the National Medical Products Administration. The sevelamer carbonate powder for oral suspension, which is imported by Beimei Pharmaceutical, its application was accepted.

 

In March 2022, Beimei Pharmaceutical signed an exclusive license agreement with Synthon B.V., a Netherlands pharma, for the registration and commercialization of sevelamer carbonate powder for oral suspension in mainland China. The NDA has been officially accepted by the Chinese CDE.

 

Sevelam is mainly used for hyperphosphatemia in patients with chronic kidney disease (CKD). Its oral suspension has been approved for pediatric patients outside of China. It is the only new phosphorus binder that has indications for children. Also, there has no sevelamer carbonate in the oral suspension dosage form been approved for marketing in China, and this product will bring a new treatment option for children patients.

 

About Shenzhen Beimei Pharmaceutical Co., Ltd.


 

Beimei pharmaceutical focuses on the field of pediatric prescription medicines, headquartered in Shenzhen, China, incorporating R&D, global licensing, manufacture, marketing and distribution, and has more than 30 pediatric products in its portfolio and pipeline, covering the respiratory system, anti-infection (antibacterial), nervous system, digestive system, endocrinology, ENT and other fields.

 

Beimei Pharmaceutical has established long-term partnerships with companies such as Hetero, Cipla, EMP, Deva, Dr Reddy, LTS, MedPharma, Synthon, NTC, etc., and completed over 100 million RMB series A and series B/B+ financing, which will further support Beimei to be a pioneer in Chinese pediatric field to meet the clinically unmet demand and provide Chinese pediatric patients with products that are with high-quality, good tasting and can be accurately administrated. For more information, please visit our website at http://www.beimeiyaoye.com

 

About Synthon B.V.



Synthon B.V., founded in 1991 and headquartered in the Netherlands, is a science-based international pharmaceutical company specializing in the development and manufacture of high-quality generic and hybrid medicines for patients around the world. 

 

Synthon B.V. has laboratories, offices and manufacturing facilities in nine countries and 1,600 employees worldwide. The company's products are currently approved by regulatory authorities in approximately 100 countries/regions, marketed through the world's largest pharmaceutical companies as strategic partners, or marketed directly in specific areas. The product range covers a variety of therapeutic fields, including oncology, urinary system, cardiovascular system, central nervous system and so on. For more information, visit www.synthon.com