History and Future

History - the past days

2004.09 Beijing Biote Pharmaceutical Co., ltd was incorporated.

2005.11 Clinical trial completed for Leuprorelin Acetate microspheres sustained release for injection.

2009.07 Leuprorelin Acetate microspheres sustained release for injection was approved by China FDA, licence number: H20093809, which was the first microsphere product granted in China.

2009.12 Facility dedicated for lyophilized powder and small volume solution completed and passed China FDA inspection. Annual capacity 200k unit. GMP certificate number: K5134.

2010.06 Launch of Leuprorelin Acetate microspheres sustained release for injection in China.

2011.08 National Development and Reform Commission set the price limit for leuprorelin acetate microspheres sustained release at 1899 RMB (311 USD).

2011.11 The company was certified as High-Tech enterprise by Beijing Science and Technology Bureau, Finance Bureau and Inland Revenue.

2012.01 Purchased 26500 square metres ground from Beijing Miyun Industrial Park for new facility. 

2012.07 Foundation of the new facility.

2013.05 Validation of equipments in new facility.

2013.07 The entire company migrated from Changping to Miyun new site.

2013.11 China FDA GMP inspection of the new site.

2014.01 The new site received CFDA GMP certificate.


Future - the sunshine days

Being the leader of Chinese companies in microspheres for injection sector we have unparalleled expertise in developing, manufacturing and marketing of microsphere injectables.

Using our proprietary microsphere technology as the foundation, trying to apply microsphere delivery to various APIs, we invest in our own R&D to achieve product commercialization as the final goal.

At the same time we are expanding the product portfolio, trying to bring into China the most advanced technologies and world-class products in the sector we know well - Gynecology. By utilizing the relationship we have built with the doctors in gynecology/ obstetrics departments throughout China during the past years while marketing our drug product we are now making an entry to the medical device business.

The project selection is heavily biased towards market demand. Benefiting from our current sales team and the integration of external resources we make sure our products keep their frontline position in the sector.

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