We currently manufacture biopharmaceuticals at our production facilities in Shenyang, Liaoning and Shenzhen, Guangdong. Our Shenyang facilities consist of a mammalian cell-based production plant, where we manufacture EPIAO and TPIAO, and a bacterial cell-based production plant, where we manufacture Intefen and Inleusin. All packaging activities in relation to these products in the PRC are conducted at our Shenyang facilities. We also manufacture our product candidates for clinical trials at these facilities. We manufacture SEPO and Sparin at our Shenzhen facilities.

 

Quality Control and Assurance

As of December 31, 2014, our quality control team consisted of 65 dedicated employees, of whom nine held master’s or higher degrees. As of December 31, 2014, our quality control team members on average had over ten years of industry experience.

We have our own independent quality control system and devote significant attention to quality control of the design, manufacturing and testing of our products. Our stringent product quality control starts from the research and development stage. Our laboratories are operated by highly educated and skilled technicians to ensure quality of all released batches of our products. We have established detailed quality control procedures guiding our internal production and external purchase of drugs and other materials used in our research experiments. To ensure high product quality, we have implemented a “quality-by-design” approach pursuant to which manufacturing processes are designed during the product development stage and quality control processes are continuously monitored.

 

Manufacturing

 

  

 Shenyang Manufacturing

Our main manufacturing facilities are located in the Shenyang Economy & Technology Development Zone. Our facilities in Shenyang are capable of bulk production of mammalian cell-based proteins and bacterial cell-based proteins, as well as formulation of final products. Our manufacturing facilities are equipped with state-of-art equipment supplied by top brands, such as bioreactors, centrifuges, chromatography systems, finish and fill lines and lyophilizers. In 2013, our mammalian cell-based production plant and bacterial cell-based production plant were both certified under the latest edition of the Chinese GMP by the CFDA.

  

 

Shenzhen Manufacturing

In December 2014, we acquired Sciprogen, together with its manufacturing facilities in Shenzhen. We manufacture SEPO and Sparin in our Shenzhen facilities. In 2013, Sciprogen’s Shenzhen production plant was certified under the latest Chinese GMP.

www.sciprogen.com 

 

  

 

Como Manufacturing

In December 2014, we acquired Sirton, together with its manufacturing facilities in Como, Italy. Our Como facilities are authorized to manufacture injectable pharmaceutical products in various formats including pre-filled syringes, lyophilized vials, liquid vials and ampoules. In 2014, our Como facilities were granted a GMP certificate for the production of human medicinal products by the Italian Medicines Agency

www.sirton.it

 

 

 

Dongguan Manufacturing (under construction)

We have started constructing new manufacturing facilities in Dongguan, Guangdong to expand our production capacities of SEPO and Sparin.

 

 

  

 

Benxi Manufacturing 

In October 2011, we commenced building a new manufacturing facility in Benxi, Liaoning, to produce dialysis consumables. The designed annual capacity of the Benxi facility is approximately 15 million liters of dialysate, approximately 2 million kilograms of dialysis powder and approximately 500,000 liters of disinfectant. We plan to primarily market these products to hospitals in China that purchase our pharmaceutical products. The new facility is expected to commence operations in 2015.