Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE) is an integrated biopharmaceutical company engaged in research/development, manufacture and marketing/sales of biopharmaceutical products in China. The recombinant, or genetically engineered, protein-based products and product candidates are designed to address large markets with significant unmet medical needs in nephrology, oncology, supportive cancer care, inflammation and infectious disease. They began operations in 1993. Currently, their principal products are EPIAO®, TPIAO®, INTEFEN® and INLEUSIN®. SUNSHINE is now one of the largest biopharmaceutical companies in China in terms of market shares, growth and profitability.
Their clinical and commercial manufacturing operations are based in Shenyang, China, where their Chinese current Good Manufacturing Practice, or cGMP, certified, 3,000 square meters, and state-of-the-art facility resides. Their manufacturing facilities consist of on-site bulk manufacturing, formulation, fill, finishing and packaging activities for EPIAO, TPIAO, INTEFEN and INLEUSIN. With these facilities, they are able to produce their products and product candidates for both clinical and commercial purposes. They plan to expand their plant in Shenyang to increase their manufacturing capacity and take further advantage of their favorable cost structure.
They maintain a sales and marketing force in 18 provinces and major cities in China, including Beijing and Shanghai and Guangzhou. Their over 150 sales and marketing professionals market, and their network of approximately 80 distributors sell their principal products to healthcare providers including, based on their internal estimates, approximately 800 hospitals, clinics and dialysis centers. Their sales force in China benefits from over ten years of experience in marketing protein-based therapeutics. As a result of their history as a provider of protein therapeutics to the Chinese market, they believe their Shenyang Sunshine brand is widely recognized throughout the PRC for quality and reliability.
Their research and development team consisted of many research personnel and medical professionals, including two PhDs, two MDs and three holders of master’s degrees and many of whom have years of experience in the healthcare and biotechnology research fields, including experience working in research institutions and hospitals and in proceeding through the SFDA drug approval process.
They focus their research and development efforts on both novel and validated protein-based therapeutics for the treatment of diseases in the areas of nephrology, oncology, supportive cancer care, inflammation and infectious diseases. Their product pipeline, which they expect will be a key contributor to their future growth, consists of six product candidates in various stages of development. They employ a market-driven approach to their research and development efforts, and their team utilizes the latest molecular biology and biochemical techniques and technologies to develop promising product candidates. Their diversified product pipeline includes a number of next-generation protein-based therapeutics including NuPIAO, their second generation EPIAO product candidate; NuLeusin, their next-generation Inleusin product candidate; TPIAO for the treatment of ITP; a human papilloma virus, or HPV, vaccine for the prevention of cervical cancer; and an anti-TNF humanized monoclonal antibody product candidate for the treatment of rheumatoid arthritis and other autoimmune diseases. They believe that each of these product candidates, if successfully developed and approved, would address significant market opportunities. For all of their programs, they conduct extensive preclinical and clinical trials in order to generate safety and efficacy data to support a filing for approval as required to the SFDA.