The second target strategic planning of Yiling pharma is “international and domestic dual registration of generic drugs”. The goal of the second stage is to designate generic drugs with large market capacity, growth potential and high technical threshold, to finishe R&D and registration in domestic and high-end international markets. While achieving the sales in international markets such as Europe and US, the domestic varieties sales activities shall be carried out by using the throughout marketing network in China. At present, the second strategic plan is developing in depth.
For the US market, Yiling Pharma has 13 ANDA products approved by US FDA, including 12 self-developed and 1 outsourced product, and commercial production and sales are steadily advancing.
For the domestic market, Yiling Pharma uses the priority review policy of “European and American collinear production” application to transfer 5 ANDA products approved by US FDA to China, of which 4 products have been included in the priority review procedure and 1 product has been approved.
In addition to domestic and international market planning, Yiling Pharma timely adjusts its R & D direction according to market changes, transformations from general generic drugs to the first generic drugs, sustained and controlled release drugs with high technical barriers and other high-end generic drugs, and further improves its own products’ competitiveness.
In order to cope with the impact of national centralized procurement of generic drug, Yiling Pharma continues to give full play to the advantages of large-scale manufacturing costs, improves the construction of entire industry chain, and builds a new API R&D and production site – Wanyang Hengshui Pharmaceutical Co., Ltd. Wanyang Site is designed and constructed in accordance with the requirements of US FDA and EU cGMP, and equipment required for production implement international and domestic first-class standards. Aiming at R&D and production of featured high-end APIs, bulk drug substance with huge market demands, supporting APIs for Yiling own drugs and APIs for innovative drugs, Wanyang focuses on the fields of cardiovascular, respiratory, digestive, oncology and antiviral diseases, currently it’s running 31 APIs, including 17 APIs for downstream production for finished production to ensure own drugs, and timely entering the APIs international market.