Shanghai Securities News China Securities Network News (Reporter Zhang Xue): The reporter learned from Baekje Shenzhou that on November 16th, the Baekje Shenzhou Small Molecule Innovative Drug Global Industrialization Base was completed and officially opened in Suzhou, Jiangsu Province.
It is reported that the newly completed industrial base has a construction area of nearly 50000 square meters and is expected to produce up to 1 billion solid formulations per capsule annually. The base has a commercial scale and flexible production capacity for clinical medication, which can quickly achieve high-quality transformation of large and small molecule independent research and development pipelines from laboratory to clinical product production and then to commercial production. It provides production support for the continuously growing product pipeline of small and medium-sized molecule commercial drugs and large and small molecule clinical candidate drugs. It is currently one of the few integrated bases in the world that can achieve the industrialization of new drugs.
At the beginning of the construction of the Suzhou base, advanced design concepts were introduced, strictly following the cGMP (current drug production quality management standards) of China, the United States, and the European Union, and establishing an internationally leading quality management system to meet the quality requirements of global supply of products, including Zebutinib. Zebutinib is the first independently developed anticancer drug in Chinese pharmaceutical history to be approved by the US Food and Drug Administration (FDA). It has been launched in over 65 markets worldwide, providing treatment and services to patients.
In September of this year, the Suzhou base in Baekje China passed the cGMP on-site inspection by the US FDA, marking that the Zebutinib produced by the Suzhou base has officially obtained the qualification for commercial supply to the US market. It also proves that the sustainability and high maturity of the quality system of the Suzhou base in Baekje China have been internationally recognized.
Since settling in the Suzhou Industrial Park in 2015, the Baiji Shenzhou Suzhou Base has established a clinical and commercial scale production capacity for small molecule drugs, as well as a production capacity for large molecule clinical raw materials; The Suzhou Pharmaceutical Research and Development Center of Baekje Shenzhou is also under construction.
Ou Leiqiang, co-founder, chairman and CEO of Baekje Shenzhou, stated that the opening of the Suzhou Innovative Drug Global Industrialization Base is of great significance to Baekje Shenzhou - it not only enhances Baekje Shenzhou's independent commercial production capacity, but also further strengthens the company's small molecule research and development capabilities in the later stage. Baekje will continue to invest and work together with partners to save the lives of more patients in China and even around the world.