Baiji Shenzhou new production base approved for commercial production

April 20, 2021

Beijing, China and Cambridge, Massachusetts, USA April 8, 2021, Baiji Shenzhou (NASDAQ: bgne; SEHK: 06160) is a biotechnology company in the commercial stage, focusing on the development and commercialization of innovative drugs worldwide. The company announced today that the State Drug Administration (nmpa) has approved its Guangzhou biopharmaceutical production base to carry out the commercial production of anti-PD-1 antibody baizean (tirizumab). Guangzhou biopharmaceutical production base is wholly owned by Baiji Shenzhou, covering an area of more than 100000 square meters (1000000 square feet). It has been approved to use 8000 liters of production capacity for commercial production to produce and supply baizean for the Chinese market. At present, another stage of construction of Guangzhou biopharmaceutical production base is under way, which is expected to be completed by the end of 2022, and its total production capacity will be increased to 64000 liters.

Dr. Wu Xiaobin, President, chief operating officer and general manager of China, said: "in order to meet the expected supply demand, the company started to build the commercial scale biopharmaceutical production base in 2017. Since then, baezean has been approved for treatment of a number of indications in China and included in the national medical insurance drug list (nrdl). We have also entered into licensing cooperation with Novartis on baezean in Europe, North America and Japan. The approval of Guangzhou biopharmaceutical production base for commercial production will greatly improve our production capacity of baizean and other biopharmaceuticals in the company's R & D pipeline, and promote us to continue to fulfill our firm commitment to the quality, safety and compliance of drug production. " The construction of Baiji Shenzhou Guangzhou biopharmaceutical production base conforms to the existing cGMP adopted by the US Food and Drug Administration (FDA), China National Drug Administration (nmpa) and European Drug Administration (EMA). The base is expected to become a biopharmaceutical production base for paperless production in China, and introduce high and new technologies including 3D modeling, digital twin, modular design and artificial intelligence to improve production quality and efficiency.

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