Fosun Kite Officially Launches Its First CAR-T Commercial Manufacturing Facility in Zhangjiang

On December 18, the inauguration ceremony of Fosun Kite’s first CAR-T industrialized production base was successfully held in Zhangjiang, Shanghai.

Located within Phase I of the Tianci International Pharmaceutical Park at the Shanghai Zhangjiang Innovative Drug Industry Base, this facility covers a construction area of approximately 10,000 square meters. It is designed, constructed, and managed in strict accordance with Good Manufacturing Practice (GMP) standards, featuring dozens of production lines capable of parallel processing for CAR-T product manufacturing. The base has currently completed final acceptance inspection and is proceeding with equipment and facility validation as well as trial production according to schedule, with commercial production capacity expected to be established by 2020.

Peng Song, Executive Deputy Director of the Shanghai Science and Technology Innovation Office; Liu Ping, Chief Engineer of the Shanghai Municipal Commission of Economy and Informatization; Zhang Qing, Deputy Director of the Shanghai Municipal Medical Products Administration; Chen Fangyuan, Deputy Secretary-General of the Shanghai Municipal Committee of the Chinese People's Political Consultative Conference and Full-time Deputy Chairperson of the Shanghai Municipal Committee of the Chinese Peasants and Workers Democratic Party; Tang Shiqing, Vice Chairperson of the Pudong New Area Committee of the Chinese People's Political Consultative Conference and Director of the Science and Economy Commission; and the Biotechnology Division of the Shanghai Municipal Science and Technology CommissionPharmaceuticalsCao Hongming, Director of the Division; Zhan Qinghua, Director of Shanghai Science and Technology Innovation Center Customs; Yuan Tao, Party Secretary and Chairman of Zhangjiang Group; and Li Hanpu, Chairman of Tianci International Pharmaceutical, among other leaders and guests, attended the ceremony to jointly witness this important moment.

Chen Qiyu, Co-President of Fosun International and Chairman of Fosun Pharma

Chen Qiyu, Co-President of Fosun International and Chairman of Fosun Pharma, stated: “The official inauguration of Fosun Kite’s industrialized production base for cell therapy would not have been possible without the support and assistance from the Shanghai Municipal Government, the Pudong New Area Government, and particularly various levels of government bodies including the Shanghai Science and Technology Innovation Office and the Zhangjiang Administration. Shanghai Zhangjiang has gathered a large number of high-tech innovative pharmaceutical companies. Fosun Pharma has established three flagship enterprises in this region—Henlius, Intuitive Fosun, and Fosun Kite. In the future, we believe that more innovative technologies and products will come to Zhangjiang for development. Meanwhile, Fosun Pharma is honored to collaborate with Kite, a global leader in immune cell therapy. The outstanding clinical efficacy of Kite’s CAR-T product, along with its successful application and rapid approval, marks a significant milestone in the advancement of human health. We believe that the success of the collaboration between Fosun and Kite will also be epoch-making for the research, development, and industrialization of immune cell therapy in China, bringing hope for life to patients with relapsed or refractory hematologic malignancies in clinical practice.”

Wu Yifang, President and CEO of Fosun Pharma and Chairman of Fosun Kite

Wu Yifang, President and CEO of Fosun Pharma and Chairman of Fosun Kite, stated, “Since Fosun Pharma announced the establishment of Fosun Kite in partnership with Kite Pharma on January 11, 2017, we have made steady progress over the past three years. From introducing Yescarta, the world’s first approved CAR-T therapy for specific types of non-Hodgkin lymphoma, to obtaining approval for Investigational New Drug (IND) registration in China, and now to the official inauguration of our production facility, these milestones mark a solid step forward in the industrialization of Yescarta in China and in making this therapy accessible to Chinese cancer patients. As the first CAR-T cell therapy production line established in the Zhangjiang Innovative Drug Industrial Base, Fosun Kite will contribute to positioning Zhangjiang as a high ground for the development of the cell therapy industry chain and support the Pudong New Area’s strategic layout for the high-quality development of the biopharmaceutical sector. Cell therapy represents a revolutionary approach to cancer treatment. In China, there is no established path for its industrialization; the road is long and challenging, but perseverance will lead to success. I believe that with joint efforts from all parties, our path toward cell therapy industrialization will continue to improve, ultimately benefiting cancer patients in China.”

Dr. Wang Liqun, CEO of Fosun Kite

Dr. Wang Liqun, CEO of Fosun Kite, stated, “I returned to Shanghai from the United States in 2007 and came to Zhangjiang. I have always firmly believed that this place is the most fertile ground for innovation in China. Currently, it is also the best era for the development of biopharmaceuticals. The industrialization journey of CAR-T in China has no established model to follow. We will work closely with regulatory authorities to promote the early approval and market launch of Yescarta and other cell therapy products in China, benefiting Chinese cancer patients. There will still be many challenges on the road to success. However, I believe in our team’s capabilities. In facing the known, we will strive for excellence; in confronting the unknown, we will proceed with reverence and courage to innovate.”

Yuan Tao, Secretary of the Party Committee and Chairman of Zhangjiang Group

Yuan Tao, Secretary of the Party Committee and Chairman of Zhangjiang Group, stated, “Biopharmaceuticals are a traditional strength of Zhangjiang. Home to the most densely concentrated biopharmaceutical R&D and manufacturing cluster in China, Zhangjiang holds a leading position domestically in multiple fields. Since the beginning of this year, Zhangjiang has implemented a series of initiatives in cell therapy: in May, it officially announced the construction of a Cell Industry Park; in November, the Zhangjiang International Summit on Cell Therapy was successfully held. The influx of numerous domestic and international cell R&D institutions and manufacturing enterprises demonstrates the robust momentum of Zhangjiang’s development in cellular immunotherapy. It is our honor that Fosun Kite, a leading enterprise in China’s cellular immunotherapy industry, has established its industrial production base at the Zhangjiang Innovative Drug Base. Fosun Kite is the first manufacturer of CAR-T cell products at the Innovative Drug Base. We believe that with the official launch of the production base, Fosun Kite will undoubtedly accelerate its growth and solidify its position as an industry leader.”

According to Wang Liqun, the industrial base unveiled today comprises dozens of different workstations and production lines. “The base will be configured according to capacity demands, ensuring neither overcapacity nor supply shortages.”

Wang Liqun candidly stated, “Cell therapy presents an ‘opportunity window’ for Chinese pharmaceutical companies. Taking CAR-T as an example, only two products have been marketed worldwide, merely two years earlier than in China. Compared with other small-molecule drugs, this time gap is not significant. Furthermore, in accordance with the inherent laws of scientific development, technologies tend to reach a period of explosive growth after accumulating over a certain timeframe. Similarly, as human understanding of tumor treatment deepens, promising ideas will emerge. In these two respects, Chinese pharmaceutical companies are poised to achieve overtaking on a curve in the field of cell therapy.”

Fosun Kite

As a pioneer in China’s immune cell therapy industry, Fosun Kite Biotechnology Co., Ltd. is a joint venture between Fosun Pharma Group and Kite Pharma (a Gilead Sciences company), registered and established in Shanghai, China, in April 2017. In the same year, Fosun Kite introduced Yescarta (FKC876), the world’s first approved CAR-T cell therapy for specific types of non-Hodgkin lymphoma, from Kite Pharma in the United States, and rapidly obtained approval to conduct registration clinical trials in China. In January 2019, with strong support from the Zhangjiang Science City Construction and Management Office, Fosun Kite’s industrial production base was established in the Tianci International Pharmaceutical Park.

Zhangjiang Innovative Drug Industrial Base

In April this year, the Pudong Biopharmaceutical Industry Map was released, and the Zhangjiang Innovative Drug Industrial Base was officially unveiled. Located in the southern area of Zhangjiang, the base covers an area of approximately 3 square kilometers and is positioned as an industrialization hub for innovative drugs and medical technologies, as well as a CMO/CDMO contract production base. It focuses on undertaking the transformation of scientific and technological achievements in innovative drugs and high-end manufacturing within the Zhangjiang Science City.

As the first CAR-T cell therapy product manufacturer to establish its presence in the Zhangjiang Innovative Drug Industrial Base, the official inauguration of Fosun Kite’s first CAR-T industrial production base marks another step forward in the industrialization of Yescarta in China and its accessibility to Chinese cancer patients.

Source: Hello Zhangjiang Author: Little Z