Gracell Biotechnologies Announces Suzhou Manufacturing Facility Receives MPMC for CAR-T Cell Therapy Products

Suzhou, China, Jan. 15, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing efficient and affordable cell therapies for cancer treatment, today announced that its Suzhou manufacturing facility has successfully passed the comprehensive inspection by the Jiangsu Medical Products Administration (JSMPA) and been granted a Drug Production License (MPMC). Issued on January 4, 2021, the license signifies that Gracell’s production base located in the Suzhou Industrial Park (SIP) fully complies with the Good Manufacturing Practice (GMP) standards set by China’s National Medical Products Administration (NMPA), with both hardware facilities and software systems meeting the quality regulatory requirements for CAR-T cell therapy product manufacturing.

Since the new Drug Administration Law of the People’s Republic of China came into effect on December 1, 2019, China has abolished Good Manufacturing Practice (GMP) certification, and the National Medical Products Administration (NMPA) no longer accepts applications for GMP certification. The new Measures for the Supervision and Administration of Drug Production came into effect on July 1, 2020. Compared with the previous version, the new Measures set forth stricter and more detailed requirements for licensing conditions and related supervisory management of drug production. Only by fully complying with these stringent requirements can a drug manufacturing site successfully pass the on-site inspection and obtain a Drug Production License.

Since March 2020, Gracell has established a quality management system that fully complies with U.S. FDA cGMP, EU GMP, Chinese GMP, and relevant regulatory guidelines for cell therapy products both domestically and internationally. In November 2020, Gracell’s Suzhou manufacturing facility successfully passed a two-day on-site inspection conducted by the GMP inspection team of the Jiangsu Provincial Medical Products Administration. On January 4, it officially obtained the Drug Production License, becoming one of only five CAR-T cell companies in China to hold this license.

“We are committed to transforming the manufacturing of traditional CAR-T cell products, achieving high efficiency, low cost, and rapid turnaround in the production of cell and gene therapy products,” said Wei Cao, Founder, Chairman, and CEO of GracellWilliam Cao) The Doctor stated, “We are pleased to have obtained the license issued by JSMPA, which allows us to further advance our current clinical programs, including the FasTCAR-T project, thereby making transformative CAR-T cell therapies accessible to more patients.”

About Gracell

Gracell Biotechnologies Inc. (“Gracell”) is a global, clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies. Leveraging its proprietary FasTCAR and TruUCAR technology platforms, Gracell is developing a pipeline of autologous and allogeneic cell therapy candidates designed to overcome key industry challenges associated with conventional CAR-T therapies, including prolonged manufacturing timelines, suboptimal production quality, high treatment costs, and limited efficacy against solid tumors.

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