Chongqing - Recently, Chongqing Precision Biotech Co., Ltd. has received official acceptance from the National Medical Products Administration (NMPA) for the New Drug Application (NDA) of its Class I biological new drug, pCAR-19B (Pukilin Injection).

The successful NDA acceptance positions pCAR-19B to potentially be China’s first approved CAR-T therapy for this condition, marking a historic milestone for Chongqing’s scientific community and a significant advancement in biopharmaceuticals.

Developed over seven years, pCAR-19B targets CD19-positive relapsed or refractory acute lymphoblastic leukemia (ALL) in children and young adults aged 3-21. ALL is the most common cancer in children and a major cause of cancer-related deaths in youth worldwide. 

pCAR-19B uses advanced CAR-T cell technology to attack leukemia cells specifically. "Our goal is to develop CAR-T therapies that are accessible, effective, and affordable for the general public," said Qian Cheng, Chairman and Chief Scientist at Chongqing Precision Biotech.

Zhang Yingzi, Director at Chongqing Precision Biotech, highlighted that pCAR-19B is their first product. Despite numerous challenges, including experiencing the COVID-19 pandemic, Zhang is thrilled about its upcoming market entry and potential to save young lives.

The project started clinical trials in February 2019 and entered Phase I in Wuhan by November. Despite COVID-19's onset in December and subsequent challenges, the team maintained patient monitoring and trial progress amid lockdowns and restricted hospital access.

At the end of last year, pCAR-19B was approved for inclusion in the national "Breakthrough Therapy" list. This June, it is expected to be included in the national "Priority Review" list. Under normal procedures, it will take 120 working days to receive the market approval.

A researcher conducting experiments at the Western (Chongqing) Science City. (Photo/Lei Jian)

PCAR-19 B has offered hope to over a hundred patients and their families, underscoring its potential impact.

Zhang shared a case of a 10-year-old boy with relapsed ALL who, although he contracted COVID-19 during his CAR-T treatment in November 2022, achieved complete remission. Nearly two years later, he remains in good health.

Chongqing Precision Biotech Co., Ltd. develops advanced cell and gene therapies. It has made notable progress with four CAR-T therapies and nine clinical trial approvals. Their PRIMCAR® platform is behind MC-1-50, a CD19-targeting CAR-T therapy now in Phase I trials for two indications.

Chongqing Precision Biotech is building the "Chongqing Regional Cell Preparation Center" in the Western (Chongqing) Science City. The 154-acre project has a planned investment of three billion yuan.

The biopharmaceutical industry is crucial for national health and security. It is also a key focus for the Western (Chongqing) Science City, which aims to create a leading modern manufacturing cluster.