On July 20, 2024, Chongqing Precision Biotech Co., Ltd. announced that China National Medical Products Administration (NMPA) has formally accepted the New Drug Application for its National Class I biological new drug pCAR-19B cell autologous infusion preparation (Priscabtagene Autoleucel Injection), China’s first CAR-T product for the treatment of CD19 positive relapsed/refractory acute lymphoblastic leukemia (ALL) patients aged from 3 to 21 years old.  

Leukemia is one of the most common malignant tumors in the world. The total number of cases and the number of new cases each year are on the rise. Among them, acute lymphoblastic leukemia (ALL) is the most common malignant tumor in children, with an incidence of about 3~ 5/100,000, and it is also one of the main diseases that lead to the death of children and adolescents, among which B-ALL accounts for about 80% of ALL. The successful NDA acceptance of pCAR-19B makes it possible to become the first innovative biopharmaceutical listed in this treatment indication in China.

In addition, Precision Biotech also has a product for the treatment of adult leukemia, which has entered the phase II clinical study. Our candidate MC-1-50 targeting CD19 developed by PRIMCAR ®, a short-time and efficient preparation platform, is currently undergoing phase I clinical trials for two indications in Peking University Cancer Hospital and Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, respectively. The CEA-targeted CAR-T product C-13-60,as the first clinically CAR-T product to be registered in China ,as well as C-4-29, the first domestic product targeted both hematological and solid tumor, have provided a boost in the treatment of malignant tumors.

The first CD19-targeted CAR-T therapy product in China

pCAR-19B optimizes the structure of CAR (Chimeric Antigen Receptor) for China population, and adopts a safer gene transduction vector system, so it has better effectiveness and safety. The data of phase I clinical trial showed that all the 9 patients in the group achieved complete remission (CR), with an overall remission rate of 100%, and the patients who achieved complete remission (CR) for the first time also had negative minimal residual lesions (MRD). No dose-limited toxicity (DLT) and treatment-related deaths occurred, and the overall safety and tolerance were good.

Milestones for pCAR-19B Study

In February 2019, pCAR-19B was approved by China Food and Drug Administration to carry out the clinical trial, which is the first CAR-T registration clinical trial for children and adolescents with B-cell acute lymphoblastic leukemia in China.

In November 2019, the phase I clinical trial of pCAR-19B was initiated in Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

In January 2022, the phase II clinical trial of pCAR-19B was officially initiated in Beijing Children's Hospital, Capital Medical University and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and clinical trials were carried out in hematology departments of more than 10 3A hospitals nationwide in order to better evaluate the efficacy and safety of pCAR-19B.

In November 2023, pCAR-19B, as the first CAR-T product for the treatment of childhood leukemia in China was approved to be included in the list of "Breakthrough Therapy Varieties".

In June 2024, pCAR-19B cell autologous infusion preparation (Priscabtagene Autoleucel Injection) is proposed to be included in the "Priority Evaluation Variety" for the treatment of CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia patients aged 3-21 years.

The "last mile " of the product listing is the terminal point and also the starting point! pCAR-19B is our company's first NDA product, which is a historically significant milestone for us. Seven years of ingenuity and pursuit of excellence, to us, time is but the faithful witness in the process of excellence. It is the persistence and dedication of our team, the cooperation of researchers from all sides, and the care and support of shareholders and competent departments that enable us to overcome difficulties and overcome the COVID-19 epidemic, and ultimately ensure high-quality research results. In the next 3-5 years, as more new drugs are approved for marketing, Precision Biotech will provide more accessible, affordable and well-used innovative drugs to patients in China and around the world!

About Chongqing Precision Biotech

Chongqing Precision Biotech is dedicated to innovating gene editing and synthetic biotechnology, focusing on tumor immunotherapy and developing gene and cell drugs. The company has a high-level scientific research team, 18,000 square meters of gene and cell research and development center, implemented and promoted more than 10 breakthrough technology product research and development pipelines, more than 150 (including subsidiaries) domestic and foreign patent applications and layout. It is the first biopharmaceutical enterprise in the western region to obtain CAR-T production license, and now it has obtained 9 implied licenses of Class I biological new drugs in 4 countries. In the future, Precision Biotech will take its new 100,000 square meter cell drug research and development and production base (under construction) as the source of innovation, base itself in Chongqing and face the whole country, and aspire to become a global, innovative and pioneering biopharmaceutical enterprise.