Bioheng‘s Auto CAR-T Product, CTB001, Received Orphan Drug Designation (ODD) from the U.S. FDA

Reprint to:


Recently, Bioheng Biotech Co., Ltd ( hereinafter referred to as ' Bioheng) announced that its anti-claudin 18.2 autologous CAR-T cell therapy product CTB001 received Orphan Drug Designation ( ODD ) from the Food and Drug Administration ( FDA ) for the treatment of gastric cancer. Gastric cancer has a high incidence in Asian countries such as China and Japan, and the mortality rate ranks the third in the global mortality rate of malignant tumors, behind lung cancer and colorectal cancer. At present, conventional chemotherapy and surgical resection are mainly applied for the gastric cancer treatment, therefore the treatment drugs and methods are very limited.

 

About CTB001 :

Claudin18.2 is a pan-cancer target and is abnormally expressed in various primary tumors and metastases, including gastric cancer, pancreatic cancer, cholangiocarcinoma, ovarian cancer and lung adenocarcinoma. CTB001 is a fourth-generation autologous CAR-T cell therapy product targeting claudin18.2, which uses Bioheng Explored CAR-T platform technology to enhance the anti-tumor efficacy of the product.

 

The breakthrough of CAR-T therapy provides a new solution for cancer treatment, with high unmet clinical needs. CTB001 shows excellent efficacy and safety in exploratory clinical studies, and provides strong data support for the upcoming domestic declaration.

 

Bioheng indicates:

CTB001 is the first clinical validation of Bioheng Explored CAR-T platform technology. It is a very promising immunotherapy that can accurately, quickly and efficiently bring good benefits to claudin18.2-positive cancer patients.

 

The qualification of CTB001 obtained by FDA for orphan drugs will further accelerate the development and commercialization of cell and gene therapy, and promote Bioheng to enter the global innovative drug market. In the future, we look forward to bringing more products to clinical trials and providing more choices for solving the unmet medical needs.

 

About ODD

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act. After obtaining the ODD, pharmaceutical companies could receive various incentives for the drug development, including 25% federal tax credit for expenses incurred in conducting clinical research within the United States, Waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, qualified to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies for orphan drugs, eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan and 7-year marketing exclusivity.

 

Related News


Bioheng's CD7 UCAR-T and Allogeneic HSCT Sequential Therapy Study Published in the New England Journal of Medicine

On April 25, 2024, The New England Journal of Medicine published the latest findings by the team of He Huang, M.D., PhD., and Yongxian Hu, M.D., PhD., from the First Affiliated Hospital, Zhejiang University School of Medicine, titled "Sequential CD7 CAR-T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis"[1]. The study introduces an innovative treatment strategy that combines CD7 CAR-T with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for the first time.


Bioheng Received CDE IND Approval for CTA101 UCAR-T

On March 17,2022, China National Drug Administration Drug Review Center ( CDE ) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug ( Acceptance No. : CXSL2101509 ) . CTA101 is independently developed by Nanjing Bioheng Biotech Co., Ltd ( hereinafter referred as ' Bioheng), targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ).


Bioheng‘s Auto CAR-T Product, CTB001, Received Orphan Drug Designation (ODD) from the U.S. FDA

Recently, Bioheng Biotech Co., Ltd ( hereinafter referred to as ' Bioheng) announced that its anti-claudin 18.2 autologous CAR-T cell therapy product CTB001 received Orphan Drug Designation ( ODD ) from the Food and Drug Administration ( FDA ) for the treatment of gastric cancer. Gastric cancer has a high incidence in Asian countries such as China and Japan, and the mortality rate ranks the third in the global mortality rate of malignant tumors, behind lung cancer and colorectal cancer. At present, conventional chemotherapy and surgical resection are mainly applied for the gastric cancer treatment, therefore the treatment drugs and methods are very limited.


Bioheng Received Orphan Drug Designation(ODD) from the U.S. FDA for the Treatment of T-ALL

Nanjing Bioheng Biotech Co., Ltd. Announced UCAR T cell therapy product targeting CD7, code CTD401, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL).


Bioheng Raised $80 Million in Series B Financing to Advance Allogeneic Immuno-Cell Therapies

NANJING, China, March 24, 2021 /PRNewswire/ -- Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company  dedicated on developing novel cellular immunotherapy for cancer, today announced that it had secured $80 million in Series B Financing. The Series B was co-led by GL Ventures, the venture capital unit of Hillhouse Capital, Decheng Capital and Octagon Capital, with the participation of BlueRun Ventures China and Shenzhen Capital Group Company.

Contact Us