Recently, Nanjing 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.
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.
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.
Nanjing Bioheng Biotech Co., Ltd. (Bioheng), founded in 2017, is a leading biomedical company specialized in the development and commercialization of allogeneic cellular immunotherapy. At present, Bioheng has established 7500m2 high-standard translational center and GMP-level manufacturing plant that is in compliance with NMPA and FDA regulatory guidelines.
In March 2021, Bioheng secured an $ 80 million of serial B round of investment co-led by Hillhouse Venture Capital, Decheng Capital and Octagon Capital, accumulating 100 million of financing within 4 years. By November 2021, Bioheng has applied 52 core patents, and been selected for “Cultivating Unicorn Enterprises”, “Nezha Enterprise”, “Entrepreneurship and Innovation Talents” Program of Jiangsu Province, Nanjing High-level Entrepreneurial Talent Plan, Nanjing Expert Studio, etc. Bioheng has been awarded National Science and technology SMEs, National Intellectual Property Management Enterprise, Nanjing Immunotherapy Excellence Center, etc.
Bioheng is a global leader in developing allogeneic “off-the-shelf” universal CAR-T cell therapy, which may fundamentally solve the dilemma of “high cost, long waiting time, difficult manufacturing and individualization” of traditional CAR-T therapy, and ultimately realize the affordability and accessibility of immunotherapy. Committed to “bridge the life and health”, Bioheng is dedicated to provide every patient an equal chance of cure.
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