On June 22, 2023, the FDA granted Wuhan Binhui Biotechnology Co., Ltd. the Fast Track Design (FTD) qualification for the candidate drug BS001 (OH2) injection for the treatment of unresectable stage III or IV melanoma that has developed resistance or progression to PD-1 therapy.

FTD is a qualification granted by the FDA to investigational drugs in order to promote the development of new drugs for treating serious diseases and addressing unmet clinical needs. Preclinical and/or clinical data can fully demonstrate the potential of the drug to address unmet clinical needs. In a clinical trial conducted at Peking University Cancer Hospital, it was found that the objective response rate (ORR) was as high as 62.5% and the overall survival time (OS) was significantly prolonged in the subgroup of patients who failed PD-1 treatment and had disease stage III-IVM1a treated with BS001 (OH2) injection.

As a channel for accelerating drug research and evaluation, FTD certification is an important step in accelerating the commercialization process of BS001 (OH2) injection project. After obtaining FTD for BS001 (OH2) injection, the company will have more opportunities to communicate and exchange ideas with the FDA in the subsequent research and evaluation process, timely discuss the development plan and trial data of candidate drugs with the FDA, and identify and solve problems that arise during the trial. Based on positive clinical data support in the early stage, the company is discussing clinical trial plans with the FDA, which are expected to directly carry out critical phase III clinical trials in the United States for the treatment of unresectable stage III or IV melanoma that is resistant or progressing after anti-PD-1 treatment.

Wang Hanming, CMO of Binhui Biotechnology, stated that during the Dragon Boat Festival, during which dragon boats competed to cross the river, obtaining the FDA's FTD qualification was the best recognition for Binhui Biotechnology's "turning the tide towards the ocean". The company will fully utilize the preferential policies of FTD, actively communicate progress in clinical trials, roll submit new drug research materials when submitting marketing applications, ensure and accelerate the clinical research and registration of BS001 (OH2) injection, and demonstrate China's strength on the international stage!

关于FTD

Fast Track Design (FTD) is a qualification granted by the FDA to investigational drugs in order to promote the development of new drugs for the treatment of serious diseases and to address unmet clinical needs. This qualification was initially included in the Food and Drug Administration Modernization Act (FDA) of 1997, and later revised as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.

The drugs that obtain FTD must simultaneously meet the following conditions:

1. Used to treat serious illnesses;

2. Preclinical and/or clinical data can demonstrate the potential of this drug to address unmet clinical needs.

After obtaining FTD for drugs, new drug development companies will have more opportunities to communicate and exchange ideas with the FDA in the subsequent drug development and evaluation process. Discussing the development plan and data of drugs under study with the FDA in the early stages of drug development can timely identify and solve problems that arise during development, which helps accelerate the subsequent development and approval of drugs for market launch. In addition, new drug development companies can submit rolling submissions of new drug research materials to the FDA when submitting their marketing applications (NDA/BLA). These preferential policies provide favorable guarantees for accelerating the research and development of new drugs.

About OH2 Injection

The injection of oncolytic virus BS001 (OH2) is carried out using herpes simplex virus type II as a carrier. Molecular cloning, DNA homologous recombination, and other techniques are used to remove the neurovirus genes and immunosuppressive genes from the genome of the wild-type virus, and to insert immune enhancing factor genes for modification. It has the effects of direct oncolysis, induction of local and systemic anti-tumor immune responses, and broad-spectrum anti-tumor effects.

OH2 injection has obtained invention patent authorization and national major new drug development special funding. It was approved by the National Medical Products Administration (NMPA) Drug Evaluation Center in June 2018 and licensed by the US FDA to conduct clinical trials in August 2021. It has become the world's first oncolytic virus to enter clinical research using type II herpes simplex virus as a carrier. In July 2022, OH2 injection was certified as an orphan drug by the US FDA for the treatment of stage IIb to IV melanoma. It is the first candidate oncolytic virus drug independently developed by China and certified as an orphan drug by the US FDA; In February 2023, CDE included OH2 injection as a breakthrough treatment variety; In June 2023, it was granted FTD qualification by the FDA.