On August 5th, the official website of the National Medical Products Administration (NMPA) of China announced that the anti PD-1 antibody drug, Paprilimab (AK105), jointly declared by Kangfang Biotechnology and Zhengda Tianqing, has been approved. According to public information, the approved indications for the use of paclitaxel monoclonal antibody are for the treatment of recurrent or refractory classic Hodgkin's lymphoma (r/r cHL) that has undergone at least second-line systemic chemotherapy.
Paranpril monoclonal antibody is a recombinant humanized anti PD-1 monoclonal antibody developed and commercialized by a joint venture between Kangfang Biotechnology and China Biopharmaceutical's subsidiary, Zhengda Tianqing. It is reported that the new anti PD-1 monoclonal antibody, which uses immunoglobulin G1 subtype and is modified by crystallization (Fc) segment, has a slower antigen binding and dissociation rate. These characteristics enable it to persistently block the activity of the PD-1 pathway and maintain stronger T cell anti-tumor activity.
Previously, Pianzumab was awarded breakthrough therapy recognition, fast track qualification, and orphan drug qualification by the US FDA. As of now, Panaprizumab has submitted three new indication marketing applications in China and one indication marketing application in the United States:
In August 2021, the application for the third line treatment of metastatic nasopharyngeal carcinoma with piazepril monoclonal antibody was accepted by NMPA;
In July 2021, the application for the first line treatment of locally advanced or metastatic squamous non-small cell lung cancer with combination therapy of paclitaxel and chemotherapy was accepted by NMPA;
In May 2021, the third line treatment of metastatic nasopharyngeal carcinoma with paclitaxel monoclonal antibody passed the Real Time Oncology Review and submitted a Biological Product License Application (BLA) to the US FDA;
In May 2020, the application for the marketing of paclitaxel monoclonal antibody treatment for recurrent or refractory classic Hodgkin's lymphoma after at least second-line systemic chemotherapy was accepted by NMPA.
The indications for the approval of paclitaxel monoclonal antibody this time are recurrent or refractory classic Hodgkin's lymphoma (r/r cHL). Lymphoma is a type of cancer that occurs in the lymphatic system and is mainly divided into two types: Hodgkin's lymphoma and non Hodgkin's lymphoma. Most patients with Hodgkin's lymphoma belong to the "classic type", where large abnormal lymphocytes appear in their lymph nodes. With the development of medicine and the continuous emergence of treatment methods, Hodgkin's lymphoma has become a cancer with good prognosis, but the survival rate of advanced patients will gradually decrease. For these patients who are difficult to treat or experience recurrence, new treatment options are still needed.
According to data released by Kangfang Biotechnology at the 35th Annual Conference of the Society for Cancer Immunotherapy (SITC 2020) in November 2020, a phase 2 clinical study conducted on r/r cHL patients showed significant clinical benefits in r/r cHL patients who had undergone at least two efficacy evaluations. Among them, the objective response rate (ORR) reached 83.6%, and the complete response rate (CR) reached 49.3%.
The study also showed that piazepril monoclonal antibody exhibited good safety characteristics in r/r cHL subjects, with a lower incidence of overall drug related adverse events (TRAE), grade 3 and above TRAE, drug related severe adverse reactions (SAE), drug cessation TRAE, drug suspension TRAE, and immunotherapy related adverse reactions (irAE), indicating potential safety advantages.
Congratulations on the approval of Pianzumab and hope that its arrival can bring more treatment options to patients.