On August 5th, the official website of the National Drug 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 the public information, the approved indications of paclitaxel monoclonal antibody this time are: for the treatment of recurrent or refractory classical Hodgkin lymphoma (r/r cHL) after at least second-line systematic chemotherapy
Screenshot source: NMPA official website
Parapril monoclonal antibody is a recombinant humanized anti PD-1 monoclonal antibody, which is jointly developed and commercialized by a joint venture established by Kangfang Biology and Zhengda Tianqing, a subsidiary of Sino Biopharmaceutical Limited. 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
Prior to that, Paraprizumab had been awarded the breakthrough therapy certification, 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:
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In August 2021, the application for the third line treatment of metastatic nasopharyngeal carcinoma with Panaprizumab was accepted by NMPA
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In July 2021, the application for the first line treatment of locally advanced or metastatic squamous non-small cell lung cancer with combination chemotherapy of piazepril monoclonal antibody was accepted by NMPA
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In May 2021, Panaprizumab submitted a Biological Product License Application (BLA) to the US FDA through Real Time Oncology Review for the third line treatment of metastatic nasopharyngeal carcinoma
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In May 2020, the marketing application of pacrolimusrelapsed after at least second-line systematic chemotherapy or refractory classical Hodgkin lymphomawas accepted by NMPA
This time, the approved indication of paclitaxel monoclonal antibody is: recurrent or refractory classical Hodgkin lymphoma (r/r cHL). Lymphoma is a cancer of the Lymphatic system, which is mainly divided into Hodgkin lymphoma and non Hodgkin lymphoma. Most patients with Hodgkin lymphoma belong to“ Classic&# quo;, Large abnormal lymphocytes may appear in their lymph nodes. With the development of medicine and the emergence of treatment methods, Hodgkin lymphoma has become a cancer with good prognosis, but the survival rate of patients with advanced stage will gradually decline. 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 paclitaxel monoclonal antibody exhibited good safety characteristics in r/r cHL subjects. The overall incidence of drug related adverse events (TRAE), grade 3 and above TRAE, drug related severe adverse reactions (SAE), drug discontinuation induced TRAE, drug suspension induced TRAE, and immunotherapy related adverse reactions (irAE) were all low, indicating a potential safety advantage
