China News Service, Beijing, February 25th. China National Biopharmaceutical Co., Ltd. recently announced that the anti-PD-1 monoclonal antibody drug "Paampril" jointly developed by the group and Kangfang Biotechnology (Cayman) Co., Ltd. is the first-line treatment of chemotherapy The interim analysis of the Phase III clinical trial in patients with squamous non-small cell lung cancer showed excellent results, reaching the expected primary endpoint of the objective response rate.
The safety data of this clinical trial was consistent with the known risks, and no new safety issues appeared.
Currently, lung cancer is the number one malignant tumor in China in terms of morbidity and mortality. Among all lung cancers, non-small cell lung adenocarcinoma accounts for about 80% of the total.
The results of the interim analysis of the study were reviewed by the Independent Data Review Committee (IDMC). The results showed that Paclitaxel combined with paclitaxel and carboplatin compared with placebo combined with paclitaxel and carboplatin can significantly reduce the risk of disease progression or death. The end point of the study reached the superiority threshold preset by the protocol, and the safety characteristics were consistent with the results of the previously reported studies of Paimrizumab, and there were no new safety issues.
The detailed research results will be announced in subsequent academic conferences.
The Fc receptor and complement-mediated utility functions of Paampril are completely removed by mutations in the Fc region. Compared with the PD-1 antibodies that have been marketed abroad, the antigen binding and dissociation rate is slower.
These characteristics enable Paampril to more effectively block the PD-1 pathway activity and maintain stronger T cell anti-tumor activity, which is expected to become an anti-PD-1 drug with better clinical benefits.
Paimrizumab was jointly developed and commercialized by a joint venture established by Kangfang Biological and China Biopharmaceutical Co., Ltd. (1177.HK)'s Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
At present, the main indications for Pianpril include liver cancer, gastric cancer, lung cancer and other diseases. At the same time, a number of clinical trials in combination with Chia Tai Tianqing's existing fist product Anlotinib are carried out in multiple tumor types.
In May 2020, the National Medical Products Administration has accepted the new drug listing application of piprimumab for the treatment of relapsed or refractory classic Hodgkin lymphoma (r/rcHL) after at least second-line chemotherapy.
The registered clinical trial of Paampril for the third-line treatment of metastatic nasopharyngeal carcinoma also reached the primary endpoint.
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