目前，派安普利单抗已经在中国获批3项适应症，涵盖非小细胞肺癌、霍奇金淋巴瘤、鼻咽癌。此外，该产品一线治疗转移性鼻咽癌的上市申请已提交，治疗肝癌、胃癌等适应症的后期阶段临床研究也正在推进。On November 21, the Chinese National Medical Products Administration's official drug review website announced that akeso (09926) and Zhengda Tianqing's anti-PD-1 antibody, Paimapilizumab injection, as well as Zhengda Tianqing's hydrochloride anlotinib capsules, have had their market application accepted.
According to Zhitong Finance APP, on November 21, the Chinese National Medical Products Administration's official drug review website announced that akeso (09926) and Zhengda Tianqing's anti-PD-1 antibody, Paimapilizumab injection, as well as Zhengda Tianqing's hydrochloride anlotinib capsules, have had their market application accepted.
In recent years, the rapid development of immunotherapy is changing the treatment landscape for advanced liver cancer, especially as targeted combination therapy has become an important first-line treatment model for advanced HCC. Paimapilizumab is a novel differentiated anti-PD-1 monoclonal antibody, developed by akeso, which is responsible for further development and commercialization through a joint venture with Zhengda Tianqing.
Currently, Paimapilizumab has been approved in China for three indications, covering non-small cell lung cancer, Hodgkin lymphoma, and nasopharyngeal carcinoma. Additionally, a market application for its use in first-line treatment of metastatic nasopharyngeal carcinoma has been submitted, and late-stage clinical research for treating liver cancer and gastric cancer is also underway.
In September of this year, the results of a phase 3 study on Paimapilizumab combined with anlotinib for first-line treatment of advanced hepatocellular carcinoma were announced at the European Society for Medical Oncology (ESMO) annual meeting. At that time, Zhengda Tianqing's press release stated that they would submit a market application for the new indication of this combination therapy to the CDE. Therefore, it is inferred that the application accepted this time may be for a combination therapy for first-line treatment of advanced hepatocellular carcinoma.
At the 2024 ESMO annual meeting, phase 3 clinical research results for anlotinib combined with Paimapilizumab for first-line treatment of advanced hepatocellular carcinoma were presented for the first time. This study achieved "dual endpoint positivity": the median progression-free survival (PFS) was 6.9 months, and the median overall survival (OS) was 16.5 months, with both PFS and OS meeting the preset endpoints. Safety analysis showed that the safety data of anlotinib combined with Paimapilizumab were consistent with known risks, and no new safety signals were observed.
