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, it was announced on the official website of the Drug Evaluation Center of the China State Drug Administration that Kangfang Biology (09926) and the anti-PD-1 antibody amprizumab injection being developed by Chia Tai Tianqing and the marketing applications for anrotinib hydrochloride capsules being developed by Chia Tai Tianqing were accepted.
The Zhitong Finance App learned that on November 21, the official website of the Drug Evaluation Center of the China State Drug Administration announced that Kangfang Biotech (09926) and the anti-PD-1 antibody amprizumab injections being developed by Chia Tai Tianqing and the marketing applications for anrotinib hydrochloride capsules being developed by Chia Tai Tianqing were accepted.
In recent years, the rapid development of immunotherapy is changing the treatment pattern for advanced liver cancer. In particular, target-free combination therapy has become an important first-line treatment model for advanced HCC. Peiamprilimab is a novel differentiated anti-PD-1 monoclonal antibody. The product was developed by Kangfang Biotech, and Chia Tai Tianqing Kangfang, a joint venture between Kangfang Biotech and Chia Tai Tianqing, is responsible for subsequent development and commercialization.
Currently, pimiprizumab has been approved for 3 indications in China, covering non-small cell lung cancer, Hodgkin lymphoma, and nasopharyngeal cancer. In addition, an application for marketing of this product for first-line treatment of metastatic nasopharyngeal cancer has been submitted, and late-stage clinical research on indications such as liver cancer and gastric cancer is also underway.
In September of this year, the results of a phase 3 study on first-line treatment of advanced hepatocellular carcinoma with piamprimab combined with anlotinib were announced at the European Society of Medical Oncology (ESMO) annual meeting. Chia Tai Tianqing said in a press release at the time that it will submit a marketing application to the CDE for the new indications of this combination therapy. It is presumed from this that it may be a marketing application for combination therapy to be accepted for first-line treatment of advanced hepatocellular carcinoma.
At the 2024 ESMO annual meeting, the results of a phase 3 clinical study of anlotinib combined with amprizumab first-line treatment for advanced hepatocellular carcinoma were unveiled. The study achieved “double endpoint positivity”: median progression-free survival (PFS) was 6.9 months, median overall survival (OS) was 16.5 months, and both PFS and OS reached the pre-set end points. Safety analysis showed that the safety data for anlotinib combined with amprizumab was in line with known risks, and no new safety signals emerged.
