值得注意的是，乐普生物半年报显示，MRG003针对鼻咽癌适应症已经获美国食品药品监督管理局（FDA）授予突破性疗法认定。目前，乐普生物已完成MRG003针对鼻咽癌的2b期注册性临床研究的患者入组。此外，该产品针对头颈鳞癌的3期临床注册性研究目前也在积极入组中。Lupin-B (02157) is now up more than 4%, as of the time of writing, up 4.44%, at HK$ 3.06, with a turnover of 8.1931 million Hong Kong dollars.
According to the Zhongtong Financial APP, Lupin-B (02157) is now up more than 4%, up 4.44% as of the time of writing, at HK$ 3.06, with a turnover of 8.1931 million Hong Kong dollars.
On the news front, on September 19th, the official website of the National Medical Products Administration's Center for Drug Evaluation announced that Lupin Biological's injection of Vecocetaxel monoclonal antibody is planned to be included in the priority review, and is applicable to patients with recurrent/metastatic nasopharyngeal cancer who have previously failed at least second-line systemic chemotherapy and PD-1/PD-L1 inhibitor therapy. It is reported that the drug is an antibody-drug conjugate (ADC) targeting EGFR developed by Lupin Biological, with the research and development code MRG003.
It is worth noting that Lupin Biological's semi-annual report shows that MRG003 has already been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for nasopharyngeal cancer indications. Currently, Lupin Biological has completed patient enrollment for the phase 2b registration clinical study of MRG003 for nasopharyngeal cancer. In addition, the product is also actively enrolling for a phase 3 clinical registration study for head and neck squamous cell carcinoma.
