Telegraph

7x24 real-time news feed, auto refreshBeijing Time:

B
[3 days and 2 boards Laimei Pharmaceutical: Nanocarbon-iron combined radiotherapy is still in phase II clinical trials] On October 14th, Laimei Pharmaceutical (300006.SZ) issued an announcement of abnormal stock trading fluctuations. The company is concerned that the market and media have recently paid attention to the clinical trials of the company’s nanocarbon-iron suspension injection (CNSI-Fe) (referred to as nanocarbon-iron). This matter is mainly due to the company's holding subsidiary Ingrui Medicine recently publishing academic papers on the Phase I clinical trial of its independently developed nanocarbon iron in relevant academic journals, as well as the interpretation of clinical trial results or individual case results disclosed by relevant partner hospitals. As of now, nanocarbon iron combined with radiotherapy is still in the phase II clinical trial stage. Subsequently, the results of the phase II clinical trial of combined radiotherapy must be used to advance the application for breakthrough therapy designation, or conduct phase III clinical trials, apply for drug marketing authorization (NDA) and other core links. There are major uncertainties in the above-mentioned core links, and there are risks such as the results of phase II clinical trials not meeting expectations, the inability to apply for or be approved for breakthrough therapy designation, the inability to conduct or complete phase III clinical trials, the inability to submit or approve NDA, and the delay in review and approval progress.
B
[Alice: The phase III clinical trial of fumetinib did not meet the primary study endpoint] On October 7, Ellis (688578.SH) announced that the company's product fumetinib mesylate tablets ("vometinib") monotherapy is FURVENT for the treatment of previously untreated patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations. The Phase III trial did not meet its primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR). Clinical benefit was observed on secondary endpoints such as investigator-assessed PFS and BICR-assessed confirmed objective response rate (ORR); although overall survival (OS) data are not yet mature, a clear trend of improvement has been observed. The safety profile observed in the FURVENT trial was consistent with previous clinical studies of fumetinib, and no new safety signals were found. Together with ArriVent, the company is evaluating FURVENT's complete data set to determine next steps. As of September 30, 2026, the company has invested a total of approximately 70.82 million yuan in key clinical trials of fumetinib for first-line treatment of exon 20 insertion mutations. The above-mentioned research and development expenses have been included in the profits and losses of the corresponding accounting period when they are incurred, and will not have a significant impact on the company's current performance.