B[Maiway Bio: 9MW2821 clinical data will be presented in an oral report at the 2026 ESMO Conference] On October 18, Maiwei Bio (688062.SH) announced that the company will announce the phase II clinical data of the innovative drug 9MW2821 targeting nectin-4 ADC for patients with triple-negative breast cancer (TNBC) in the form of an oral report at the 2026 European Society for Medical Oncology (ESMO) Congress. As of April 10, 2026, among 60 patients with evaluable efficacy, the objective response rate (ORR) was 30.0%, the disease control rate (DCR) was 80.0%, the median progression-free survival (mPFS) was 3.7 months, the median duration of response (mDOR) was 8.7 months, the median overall survival (mOS) has not yet matured, and no new safety signals have been observed. The company is advancing four phase III key registration clinical trials, among which UC single drugs and combination therapies have been included in the national breakthrough therapy list. 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[The concept of innovative drugs fluctuated and fell, and Alex dropped by 20cm.] On October 8, the concept of innovative drugs fluctuated and fell by 20cm, with Ellis falling by the limit of 20cm, Bepsis falling by more than 10%, and Yahong Pharmaceutical, Maiwei Biotech, Technomax, Huiyu Pharmaceutical, Rejing Biotech, etc. followed suit. On the news, Arris announced that the phase III clinical trial of fumetinib did not meet the primary study endpoint. Affected by this news, partner ArriVent's US stock price plummeted 47% in a single day on October 6. B[Zhongsheng Pharmaceutical: ZSP1601 tablets are included in the breakthrough therapy drug program] On October 7, Zhongsheng Pharmaceutical (002317.SZ) announced that ZSP1601 tablets, a class of innovative drug independently developed by the company’s holding subsidiary Zhongsheng Ruichuang, was included in the breakthrough therapy drug program by the Drug Evaluation Center of the State Food and Drug Administration, and the proposed indication is metabolism-associated steatohepatitis (MASH). ZSP1601 tablets are a first-in-class innovative drug (First-in-Class) for the treatment of MASH with global independent intellectual property rights and a new mechanism of action. It is a major national new drug creation project. The phase IIb clinical trial of ZSP1601 tablets for the treatment of MASH has obtained positive data results, and the primary efficacy endpoint of pathological improvement was achieved after 48 weeks of treatment. At the same time, it achieves the triple benefits of anti-fibrosis, reducing liver fat content, and improving liver enzymes, with fast onset, robust effect, and excellent safety.
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