Beijing Konruns Pharmaceutical (603590.SH) mentioned during a specific research interview that KC1036 has made breakthroughs in clinical diversification and has entered late-stage clinical research for stage III esophageal squamous cell carcinoma. KC1036 is an independently developed multi-target receptor tyrosine kinase inhibitor by the company, with multiple clinical trials progressing orderly according to plan. Key studies include the clinical research of treating late-stage esophageal squamous cell carcinoma with KC1036, KC1036 in combination with PD-1 antibody as first-line maintenance therapy for locally advanced or metastatic esophageal squamous cell carcinoma, KC1036 treating late-stage Ewing's sarcoma in adolescents aged 12 and above, and phase II clinical research of KC1036 treating late-stage thymoma patients, all progressing smoothly at present.
Traditional Chinese Medicine innovative drug ZY5301, under orderly progress for market approval application, is the first precise reapproved traditional Chinese medicine innovative drug of class 1.2 for the indication of "chronic pelvic pain due to sequelae of pelvic inflammatory disease." This variety, derived from over a decade of research from a single traditional Chinese medicine, Herba Lycopodii, is an extract of the effective part with clear components, controllable quality, high safety, and clinical evaluation standards aligned with international practices. It has received continuous support from national programs such as the National High-Tech Research and Development Program (863 Program) and national major new drug development projects.
In March 2024, the phase III clinical research of ZY5301 was successfully concluded at the leading unit, Beijing Traditional Chinese Medicine Hospital affiliated with Capital Medical University, with a data review meeting and completion of unblinding, achieving the primary research endpoints.
As disclosed in the announcement, in July 2024, the results of the phase II clinical research of ZY5301 were published online in the international prestigious medical journal "JAMA" sub-journal, demonstrating not only high recognition of the scientific rigor of the phase II clinical research of ZY5301 by international journals but also high recognition of its efficacy and safety in treating chronic pelvic pain due to sequelae of pelvic inflammatory disease in women. This marks the first publication of research results on traditional Chinese medicine in this treatment field in the "JAMA" journal series.