Mengyang Pharmaceutical announces the completion of Phase II clinical trial for Class 1 new drug DH001, with the first subject administration completed

2023-09-23

Mengyang Pharmaceutical is a modern joint-stock pharmaceutical high-tech enterprise, mainly engaged in the research and development, production, and sales of traditional Chinese medicine, chemical drugs, and health food. The company's mission is to improve the quality of life of cancer patients and is committed to becoming a leader in the field of cancer treatment related diseases.



On September 23, 2023, Mengyang Pharmaceutical announced in Shanghai that its independently developed small molecule drug, Class 1 new drug DH001 (R&D code), has completed its first phase II clinical trial for cancer patients. This Phase II clinical study (CTR20232122) is a preliminary evaluation of the preventive effect and safety of different doses of DH001 on cardiac toxicity in cancer patients after the use of doxorubicin, providing a basis for subsequent confirmatory studies. This study is a randomized, double-blind, placebo-controlled multicenter clinical trial. This clinical trial will be conducted in 12 hospitals, including Harbin Institute of Hematology and Oncology, Peking University Cancer Hospital, Peking University Third Hospital, Zhengzhou University First Affiliated Hospital, Zhejiang Cancer Hospital, and Zhejiang University Medical College Second Affiliated Hospital. Professor Ma Jun, Director of Harbin Institute of Hematology and Oncology, and Professor Zhu Jun from Peking University Cancer Hospital jointly served as the main researchers for the Phase II clinical trial of DH001.



Dr. Huang Qian, Vice President of R&D at Mengyang Pharmaceutical, stated that clinical research on preventing doxorubicin induced cardiac toxicity is a huge challenge for us, and there is very little information available for reference both domestically and internationally. The Phase II clinical trial protocol of DH001 (LXC2104DH001) has undergone dozens of revisions and improvements. This clinical plan was jointly developed through multiple communications and exchanges with authoritative experts in oncology, cardiology, ultrasound, and other fields in China. At the same time, it was revised under the guidance of CDE experts, and the inclusion criteria, exclusion criteria, and endpoint indicators were fully discussed. We hope to protect patient rights with the most rigorous attitude and professional knowledge, and always adhere to the principle of "patient-centered drug clinical trial design". Here, we wish the project smooth progress and look forward to DH001 being launched soon, reflecting its potential clinical value and benefiting more patients.



Dr. Zhang Min, Chairman of Mengyang Pharmaceutical, stated that the trend of "chronic disease" in tumor diseases is obvious, and "survival with tumors" will become the norm. The cardiac toxicity associated with anti-tumor drugs poses great potential risks to patients' lives and seriously affects their quality of life. DH001 is an active monomer discovered from the traditional Chinese medicine Schisandra chinensis. It has demonstrated excellent safety and tolerability data in phase I clinical trials, with high oral utilization. We are very much looking forward to seeing DH001 demonstrate good therapeutic effects in subsequent clinical studies, hoping to ultimately benefit a large number of cancer patients.



Mengyang Pharmaceutical is committed to exploring the treasure trove of traditional Chinese medicine, developing new drugs based on the classic formulas of famous traditional Chinese medicine practitioners and effective ingredients derived from natural medicines, protecting China's intangible cultural heritage, and benefiting humanity. The company adheres to the principle of serving the country through industry and continuous innovation. In today's increasingly strong motherland and as the people of the whole country strive to realize the Chinese Dream of national rejuvenation, Mengyang Pharmaceutical, as a responsible and responsible national pharmaceutical enterprise, will do its best to promote traditional Chinese medicine and bring the ideal of health to patients!


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