On January 21, 2022, Mengyang Pharmaceutical announced that its self-developed small molecule chemical drug Class 1 new drug DH001 has completed phase I clinical trial.The study (LXC2008DH001) is a Phase I clinical study in healthy adult subjects in China to evaluate the safety, tolerability and pharmacokinetics of DH001 after single and multiple oral doses in healthy adult subjects. A total of 63 healthy subjects were included in the study using a double-blind design, of which 51 received single or multiple oral doses of DH001. The study showed that there were no dose-limiting toxicities and no serious or important adverse events of DH001, demonstrating the safety and tolerability of DH001. At the same time, the study evaluated the pharmacokinetic parameters of different doses of DH001 in single and multiple doses in healthy adult subjects, and the results showed that its absorption and utilization exceeded expectations, laying a solid foundation for the phase II clinical study.
About doxorubicin cardiotoxicity
Doxorubicin is a milestone in the development of medical oncology and has been widely used in clinical practice, but its serious cardiotoxicity has been plaguing clinicians and patients. At present, the mechanism of doxorubicin causing cardiotoxicity is still not fully understood, and it is generally believed that the free radicals produced by doxorubicin are one of the main causes of cardiotoxicity, which involves the Fe3+-mediated non-enzymatic pathway and the glutathione redox reaction cycle pathway. Doxorubicin produces a large number of free radicals that cannot be metabolized in time, damaging biological macromolecular substances in cells, such as enzymes and nucleic acids, causing oxidation of lipids and proteins in cell membranes, resulting in changes in the structure and function of cardiomyocytes, including diastolic and systolic dysfunction of the heart.
DH001 is an effective monomer found in traditional Chinese medicine in China, which can reduce the incidence and severity of cardiotoxicity caused by doxorubicin by improving cardiac function, and is suitable for patients treated with doxorubicin.Dr. Min Zhang, Chairman of Mengyang Pharmaceutical, said: "Guiding Principles for Clinical R&D of Clinical Value-Oriented Anti-tumor Drugs" issued by the National Center for Drug Evaluation (NMDER) No. 46 proposes that the research and development of new drugs should be aimed at providing patients with better (more effective, safer or more convenient) treatment options. At present, malignant tumors are showing a trend of chronic disease, which makes cancer patients have higher expectations for the safety of drugs and long-term quality of life. This is consistent with Mengyang Pharmaceutical's positioning of "taking the mission of improving the quality of life of cancer patients and becoming a leader in the field of cancer treatment-related diseases". We have laid out this field in advance, and more drugs in the field of oncology treatment related diseases will enter clinical research in the future. We believe that DH001 will bring us greater surprises in the next clinical trials, and we look forward to the early launch of the drug to relieve patients' pain."
About Mengyang Pharmaceutical
Mengyang Pharmaceutical Co., Ltd. is a joint-stock modern pharmaceutical high-tech enterprise, mainly engaged in the research and development, production and sales of natural medicines, chemical drugs and biological drugs, and is committed to excavating the treasures of traditional medicine of the motherland, developing the classic prescriptions of famous and old Chinese medicine and the active ingredients derived from natural medicines into new drugs, protecting China's intangible cultural heritage and benefiting mankind. The company adheres to the industry to serve the country and innovate, in today's increasingly powerful motherland, when the people of the whole country are working hard to realize the Chinese dream of the great rejuvenation of the Chinese nation, Mengyang Pharmaceutical, as a responsible and responsible national pharmaceutical company, will do its best to realize the dream of promoting the motherland's medicine and bringing health to patients!
