Zhongke Health Industry Group has collaborated with China Pharmaceutical University on the project of Class 1 Innovative Drug Application for Ganoderma Lucidum Spore Oil.

中科健康产业集团 2021年11月15日 16:02

On November 15th, Zhongke Health Industry Group and China Pharmaceutical University jointly signed a cooperation agreement on the Application for Class 1 Innovative Drug Status of Zhongke Ganoderma Lucidum Spore Oil. The two parties will conduct in-depth strategic cooperation on the application of Ganoderma Lucidum Spore Oil as a Class 1 innovative traditional Chinese medicine (TCM). Professor Guo Qinglong—PhD supervisor of China Pharmaceutical University, Director of the Jiangsu Key Laboratory of Tumorigenesis and Intervention, and Director of the National MOST Platform for Preclinical Pharmacodynamic Evaluation and Service of Antineoplastic Drugs—together with Wang Lian’an, Chairman of Zhongke Health Industry Group, and the R&D teams of both sides attended the signing ceremony.

In accordance with the relevant requirements of the National Medical Products Administration (NMPA) for new drug registration, the two parties will carry out the separation, enrichment and scientific compatibility of active ingredients in Ganoderma lucidum and its spores, and develop Ganoderma Lucidum Spore Oil Soft Capsules, a Class 1 innovative TCM new drug with independent intellectual property rights. The pharmacodynamic focus of this project is to inhibit the occurrence and metastasis of primary tumors and alleviate cancer-related fatigue. It is planned that within two years, the two sides will systematically complete a full range of basic research work including TCM resource research, prescription basis formulation, production process research, quality standard establishment, analytical method validation, stability studies, pharmacodynamic studies, long-term toxicity studies, acute toxicity studies and clinical protocol design, finish all preclinical research, and apply for clinical trial approval.

Professor Guo Qinglong stated at the signing ceremony that as a leading enterprise in the Ganoderma industry, Zhongke Health Industry Group is a pacesetter in the modern scientific research of Ganoderma domestically and even globally. For this cooperation, China Pharmaceutical University will leverage the strength of its research teams, fully mobilize professional resources, drive and elevate the overall efficiency and standard of the enterprise’s innovative drug R&D, and facilitate the smooth progress of the preclinical application for the joint project. He expressed the expectation that Ganoderma Lucidum Spore Oil will enter the clinical stage at an early date, filling the gap in innovative drug R&D in the Ganoderma Lucidum Spore Oil field. A renowned expert in tumor pharmacology, Professor Guo Qinglong has presided over the R&D of 2 national Class 1 new drugs, 3 Class 2 new drugs and numerous Class 3 and Class 4 new drugs, and was awarded the Second Prize of the National Science and Technology Progress Award in 2016.

Chairman Wang Lian’an noted that Zhongke has long maintained a stable, long-term and in-depth strategic partnership with China Pharmaceutical University, and the group is fully confident in this cooperation. Zhongke has always focused on the modernization of traditional Chinese medicine (TCM) and committed itself to advancing the R&D of Ganoderma-based anti-tumor innovative drugs. In the field of Ganoderma-based anti-tumor research, Zhongke has obtained 14 national invention patents, 1 new drug certificate, 2 drug production approvals and 3 clinical trial approvals for new drugs. He said it is the group’s hope that the conclusion of this strategic cooperation on the application for Zhongke Ganoderma Lucidum Spore Oil as a Class 1 innovative drug will further accelerate the development of Zhongke’s ongoing TCM innovative drug projects, achieve more zero-to-one breakthroughs, expedite the early launch of more clinical TCM anti-tumor drugs, and contribute to the cause of human health.