On June 25, 2020, the clinical trial application (ind) submitted by Shandong Xinchuang Biotechnology Co., Ltd. was accepted by nmpa. This product is a new class 1 biological product developed by our company. It is also the first bacterial oncolytic drug to be accepted by ind in the world.
Clostridium gloeosporioides spore lyophilized powder for injection is a class 1 new biological product developed by our company for the treatment of advanced solid cancer with independent intellectual property rights. Up to now, there is no similar product of oncolytic bacteria on the market at home and abroad. After 15 years of scientific and technological research at home and abroad, the product has mastered the key core technology of Clostridium gondii oncolysis, breaking the monopoly of oncolytic technology and technical standards in Europe and the United States for a long time, filling the gap at home and abroad, making China in the international leading position in the field of bacterial oncolysis.
At present, this product has applied for 17 domestic and foreign invention patents, 13 authorized (4 in China, 7 abroad, 2 in International), and core patents (ZL) He was awarded the Chinese patent Excellence Award, the national major new drug creation science and technology major special project (2019zx09301166), the Shandong provincial major new drug creation special project (2017cxgc1407), the excellent enterprise award of China Innovation and entrepreneurship competition, and one of the only two award-winning enterprises in the field of biomedicine in Shandong Province. He was awarded the innovation competition action plan of small and medium-sized enterprises in Shandong Province He won the first prize of technical innovation achievements of outstanding staff in national energy chemical geology system. Professor Wei, the chief scientist of the project, won the prize of "science and technology person influencing Jinan" in 2018; senior engineer Wang Yong, the project leader, has successively won the May 1st Labor Medal of Shandong Province, the May 1st Labor Medal of Jinan City, and the "most beautiful scientific and technological worker" of high tech Zone.
The company has invested 216 million yuan in platform construction and product development. Through 7 kinds of tumor models, 28700 animal experiments and 39600 pathological sections, the experimental data show that the product has the advantages of safety and controllability, strong targeting, obvious oncolytic effect, killing tumor metastasis and preventing tumor recurrence, and cooperating with immunotherapy to complement each other. The pharmaceutical and pharmacodynamics of this product has been completed On June 22, 2020, ind, a new class 1 biological product drug, was officially submitted to CDE for all preclinical research work such as pharmacology and toxicology. On June 25, 2020, it was granted the acceptance number of clinical trial application issued by nmpa: cxsl2000177. It is expected that the clinical trial license can be obtained before and after October to carry out the human clinical trial of this product. We will strive to complete phase I ~ III clinical trials in 2023, apply for new drug certificate, and strive to become the world's first bacterial oncolytic drug.
Shandong Xinchuang Biotechnology Co., Ltd., established in 2011, is a high-tech enterprise integrating talents, projects, platforms and industry university research cooperation, focusing on the industrial technology research of tumor bacterial therapy, tumor cell therapy, stem cell and regenerative medicine, and accurate diagnosis. The company has standardized management, perfect quality control system and management system, and has established party branches and trade unions. It has been rated as a five-star Party Organization for two consecutive years.
The company has strong R & D strength and outstanding scientific research achievements. It has applied for 23 invention patents worldwide, and has authorized 17 patents. It has undertaken 24 scientific research projects of national, provincial, Jinan City and High-tech Zone, and obtained funding support of tens of millions of yuan. The R & D headquarters is located in Hanyu Jingu, Jinan high tech Zone, with 1800 square meters BSL-2 (Biosafety Level 2) purification laboratory, including tumor bacterial therapy experimental center, cell and regenerative medicine experimental center, animal feeding room, animal laboratory, pathology room, and anatomy room. It has a number of domestic research and development platforms, including academician workstation of Shandong Province, expert workstation of "national talent project" of Shandong Province, precision Medical Engineering Laboratory of bacterial anti-tumor drugs of Shandong Province, gazelle enterprises of Shandong Province, tumor biological immune technology Engineering Laboratory of Jinan City, post doctoral innovation practice station of Jinan City, and Shandong Jingji bioengineering center of university research and development institutions The foreign R & D Institute, Sino US bacterial product pharmacological analysis center, was awarded the honorary titles of Shandong gazelle enterprise independent innovation top 10, Jinan specialized and special new small and medium-sized enterprise with abundant scientific research results.