"Face-to-face" symposium between regulators and enterprises
Recently, Li Yaohua, director of the Yangtze River Delta Branch of the Medical Device Technical Evaluation and Inspection of the State Food and Drug Administration, and his party investigated Nanjing Shihe Gene Biotechnology Co., Ltd. (hereinafter referred to as "Shihe Gene"). Accompanied by Dr. Shao Yang, the founder and chairman of Shiho Gene, the research group visited the exhibition hall of Shiho Gene and learned in detail about the development process and innovative achievements of Shiho Gene. At the symposium, Li Yaohua listened carefully to the progress of the company's innovative medical device research and development and declaration.
In order to better implement the innovative achievements in clinical practice, Shiho Genomics actively promotes the establishment of industry standards, and has accumulated rich experience in product design and development, clinical validation, quality control of the whole process of testing, and medical device registration and declaration. Shihe Gene has now formed a product pipeline with three types of main products, supporting Class I and Class II diagnostic reagents and medical devices, covering the whole process of high-throughput sequencing and testing, and a complete range of products, with nearly 60 domestic and foreign invention patents, and a number of core technologies and products are the first in China.
Yishengkang ™ Lung Cancer 6 Gene Kit (National Machinery Injection 20183400408)
Shihe No. 1 ® Large Panel Kit (National Machinery Approval 20233401452)
It is worth mentioning that Shiho Gene is the only company in the domestic tumor precision detection industry that has 2 NGS innovative medical device products on the market. In 2018, the Yishengkang ™ Lung Cancer 6 Gene Kit independently developed by Shihe Gene was innovatively approved and marketed by the State Food and Drug Administration, becoming one of the first batch of tumor high-throughput sequencing kits in China. In 2023, the Shiho No. 1 ® large panel kit independently developed by Shiho Genomics will be innovatively approved and listed by the State Food and Drug Administration, achieving a breakthrough of "zero" in domestic tumor NGS large panel kits. In addition, a number of three types of in vitro diagnostic products have entered the registration and declaration stage.
Li Yaohua highly affirmed the achievements of Shihe Gene in the field of precision medicine, and encouraged enterprises to give full play to their technological advantages and talent advantages, focus on genetic testing, molecular diagnosis and other subdivisions, continue to improve their innovation capabilities, and continuously enhance their core competitiveness. At the symposium, experts from the drug regulatory department patiently answered the registration difficulties and doubts of the company's consultation, and further pointed out the direction for the optimization of the company's product registration process.
Jiangsu is not only a major pharmaceutical province, but also a province that has been in the forefront of the country for the declaration and approval of innovative medical devices for a long time. Dr. Shao Yang said that Jiangsu's high-quality business environment and the government's all-round services have made the current Shihe Gene, especially the approval of the Shihe No. 1 ® large panel kit, which allows the entire industry to see the country's determination to vigorously promote the transformation of innovative medical device R&D achievements and product launch. Through the continuous development of molecular diagnostic technology, we will strive to transform and bring more high-quality R&D results to the market for the benefit of patients.
Su Ke