0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 It is reported that on November 20, "Chang'anxin" was approved by the National Drug Administration (NMPA) to allow it to be launched.
The guests who participated in the press conference included Wang Jianping, former executive vice president of Sun Yat-sen University, Zhang Feng, director of the Medical Device Supervision Department of Guangdong Provincial Drug Administration, Chen Jie, founder of Yuansheng Venture Capital, Xie Jiasheng, executive president of Guangdong Medical Valley, Huang Xianda, professor of the Chinese University of Hong Kong, Song Xianrang, deputy director of Guangdong Cancer Hospital, Southern Medical University Southern Hospital, Director of the Department of Gastroenterology, Liu Side, , Managing Director of Chende Capital, Hu Xiaofang, General Manager of Kelly Territ Medical, Wang Xingang, etc.
With the development of urbanization and the acceleration of life, the human disease spectrum has also changed. According to a report jointly released by the National Cancer Center and the Cancer Hospital of Peking Union Medical College, Chinese Academy of Medical Sciences, China's population accounts for 21.79% of the global cancer incidence, and the cancer incidence level is the same as the world average. However, due to the lack of early screening awareness, the domestic cancer survival level is relatively low.
" The 5-year survival rate of colorectal cancer cure rate in China is 10% lower than that in the United States. This is not because of the poor doctor level in China, but because of the low early detection rate. " Wang Jianping said that the early cancer detection rate in the United States reaches 40%, while China only has about 15%. Although several major cities in China have conducted comprehensive colorectal cancer census, the methods are nothing more than questionnaires and occult blood experiments. "The high-risk population screened by the questionnaire survey is questionable, and the occult blood test is not very accurate. So there should be other methods to help with the screening of colorectal cancer," Wang Jianping added.
data shows that "Chang'anxin" is the first methylation marker of fecal colorectal cancer selected in the population in my country, and has been approved by the National Medical Products Administration for auxiliary diagnosis of colorectal cancer. In principle, the method used by "Chang'anxin" is fecal DNA detection, also known as fecal gene detection . With the help of the loss of substances in the intestinal mucosal cells carried by feces, this technology can achieve early screening of colorectal cancer.
In 2014, Exact Sciences in the United States took the lead in developing fecal DNA intestinal cancer screening related products, and obtained FDA approval in the same year to achieve full coverage of medical insurance. One of the key figures in promoting the implementation of this technology is Zou Hongzhi, who went to the Mayo Medical Center in the United States to engage in postdoctoral research. In 2009, the modified patent was acquired by Exact Sciences, and Zou Hongzhi joined Exact Sciences as the R&D director, leading the development of the CologuardTM fecal and bowel cancer screening kit.
In 2015, after returning to China, Zou Hongzhi founded Kang Liming Biotechnology, focusing on the research, development, production and sales of early tumor diagnosis products such as the "Chang'anxin" fecal DNA intestinal cancer detection kit, and providing corresponding testing services. In Zou Hongzhi's positioning, "Chang'anxin" directly benchmarks the product Cologuard of the "old boss". "In terms of sampling, 'Chang'anxin' only needs 4.5g of feces, while Cologuard needs a whole piece of feces and collects an occult blood sample; in terms of product performance, 97.85% of the detection specificity of 'Chang'anxin' is also higher than Cologuard's 86.6% of this data." Zou Hongzhi introduced at the press conference.
Currently, "Chang'anxin" is priced at 1,198 yuan and has not been included in the medical insurance catalog. However, Zou Hongzhi revealed that the relevant work has been put on the agenda and it is expected to achieve rapid promotion of products with the help of medical insurance in the future.
Huang Xianda believes that in addition to genetic testing, the method of to deal with cancer also requires "acquired" control, and products like "Chang'anxin" can help potential patients detect related risks as soon as possible and get timely intervention. Liu Side also proposed in the discussion on the diagnosis and treatment of intestinal cancer that early diagnosis of screening can greatly reduce the incidence and mortality of cancer.
It is understood that "Chang'anxin" made a relevant application on April 4 this year and passed the approval on November 20, which took about 7 months. "In the past two years, the country's approval of medical devices and drugs has been greatly accelerated. Judging from the product situation of Kang Liming Bio this time, we can find that the country attaches great importance to innovative medical products." Zhang Feng introduced.
There is no doubt that it is currently in a period of rapid development of the domestic big health industry. From "Healthy China 2030" to "Document No. 42 of the General Office of the CPC Central Committee" in the field of medical devices, it is promoting the research and development and implementation of more innovative medical products.
Kang Liming Bio has now completed the angel round, Pre-A round and A round financing. Zou Hongzhi revealed that the B round of financing has been basically finalized and plans to be listed within the next 3 to 5 years. In addition, Zou Hongzhi also announced Kang Liming Bio's sales plan for the next five years, and is expected to achieve sales of 200 million yuan in 2020 and 1.5 billion yuan in 2023. From another perspective, this reflects the large potential market for "Chang'anxin".
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