Per reporter: Huang Xinlei Per editor: Liang Xiao
Bacterial resistance has become the "sword of Damocles" that threatens human health.
On September 22, at the Nanjing International New Medicine and Life and Health Industry Innovation Investment Summit, Chen Yuxin, chairman of Jiangsu Pulai Pharmaceutical Biotechnology Co., Ltd. (hereinafter referred to as Pulai Pharmaceutical), said in an interview with the "Daily Economic News" reporter that bacteria are more and more tolerant of antibiotics, but it is difficult to develop resistance to drugs such as antimicrobial peptides.
Chen Yuxin said that antimicrobial peptides belong to polypeptide drugs, and the current number has the highest compound annual growth rate in the global pharmaceutical market, with a growth rate of 15% to 20%, while the compound annual growth rate of biological drugs is about 8% to 10%, and the compound annual growth rate of small molecule drugs is less than 5%.
Chen Yuxin, chairman of PrePharmaceutical Image source: Courtesy of the organizer
According to Chen Yuxin, the history of peptide drugs is very short. Before 2000, there were only about 40 kinds of peptide drugs that entered the clinical trial stage every year, and in the first decade of the 21st century, there were about 100 kinds of peptide drugs that entered the clinical trial stage every year, and in the past 10 years, more than 400 kinds of peptide drugs have entered the clinical trial stage every year. At present, peptide drugs have reached a period of major outbreaks.
According to the statistics of science magazine, there are currently 29 antimicrobial peptide varieties in the world that have entered clinical trials, and 2 in China.
In August 2016, the former National Health and Family Planning Commission and 14 other departments jointly issued the "Notice on Printing and Distributing the National Action Plan for Curbing Bacterial Drug Resistance (2016-2020)" to support the research and development of new anti-infective drugs, especially innovative drugs with different mechanisms of action and molecular structures, and strive to develop and market 1 to 2 new antibacterial drugs by 2020.
At the end of 2019, the General Office of the National Health Commission issued the Notice of the General Office of the National Health Commission on Strengthening the Diagnosis and Treatment management of chronic refractory wounds (ulcers) on the body surface, requiring the establishment of various difficult chronic refractory wound repair departments represented by diabetic foot, pressure injury (pressure ulcers, pressure sores) special bacterial infectious wounds in secondary and tertiary hospitals.
Chen Yuxin believes that the future market space for antimicrobial peptides may be very huge. According to the data he provided, there are currently 11.4 million people in China with "diabetic foot", nearly 1/3 of the patients have amputated limbs, the treatment cost is about 30,000 yuan / person; there are 465,000 patients with pressure sores, and the treatment cost is about 100,000 yuan / person ~ 500,000 yuan / person; there are 26 million burn patients, and the treatment cost is about 10,000 yuan / person ~ 1 million yuan / person; the number of orthopedic patients is 40 million people, and the treatment cost is more than 20,000 yuan / person.
"Pl-5 of Prepharm is the first innovative drug of antimicrobial peptide in the clinical trial stage in China, and also the first innovative drug of polypeptide in the field of anti-infection at home and abroad. We expect that in early 2021 PL-5 will enter the third phase of clinical trials, and the research and development speed will lead the country. ”
According to reports, the clinical application of pl-5 is positioned in open wound infections caused by diabetic feet, pressure sores, large-scale burn burns and other reasons, including some superficial skin infections caused by common bacteria and stubborn drug-resistant bacteria infections. During the phase iib clinical trial, Premed Pharma selected 28 top medical institutions in the field of wound treatment in China as clinical trial units. Chen Yuxin said that in this way, it is easy for drugs to be recognized by doctors after they are listed.
Chen Yuxin said that during his study abroad, he proposed the "cell membrane differentiation mechanism" of antimicrobial peptides, developed a polypeptide antibacterial technology and obtained the exclusive patent of PL-5 permanent authorization.
The "cell membrane differentiation mechanism" of antimicrobial peptides lies in the fact that almost all bacterial cell membranes carry negative charges, while human cell membranes are neutral fats, resulting in positively charged antibacterial peptides being adsorbed by the bacterial cell membrane through electrostatic action, and then self-folding and molecular flipping occur, and finally destroy the cell membrane, resulting in bacterial death.
"It's like throwing a bomb in a pool of water, and the cell membrane explodes in an instant, and the bacteria die."
Chen Yuxin mentioned that due to the irregular use of antibiotics, many patients have developed resistance to bacteria and fungi in their wounds. What is more dangerous is that once bacteria and fungi enter the bloodstream, it will cause sepsis, and the mortality rate of patients is as high as 60%. PL-5 has a very strong bactericidal advantage over superbug MRSA and bacterial fungi such as NDM-1 gene multidrug-resistant Acinetobacter baumannii.
The experiments of Premed Also confirm this. After feeding bacteria with antibiotics below the lethal amount, 4 to 5 generations of bacteria will become resistant to antibiotics, and feeding bacteria with the same dose of antimicrobial peptides until 32 generations later, increasing the dose of antimicrobial peptides, the bacteria will still die and will not develop resistance.
Daily economic news