Antibiotic R&D situation
The following chart shows the quantity of antibacterial compounds in Phase 1-3 clinical development, and they are the future "ammunition" for mankind.
Note: The above figures do not include bedaquiline and delamanid, two new drugs to treat MDR-TB that are currently in Phase 3 trials, but have already received conditional marketing approval.
The following figure shows the downtrend of global antibiotic R&D in recent years from the perspective of quantity of global new antibiotic patents.
Source: Research on the Global New Antibiotics Patent Technology and Market, Technology Intelligence Engineering, Vol. 2 No. 6
Seen from the approved quantity, the quantity of approved new antibiotics has been declining since 1980s: 16 relevant new drugs were approved by FDA in 1983-1987, the number declined to 14 in 1988-1992, to 10 in 1993-1997, to only 5 in 2003-2007; there were only 6 antibiotics coming out in 1996-2000.
According to report of IDSA, there were nearly 20 companies involving antibiotic R&D in the world in 1990s, while only GSK and AstraZeneca have antibiotic R&D projects among world pharmaceutical giants at present. Pharmaceutical companies seem unwilling to develop new antibiotics. A paper published in 2015 mentioned that giants’ interest in antibiotic development had decreased because they realized that their money made from patients taking antibiotics was less than from those taking chronic disease drugs.
The following figure shows the sharp decline trend of quantity of relevant drugs developed by European and American pharmaceutical companies.
Focus of antibiotic R&D
WHO has published the list of priority pathogens for new antibiotic R&D due to the reasons mentioned above. Pharmaceutical companies are expected to focus on them which may be a potential market in the future.
After grouping of the pathogens according to species and resistance type, experts then divided the results into three priorities: critical priority, high priority and medium priority, with details as shown in the following table:
WHO list of priority pathogens for new antibiotic R&D
|
Critical |
|
Acinetobacter baumannii - carbapenem-resistant Pseudomonas aeruginosa - carbapenem-resistant Enterobacteriaceae - carbapenem-resistant, 3rd gen. cephalosporin-resistant |
|
High |
|
Enterococcus faecium - vancomycin-resistant Staphylococcus aureus - methicillin-resistant, vancomycin medium-resistant and resistant Helicobacter pylori - clarithromycin-resistant Campylobacter species - fluoroquinolone-resistant Salmonella species - fluoroquinolone-resistant Neisseria gonorrhoeae - 3rd gen. cephalosporin-resistant, fluoroquinolone-resistant |
|
Medium |
|
Streptococcus pneumoniae - penicillin-non-susceptible Haemophilus influenzae - ampicillin-resistant Shigella species - fluoroquinolone-resistant |
Chinese enterprises to research new antibiotics can refer to the above table to develop new drugs in a more pertinent manner.
New antibiotics in China
According to my impression, the antibacterial agents applied for as Category ...
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