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

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 1 new drugs and approved in China in recent years seem to be only Jiangsu Hansoh’s morinidazole and Zhejiang Medicine’s nemonoxacin malate.

The morinidazole developed by Jiangsu Hansoh Pharma was approved for marketing by CFDA on February 24, 2014, with the trade name of Mailingda®. The drug is nitroimidazole antibiotics used to treat surgical infections and gynecological infections caused by anaerobic bacteria, and is the first nitroimidazole anti-infective drug with independent intellectual property developed by the Chinese.

Originally developed by P & G Pharmaceuticals, nemonoxacin malate was licensed to TaiGen Biotechnology in 2005, and the latter licensed the right to manufacture and sell the drug in Mainland China to Zhejiang Medicine in 2012. The drug was approved for marketing in Taiwan, China in 2014, and later was approved for marketing by CFDA on May 27, 2016, with the trade name of Taigexyn®. The drug is the new-generation non-fluorinated quinolone antibacterial agent approved for community-acquired bacterial pneumonia (CABP).

It should be mentioned that nemonoxacin is the first innovative drug benefiting from the Marketing Authorization Holder system in China since its pilot implementation, the only Category 1.1 new drug approved by CFDA in 2016, and also the first new drug approved after the issuance of the strictest new drug clinical data checking order ever in China in July 2015.

Postscript

There have been frequent hurricanes and earthquakes recently. Besides the natural disasters that affect mankind’s fate, bacteria and viruses have been fighting against us. Are the evolutionary forces stronger or mankind’s research strength better? WHO calls on pharmaceutical enterprises to join the battle!

By Xiaoxiaoyu

Click here and read: WHO: Antibiotics in an Emergency! A Review of Current R&D Situation of Global Antibiotics (1)