Chinese and U.S. leaders’ Xi-Trump meeting has been held recently after the G20 Summit, which led the China-US trade issue towards the win-win cooperation direction, however, a statement published by the U.S. White House has made the fentanyl family of China hit the internet overnight; this type of anesthetic mainly used as analgesic clinically has been brought to public attention, and many relevant manufacturers in China including Humanwell and Nhwa Pharmaceutical, etc. have successively made announcements that their fentanyl substances have not been exported to the U.S.

Double identity of this hot topic on the internet

Fentanyl is a strong agonist of the opioid receptor in human brain and is a potent opioid analgesic, with efficacy of about 10,000 times of morphine; it acts fast and for a very short time; the prescribed fentanyl injection can be used to combine with general anesthesia, neuroleptanalgesic, fast-track cardiac anesthesia, outpatient/daily surgical anesthesia, and postoperative analgesia, etc.

Besides the prescribed fentanyl used for clinical analgesia, the bootlegged fentanyl is also a new hard drug, therefore, fentanyl has double identity as both medicine and drug. What's worse is that the lethal dose of fentanyl is very small compared to the traditional drug heroin: 0.25mg fentanyl is lethal enough, which is about 1/500 the lethal dose of the latter.

According to data, the number of people who died from drug overdoses was about 72,000 in the U.S. in 2017, wherein, the number of people who died from fentanyl abuse was nearly 30,000, 40 times more than 20 years ago, and close to the number of people who died in traffic accidents and due to shootings and violence in the U.S. in 2017.

Control over fentanyl substances started 22 years ago in China

China implements a special management system for narcotic drugs and psychotropic drugs, with the Regulation on the Control of Narcotic Drugs and Psychotropic Drugs and Measures on the Listing and Control of Narcotic Drugs and Psychotropic Drugs for Non-Medical Use separately coming into force in 2005 and 2015.

China’s control over fentanyl substances can date back to 1996 that was 22 years ago. The list of narcotic drug varieties published in Jan. 1996 contained 12 fentanyl substances including alfentanil, etc., and the experimental study, production, operation, use, storage, and transportation, etc. thereof should be under strict supervision and management.

On Nov. 27, according to Geng Shuang, the spokesperson for the Ministry of Foreign Affairs in China, China has so far listed 25 fentanyl substances and 2 fentanyl precursors as controlled substances. The Chinese regulator has explicit requirements for the production, sales, and medical service, etc. of such products.

Market structure of fentanyl medicine in Chin

There are currently 5 manufacturers of fentanyl pharmaceutical products in China, separately being Sinopharm, Nhwa Pharmaceutical, Lingrui Pharmaceutical, Humanwell, and Changzhou Siyao, involving 28 pharmaceutical product approvals of 5 dosage forms.

According to the PDB sample hospital data, the total sales of fentanyl products in sample hospitals of China reached RMB993 million in 2017, according for 24.19% of the entire analgesic market in China, ranking second among analgesics. Relevant products of fentanyl are estimated to have a market size of nearly RMB3 billion in China.

From the perspective of relevant products of the 5 Chinese pharmaceutical enterprises, Yichang Humanwell leads among the similar enterprises in China upon 11 product approvals; Jiangsu Nhwa, Sinopharm Langfang Branch, and Henan Lingrui all have 5 product approvals, and Changzhou Siyao has 2 product approvals.

The main fentanyl products of Yichang Humanwell include Fentanyl Citrate Injection, Sufentanil Citrate Injection, and Remifentanil Hydrochloride for Injection preparation and API, from which the sales revenue of Yichang Humanwell exceeded RMB2 billion in 2017, and of which the market share reached 80% in the similar product market in China, showing absolute advantages.

The fentanyl citrate API and its injection as well as Remifentanil Hydrochloride for Injection preparation of Nhwa Pharmaceutical were separately approved for production and sales in Dec. 2011 and Oct. 2014, of which the sales revenue was about RMB40 million in 2017; the Fentanyl Citrate Injection as well as the remifentanil hydrochloride API and Remifentanil Hydrochloride for Injection of Sinopharm Langfang Branch were separately approved for marketing in Oct. 2012 and Dec. 2012; the fentanyl products in the 5 approvals of Lingrui Pharmaceutical and those in the 2 approvals of Changzhou Siyao are all transdermal patch preparations, with small sales. Overall, the total sales of the above 4 pharmaceutical enterprises occupied a market share of less than 2% among the fentanyl products in China in 2017.

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