Yichang Humanwell’s Class 3 Generic Drug Alfentanil Hydrochloride Approved for Marketing

Alfentanil Hydrochloride Injection (acceptance No.: CYHS1700408, CYHS1700409 and CYHS1700410, representing different specifications), a Class 3 Generic Drug filed by Humanwell Pharmaceutical has been approved for marketing on Mar.8th. The drug becomes one of the first alfentanil drugs approved for marketing in China. Alfentanil Hydrochloride Injection is a potent analgesic used for anesthesia and applies to short surgical procedures.

Application path full of twists and turns

As a fentanyl analogue, alfentanil hydrochloride mainly acts on μ-opioid receptor, is a short-acting potent analgesic used for anesthesia and applies to short surgical procedures. The drug has three effects: quick-acting in 30s; short-acting, lasting for 15min, with the duration between that of remifentanil and sufentanil; potent, 15 times as potent as morphine. Alfentanil is one of the ideal choices of target-controlled infusion because its context-sensitive half-time is relatively constant.

First marketed in the Netherlands in 1983 and introduced to the U.S. market in 1987, alfentanil hydrochloride has been safely used clinically for 30 years and its clinical effects have stood the test of time, however, it has not been marketed in China.

The marketing application road of Humanwell Pharmaceutical’s alfentanil hydrochloride can be described as full of twists and turns.

Humanwell applied for the designated-point development of alfentanil hydrochloride to the NMPA early in Sep. 2004, which was accepted; the company received the clinical trial approval in Oct. 2008 and applied for production in Jan. 2013; however, on July 22, 2015, Humanwell withdrew the variety application after the No. 117 Announcement and decided to file a new application after the improvement of the clinical data.

The pharmaceutical product was included in the priority review on Mar. 28, 2018 as a "generic drug registration application withdrawn by the applicant and changed to be refiled after the improvement according to the standards of quality and efficacy consistency with the original drug"; on May 24, 2019, the NMPA decided to check the clinical data for the 3 pharmaceutical product registration applications completed clinical trials and applied for production involved in Humanwell’s Alfentanil Hydrochloride Injection. The change of the approval status this time should mean the passing of the clinical data checking and the approval for marketing soon.

 (Source: CDE)

Should its alfentanil hydrochloride be successfully marketed, Yichang Humanwell will possess all the mainstream fentanyl products, including fentanyl, remifentanil, sufentanil, and alfentanil.

China started to implement the listing and control of the substances of fentanyl variety from May 1, 2019. According to the related data, among the 25 substances of fentanyl variety listed and controlled previously, fentanyl, sufentanil, remifentanil, and alfentanil are pharmaceutical products; wherein, fentanyl, sufentanil and remifentanil have been marketed in China. Looking for medical product suppliers offering this kind of drug? Pharmasources would be your best choice.

Nhwa Pharmaceutical also applying for the marketing

Besides Humanwell Pharmaceutical, major foreign manufacturers of alfentanil hydrochloride include Akorn and Hospira, etc., and the Chinese manufacturer Jiangsu Nhwa Pharmaceutical has filed the marketing application therefor in Oct. 2019.

 (Source: CDE)

As a designated manufacturer of narcotic drugs in China, with anesthetics as its core, Yichang Humanwell has star products including remifentanil, sufentanil, nalbuphine, and hydromorphone, etc. and achieved net profits of RMB499 million in the first half of 2019.

Furthermore, Yichang Humanwell has two class 1 new drugs being applied for marketing: remimazolam besylate and fospropofol disodium. I will pay constant attention to the latest situations thereof. 

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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