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Home Industry Insights Pharma in China
Yichang Humanwell’s Class 3 Generic Drug Alfentanil Hydrochloride Approved for Marketing

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

by PharmaSources/Caicai

March 16, 2020

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.

Big News! Yichang Humanwell’s Class 3 Generic Drug Alfentanil Hydrochloride to be Approved for Marketing Soon

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pharmaceutical product was included in the priority review on Mar. 28, 2018 as a "generic drug registration application withdrawn by the applicant and changed to be refiled after the improvement according to the standards of quality and efficacy consistency with the original drug"; on May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.

S/N

Acceptance No.

Pharmaceutical product name

Registration applicant

Acceptance date

Application date

Publicity date

1

CYHS1700407

Alfentanil Hydrochloride

Yichang Humanwell Pharmaceutical Co., Ltd.

Jan. 3, 2018

Jan. 10, 2018

Mar. 28, 2018

2

CYHS1700408

Alfentanil Hydrochloride Injection

Yichang Humanwell Pharmaceutical Co., Ltd.

Jan. 2, 2018

Jan. 3, 2018

Mar. 28, 2018

3

CYHS1700409

Alfentanil Hydrochloride Injection

Yichang Humanwell Pharmaceutical Co., Ltd.

Jan. 2, 2018

Jan. 3, 2018

Mar. 28, 2018

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