On April 22, the listing application for the new four-category generic drug "Varenicline Tartrate" by Hausen Pharmaceuticals entered the approval status, and it is expected to be approved soon, becoming the first domestic imitation of this product.
The Insight database shows that currently only Pfizer's "Varenicline Tartrate Tablets" (trade name: Changpei) was approved for import in 2008 (manufacturer: R-Pharm Germany GmbH), and the indication is for adults to quit smoking.
Varenicline is a selective partial agonist of the nicotinic acetylcholine receptor α4β2 subtype and has a high affinity for this receptor in nerves.
Varenicline binds to the α4β2 receptor to produce an agonistic effect, while blocking the binding of nicotine to the receptor.
This is the mechanism by which varenicline exerts a smoking cessation effect.
At present, the first-line drugs for treating tobacco dependence are divided into two categories.
The first category is nicotine-containing drugs, and the second category is nicotine-free drugs.
Nicotine-containing drugs, namely nicotine replacement therapy, contain a variety of dosage forms, such as patches, chewable preparations, inhalants, nasal sprays, sublingual tablets, etc.
; drugs that do not contain nicotine can be divided into two types, one is an antidepressant , Such as bupropion hydrochloride, the other is a partial agonist of nicotine acetylcholine receptors, such as varenicline.
In addition, some drugs are second-line drugs for nicotine treatment, such as clonidine, nortriptyline, nicotine vaccine, etc.
Second-line drugs are mostly used as alternative drugs when first-line drugs are ineffective, and they are rarely used in clinical practice.
For special tobacco dependents, such as those with hypertension, second-line drugs such as clonidine can be used directly according to their specific conditions.
According to the Insight database, Varenicline's global sales in 2019 reached US$1.
According to the national tobacco control survey report released by the China Centers for Disease Control and Prevention, in 2018, the smoking rate of people aged 15 and over in China was 26.
6%, and the number of smokers exceeded 300 million, and smoking cessation cannot be delayed.
Insight data shows that Hausen is the first domestic company to submit a listing application for varenicline tartrate tablets, and is expected to win the first imitation of this variety.
In addition, Shandong Weizhi Encyclopedia Pharmaceutical Co.
has also reported for listing in China and is under review.