In 2019, the market size of China's smoking cessation products was about 1200 billion yuan, accounting for 35% of the global market

There are few first-line smoking cessation drugs, and the generic drug varenicline fills the domestic gap

Smoking addiction (i.e. tobacco dependence) is a chronic disease, and the withdrawal symptoms that occur during smoking cessation make it more difficult to quit smoking, and smoking cessation drugs combined with comprehensive interventions such as smoking cessation counseling can further improve the success rate of smoking cessation.

According to the data of "2022-2028 Smoking Cessation Products Industry In-depth Survey and Market Prospect Analysis Report", China's smoking cessation products market has developed rapidly, and the market size of China's smoking cessation products in 2019 is about 1200 billion yuan, accounting for 35% of the global market, making it the world's largest smoking cessation product market. Among them, electronic cigarettes account for 90% of the market, and traditional smoking cessation products account for only about 10%. The Beijing News reporter found that the three types of first-line smoking cessation drugs nicotine replacement therapy (referred to as "NRT"), bupropion hydrochloride and varenicline tartrate recommended by the World Health Organization are only a few products that have been approved for marketing in China. With the withdrawal of varenicline from the market due to the original drug, domestic generic drugs have attracted much attention.

Only two products of nicotine replacement therapy have been approved for marketing in China

Among the smoking cessation aids recommended by the World Health Organization, nicotine replacement therapy products (such as nicotine chewing gel, nicotine patches, etc.) are first-line recommended drugs. Nicotine replacement therapy includes nicotine patches, nicotine chewing gel, nicotine sublingual tablets, etc., replacing nicotine in tobacco with low-dose medicinal nicotine, and effectively helping smokers get rid of dependence on cigarettes and weaken withdrawal symptoms by gradually reducing the dose. Once you start trying to quit smoking, choosing nicotine replacement therapy, which is used regularly, can help improve the success rate of smoking cessation.

The Chinese Clinical Guidelines for Smoking Cessation (2015) mentioned that nicotine replacement therapy drugs for smoking cessation are safe and effective, and can increase the success rate of long-term smoking cessation by 1 times. There is no significant difference in the efficacy of different dosage forms of NRT drugs in smoking cessation, and the choice can be based on the wishes of ex-smokers. These medicines are over-the-counter and can be purchased in hospitals or pharmacies, and smokers should consult a doctor before use and use them under the guidance of a doctor.

On May 5, a reporter from the Beijing News searched for "nicotine" on the official website of the State Food and Drug Administration, and the only domestic nicotine replacement therapy product approved for marketing in China was a nicotine sublingual tablet (trade name "Orfinib") from Beijing Chengji Pharmaceutical, which was listed on November 22, 2020. In terms of imported products, only Johnson & Johnson's nicotine chewing gel (trade name "Rickray") is a product. None of the nicotine patches/nicotine transdermal patches are available. In the Lilac Garden Insight database search for "nicotine" as the keyword, Novartis Pharmaceutical's nicotine transdermal patch (trade name "nicotine" or "nipai") and Johnson & Johnson's Alza company's nicotine patch (trade name "Likaidin") were approved for marketing in China, and now the approval is "non-existent".

In terms of marketing application, DSme's nicotine chewing gel was submitted for marketing in 2021 and was ultimately not approved. GlaxoSmithKline's nicotine chewable gel marketing application was also not approved in the same year.

In addition, Kunling (Tianjin) Pharmaceutical Development Co., Ltd.'s nicotine chewing gel was approved for clinical trial in 2017 with the application type of "import", and the Lilac Garden Insight database did not show the latest progress. Beijing Zesheng Biotechnology Research Institute (nicotine sublingual tablets) and Jinan Longge Pharmaceutical Technology Co., Ltd. (nicotine nasal spray) have also been declared, but have not been approved for marketing.

The original drug withdrew, and the four companies divided the varenicline market

As a smoking cessation drug specially developed for smoking cessation, varenicline tartrate tablets can effectively reduce the pleasure brought by nicotine absorption, thereby reducing the possibility of relapse, while also reducing smokers' addiction and withdrawal symptoms. Because of its relatively good effect of assisting smoking cessation, it has attracted the layout of many domestic enterprises.

Tan Xingyu, deputy chief physician of the Department of Respiratory and Critical Care Medicine at Peking University, said that the success rate of quitting smoking by simply relying on oneself is only 3%-5%; The use of nicotine patches increases the success rate of smoking cessation to 20%-30%; The smoking cessation success rate of bupropion hydrochloride sustained-release tablets is 30%-40%; Varenicline tartrate has the highest success rate, reaching 40%-50%.

The original drug of varenicline tartrate tablets is Pfizer's Champix (Chinese trade name "Changpei"), among many smoking cessation drugs, Changpei once became a star product of Pfizer's sales revenue of more than 10 billion US dollars with its excellent efficacy. In July 2008, Changpei was approved for domestic listing. However, Pfizer suspended the global sale of Changpei due to the discovery that some batches of Changpei contained more than the required acceptable daily intake of nitrosamines, which increased the risk of carcinogenesis, and has since expanded the scope of voluntary recall of Changpei. The suspension of sales once caused smoking cessation clinics around the world to fall into a situation of drug shortage.

Pfizer said in a statement that the action was taken because it detected the carcinogen nitrosamines at or above acceptable levels set by the U.S. Food and Drug Administration. However, Pfizer mentioned that although long-term intake of nitrosamines may theoretically increase the risk of cancer in humans, there is no immediate risk for patients taking this drug, and the health benefits of smoking cessation exceed the potential carcinogenic risk of nitrosamine impurities in varenicline in theory.

In November 2020, Champix's patent expired, and many Chinese pharmaceutical companies have already targeted the early layout of this variety.

In March 2019, Jiangsu Jiayi Pharmaceutical took the lead in submitting the marketing application for varenicline tartrate API according to the new 3 generic drugs, and was included in the priority review. On May 4, 2020, the marketing application of varenicline tartrate tablets of Haosen Pharmaceutical, a subsidiary of Hansen Pharmaceutical, was to be included in the priority review, becoming the first domestic company to submit the marketing application for varenicline tartrate tablets, and successfully won the first imitation in April 5, with the trade name "Alechang".

Shandong Weizhi Encyclopedia Pharmaceutical's varenicline tartrate tablets were approved for marketing in October 2022. In February this year, the varenicline tartrate tablets of Shandong Langnuo Pharmaceutical and Jiangsu Jiayi Pharmaceutical, a subsidiary of Tongyuan Pharmaceutical, were also approved for marketing, and the situation of "four parts of the world" was formed.

Antidepressants are used to aid smoking cessation

Bupropion hydrochloride sustained-release tablets are a new type of antidepressant drug, can also be used to assist smoking cessation, the drug can relieve the withdrawal symptoms in the process of smoking cessation, improve the success rate of smoking cessation, need to be prescribed by a smoking cessation clinic doctor based on a comprehensive assessment of tobacco dependence and other comprehensive assessments.

According to IQVIA data, the total sales of bupropion hydrochloride sustained-release tablets (suitable for assisted smoking cessation) in 2021 in the US market are about 450.<> million US dollars, and the main manufacturers are Dr. Reddy's and Teva.

According to data from the official website of the State Food and Drug Administration, in addition to GlaxoSmithKline's original drugs, there are 18 approvals for domestic bupropion hydrochloride sustained-release tablets, and the products of 13 enterprises such as Luye Pharmaceutical, CSPC Group Ouyi Pharmaceutical, Jingxin Pharmaceutical, and Renfu Pharmaceutical have been approved for marketing.

According to the Lilac Garden Insight database, only Wante Pharmaceutical (Hainan) and Jingxin Pharmaceutical have indicated the indication of "nicotine dependence", and the former won the first imitation. In addition to being approved for depression indications in China and the United States, Bupropion hydrochloride sustained-release tablets (SR type) were approved for use in the United States in January this year. In terms of declaration, there is no propion hydrochloride sustained-release tablet declared for the "nicotine dependence" indication.

Smoking cessation drugs can be purchased online with prescriptions

The Beijing News reporter searched for "varenicline" on Taobao and Jingdong, only Haosen Pharmaceutical's "Alechang" and Shandong Weizhi Encyclopedia Pharmaceutical's "Velichang" two brands, and "Alechang" occupies more "seats", and the other two new varenicline tablets approved for marketing this year have not yet seen sales. In the flagship store of Taobao Jishengtang Pharmacy, the price of a box of "Aile Chang" (1 mg/14 tablets) is 135.8 yuan, just click "prescription purchase", and the online doctor will issue a prescription in a few seconds, reminding you to avoid drinking, spicy, raw and cold diet during medication, and then complete the payment with electronic prescriptions.

In the review of this product in Taobao Enhua Pharmacy flagship store, some buyers said that "now I don't smoke, I don't feel irritable, and I insist on a course of treatment to quit"; Another buyer said, "This is the third box, very productive." Now I basically don't want to smoke much, insist on a course of treatment, and resolutely quit smoking." Some buyers said, "Addiction is a lifelong thing, I took medicine for 9 months before, and recently I smoked it again, and the medicine was ready." ”

On May 5 this year, Tongyuan Pharmaceutical replied to investors' question about "how many smoking cessation drug orders" said that the company's smoking cessation drugs have begun to be sold externally, and orders are gradually increasing with the development of the market.

Beijing News reporter Wang Kala