1. Basic information
Celecoxib (trade name: Celebrex) is a selective cyclooxygenase-2 (COX-2) inhibitor developed by Pfizer , by inhibiting cyclooxygenase-2 (COX-2) to prevent the production of inflammatory prostaglandins, achieving anti-inflammatory and analgesic effects.
Currently approved indications include osteoarthritis (OA), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA) in patients two years old and above, and ankylosing spondylitis (AS). ), acute pain (AP) and primary dysmenorrhea (PD), etc.
The medical insurance policy for celecoxib capsules is Category B of the National Medical Insurance, limited to second-line drugs (2019 version of the medical insurance catalog).
2. Development History
The US patent for Pfizer’s celecoxib compound expired on November 30, 2013, and the Chinese patent expired on November 13, 2014. Currently, two domestic companies have been approved to produce celecoxib API in 2013, namely Jiangsu Hengrui Pharmaceutical and Jiangsu Zhengda Qingjiang Pharmaceutical. In addition, in terms of preparations, NMPA issued an approval for celecoxib capsules to Jiangsu Hengrui in December 2019. In January of the following year, Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd. received an approval for generic celecoxib capsules.
3. Domestic registration application status
1. Domestic approved application information
Note: Hengrui and Zhengda Qingjiang were both approved as imitation Category 4 , deemed to have passed the consistency evaluation.
2. Current domestic registration application information for celecoxib capsules and tablet preparations:
2.1 Nearly 50 companies have applied for capsules, mainly Jiangsu Hisheng Pharmaceutical, Shi Pharmaceutical groups Ouyi Pharmaceutical, Qilu Pharmaceutical (Hainan) and many other companies. Currently, there are 5 companies that have entered priority approval, including Beijing Yabao Biopharmaceutical Co., Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., Qingdao Baiyang Pharmaceutical Co., Ltd., Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd., and Jiangsu Hengrui Pharmaceutical Co., Ltd. . Twelve companies have passed bioequivalence testing. Among them, CSPC Ouyi’s celecoxib capsules were approved in the United States in 2018, and Qingdao Baiyang also received FDA approval in August 2019.
2.2 Among them, 5 tablet companies are Jiangxi Baishen Pharmaceutical, Nanjing Yihua Pharmaceutical, Shandong Xierkangtai Pharmaceutical, Guizhou Liansheng Pharmaceutical, and Qingdao Guohai Biopharmaceutical; none of them entered the list. Clinical trial stage.
4. Domestic market situation of coxib products
According to data from the World Health Organization, the number of arthritis patients worldwide is approximately 400 million. In recent years, the incidence of arthritis in my country has increased The number of people has shown explosive growth, with more than 100 million patients, and the number is still increasing. Osteoarthritis is a common and frequently-occurring disease, and it is also a common chronic disease. Coxibs belong to a class of hot drugs used in the clinical treatment of arthritis today and are highly selective cyclooxygenase-2 (COX-2) specific inhibitors. Compared with traditional non-steroidal anti-inflammatory drugs, it has less adverse effects on the digestive system.
According to data from MiNei.com, the domestic anti-inflammatory and anti-rheumatic drug market (terminals in China’s public medical institutions + terminals in China’s urban retail pharmacies) has expanded year by year in recent years, exceeding 20 billion yuan for the first time in 2018, of which China’s public medical institutions The terminal is the main sales battlefield for anti-inflammatory and anti-rheumatic drugs. Currently, coxib drugs commonly used in clinical practice in China include parecoxib, celecoxib, erecoxib, etoricoxib, etc.
Among the top 10 terminal anti-inflammatory and antirheumatic drugs in China’s public medical institutions in 2018, two are coxib drugs, namely parecoxib and celecoxib. Celecoxib in 2018 Sales were 1.024 billion yuan, a year-on-year increase of 25.28%, ranking fourth. (Data source from Minai.com)
At present, there are few domestic manufacturers of coxibs, and foreign companies account for more than 80% of the shares, which is an absolute advantage. However, the market share of domestic companies is increasing rapidly year by year.
Parecoxib
Before 2017, only one company, Pharmacia, a subsidiary of the importing company Pfizer, sold it.
In 2017, Sichuan Kelun became the first domestic pharmaceutical company to receive approval for parecoxib sodium for injection. On June 13, 2018, Qilu Pharmaceutical obtained the drug approval document for parecoxib sodium for injection (Qilisu) approved and issued by the NMPA, becoming the second company after Kelun Pharmaceutical to obtain the generic version of parecoxib sodium for injection from Pfizer. Pharmaceutical pharmaceutical companies. Subsequently, 10 more companies entered. According to predictions by industry insiders, this generic drug is expected to become a billion-level product. Judging from the progress of the consistency evaluation of parecoxib, no domestic company has passed the consistency evaluation. Qilu Pharmaceutical, Kelun Pharmaceutical, Chia Tai Tianqing, and Hengrui Pharmaceutical have made relatively fast progress and have entered the review and approval stage.
Etoricoxib
Before 2018, only one company, the imported company Merck, was selling it. Since its launch in 2008, this product has grown rapidly and performed well in the market. The product ranking 3rd in the cloth market. In 2008, Merck's etoricoxib was approved for marketing in China. It is available in tablet form and has four specifications: 30mg, 60mg, 90mg and 120mg. The patent period for the etoricoxib compound expires in 2016. On September 17, 2019, Qilu Pharmaceutical’s etoricoxib and tablets were officially approved for marketing by the State Food and Drug Administration, and were deemed to have passed the consistency evaluation. This product has entered medical insurance and the market is on the rise. With the launch of Qilu generic drugs, competition for this product is gradually becoming fiercer.
Iricoxib
Iricoxib is a new drug independently developed by Jiangsu Hengrui Pharmaceuticals. It was approved by NMPA in May 2011 and its trade name is "Hengyang" ”, the dosage form is tablet, and the specification is 0.1g. This product is the first in the world. In 2018, only one local company, Hengrui, sold domestically. In 2017, the innovative drug Iricoxib entered the new version of the medical insurance catalog and is in a period of rapid growth, with its market share increasing year by year. As the first independent brand of coxib drugs in China, coupled with Hengrui's huge marketing network, the sales of Irecoxib in sample hospitals have grown rapidly in recent years and the market performance is good.
With the aging of my country’s population, anti-inflammatory drugs and anti-rheumatic drugs for chronic diseases will enter a stage of rapid growth. From the global perspective of coxibs, whether they are over-the-counter drugs or prescription drugs, coxibs are the most widely used category in clinical practice. Currently, the best-selling drug in the international market is celecoxib, and the best-selling drug in the domestic market is parecoxib. Due to the continuous entry of domestic innovative coxib drugs and generic drugs, it means that imported drugs will gradually lose their dazzling halo, and the domestic coxib market will have a broader market space in the future.