Qilu Pharmaceutical's Celecoxib Capsules Approved for Market Launch in China

By Jia Yi

On September 16, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s generic drug “Celecoxib Capsules” (Class 4) had been approved for market launch, deemed as having passed the consistency evaluation.

As a new generation of non-steroidal anti-inflammatory and analgesic drugs, celecoxib achieves anti-inflammatory and analgesic effects by selectively inhibiting cyclooxygenase-2 (COX-2) to suppress prostaglandin synthesis. The original research and development was conducted by Pfizer, and it was launched in the United States in 2002 under the brand name Celebrex, held by G.D. Searle LLC. It was approved for marketing by the National Medical Products Administration (NMPA) in China in 2012. Currently, its approved indications include osteoarthritis (OA), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA) in patients aged two years and older, and ankylosing spondylitis (AS).

Celebrex’s global sales peaked at $3 billion. After the compound patent expired in 2014, generic drugs were approved for market entry, causing a significant impact on Celebrex’s sales and leading to a severe decline. In 2019, Celebrex’s global sales amounted to only $700 million.

According to the Insight database, in addition to Pfizer’s celecoxib capsules (brand name: Celebrex) approved for import in China, six other companies, including Hengrui and CSPC, have sequentially received approval. Furthermore, nine companies have marketing applications under review, and eight companies have initiated bioequivalence (BE) trials. The figure presents statistical data by product specification and company.

Source: Insight Database (http://db.dxy.cn/v5/)

Celecoxib oral immediate-release formulations (200 mg strength) were included in the third batch of China’s National Centralized Drug Procurement. Six companies competed for this product, with four winning bidders: CSPC Ouyi Pharmaceutical, Qingdao Baiyang Pharmaceutical, Sichuan Guowei Pharmaceutical, and Zhengda Qingjiang Pharmaceutical. Their price reductions were 93.7%, 92.2%, 88.7%, and 86.4%, respectively, with per-tablet bid prices ranging from RMB 0.313 to RMB 0.683.

Note: The above reduction rates are calculated as (quoted price – ceiling price) / ceiling price, not based on the differential pricing rules.