Qilu Pharma Set to Challenge Pfizer's $1B Celecoxib Market, Joining Hengrui and CSPC in Fierce Competition

Recently, data from the NMPA website shows that Qilu Pharmaceutical's Class 4 generic marketing application for Celecoxib Capsules has entered the "under review" stage, with positive news expected in the near future. Celecoxib Capsules are a blockbuster anti-inflammatory and anti-rheumatic drug under Pfizer. In 2019, its sales in Chinese public medical institutions exceeded RMB 1 billion. With the implementation of the third batch of national centralized procurement, the monopoly of the originator drug on the market has been broken.

Figure 1: Registration Progress of Celecoxib Capsules by Qilu Pharmaceutical

Source: NMPA Official Website

Figure 2: Global Sales of Celecoxib (in million USD)

Source: Menet’s Sales Database of Multinational Listed Companies

Celecoxib is a selective COX-2 inhibitor nonsteroidal anti-inflammatory drug (NSAID), primarily indicated for the relief of signs and symptoms of osteoarthritis, adult rheumatoid arthritis, and ankylosing spondylitis, as well as for the treatment of acute pain in adults. Celecoxib was originally developed by G.D. Searle LLC, which was later acquired by Pharmacia. In 2002, Pfizer acquired Pharmacia for $60 billion, making celecoxib a Pfizer product. Data from Menet shows that the global sales peak of this product occurred in 2013, reaching nearly $3 billion. However, sales declined sharply following patent expiration, dropping to only $700 million in 2019.

The original branded product was approved for entry into the Chinese market in 2001 and is currently listed as a Class B drug in the National Reimbursement Drug List. Data from Menet shows that at terminal sales outlets of Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—celecoxib’s sales exceeded RMB 1 billion in 2018 and rose to RMB 1.07 billion in 2019.

Figure 3: Status of Approved Marketing Authorizations for Domestically Produced Celecoxib Capsules Currently on the Market

Source: Menet One-Click Search

To date, five domestic pharmaceutical companies, including Hengrui and CSPC, have received approval for their Class 4 generic versions, which are deemed to have passed the consistency evaluation. The product was included in the third batch of the National Centralized Drug Procurement program, with CSPC, Baiyang Pharmaceutical, Guowei Pharmaceutical, and Zhengda Qingjiang Pharmaceutical successfully winning bids, thereby breaking the originator’s market monopoly. Hengrui did not win a bid. Qilu Pharmaceutical is expected to compete fiercely in the non-winning bid market segment after its product receives approval.

Source: NMPA Official Website, Menet Database