Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company" or "Tonghua Dongbao") has recently received a Drug Registration Certificate for etoricoxib tablets from the National Medical Products Administration (NMPA), signaling the Company's imminent entry into the gout market.

The approval of etoricoxib tablets marks a major milestone in the commercialization of Tonghua Dongbao's pipeline drugs for gout treatment. In recent years, the Company has expanded beyond diabetes to broader metabolic and endocrine disorders. With strong confidence in the market potential for gout and hyperuricemia, the Company entered the gout field in 2021, launching multiple product pipelines aimed at broadening its business scope, enhancing its product portfolio, and driving future growth.

At present, the Company's gout and hyperuricemia pipeline includes two Class 1 new drugs and one oral chemical drug, namely etoricoxib tablets. The approval of etoricoxib tablets is a key achievement in the Company's gout strategy and lays the groundwork for the future commercialization of its two Class 1 new drugs. Both Class 1 new drugs are advancing rapidly. The Phase IIa trial of the URAT1 inhibitor has met its primary endpoint, while the XO/URAT1 dual inhibitor, which is considered to have first-in-class potential, has completed database lock for its Phase IIa trial.

About Etoricoxib Tablets

Etoricoxib Tablets are a selective COX-2 inhibitor and a new-generation non-steroidal drug, offering anti-inflammatory, pain-relief, and fever-reducing benefits. With fewer gastrointestinal side effects than traditional drugs and no sulfa group, it is safer for patients allergic to sulfonamides. Etoricoxib is widely used for conditions such as osteoarthritis, primary dysmenorrhea, and acute gouty arthritis. It is currently the only COX-2 inhibitor approved in China for the treatment of acute gouty arthritis.

Etoricoxib Tablets, developed by Merck Sharp & Dohme, was first approved in Mexico in September 2001. It was subsequently approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April 2002 and are marketed under the brand name Arcoxia. Now available in 84 countries, it is the top-prescribed anti-inflammatory painkiller in Europe.

According to data from Menet.com, the sales of Etoricoxib Tablets in Chinese public medical institutions and urban retail pharmacies totaled RMB 410 million in 2023, with a year-on-year increase of 14.91%.

About Gout and Hyperuricemia

In recent years, the prevalence of gout and hyperuricemia has obviously increased in China, especially among young people, exposing the vast unmet medical needs in this field. According to the Chinese Guidelines for the Treatment of Hyperuricemia and Gout (2019), the overall prevalence of hyperuricemia and gout in China is 13.3% and 1.1%, respectively. Gout has become the second most common metabolic disease after diabetes. A Frost & Sullivan analysis reveals that the number of people in China with gout and hyperuricemia will continue to increase, respectively reaching 52.2 million and 240 million in 2030, and the Chinese gout drug market is expected to grow to RMB 10.8 billion.