Chengdu Brilliant Pharmaceutical Nears Approval for Three Key Generic Drugs

Recently, three generic drugs submitted for marketing approval under the new classification by BRILLIANT PHARMACEUTICALS (including its subsidiaries) have entered the administrative approval stage. The products are Vortioxetine Hydrobromide Tablets, Lenvatinib Mesylate Capsules, and Ipratropium Bromide Inhalation Aerosol. Data from Menet indicates that sales of these three products at China's public medical institution terminals grew rapidly in H1 2021. With few approved manufacturers, the competitive landscape remains favorable.

Source: Official Website of the National Medical Products Administration

Lenvatinib is a multitargeted receptor tyrosine kinase inhibitor developed by Eisai. It was first approved by the FDA in February 2015, and its global sales exceeded $1 billion in 2020.

The originator product received approval to enter the Chinese market in September 2018, breaking sorafenib's long-standing monopoly in the first-line liver cancer market. It was subsequently included in the National Reimbursement Drug List (NRDL) through price negotiation in 2020. Data from Menet shows that in H1 2021, lenvatinib sales in China's public medical institutions (encompassing urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) exceeded RMB 600 million, marking a year-on-year surge of 537.92%.

Lenvatinib Mesilate Capsules from Chia Tai Tianqing Pharmaceutical and Simcere Pharmaceutical were granted marketing approval on the same day, jointly securing the first generic approval; products from Nanjing Chia Tai Tianqing and Qilu Pharmaceutical have also been successively approved, while BRILLIANT PHARMACEUTICALS' product has entered the "under review" stage, poised to become the fifth domestically manufactured version.

Source: Official Website of the National Medical Products Administration

Vortioxetine, a serotonin (5-HT) reuptake inhibitor developed by Lundbeck, is a novel antidepressant. It was first approved by the FDA in September 2013, received approval for the Chinese market in November 2017, and recorded terminal sales exceeding RMB 50 million at public medical institutions in China in H1 2021, marking a year-on-year increase of 129.36%.

Currently, seven companies in China have submitted marketing authorization applications for Vortioxetine Hydrobromide Tablets. Chia Tai Tianqing Pharmaceutical's product was approved in July 2021, marking the first generic approval in China, and BRILLIANT PHARMACEUTICALS is expected to become the second domestic manufacturer to receive approval.

Source: Official Website of the National Medical Products Administration

Ipratropium bromide is a highly selective muscarinic (M) receptor antagonist indicated for the relief of bronchospasm in chronic asthmatic bronchitis. Currently marketed ipratropium bromide formulations in China include ipratropium bromide solution for inhalation and ipratropium bromide aerosol. In H1 2021, the combined terminal sales revenue of these products in China's public medical institutions exceeded 500 million RMB, representing a 58% year-on-year increase.

Apart from the originator product, currently only the ipratropium bromide aerosols from China Resources Double-Crane and Beijing Haidelun are commercially available in China. Sichuan Puruite (a subsidiary of BRILLIANT PHARMACEUTICALS) is expected to become the third company with a product produced in China.

Source: Menet database, official website of the National Medical Products Administration, etc.

Note: Data are as of October 26. Please feel free to point out any omissions or inaccuracies!