Qilu Pharmaceutical Files for Domestic Approval as Second Chinese Manufacturer of Nintedanib Esilate Soft Capsules Amid Surging Sales Growth

On February 14, the CDE official website showed that the Nintedanib Ethanesulfonate Soft Capsules of Qilu Pharmaceutical Co., Ltd. had been accepted for production in Category 4 generic drug application. Data from MiNe Network indicated that global sales of Nintedanib exceeded 2 billion US dollars in 2020. In the terminal sales of physical pharmacies in Chinese cities, the sales growth rate was astonishing, surpassing 600%, and it was expected to exceed 40 million yuan in 2021. Currently, the manufacturers of this product in China are only Boehringer Ingelheim and NBP Pharmaceuticals of CSPC.

Data shows that Ethanesulfonic Acid Nintedanib Soft Capsules, developed by Boehringer Ingelheim, is a multi-target tyrosine kinase inhibitor (TKI) and the world's first targeted drug approved for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Sales of Nintedanib Ethanesulfonate Soft Capsules in Chinese Urban Physical Pharmacies in Recent Years (Unit: Ten Thousand Yuan)

Source: MiNeiNet Chinese Urban Physical Pharmacy Terminal Competitive Landscape

Data from MiNe Network shows that in 2020, the global sales of Nintedanib exceeded 2 billion US dollars. The sales growth at the end of retail pharmacies in Chinese cities was astonishing, surpassing 600%. It is expected to exceed 40 million yuan in 2021, with a year-on-year increase of 193.73%.

Source: MiNei Network One-Click Search

Currently, there are only two companies producing Nintedanib Ethanesulfonate Soft Capsules in China: Boehringer Ingelheim and CSPC ENBIOPHARM. Among them, CSPC ENBIOPHARM obtained the first generic approval in March last year. In addition, Sichuan Kelun Drug Research Institute | Sichuan Kelun Pharmaceutical Co., Ltd. and Jiangsu Hengrui Pharmaceuticals have both submitted their applications for marketing authorization as Category 4 generics, which are currently under review.

Source: MiNei MED2.0 China Drug Evaluation Database

In 2021, Qilu Pharmaceutical had four anti-tumor drugs approved for marketing under a new classification, which are considered to have passed the evaluation: Cisplatin Injection, Lenvatinib Mesylate Capsules, Sunitinib Malate Capsules, and Imatinib Mesylate Tablets. To date, six more anti-tumor drugs have submitted marketing applications and are under review, including the Class 1 new drug Elucor Tablet.