Nidanib has been approved for new adaptations in China

On December 18th China's National Drug Administration (NMPA) issued a notice that Boehringer-Ingelheim's TKI inhibitor Nintedanib Ofev had submitted a new application for the listing of the disease in China.
, according to an earlier press release issued by Blinger Ingeham, the new adaptation approved is for the treatment of aggressive fibrosis interstitiotic lung disease (PF-ILD).
it's worth noting that the FDA has awarded Nidanib a breakthrough therapy for PF-ILD.
Screenshot Source: NMPA's official website, Nidanibu, is a small molecule tyrosine kinase inhibitor (TKI) developed by Bringer Ingham, which can act on the signaling path of cellular growth factor (PDGFR), fibroblast growth factor (FGFR) and vascular endotrine growth factor (VEGFR) at the same time.
the product was first approved in China in September 2017 for the treatment of idiotreatable pulmonary fibrosis (IPF).
June 2020, the drug was again approved by the NMPA for systemic sclerosis-related interstitiotic lung disease (SSc-ILD).
the end of 2019, Bringer Ingham submitted a new PF-ILD registration application for Nidanibu in China, achieving simultaneous submission with the U.S. and Europe.
, according to an earlier press release issued by Blinger Ingeham, the submission of this new adaptation is primarily based on positive results from the Phase 3 BUILD study.
was a randomized, double-blind, placebo-controlled, parallel grouping of Phase 3 clinical studies.
the study was conducted at 153 research centers in 15 countries and assessed Nidanib's effectiveness, safety and tolerance to PF-ILD patients over a 52-week period.
results showed that in week 52, the INBUILD study reached its main endpoint through an assessment of patients' strength lung capacity (FVC), and Nidanib slowed the annual decline in lung function in the study population by 57 percent.
results demonstrate that the drug candidates are safe and effective for a wide range of PF-ILD patients other than IPF, providing new and effective treatment options for these patients.
interstital pulmonary disease (ILD) is a group of more than 200 diseases that can cause pulmonary fibrosis, with an average of 18%-32% of ILD patients likely to develop PF-ILD, which can lead to breathing difficulties and higher mortality rates.
for PF-ILD patients, there is currently no effective treatment option.
references: 1. Notice of the State Drug Administration of China. Retrieved Dec 18, 2020, from Nidanib two new adaptive applications filed in China to achieve global synchronization of registration applications. Retrieved Dec 12, 2019, from Nidanib two new adaptives filed for listing in China in a year! It is expected to improve the treatment status of more patients with interstitiotic lung disease! Retrieved Dec. 9, 2019, from THE FDA Grants Ofev® File Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype, Retrieved October 10, 2019, from Source: Pharmaceutical Missions and WeChat Public No