China Market Approval Tracker: May 2021
Minhua Chu ·07/19/2021
China NMPA Approval Tracker

Writer: Minhua Chu, Danni Yin

Editor: Justin Fischer

This May, three orphan drugs from multinational pharmaceutical companies received market approvals via priority review from the National Medical Products Administration (NMPA). Two of these drugs have been approved for the first time in China.

Roche’s Hemlibra (emicizumab) is a bispecific factor IXa- and factor X-directed antibody.  At the end of 2018, Hemlibra was first approved in China as prophylactic treatment for hemophilia A patients with factor VIII inhibitors. Rochel will now expand Helimbra's label for treatment of hemophilia A patients without factor VIII inhibitors.

Enspryng (satralizumab) is a humanized anti-interleukin-6 (IL-6) receptor monoclonal recycling antibody developed by Roche subsidiary Chugai Pharmaceutical. The drug treats a rare autoimmune disease known as neuromyelitis optica spectrum disorder (NMOSD) with aquaporin 4 water channel autoantibody (AQP4-IgG) seropositive.

Dalfampridine is a potassium channel blocker used to improve motor function in patients with multiple sclerosis (MS). Developed by Accorda, Biogen secured exclusive rights of development and commercialization outside the US in 2009. On January 20, 2021, Biogen submitted a New Drug Application (NDA) for dalfampridine. The drug was approved within four months.

China’s third bevacizumab biosimilar got the NMPA green light in May, after Qilu Pharmaceuticals and Innovent Biologicals. Another five bevacizumab biosimilars have already been submitted for approval. Submitting companies include Junshi Biosciences, Henlius Biotech, and Bio-Thera Solutions.


Mutations in the epidermal growth factor receptor (EGFR) gene are the most common targetable genomic drivers of non-small cell lung cancer (NSCLC), and the exon 19 deletion and the L858R point mutation occurring in the receptor tyrosine kinase domain is the most common EGFR-activating mutations.

Although some EGFR tyrosine kinase inhibitors (TKIs) have already been launched, acquired resistance is very common. This has led to the development of third-generation EGFR TKIs, such as osimertinib.

In May, an NDA was submitted a third-generation EGFR TKI BPI-7711 developed by Beta Pharma and its partner CSPC Pharmaceutical Group.  Hansoh’s almonertinib, another third-generation EGFR TKI, which was already launched for the second-line (2L) therapy in 2020, seeks to expand its label to first-line (1L) treatment.

Additionally, there are four competitors in 1L therapy late trials that may submit NDAs this year or early next year.

1L NSCLC therapy development status of 3rd generation EGFR-TKI drugs in China

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Source: PharmaDJ Intelligence

Unlike the classical exon 19 deletions or EGFR L858R point mutation, EGFR exon 20 insertion mutations are very low frequency (2%) in NSCLC, but are associated with de novo resistance to targeted EGFR inhibitors and correlate with a poor patient prognosis.

Takeda’s mobocertinib (TAK-788) is a TKI specially targeted EGFR exon 20 insertion, the NDA was granted priority review by the NMPA.

Currently, no EGFR exon 20 insertion targeted drug has been approved yet, but three are in clincial studies.

The development status of EGFR exon 20 insertion targeted drugs in China



Keywords: NSCLC EGFR bevacizumab MS NMOSD Dalfampridine Hemlibra (emicizumab)
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