Chinese regulators have approved a second new drug application filed by local pharmaceutical operator Innovent Biologics Inc (OTCMKTS: IVBXF).
The nation’s National Medical Products Administration has now authorized the oral therapeutic Limertinib as a first-line treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Specifically, “EGFR exon 19 deletions [19DEL] or exon 21 L858R mutations.”
Cases of the respiratory disease with these and other mutations affect about 40 per cent of Asian patients who have been diagnosed with NSCLC.
The news follows Innovent and its drug development partner Aosaikang Pharmaceutical Co Ltd (ASK Pharm) (SHE: 002755) securing approval of an initial NDA from the Chinese medical administration in January, for other mutations.
“Beyond the approval for EGFR T790M+ NSCLC, limertinib is also under regulatory review for first-line treatment of EGFR 19DEL+ or L858R+ NSCLC in China,” ASK Pharm Chief Strategy Officer, Tingting Song, explained on Jan. 20 prior to this week’s first-line treatment approval for the latter varieties.
This new authorization follows positive Phase III clinical trial results showing that limertinib was significantly superior to the drug Iressa (gefitinib), which is sold by AstraZeneca plc (NASDAQ: AZN) (STO: AZN). In the study, it showed a 56 per cent rate of superiority in comparison to Iressa for progression-free survival. It also demonstrated 72 per cent better risk reduction in central nervous system progression or death than the other medication.
“Limertinib is poised to significantly improve survival outcomes for mutation-positive patients,” Innovent said in a news release on Friday.
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Approval strengthens Innovent’s oncology market position
Limertinib is the fifteenth drug Innovent has obtained approval for in China, the majority of which are for cancers.
Hodgkin’s lymphoma, colorectal cancer, chronic lymphocytic leukaemia and esophageal cancer are other varieties in the disease group that Innovent has developed treatments for.
Innovent also focuses on treating other types of ailments and is currently developing 23 other therapeutics. Last week, the company launched a new drug for thyroid eye disease throughout China. Innovent says that SYCUME (teprotumumab N01) is the nation’s first treatment available for the condition.
Photo credit: Innovent
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Innovent has immense financial success in 2024
Last year, the drug developer reported turning a profit for the first time since its founding in 2011 and public listing in 2018. Innovent also had positive EBITDA for the first time and cut its losses by over 90 per cent.
This success was driven by a 51.8 per cent year-over-year increase in revenue at about US$1.3 billion, propelled by sales of cancer drugs like limertinib.
It is not uncommon for biopharma companies to spend years on research and development before cashing in on their efforts.
As of April, Innovent is valued at approximately US$10.5 billion. Its current cash balance is sitting at approximately US$1.4 billion and debt is minimal.
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