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Chi-Med cues up two more regulatory filings in cancer

Hong Kong based firm reports strong sales in first marketed product

chi-med

Hong Kong biotech Chi-Med is on track to file one new cancer drug this year and another in the first half of 2020, as it reports initial sales for its first drug Elunate in China.

The company – also known as Hutchison China MediTech – gained approval last September for Elunate (fruquintinib) in China, making it the first home-grown drug in the VEGF inhibitor class to reach the market there when it launched in November.

Elunate made sales of $11.4m in the first half of the year in its initial colorectal cancer indication, and that could accelerate if Chi-Med can get the product included in the China National Reimbursement Drug List (NRDL) at the next update later this year. It’s early take-up is already outstripping that of other VEGF inhibitors at this early stage, according to the biotech.

It’s thought that Chi-Med’s first product could be eclipsed however by Chi-Med’s other late-stage candidates, which won’t face the same level of competition as Elunate in the market given there are five other small-molecule VEGF inhibitors on the Chinese market.

During its interim results presentation today, Chi-Med also said that with positive phase 3 data in hand for VEGF, FGFR and CSF-1R inhibitor surufatinib in non-pancreatic neuroendocrine tumours (NET) it is on course to file for approval in China before year-end.

It is also expecting to be able to file for approval with the China National Medical Products Administration (NMPA) in the first few months of 2020 for potential first-in-class MET inhibitor savolitinib, partnered with AstraZeneca.

Earlier this year, Chi-Med reported positive clinical results of savolitinib as a monotherapy and in combination with AZ’s Tagrisso (osimertinib) in lung cancer, and alongside AZ’s cancer immunotherapy Imfinzi (durvalumab) in kidney cancer.

Simon To

Simon To

With three public listings completed and its first commercial revenues coming in, Chi-Med has the financial resources it needs to take these programmes forward, and is also now planning to advance another candidate – IDH 1/2 inhibitor HMPL-306 – into clinical testing.

Following after its first three drugs are potential first-in-class selective Syk inhibitor HMPL-523, in phase 1 testing for non-Hodgkin’s lymphoma, and a PI3K delta inhibitor (HMPL-689) heading for phase 2 trials in haematological cancers.

“Our organisation is expanding rapidly, with our New Jersey-based international clinical and regulatory team scaling up to manage global registration studies on surufatinib and fruquintinib and early development on our B-cell malignancy assets,” said Chi-Med’s chairman Simon To.

“Our in-house oncology commercial team in China is also growing fast, managing medical affairs and getting ready for the potential launch of surufatinib late next year,” he added.

Within two years, To expects Chi-Med to become “a fully integrated and globally-facing biopharmaceutical company with capability to discover, develop and launch multiple novel drug innovations.”

Article by
Phil Taylor

30th July 2019

From: Sales

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