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January 18, 2019updated 27 Oct 2021 1:49pm

Chinese authorities approve Sino Pharma’s lenalidomide for multiple melanoma

Chinese Sino Pharmaceutical has announced that China’s National Medical Products Administration has approved its subsidiary Chia-Tai Tianqing Pharmaceutical’s anti-tumour drug lenalidomide for multiple melanoma.

By Allie Nawrat

Chinese Sino Pharmaceutical has announced that China’s National Medical Products Administration has approved its subsidiary Chia-Tai Tianqing Pharmaceutical’s anti-tumour drug lenalidomide for multiple melanoma.

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The approval is due to the convenience of oral administration, proven efficacy and good safety profile, and allows the drug to be taken in conjunction with dexamethasone.

Lenalidomide is a synthetic glutamic acid derivative and a more chemically stable analogue of thalidomide, which is known for causing birth deformities in the babies of mothers prescribed it to mitigate morning sickness.

The mechanism through which thalidomide caused birth defects has been a mystery, however, recent research by the Dana-Farber Institute found a link between the drug and SALL4 protein production in cells.

Chia-Tai’s drug has many mechanisms of action. It can induce tumour cell apoptosis directly and indirectly, as well as inhibiting angiogenesis and having immunomodulatory effects.

Lenalidomide is a generic version of Celgene’s Revlimid. The drug was approved for multiple melanoma in the US in 2006 and in Europe in 2007. It was approved for use under the UK’s National Health Service in 2009.

The drug is also available in Europe and the US for myelodysplastic syndromes and mantle cell lymphoma. However, the UK’s pricing regulator the National Institute of Health and Care Excellence concluded it was too expensive for use by the NHS for this indication. It is currently unclear if the Chinese authorities are planning to approve Sino Pharma’s generic for this indication as well.

Earlier in January, Sino Pharma announced the Chinese regulator had approved its registration of two doses of a combination therapy developed by its subsidiary Jiangsu Chia Tai Fenghai Pharmaceutical.

The combination is an antibacterial drug, which includes linezolid and glucose injection; linezolid consists of a range of synthetic antibiotics used for a range of respiratory, haematology and infectious diseases.

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Free Whitepaper
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What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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