The impression that drug launches happen ‘a decade after approval in Europe’ is rapidly becoming a part of China’s past, claimed Christoph Heinemann, transformation leader at Sanofi, at the Pharma Integrates event last month.
He went on to say that clinical trials are now also occurring at a much faster pace.
“We've seen, over the last few years, a tremendous acceleration of the regulatory system [in China]. They've approved five or 10 times the number of clinical trials and new drugs, and they've updated their national reimbursement list,” said Heinemann.
China’s government has introduced a number of changes, such as those aimed at speeding up clinical trials and accepting data developed overseas, that will see its drug discovery and approval landscape alter dramatically, Heinemann continued.
He compared the pace of change to be significantly stronger in China, compared to Europe and the US, and noted that the last two years have seen an even greater increase in transformation.
He explained, “In terms of individualised chimeric antigen receptor (CAR)-T therapies, there are more patients involved in clinical trials in China than US trials. If you looked at the in-flow of venture capital into [China], which is building its own biotech industry, it has reached the levels of other notable biotech hot spots in the world.”
Cellular Biomedicine Group, for example, signed a deal with Novartis in September 2018, to produce its Kymriah (tisagenlecleucel) CAR-T in China, which could potentially expand into the Southeast Asian region. The company is also developing its own ‘broad range of cell therapies’, including a proprietary, investigational CAR-T therapy, CD-19 – currently in a Phase I clinical trial.
Heinemann advised the European audience that it could no longer think of China, in terms of drug development and manufacture, as it did a few years ago.
“Everybody has to deal with this topic but we really have to watch out for the speed and scale of the transformation,” he concluded.