China At Global Rare Disease Crossroads: CANbridge CEO
Reimbursement, Regulatory Changes Herald New Era?
The Beijing/Boston-based bioventure shocked the industry with its recent announcement of the return of exclusive rights to an oncology assets in the greater China area to its US licensee, in an effort to focus squarely on rare diseases. CEO James Xue shares his views on this market in China in an exclusive interview with Scrip.
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Already priced domestically at a deep discount to counterpart PD-1s in the US, Beigene's tislelizumab could potentially get the first global approval for a China-originated drug in this class, as the immuno-oncology sector as a whole continues to come under pressure in China.
As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.