Some blockbuster drugs from Bristol-Myers Squibb, Amgen, AstraZeneca, Eli Lilly and Gilead will likely be approved in China in 2018, as the country implements regulatory improvements aimed at speeding up drug approvals.
In a recent report (Chinese), local pharmaceutical database PharmCube predicted 16 possible blockbuster approvals in China in 2018. Many of those drugs either have already gained or will likely be included in the priority review pathway of China FDA.
Opdivo was the talk of the week in China’s drug industry when Bristol-Myers Squibb submitted for CFDA approval early November. The agency’s Center for Drug Evaluation (CDE) moved it under priority review mid-December. Because of the attention around the medication and the comparatively speaking smaller backlog for biologics evaluation, PharmCube predicted that it’s poised to become the first PD-1/PD-L1 therapy in China by the first quarter.
But competition is not far behind. Besides archrival Keytruda, several locally developed—and probably cheaper—candidates might also reach the CDE in 2018. These include:
- Innovent’s IBI308, the second PD-1 filed to the CDE, which is under a co-development deal with Eli Lilly.
- BeiGene’s Celgene-partnered tislelizumab (BGB-A317), which is in pivotal studies in relapsed or refractory classical Hodgkin lymphoma, non-small cell lung cancer and liver cancer.
- Jiangsu Hengrui Medicine’s SHR-1210, for which Incyte holds ex-China rights.
PharmCube also based its Opdivo timeline estimate on the CDE’s previous record-setting approval of AstraZeneca’s Tagrisso, which went from a priority review designation to final decision in just three weeks. Because foreign drugs previously needed to apply for a local clinical trial waiver first, Tagrisso actually went through the entire China registration in two and a half years. But that has changed for its Merck-partnered Lynparza.
Through a new policy rolled out in October, CFDA is allowing foreign medications to skip the redundant waiver application and use data from China-included multicenter clinical trials directly for new drug applications.
And Lynparza was the first to have filed under that new rule. Expecting it to be put on expedited review later, PharmCube projected that its second-line ovarian cancer application will be approved in the third quarter.
Gilead’s hepatitis C star Harvoni also sits on PharmCube’s list. The Big Biotech has already successfully launched Sovaldi in China at one-fifth of its U.S. price. But again, competitions in the forms of BMS’s dual-drug regimen Daklinza and Sunvepra, as well as Abbvie’s ombitasvir and dasabuvir, are already there.
Plus, local company Ascletis’ NS3/4A drug danoprevir, also in accelerated review, will likely be OKed in the second quarter, according to PharmCube. The company’s HCV HS5A inhibitor is also in late-stage clinical development and it has in-licensed Medivir’s NS5B inhibitor MIV-802.
Amgen’s PCSK9 inhibitor Repatha, Lilly and Chi-Med’s cancer drug fruquintinib, Eisai’s Lenvima, Lilly’s Trulicity, Gilead’s hep B therapy Vemlidy, Novartis’ ALK inhibitor Zykadia, and FibroGen and AZ’s roxadustat—a first-in-class, orally administered treatment for anemia associated with chronic kidney disease—are all included in PharmCube’s list.