Pfizer partnered Chinese C-stone PD-(L)1 blocked by FDA In March, the FDA snubbed Eli Lilly and Innovent Biologics’ Tyvyt (sintilimab) in newly diagnosed NSCLC because the application was based on China-only pivotal data comparing the drug with an outdated therapy. Before that, Chinese PD-1/L1 developers had counted on using China-only trials to pursue U.S. approvals based on some comments FDA oncology chief Richard Pazdur, M.D., made during a 2019 event.
The FDA’s tough stance against single-country data and repetitive PD-1/L1 studies from China affects CStone as well.
Meanwhile, in China, the PD-1/L1 competition is getting bloody as companies offer huge discounts trying to secure market share through national reimbursement.
CStone Pharmaceuticals is exploring strategic options including a sale, Bloomberg reports, citing people familiar with the company.
The news comes just one month after the company’s Pfizer-partnered PD-L1 inhibitor Cejemly (sugemalimab) got an expanded approval in China for unresectable stage 3 non-small cell lung cancer (NSCLC) that hasn’t progressed following chemoradiotherapy. The drug earned its initial go-ahead late December for use alongside chemotherapy in newly diagnosed metastatic NSCLC.
Pfizer had signed on to help develop and lead marketing of Cejemly in China back in 2020. The deal saw the drugmaker make a $200 million equity investment to take a 9.9% stake in CStone. The pair also set up a strategic partnership to bring additional oncology assets to the Chinese market.
Now, CStone has tapped Goldman Sachs to help gauge buyer interest, according to Bloomberg's report. Besides a full-on takeover, a sale of a controlling stake is also on the table, and the company could eventually decide against any deal, the people reportedly said.
An overall biotech bear market aside, the FDA’s recent clampdown on cancer drugs with China-only data played a part.
[ This development could postively benefit ONCY and its strategic partnerhsip with Adlai Nortye since ONCY already has clinical data from North America and Europe. This would permit a Big Pharma acquirer of ONCY the opportuntiy to file for an accelerated approval on pelreorep on this data. Once an accelerated approval is granted, Adlai Nortye could become involved with the submission of Chinese generated data that would be part of a Phase IV confirmatory study involving pelareorep + immune checkpoint inhibitors in the treatment of breast cancer. ]