Innovent Biologics is ready to make its play for the Chinese PCSK9 inhibitor market. Having racked up another two phase 3 wins, Innovent is preparing to file for an approval that would position it as a rival to Amgen’s Repatha and Sanofi’s Praluent in China.
Neither Repatha or Praluent have lived up to commercial expectations, despite the cholesterol-lowering drugs delivering clear wins in the clinic. The multiyear commercial struggles of the incumbent products hasn’t deterred Innovent, though, which followed up its first phase 3 win in Chinese patients with two more successes that tee it up to file for approval of IBI306 in its home market this year.
CREDIT-1 is the larger of the two studies. Innovent set out to randomize 800 patients with non-familial hypercholesterolemia to receive placebo or IBI306 every four, six or eight weeks. After 48 weeks, levels of LDL cholesterol had fallen versus placebo by 57% in the six-week group and by 65% in the four-week cohort.
The other study, CREDIT-4, set out to enroll 300 patients with hypercholesterolemia to test the effect of the four-week IBI306 regimen. After 12 weeks, LDL cholesterol levels were down 63% compared to the placebo control cohort.
Innovent is yet to share safety data but said it saw a good profile, consistent with the approved PCSK9 inhibitors, in both studies. The challenge now is to get IBI306 to market and grow sales despite the prior approvals of other PCSK9 inhibitors.
Amgen’s Repatha became the first PCSK9 inhibitor to win approval in China in 2018. Sanofi’s rival therapy Praluent launched in China in 2020, giving both products a good head start over IBI306. Despite that, Innovent has spied a gap in the market, noting that the incumbents have “some limitations in terms of economy and convenience.”
In the U.S., Repatha is administered every two weeks via a prefilled autoinjector or every month using an on-body infusor. Patients inject themselves with Praluent every two or four weeks, depending on which dose they are prescribed. Innovent studied dosing windows ranging from two to eight weeks across its phase 3 program, with the four-week gap being the one regimen studied across all three trials.
Theoretically, Innovent or a partner could use the perceived benefits of IBI306 to make an assault on the U.S. PCSK9 market. However, with Eli Lilly and Innovent’s checkpoint inhibitor looking unlikely to win FDA approval on the strength of Chinese data, any U.S. development program could require more investment in clinical trials to enter a commercial market that has underwhelmed to date.