I last discussed Syneos Health on August 15, in a popular post on early stage commercialization. When I checked for recent news I discovered that Syneos Health received a commercialization setback in India for the QL2107 Injection.
[T]he Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has rejected its Phase III clinical trial proposal for QL2107 Injection….
After detailed deliberation, the committee opined that, “the proposed clinical trial is focused completely on Pharmacokinetic (pK) parameters. Moreover, primary objective and secondary objective of phase-III study protocol has not been demonstrated for confirmation of therapeutic benefit and efficacy end point. Hence, the committee didn’t recommend to conduct the clinical trial in India.”
So what is the QL2107 Injection? First off, it comes from a Chinese company.
Qilu Pharmaceutical is one of the leading vertically integrated pharmaceutical companies in China focusing on the development, manufacturing and marketing of active pharmaceutical ingredients (APIs) & finished formulations….Dedicated to offering more affordable medicines to the world and improving people’s well-being, Qilu has exported its products to over 100 countries.
The literature on QL2107 repeatedly refers to Qilu Pharmaceutical rather than Syneos Health. But presumably there’s a partnership somewhere.
According to this website, QL2107 is a “pembrolizumab biosimilar,” a fancy way to say that it is similar to pembrolizumab (brand name Keytruda®), a monoclonal antibody with possible anti-cancer applications. It’s already undergone clinical trials.
But a Phase III clinical trial is special. The Gilead Clinical Trials website defines the four phases of clinical trials, including the third:
Phase 3 trials continue to evaluate a treatment’s safety, effectiveness, and side effects by studying it among different populations with the condition and at different dosages. The potential treatment is also compared to existing treatments, or in combination with other treatments to demonstrate whether it offers a benefit to the trial participants. Once completed, the treatment may be approved by regulatory agencies.
Although there is a fourth phase, continuous monitoring, that is obviously important.
In summary, QL2107 is not a home run or even a triple. At least in India, it’s stuck at second.
Bredemarket 