According to an investigation by Pharm eDaily, the premium pharmaceutical and biotech content service of Edaily, on the 16th, it was confirmed that Elevar Therapeutics had been recruiting personnel until recently for projects related to riboceranib, a combination therapy with Kamrelizumab from China’s Hengrui Pharmaceuticals, and lirapugratinib, a new drug for cholangiocarcinoma. The position in question is for an Executive Director responsible for U.S. insurance coverage. Although the official recruitment portal is currently closed, traces of a job posting with the same details remain online.
According to the job posting, the role involves securing insurance coverage and market access for the riboceranib-camrelizumab combination therapy and lirapugratinib from U.S. insurers, hospital networks, and hospital group purchasing organizations (GPOs). In essence, this is a hands-on commercialization leadership role responsible for establishing relationships with relevant organizations from the pre-approval stage and overseeing and managing market entry strategies to ensure they translate into actual prescriptions and sales following launch.
As this is an executive-level position, the hiring requirements are quite stringent. Elevate Therapeutics has set the annual salary for this role at $200,000 to $285,000 (approximately 300 million to 430 million won), but requires at least 15 years of experience in reimbursement and contract management with U.S. insurers and hospitals in the oncology field as a prerequisite.
This hiring move is interpreted as preparation for commercialization, contingent upon the U.S. FDA approval of the company’s candidate drugs. The company is effectively aiming to secure early access to insurance providers, hospitals, and group purchasing organizations (GPOs) to enter the prescription market as quickly as possible following approval. An industry insider stated, “To expedite insurance listing and distribution negotiations, an organization must be in place at least several months before approval to minimize delays in market entry,” adding, “It is common practice to proactively prepare for commercialization for any pipeline with even a slight chance of approval.”
In fact, there are numerous cases where companies proactively prepare for commercialization regardless of whether approval is ultimately granted. In 2019, U.S.-based Spectrum announced that, confident in securing U.S. FDA approval for Rolontis—which it had licensed from HanmiPharm—it would begin commercialization preparations, including hiring staff. However, due to the COVID-19 pandemic, the on-site inspection of the Rolontis manufacturing facility was postponed, resulting in a CRL from the FDA in 2021 and a delay in the commercialization schedule. U.S.-based RipleyImmune prepared for market entry last year by announcing that it had established commercialization infrastructure ahead of the anticipated FDA approval of its melanoma treatment RP1; however, after receiving a second CRL from the FDA in April of this year, the company proceeded with staff reductions.
Elevate Therapeutics also received its third CRL from the FDA on the 9th. However, the fact that the inspection results for the active pharmaceutical ingredient (API) manufacturing facility for riboceranib were confirmed as “VAI” immediately after receiving the CRL is viewed as a factor that partially reduces uncertainty in the process of reapplying for approval. Previously, on the 14th, Eleva Therapeutics received a Seohan from the FDA, delivered via Hengrui Pharmaceuticals, confirming the completion of the inspection of its API manufacturing facility. The FDA ultimately classified the cGMP inspection results for the facility as “VAI.” “VAI” is a rating assigned when the FDA determines that, although issues were identified during the inspection, they are not severe enough to warrant mandatory regulatory action and can be addressed through the company’s voluntary corrective actions.
Consequently, although the new drug application was not approved at this time, HLB INC. plans to proceed with corrective actions and a resubmission through Eleva Therapeutics in the future. As a result, Eleva Therapeutics’ personnel responsible for insurance and market affairs are likely to focus on maintaining the foundation for U.S. commercialization—even amid changes to the approval timeline—rather than preparing for an immediate product launch. This is to minimize time-to-market once approval is ultimately granted.
Meanwhile, it is noteworthy that the job posting specifies that the hired personnel will be responsible for both the riboceranib-camrelizumab combination therapy and lirapugratinib. Since liver cancer and bile duct cancer both fall under the field of gastrointestinal oncology—and there is significant overlap among the medical oncologists treating these conditions—it appears the company intends to manage the U.S. market entry strategies for these two pipelines as a unified effort.
An HLB INC. official also stated, “Most physicians treating liver or bile duct cancer belong to the same clinical group,” adding, “Since the patient populations for these liver and bile duct cancer candidates will not differ significantly upon new drug approval, we can expect synergies between the two pipelines.”
Of course, neither candidate is entirely free from regulatory uncertainties. In the case of the new liver cancer drug, a VAI designation does not guarantee approval. Since a CRL was issued, all existing approval procedures have been suspended and must be restarted from scratch; furthermore, the schedule for re-inspection or resubmission may change depending on the FDA’s final decision.
Although lirapugratinib has been designated for Priority Review by the FDA, shortening the review period by about four months compared to standard review, the key factor for final approval is whether the FDA will determine that the data—which is based on a Phase 1/2 single-arm study rather than a large-scale Phase 3 comparative trial—demonstrates sufficient clinical significance compared to existing treatments.
