[Click eStock] "Hanmi Pharm, Launch Delay Inevitable Due to Rollontis CRL"... Target Price Down

[Asia Economy Reporter Ji Yeon-jin] Daishin Securities announced on the 9th that it has lowered the target price of Hanmi Pharm to 370,000 KRW, stating that the launch of the new drug 'Rolontis,' a bio-new drug licensed to the global pharmaceutical company Spectrum, is inevitably delayed due to the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The buy investment opinion was maintained.

Rolontis is a long-acting bio-new drug under development for the treatment of neutropenia in cancer patients undergoing chemotherapy. It was licensed to Spectrum in the U.S. in 2012 for $23.8 million. Through the CRL, the FDA requested supplementary data related to Rolontis production and a re-inspection of manufacturing facilities,

but detailed information was not disclosed. The DS (drug substance) of Rolontis is produced at Hanmi Pharm's Pyeongtaek bio plant, and the DP (drug product filling) is produced through a local CMO in the U.S.; it is estimated that both plants will require additional inspections.

Yoonjin Lim, a researcher at Daishin Securities, said, "It is fortunate that additional clinical trials are not required, but delays in FDA approval and launch are inevitable due to the need for supplementary data and re-inspection." She added, "In the past, Celltrion's 'Truxima' took about 18 months from receiving a CRL in May 2017 to final approval in November 2018." Researcher Lim expects that, since Hanmi Pharm's plant inspection was delayed once due to COVID-19, additional inspections and final approval will take at least more than one year.

Rolontis's competitor drug, Amgen's 'Neulasta,' achieved sales of $2.3 billion last year. Although sales have decreased by an average of 20% annually over the past three years due to the launch of multiple biosimilars since the patent expired in 2018, it is securing competitiveness by expanding the formulation from the existing subcutaneous injection to the 'Neulasta Onpro' patch formulation.

Poziotinib, a second-line treatment for non-small cell lung cancer, is scheduled to apply for conditional FDA approval within this year. Poziotinib was designated as a fast track by the FDA in March, raising expectations for expedited review. The non-alcoholic fatty liver disease candidate (Triple agonist) is expected to have Phase 2b clinical trial results within this year, and since there is no approved treatment, it is a field with high unmet needs, maintaining expectations for new technology licensing.

This content was produced with the assistance of AI translation services.