Nobo Medicine is accelerating the commercialization of its lead pipeline, the blood cancer treatment "Poseltinib." The company aims to apply for domestic new drug marketing authorization as early as next year. It plans to challenge for an IPO (initial public offering) next year, leveraging the research achievements of major new drug pipelines including Poseltinib.
On Friday, Nobo Medicine announced that its Poseltinib-based combination therapy, being developed as a treatment for relapsed/refractory primary central nervous system lymphoma (R/R PCNSL), has been designated as a target of the Ministry of Food and Drug Safety's Global Innovative Product Fast Track Review (GIFT).
The Ministry of Food and Drug Safety's Global Innovative Product Fast Track Review is a system that rapidly supports the development and approval of innovative drugs among treatments for life-threatening severe diseases or rare diseases.
Since its introduction in 2022, most designated new drugs have come from overseas pharmaceutical companies. It is relatively rare for a domestically developed new drug by a Korean company to receive such designation.
Nobo Medicine has been researching Poseltinib as various treatments after licensing it in from Hanmi Pharmaceutical. Poseltinib is an oral small-molecule targeted anticancer agent that works by inhibiting Bruton's tyrosine kinase (BTK), which is involved in B-cell receptor signaling. It was the first treatment of this type to be selected for the Ministry of Food and Drug Safety's Global Innovative Product Fast Track Review.
Considering Poseltinib's relatively high target selectivity and central nervous system penetration characteristics, Nobo Medicine is developing it as a new blood cancer treatment that combines oral drugs without chemotherapy.
In a Phase 2 clinical trial involving 82 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the drug recorded an objective response rate (ORR) of 84%, a complete response rate (CR) of 61%, and a median progression-free survival (mPFS) of 19.8 months.
Based on these clinical results, Nobo Medicine has expanded the research scope of Poseltinib to include consolidation therapy for patients with primary central nervous system lymphoma (PCNSL) and DLBCL patients who are positive for minimal residual disease (MRD) after first-line treatment, as well as maintenance therapy following "CAR-T" and bispecific antibody treatments.
In particular, the indication for relapsed or refractory PCNSL was previously designated as a developmental-stage rare drug by the Ministry of Food and Drug Safety. It was also selected as a Phase 2 clinical trial support project by the Korea Drug Development Foundation (KDDF).
Currently, clinical trials for marketing authorization are underway at 14 hospitals in South Korea. Nobo Medicine aims to apply for domestic marketing authorization by the end of next year and launch it as the first domestically produced new drug in 2028.
Nobo Medicine also holds subsequent pipelines, including "Emricasan," an atrial fibrillation treatment leveraging the association between clonal hematopoiesis (CH) and inflammation, and "NB-2565," a myeloproliferative neoplasm treatment.
Nobo Medicine has selected Korea Investment & Securities as its listing sponsor and is preparing for a KOSDAQ special listing based on technology. The company explained that its strengths lie in its expertise in the blood disease field and new drug research capabilities based on proprietary biomarker technology.
Co-CEO Ko Young-il, the founder, is a professor of hematology and oncology at Seoul National University Hospital, leading clinical research on blood cancer and new drug development. Co-CEO Lee Myung-se is a new drug commercialization expert who has worked at global pharmaceutical companies and oversees commercialization strategy.
A company official said, "The GIFT designation is an achievement recognizing the innovativeness of Poseltinib," adding, "As it is rare for a domestic new drug to be selected for GIFT, we plan to systematically proceed with approval documentation and review preparation."
The official further noted, "By utilizing the Ministry of Food and Drug Safety's concurrent review and regulatory consultations, we can pre-review major approval issues at the development stage and reduce uncertainties in the review process," and added, "Based on our network with domestic medical institutions, we will prepare to quickly enter the treatment field immediately after approval."
in THEBIO
