HLB announced on the 8th that the European Medicines Agency (EMA) has decided to exempt the submission of the Paediatric Investigation Plan (PIP) required for the new drug approval application related to its liver cancer drug.
EMA notified Elevar Therapeutics, HLB's U.S. subsidiary preparing to apply for new drug approval as a first-line treatment for liver cancer in Europe. Following the confirmation of the PIP exemption for Camrelizumab, the PIP for Lenvatinib was also exempted, which is expected to accelerate Elevar's European approval application process. PIP refers to the clinical development plan that must be conducted for the approval of medicines for children and adolescents aged 2 to under 18 years.
Considering that preparing the PIP protocol takes more than six months, this exemption can reduce both time and costs. After U.S. approval, the company plans to proceed immediately with the European application process, followed by applications in Korea and other Asian regions.
At the end of last year, Elevar signed a regulatory consulting contract with a European pharmaceutical company for the new drug approval application. HLB plans to sell directly in the U.S. and through partnerships in Europe. Once the European marketing authorization application is submitted, negotiations for technology export to multinational pharmaceutical companies in Europe are also expected to gain momentum.
With the U.S. FDA's new drug approval decision date approaching, preparations for sales in the U.S. are also progressing smoothly. Elevar has proactively obtained drug sales licenses in all states where sales can be made before new drug approval. The company currently holds licenses in 43 U.S. states, while the remaining 7 states issue licenses after new drug approval according to state regulations.
Production and marketing preparations for the new drug are also gaining momentum. Orders for Lenvatinib and Camrelizumab have been placed, and the new drugs are currently being manufactured at the Hansoh Pharmaceutical factory. After new drug approval, transportation and customs clearance procedures will be carried out immediately, with plans to supply the new drug across the U.S. before September 3. Marketing personnel recruitment is underway, and the U.S. has been divided into 7 regions and 59 districts to initiate focused sales activities by district.
HLB Group CTO Yonghae Han said, "As the U.S. new drug approval is within sight, the company is accelerating the next step, the European approval application process," adding, "Approval in the U.S. will be a strong signal that will be followed by continuous approvals in various regions worldwide and rapid expansion into multiple other indications."
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