[팜뉴스=김응민 기자] With only a few days left until the US FDA approval deadline for the new liver cancer drug HLB, the European Medicines Agency (EMA) has approved the Pediatric Investigation Plan (PIP), which is normally required on for the approval of new drugs, in relation to the new HLB scheme. liver cancer drug By deciding to exclude the submission, the process and time for applying for approval for new drugs was greatly shortened.
HLB announced that the EMA has informed its US subsidiary Elevar Therapeutics of this decision, which is preparing to apply for new drug approval for first-line liver cancer treatment in Europe. Following the PIP exemption for camrelizumab, which has already been confirmed, the PIP for rivoceranib has also been exempted, allowing Eleva, which is leading the new drug approval application, to accelerate its application for approval European even more.
PIP refers to the clinical development plan that must be carried out for the approval of drugs for children and young people aged 2 to 18 years.
Given that it normally takes more than six months to prepare a PIP protocol, this decision gave the company significant advantages in terms of time and cost. The green light has been turned on for the plan to apply for continuous global new drug approval in the sense that the company plans to proceed with the European application process immediately after the US approval and then apply for Korea and Asia.
Elevar previously signed a licensing consultancy contract with a European pharmaceutical company to apply for new drug approval at the end of last year. HLB has announced plans for direct sales in the US and sales agency partnerships in Europe. Once the European product approval application is made, European technology export negotiations with international pharmaceutical companies are expected to gain momentum.
Meanwhile, the US FDA new drug approval decision date is approaching, and preparations for sales in the US are also going smoothly.
First, Eleva obtained drug sales licenses in all states that can preemptively sell drugs before new drugs are approved. The company currently has licenses in 43 states in the US, and the remaining 7 states grant licenses after approval of new drugs in accordance with state regulations.
Preparations for the production and marketing of new drugs are also accelerating. This is because the company has already placed orders for rivoceranib and camrelizumab, and the new drugs are currently being manufactured at the Hengseo Pharmaceutical factory.
The plan is to proceed with shipping and customs clearance procedures immediately after approval of the new drug and to ship the new drug throughout the United States as early as September 3 or sooner. To this end, we are in the process of recruiting marketing personnel and plan to subdivide the United States into 7 regions and 59 areas and begin an intensive sales process for each region.
Yonghae Han, CTO of HLB Group, said, “As the approval of a new drug in the United States becomes more visible, the company is also accelerating the next step, the application for approval in Europe,” adding, “Approval of a new drug . drug in the United States is an ongoing process in different regions of the world.” “With approval, it will be a strong signal for rapid expansion into many other indications.”
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