EMA Grants Paediatric Investigation Plan Waiver for HLB's Rivoceranib

· EMA's PIP waiver speeds up HLB's European marketing application
· New drugs are being manufactured at Jiangsu Hengrui Pharma's facility

European Medicines Agency grants paediatric investigation plan waiver for HLB's rivoceranib (Image=IT Times)

SEOUL, South Korea, May 8, 2024 (IT Times) - HLB, a leading biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted a Paediatric Investigation Plan (PIP) waiver for HLB's rivoceranib to Elevar Therapeutics, HLB's US subsidiary, as it prepares to submit a Marketing Authorization Application for the first-line treatment of liver cancer in Europe.

The PIP waiver for rivoceranib, which follows the PIP waiver already granted for camrelizumab in combination with HLB liver cancer, will further accelerate Elevar's European marketing authorization application.

The PIP protocol typically takes more than six months to complete. The EMA's decision provides significant time and cost benefits for HLB. It also gives the green light to the company's plans for a series of global New Drug Authorization applications, with a European filing planned immediately after the US approval, followed by filings in Korea and Asia.

Late last year, Elevar signed an agreement with a European pharmaceutical company to provide regulatory consulting services for its new drug application. HLB has revealed plans for direct sales in the US and sales representation through partnerships in Europe. The company expects the filing for European approval to boost its technology export negotiations with multinational pharmaceutical companies.

As the US FDA decision date approaches, preparations for US sales are on track. Elevar has received marketing authorizations for the drug in all states that allow pre-approval sales. The company is now licensed in 43 US states, with the remaining seven states granting licenses post-approval in accordance with state regulations.

Production and marketing readiness is also accelerating. HLB has placed orders for rivoceranib and camrelizumab, and the new drugs are currently being manufactured at Hangseo Pharmaceutical's facility. Upon approval of the new drug, HLB plans to immediately initiate transportation and customs clearance procedures to supply the new drug to the entire US market as early as September 3 or earlier. To this end, the company is hiring marketing personnel and plans to subdivide the United States into seven regions and 59 zones for intensive sales procedures.

"With the US approval in sight, we are also accelerating the next step, which is to apply for European approval," said Han Yong-hae, CTO of HLB Group. "The approval of the new drug in the US, along with successive approvals in other parts of the world, will be a strong signal for rapid expansion into multiple other indications."

IT Times YoungHa Kim (yhkim@ittimes.com)

Source: IT Times https://www.ittimes.com/news/articleView.html?idxno=32601

EMA Grants Paediatric Investigation Plan Waiver for HLB's Rivoceranib - IT타임스