Home Liver DiseasesLiver Cancer HLB’s FDA filing for rivoceranib getting delayed

HLB’s FDA filing for rivoceranib getting delayed

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HLB’s FDA filing for rivoceranib getting delayed

HLB Lifescience recently took over Mediforum Pharm to manufacture investigational anticancer drug rivoceranib, but its submission of the New Drug Application (NDA) to the FDA is being put off due to Covid-19.

On Sept. 1, Mediforum Pharm said that HLB Lifescience would participate in the third-party paid-in capital increase in a public filing.

HLB Chairman Jin Yang-gon said its submission of the New Drug Application for rivorceranib to the FDA might be delayed.

Following the plan, HLB Lifescience will acquire 3,128,871 shares of Mediforum Pharm for about 14 billion won ($12 million) and become the largest shareholder on Oct. 14. HLB will also take over 10 billion won worth convertible bonds.

Through the acquisition of Mediforum, HLB Lifescience aims to grow as a comprehensive pharmaceutical company capable of R&D, manufacturing, and distributing medicines, HLB Bio Group said. The takeover will give HLB the capacity to manufacture rivoceranib at Mediforum’s factory in Namyangju, Gyeonggi Province.

Mediforum Pharm plans to hold a shareholders’ meeting on Oct. 16 to change the company name and appoint directors.

On Sept. 29, the company said it planned to change its name to HLB Pharmaceutical.

Despite HLB’s push to speed up the production of rivoceranib, the key pipeline, its entry in the U.S. market is slower than expected.

At an investment forum in Seoul on Tuesday, HLB Chairman Jin Yang-gon said the company was having a problem earning detailed data for analysis, required for NDA, due to the Covid-19 pandemic.

“We’re facing delays in our plans to enter the U.S. market with rivoceranib as the third-line and fourth-line treatment for gastric cancer, and then as the first-line drug,” Jin said. However, the company was swiftly conducting trials in first-line liver cancer, colon cancer, and adenocarcinoma, he noted.

Another HLB official also said on the same day that the company’s initial goal to submit NDA within this year might be “put off a little bit more.”

Last year, HLB said it would apply for NDA for rivoceranib as the third-line and fourth-line gastric cancer treatment in the U.S. within 2020. At the end of 2019, the company said in a public disclosure that it completed the Pre-NDA meeting with the FDA.

After Jin’s comment, the stock price of HLB plummeted on Tuesday. HLB shares went up as high as 105,300 on Tuesday morning but slid to as low as 98,900 won at 2 p.m after Jin’s remarks. The stock closed at 100,200 won.

HLB Lifescience’s stock price also dropped 4.32 percent to close at 29,900 won on Tuesday.

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