[비즈니스포스트] Jin Yang-gon, Chairman of HLB Group, has reached the final hurdle of achieving results with the liver cancer treatment drug Rivoceranib.
Since the US Food and Drug Administration (FDA)’s new drug approval process was completed without any particular problems, all that remains is to wait for approval.
Jinyanggon commercialization speed battle” height=”150″ src=” width=”300″ /> ▲ According to HLB on the 26th, the final review of Rivoceranib was completed without any issues, so approval is expected as early as the end of April. . The photo shows Jin Yang-gon, Chairman of HLB Group.
According to Business Post coverage on the 26th, HLB expects that the U.S. FDA will approve riboceranib combination therapy as early as the end of April.
Since HLB applied for approval under the Prescription Drug Applicant Fee Act (PDUFA), the U.S. FDA must notify the company of whether the new drug will be approved by May 16, but approval may come sooner than this deadline.
This appears to be due to the fact that no special issues came up during the final review meeting with the FDA on the 25th by the US subsidiary, Eleva.
The final review meeting is an event where the FDA points out deficiencies in the data submitted by the company in the final stage of review and requests supplementation if necessary. This is because there were no issues raised in the final review that could affect approval.
In a phone call with Business Post, an HLB official said, “The fact that no problems were raised in the final review following the interim review is a very encouraging result in terms of whether or not to approve a new drug.” He added, “We expect to be able to obtain approval internally without any problems.” .
In addition, the FDA usually holds an advisory panel meeting, which is a hearing to listen to the opinions of external experts on problems discovered during the document review process, but this hearing was completely omitted in the HLB new drug approval process.
Accordingly, Chairman Jin is expected to accelerate preparations for commercialization in the U.S., which have been in progress since early this year.
It is expected that it will quickly become established in the United States, given that large U.S. PBMs (prescription benefit management companies) are already showing great interest in listing the two drugs for insurance benefits.
HLB’s U.S. subsidiary, Elevar, is prioritizing negotiations with large PBMs after new drug approval and is also proceeding with the process to be listed as a preferred therapy in the NCCN guidelines, which specialists most often refer to when prescribing.
Jinyanggon commercialization speed battle” height=”150″ src=” width=”300″ />
In addition, Chairman Jin went on a business trip to the United States in January of this year and carefully reviewed the preliminary work for direct local sales.
At that time, we inspected the entire commercialization process by not only meeting with local specialists but also recruiting marketing experts.
Chairman Jin has planned to launch Rivoceranib in September of this year by preparing for sales early on, as approval for Rivoceranib is expected on May 16th at the latest.
This is considerably faster than when GC Pharma received approval for the blood product Alliglo in Korea in December of last year and began selling it in the United States in July of this year.
Even GC Green Cross has done the groundwork for sales, including reorganizing the corporation, before receiving permission.
Chairman Jin appears to have begun commercialization as quickly as possible, seeing results for the first time in about 16 years since acquiring LSK BioPartners, the developer of riboceranib, in 2008.
In fact, since the long development period and enormous clinical costs were incurred even after the acquisition of the Rivoceranib developer, it is interpreted that the company quickly recovered the costs and accelerated the development of the follow-up pipeline.
In fact, HLB Group is actively investing to secure follow-up candidates since the possibility of Rivoceranib’s approval has increased.
For example, after making an investment of 1 billion won in Arteon Bio in February, the company made another strategic investment of 1 billion won in Neuroventi, a bio venture specializing in brain diseases, in March. Reporter Jang Eun-pa
