HLB Chairman Jin Yang-gon announces the FDA’s notification of a CRL for its combination therapy of Rivoceranib and Camrelizumab on the company’s official YouTube channel on May 17, 2024
HLB Co. and its affiliate stocks tumbled on Friday after the South Korean biotech group’s highly anticipated new cancer treatment Rivoceranib has failed to pass the first screening test of the US Food and Drug Administration (FDA).
Korea’s secondary Kosdaq market-listed HLB plummeted by the daily limit of 30% to 67,100 won ($49.41), and shares of its all seven Kosdaq-listed units – HLB Therapeutics Co., HLB Pharmaceutical Co., HLB Life Science Co., HLB PanaGene Co., HLB BioStep Co., HLB Innovation Co. and HLB Global Co. – also nosedived 30%.
The HLB panic caused HLB to lose more than 3 trillion won in market capitalization, about one-fourth of its previous value, as well as more than 5 trillion won in total market cap when including seven other HLB companies, in one day. The market rout weighed down on the broad Kosdaq market, closing down 1.7% on the day.
Investors dumped HLB Group stocks after HLB Chairman Jin Yang-gon announced on the company’s official YouTube channel on Friday morning that the company received a complete response letter (CRL) from the FDA earlier the day about its new drug application (NDA) for the combination therapy of Rivoceranib and Camrelizumab.
HLB Chairman Jin Yang-gon holds a press conference to explain the CRL on May 17, 2024
Rivoceranib is a new drug developed by the Korean biotech company to treat liver cancer, and Camrelizumab is an anti-cancer treatment developed by Jiangsu Hengrui, HLB’s Chinese partner.
NOT OUTRIGHT REJECTION
The FAD issues a CRL to notify disapproval of a new drug in its present form after initial reviews. But this is not an outright rejection, explained Jin, adding that the company will resubmit a new NDA as soon as possible after addressing the deficiencies in the previous application.
Jin attributed the FDA’s rejection mainly to issues with Camrelizumab, such as the Chinese drug’s manufacturing and quality control processes, which are not the concern of Rivoceranib.
“I have not had the chance to check the CRL the FDA sent separately to Jiangsu,” said Jin, adding that the Chinese partner’s fix of its earlier problems might have failed to meet the FDA’s requirements.
Another issue the FDA has raised was its incomplete medical due diligence of the drugs’ clinical trials due to ongoing wars between Russia and Ukraine.
The FDA attempted to visit hospitals in those two countries where a high proportion of Caucasian patients went through clinical trials to confirm the efficacy of their drugs, but could not go due to travel bans, Jin explained.
UNCERTAINTIES REMAIN DESPITE CONFIDENCE
Jin expects Jiangsu Hengrui will swiftly address the problems, citing the Chinese pharmaceutical company’s proven track record of developing 17 globally approved medicines.
HLB factory
“There is nothing HLB has to do now because there is no direct issue with Rivoceranic,” said Jin. “We will address the issues promptly with Jiangsu Hengrui through close consultation.”
The two partners applied for an NDA to use Rivoceranib and Camrelizumab as a combination therapy to treat liver cancer.
In October last year, the Korean drug developer’s US subsidiary Elevar Therapeutics acquired global rights, excluding Korea and China, for Camrelizumab to develop and market the combination therapy.
However, it remains to be seen whether their resubmission will get the FDA nod.
In April 2018, Celltrion Inc., a Korean biosimilar giant, received a CRL from the FDA for its breast cancer treatment Herzuma. After its prompt resubmission with addressed issues, the company got the green light in December.
This underscores the importance of a CRL response timeline.
If HLB fails to resubmit an NDA in one year after the reception of a CRL, or its solutions fail to meet the FDA’s requirements, its liver cancer treatment will be rejected permanently.
By Byeong-Hun Yang and Yoo-Rim Kim
hun@hankyung.com
Sookyung Seo edited this article.
