Shares of HLB (028300) and its affiliates rallied on news that the company plans to refile for U.S. approval of rivoceranib, its liver cancer drug.
HLB traded at 47,325 won as of 3:17 p.m. on the 6th, up 17% from the previous session.
HLB Pharmaceutical (047920) hit its daily upside limit at 13,010 won, a gain of 29.97%. HLB Life Science (067630) rose 25.17% to 4,475 won, as group shares advanced together.
The rally came after the U.S. Food and Drug Administration closed out a routine inspection of the manufacturing site for rivoceranib's finished drug product with a "voluntary action indicated" (VAI) classification, easing uncertainty over the facility's role in the approval process. Expectations for the refiling grew in the market, lifting HLB group shares across the board.
Elevar Therapeutics, HLB's U.S. subsidiary, received the FDA's inspection closeout letter on the 3rd from its partner, China's Hengrui Pharmaceuticals, HLB said. The FDA classified its routine current good manufacturing practice (cGMP) inspection of the finished-drug site for rivoceranib as VAI.
A VAI classification is issued when an FDA inspection identifies some observations but the agency determines the company can correct them voluntarily, requiring no formal regulatory action. Based on the outcome, HLB plans to finalize the materials needed to resubmit its new drug application (NDA) for rivoceranib and to file again with the FDA together with Hengrui.
Rivoceranib is being developed as a first-line liver cancer treatment in combination with Hengrui's immuno-oncology drug camrelizumab. HLB had previously submitted an NDA to the FDA but received a third complete response letter (CRL) in July.
At the time, a general cGMP inspection of Hengrui's active pharmaceutical ingredient plant was a key variable. Because rivoceranib is also produced at that site, concerns were raised that observations at the facility could affect the approval. With the VAI finding in this inspection, much of the uncertainty surrounding the manufacturing site has been resolved, HLB said.
