HLB称rivoceranib FDA审批核心问题大多解决，集团股集体涨停

HLB group stocks surged straight to their daily limits en masse. The rally is interpreted as an explosion of previously suppressed investor sentiment, following the company's official statement that most of the core problems cited as reasons for the failed U.S. Food and Drug Administration (FDA) approval of its liver cancer drug "rivoceranib" have largely been resolved.
According to the Korea Exchange, HLB (028300) traded at 34,700 won on the KOSDAQ market on the afternoon of the 15th, up 8,000 won (29.96%) from the previous trading day, soaring to its price limit. The simultaneous surge of major affiliates within the group was equally fierce. HLB Innovation (024850) (30.00%), HLB Pharmaceutical (047920) (30.00%), and HLB Therapeutics (30.00%) all hit their upper limits. Following them, HLB Pep (29.97%), HLB Biostep (29.86%), and HLB Life Science (29.82%), among other group stocks listed on the KOSDAQ, halted trading at their ceiling prices. HLB Global (003580), listed on the securities market (KOSPI), also joined the upper-limit ranks, jumping 29.99% to 1,439 won. It was a remarkable spectacle of eight stocks from a single group locking in their upper limits side by side.
Investor sentiment moved on news that the active pharmaceutical ingredient manufacturing site issue, which had been the reason for the suspension of the liver cancer drug's U.S. approval, had entered a resolution phase. HLB's U.S. subsidiary Elevar Therapeutics announced that on the 14th it had received a letter from its partner, China's Hengrui Pharmaceuticals, confirming the closure of the FDA's current Good Manufacturing Practice (cGMP) inspection of the rivoceranib active pharmaceutical ingredient manufacturing facility. The FDA determined that Hengrui's manufacturing facility generally complies with current cGMP standards and ultimately classified the inspection result as "Voluntary Action Indicated (VAI)." A VAI classification means the inspection will no longer have a negative impact on the evaluation of new drug approval applications linked to that manufacturing facility.
Earlier, HLB had experienced extreme stock price volatility, plunging to its lower limit for two consecutive days on the 10th on news that it had received a Complete Response Letter (CRL) after rivoceranib's U.S. FDA approval fell through. At the time, one of the main reasons the FDA sent the CRL was precisely the result of the general cGMP inspection of Hengrui's active pharmaceutical ingredient manufacturing site. The market interpreted this final VAI classification notice as a signal that the biggest uncertainty in the new drug approval process, including the manufacturing facility issue pointed out by the FDA, had been resolved, responding with strong buying interest.
HLB plans to accelerate the drug approval process using this inspection closure as a springboard. A company official said the FDA had concluded its review of the camrelizumab-related supplementary requirements it had demanded in the previous CRL without any particular issues. The official also explained that with the active pharmaceutical ingredient manufacturing facility inspection also concluded as VAI, most of the core matters that had been problems in the new drug approval process had been resolved. "As the reasons for the CRL have effectively been resolved immediately, we plan to concentrate all our capabilities so that rivoceranib's new drug approval process can resume promptly through expedited official inquiries and close consultation with the FDA," an HLB official said.