[CBC News] HLB has initiated follow-up procedures for resubmitting the U.S. marketing application for its liver cancer drug Rivoceranib, but its stock price hit the lower limit for two consecutive days. The market reaction is interpreted as heavily weighing the fact that a 'manufacturing facility issue,' rather than clinical data, blocked approval once again, and that even the timing of the resubmission remains uncertain.

On the KOSDAQ market on the 13th, HLB finished trading at 25,650 won, having fallen by the daily price limit compared to the previous trading day. On the 10th, it also closed at 36,600 won, down 29.89%, marking two consecutive days of hitting the lower limit. Compared to the closing price of 52,200 won on the 9th, the stock has plunged approximately 50.9% in just two days. With expectations for U.S. approval already largely reflected in the company's valuation, news of receiving a third Complete Response Letter (CRL) triggered a flood of sell-offs.

■ Third CRL, Cause Once Again 'Manufacturing Facility'

On the 10th, HLB announced in a regulatory filing that its U.S. subsidiary Elevar Therapeutics received a CRL from the FDA regarding the New Drug Application (NDA) for Rivoceranib. This CRL was issued after deficiencies were identified during an inspection of the Chinese manufacturing facility operated by Hengrui Pharma, which is listed in the drug's approval documents, for compliance with Good Manufacturing Practice (cGMP) standards. The FDA conveyed its position that it cannot grant approval until the deficiencies at the facility are resolved and compliance with cGMP standards is confirmed. Even after the manufacturing facility issues are resolved, a re-inspection may be conducted as necessary, and the approval process can only proceed if the facility passes this inspection.

The company clarified that this CRL did not include any issues regarding the clinical efficacy and safety data or requests for additional clinical trials. However, this only means that the clinical data of the drug itself was not a direct cause for the supplement request, and it should not be over-interpreted as meaning U.S. approval is imminent. This is because completing the corrective actions for the manufacturing facility and undergoing the FDA confirmation process still remain.

■ Resubmission Timing Undetermined… 'Expressing Intent is Different from Actual Submission'

HLB is currently in the process of obtaining the Form 483 issued to the Hengrui Pharma manufacturing facility to analyze the detailed deficiencies. The company has also requested the response letter and corrective and preventive action plan submitted by Hengrui Pharma to the FDA. HLB plans to determine the direction of supplements and the resubmission schedule based on these documents. Elevar intends to request a procedure to confirm the specific reasons following the FDA's decision, as well as a pre-approval inspection.

However, a distinction must be made between the company expressing its intent to resubmit and actually re-submitting the approval documents to the FDA. The company is currently at the stage of analyzing the deficiencies and formulating a response plan, so the date for resubmission has not yet been finalized.

■ Repeating Manufacturing Facility Issues… Growing Uncertainty

Rivoceranib is being developed as a first-line treatment for liver cancer in combination with Camrelizumab, an immuno-oncology drug from Hengrui Pharma. HLB submitted the NDA to the FDA in 2023, but this marks the third CRL following the first one in May 2024 and the second in March 2025. The fact that manufacturing facility issues have repeatedly caused approval delays across three consecutive instances is a key factor exacerbating market uncertainty. Future timelines are largely dependent on the corrective actions taken at the Hengrui Pharma manufacturing site—which is difficult for HLB to directly control—as well as the FDA's judgment.

The benchmark for a stock price recovery is likely to be concrete improvements at the manufacturing facility, rather than a simple announcement of a resubmission plan. Only when the specific contents of the Form 483 deficiencies, the completion timeline for Hengrui Pharma's corrective actions, the results of consultations with the FDA, and the necessity of a re-inspection are confirmed will it be possible to assess how far the U.S. approval process can proceed. While HLB has expressed its intention to push for a resubmission at the earliest possible date, a resubmission does not immediately equate to approval. From an investor's perspective, it is necessary to verify whether the manufacturing and quality control standards demanded by the FDA have been actually met, independent of the company's own explanations.