[비즈한국] It has been belatedly confirmed that a domestic pharmaceutical company’s challenge to become the second Korean recombinant hyaluronidase following Alteogen196170's 'Tergase' has been thwarted due to safety concerns, drawing significant attention.
According to the minutes of the Central Pharmaceutical Affairs Deliberation Committee (CPADC) under the Ministry of Food and Drug Safety (MFDS) released on the 10th, the MFDS did not deem the recombinant drug application filed by Company A as eligible for item approval. Reviewing the meeting minutes at the time, 9 out of 11 committee members present opposed the approval.
Some committee members suggested minority opinions, such as restricting approval only to dermatology or granting priority approval considering it is a domestically developed drug, leaving the decision of use in clinical practice to medical professionals. However, the majority of the committee judged that "as clinical trial results confirmed adverse reactions of skin discoloration at the injection site in a vast majority of patients, and since the cause has not been clearly identified, item approval is inappropriate."
One member pointed out, "With alternative drugs that have already proven their safety existing in the market, there is insufficient justification to accept risks for which the causes are not understood. We cannot guarantee safety upon repeated administration, and considering the nature of the formulation as an enhancer of other drug absorption, risks during combination therapy cannot be ruled out."
Another member also stated, "As hyaluronidase is a drug that can be used for treating filler side effects, an incidence rate of over 90% for skin discoloration is clinically unsuitable, even if the discoloration disappears after two weeks."
The industry has focused on identifying the unfortunate protagonist whose item approval was rejected. Currently, there are very few companies developing recombinant hyaluronidase in Korea. Alteogen received item approval from the MFDS and launched its product in July 2024, while Amicogen092040 only secured non-clinical trial results on the 5th. Another competitor, Huons Lab, applied for item approval for 'Hydaizyme Injection' to the MFDS last December, and the review is currently ongoing.
Within the industry, Company A is speculated to be the likely candidate. It is known that Company A had previously received export-only item approval and was preparing an application for domestic market launch.
Bizhankook inquired with Company A for verification, but a representative from Company A only stated, "We have nothing to comment on." This is in contrast to the industry practice where biotech companies actively publicize their new drug development stages or the fact that they have applied for approval.