[Edaily Reporter Kim Jinsoo ] Here are the clinical trial and product approval updates that garnered attention in the domestic pharmaceutical and biotech industry this week (June 22–26).

Cellid Co., Ltd. Fails to Meet Primary Endpoint in Phase 3 COVID-19 Vaccine Trial

Cellid Co., Ltd.(299660)announced on the 26th that it failed to demonstrate non-inferiority

for

the primary immunogenicity endpoint in the global Phase 3 clinical trial of its COVID-19 vaccine candidate, “AdCLD-CoV19-1 OMI.”

This clinical trial was conducted to demonstrate immunogenicity non-inferiority by administering either AdCLD-CoV19-1 OMI or Pfizer’s COVID-19 vaccine “Comirnaty 2-dose.” The study involved 4,000 adults aged 19 and older.

The primary endpoint was “evaluation of immunogenicity through the confirmation of neutralizing antibodies and seroconversion rates.” The seroconversion rate (SRR)—the proportion of subjects whose neutralizing antibody titers increased by at least fourfold compared to baseline—was 17.12% (139 out of 812) in the test group and 42.64% (171 out of 401) in the control group. The difference between the test group and the control group was –25.51%. Since this value is greater than the –10% non-inferiority margin specified in the clinical trial protocol, the test group failed to demonstrate non-inferiority compared to the control group.

However, in terms of safety, no serious adverse drug reactions were reported following vaccination with AdCLD-CoV19-1 OMI, and the vaccine was confirmed to meet the predicted safety profile.

Cellid Co., Ltd. stated, “Based on the safety results obtained, we plan to continue developing a COVID-19 vaccine and are reviewing various additional clinical trial designs and strategies to supplement the immunogenicity results.”

Shaperon Inc. Fails to Demonstrate Statistical Significance in NuGel Phase 2b Trial

Shaperon Inc.(378800)announced on the 24th that it failed to meet the primary endpoint in the global Phase 2b clinical trial of “NuGel,” an atopic dermatitis treatment currently under development.

NuGel is a non-steroidal topical treatment for atopic dermatitis developed using Shaperon Inc.’s GPCR19-based inflammatory complex modulation platform. Shaperon Inc. conducted a Phase 2 clinical trial in patients with mild to moderate atopic dermatitis, setting the degree of improvement in the EASI (Eczema Severity Assessment Index) at Week 8 compared to the placebo group as the primary endpoint.

According to the clinical results, the difference in the primary endpoint between the Nugel treatment group and the placebo group did not meet the pre-specified statistical significance level (two-sided 0.025).

Consequently, Shaperon Inc. plans to conduct additional analyses with a contract research organization (CRO) by September and establish a future development strategy in consultation with regulatory authorities and external experts.

Shaperon Inc. stated, “During the Phase 2b clinical trial, we provided patients with moisturizers for unrestricted use, which may have diluted the difference in efficacy,” adding, “We are also considering the introduction of a quasi-registrational study to review future approval strategies and the possibility of advancing to Phase 3 clinical trials.”

Medy-Tox Inc. Obtains NMPA Marketing Authorization

for

Hyaluronic Acid Filler

Medy-Tox Inc.(086900)announced on the 25th that it has

obtained marketing authorization

from

China’s

National Medical Products Administration (NMPA) for its hyaluronic acid filler “Neuramis Deep Lidocaine.”

With this approval, “Nuramis” is scheduled to be launched in China under the brand name “Fillux Deep Lidocaine,” marking the official start of Medy-Tox Inc.’s push into the Chinese aesthetic market.

In late 2024, Medy-Tox Inc. signed separate exclusive distribution agreements with Hainan Stou Investment Co., Ltd. in China for the export of Medy-Tox Inc.’s hyaluronic acid (HA) filler “Nuramis” and its affiliate NuMeco’s next-generation toxin product “Newlux,” granting the company local distribution rights for a period of five years. Hainan Stou plans to maximize the local marketing and distribution capabilities of “Neuramis” in China through collaboration with Sinopharm, China’s largest pharmaceutical company.

A Medy-Tox Inc. official stated, “China is a key hub that accounts for a significant portion of the Asian aesthetic market, and obtaining product approval for ‘Nuramis’ will serve as an opportunity to further strengthen Medy-Tox Inc.’s position as a global filler brand, going beyond simply creating new markets,” adding “We plan to proceed with the approval process for adding to our filler lineup as scheduled during the fourth quarter of this year and will enhance synergies in our China market strategy through an integrated portfolio of botulinum toxin products and hyaluronic acid fillers,” the spokesperson added.