[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 (July 13–16).

Celltrion

Receives

Approval for Phase 1 Clinical Trial of ‘CT-P68,’ a Tremfya Biosimilar

Celltrion(068270)announced on the 15th that it had obtained

approval

from the Ministry of Food and Drug Safety (MFDS) for its Investigational New Drug (IND) application to conduct a

Phase 1 clinical trial

of

‘CT-P68,’ a biosimilar of ‘Tremfya

(TREMFYA).’

Following this approval, Celltrion plans to begin clinical trials involving 258 healthy adults to conduct a comparative study demonstrating the safety and pharmacokinetic (PK) equivalence between the originator drug TREMFYA and CT-P68.

Tremfya is a treatment for autoimmune diseases that works by selectively inhibiting the interleukin (IL)-23 protein, which plays a role in triggering inflammation. It is prescribed for conditions such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, and its global sales are projected to reach approximately $5.155 billion (about 7.7325 trillion won) by 2025.

A Celltrion spokesperson stated, “The development of CT-P68 has further accelerated our efforts to secure new growth drivers in the field of autoimmune disease treatments,” adding, “We will do our utmost to proceed with clinical development without a hitch, continuously strengthen our competitiveness in the global market, and provide patients with a wider range of treatment options.”

Meanwhile, Celltrion plans to expand its portfolio of biosimilars from the current 11 to 18 by 2030. The company is developing a pipeline of follow-on products, including the Ocrevus biosimilar (CT-P53) and the Talz biosimilar (CT-P52) in the autoimmune disease treatment sector, as well as the Keytruda biosimilar (CT-P51) and the Dazalex biosimilar (CT-P44) in the oncology sector.

MedPacto, Inc. Submits Application for Australian Clinical Trial

of

Bone Disease Treatment ‘MP2021’

MedPacto, Inc.(235980)announced on the 15th that it has submitted a Phase 1 clinical trial protocol for ‘MP2021,’ a new drug candidate for bone and autoimmune diseases, to the Australian Human Research Ethics Committee (HREC).

MP2021 is a first-in-class drug candidate that targets “TM4SF19,” a cell membrane protein that induces the formation of multinucleated osteoclasts, which destroy bone. It is entering clinical trials with the aim of treating bone diseases—such as rheumatoid arthritis, osteoporosis, and bone metastases from cancer—as well as inflammatory autoimmune diseases.

MedPacto, Inc. confirmed MP2021’s excellent anti-inflammatory effects and its ability to improve damage to bone and cartilage tissue during the preclinical (animal testing) phase, and its safety was also demonstrated through toxicity assessments conducted in Europe.

MedPacto, Inc. selected Australia as the location for its Phase 1 clinical trial to rapidly secure data that meets global standards and to recruit patients with rare bone-related diseases. Clinical data from Australia is recognized by global regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, the incidence of certain degenerative bone diseases caused by osteoclasts is particularly high among Australians, and as a result, related research is actively underway in Australia.

Along with the start of this clinical trial for MP2021, MedPacto, Inc. is also developing another new modality (therapeutic approach) targeting “TM4SF19” with the goal of expanding its range of indications.

In addition to its existing fusion protein formulations, the company has recently partnered with a major Japanese pharmaceutical company to concurrently conduct preclinical research on a next-generation antibody-drug conjugate (ADC) drug candidate.

A MedPacto, Inc. official stated, “This application for the Phase 1 clinical trial of MP2021 in Australia signifies that MedPacto, Inc.’s new pipeline has entered full-scale clinical development,” adding, “Along with the clinical trial, we will successfully lead research on the convergence of next-generation antibody therapeutics and ADC technologies to demonstrate our competitiveness in the global market.”

G2GBIO, Inc. Unveils Phase 1 Data for Once-Monthly Dementia Treatment

#G2GBIO, Inc. announced on the 16th that it presented

Phase 1

multiple-dose (MAD) data for “GB-5001,” a

once-monthly

Alzheimer’s disease treatment currently in development, at the Alzheimer’s Association International Conference (AAIC 2026).

G2GBIO, Inc. explained that Professor Seon Woo-jeong, a member of Professor Hong Jang-hee’s research team from the Department of Clinical Pharmacology at Chungnam National University Hospital—which conducted the GB-5001 clinical trial—presented findings on safety, tolerability, steady-state attainment, and pharmacokinetic results during repeated dosing at the conference. The presentation drew significant interest and positive feedback from medical professionals, who recognized the drug as a long-acting dementia treatment option capable of improving medication adherence.

For patients with Alzheimer’s dementia, memory impairment makes it difficult to take medication at scheduled times, and since more than 60–70% of patients are known to have dysphagia, there is high demand in the medical field for long-acting injectable formulations.

Previously, in a Phase 1 single-dose (SAD) clinical trial conducted on healthy adults, data showed that drug release was sustained for up to 99 days. Additionally, blood drug concentrations were found to be dose-proportional following single doses of 70 mg, 140 mg, and 280 mg. Population pharmacokinetic simulation results showed that the 140 mg dose exhibited steady-state pharmacokinetics similar to those of the 5 mg dose of Aricept (the comparator drug), while the 280 mg dose showed steady-state pharmacokinetics similar to those of the 10 mg dose of Aricept.

Seol Eun-young, Director of the G2GBIO, Inc. Research Institute, stated, “Since donepezil is a standard treatment used by a wide range of patients due to its excellent accessibility and affordability, the importance of long-acting formulations in the market is expected to grow even further.”