Korean pharmas to make strong presence at BIO USA

promotes CDMO services and innovative new drug pipelines

to be held in Boston, USA for four days starting on the 16th

Wuxi will not participate... Korean CDMOs plan to actively promote their technological capabilities and manufacturing capacity

Innovative new anticancer drugs such as bispecific antibodies, targeted anticancer drugs, and immune-oncology drugs are also waiting in the wings

The domestic pharmaceutical and biotech industry will showcase its contract development and manufacturing (CDMO) and new drug candidate technologies at Bio USA, the world's largest biotech convention.

 

Various Korean companies have also set out to participate in BIO USA 2025, which will be held in Boston, USA, for four days from the 16th of this month, to expand partnerships and discuss global technology exports.

 

Samsung Biologics, Lotte Biologics, Celltrion, and Kolon Life Science plan to showcase their manufacturing capabilities in the CDMO sector.

 

With China's largest CDMO firm, WuXi Biologics, deciding not to participate for the second consecutive year, domestic pharmaceutical and biotech companies are expected to reap reflective benefits.

 

Additionally, CareGen, Aptamer Sciences, and Pharos iBio will promote their innovative new drugs.

 

CDMO companies promote manufacturing capacity again this year Samsung BioLogics plans to expand partnerships with multinational pharmaceutical companies based on its world-class manufacturing facilities.

 

With the start of operations at its fifth plant, the company has secured a total manufacturing capacity of 780,000 liters per year and is accelerating the diversification of its CDMO order portfolio.

 

Lotte Biologics plans to actively target the North American CDMO market leveraging its Syracuse plant in the US.

 

At this year's BIO USA, the company is expected to not only attract new partners but also discuss contract renewals with existing partners.

 

Industry observers predict that Lotte Biologics' plant, which has completed certification under the US Food and Drug Administration's (FDA) current Good Manufacturing Practice (cGMP) standards, will begin securing orders in earnest starting in the second half of this year.

 

Celltrion is shifting its strategy from focusing on its products to expanding its CDMO business.

 

The company is emphasizing its technological capabilities to drive CMO demand in Europe and is expected to highlight its customized biopharmaceutical development collaboration model.

 

These three companies are particularly focused on antibody-drug conjugates (ADCs).

 

Samsung BioLogics, and Samsung Bioepis, have invested in ADC development companies Aimed Bio, Swiss Araris Biotech, and U.S.-based BrickBio through the Samsung Life Science Fund.

 

They are also continuing to invest in companies developing new drug candidates, not just manufacturing facilities.

 

Lotte Biologics, which recently signed an ADC manufacturing contract with an Asian materials company, has also invested in new ADC drug development companies such as Pinot Bio and Kanap Therapeutics.

 

Celltrion is directly involved in new ADC drug development.

 

Earlier this year, Celltrion disclosed the preclinical results of its ADC candidate 'CT-P71.' CT-P71 utilizes the ADC platform of Pinot Bio, a domestic ADC development company.

 

CT-P71 is an ADC therapy targeting bladder cancer and other various solid tumors.

 

The candidate specifically targets Nectin-4, a cell surface protein overexpressed in various solid tumors such as urothelial cancer and breast cancer.

 

Additionally, Celltrion has received approval for the Phase I clinical trial of CT-P70.

 

CT-P70 is an ADC therapy candidate for solid tumors such as non-small cell lung cancer.

 

CT-P70 targets 'c-MET,' which prompts tumor growth when activated in cancer cells.

 

BIO USA 2024 Korea Pavillion (Pic=KoreaBIO)

Technology exports of new drug candidates a success?...

 

domestic companies discuss partnerships with global companies At the event, Kolon Life Science will discuss technology export partnerships with global pharmaceutical companies regarding its pipeline of new drugs under development.

 

The main pipelines to be introduced are ▲ KLS-2031, a gene therapy for neuropathic pain, and ▲ KLS-3021, an anti-cancer gene therapy.

 

KLS-2031 has completed Phase 1/2a clinical trials in the US, and KLS-3021 is in preclinical development, with preparations for global technology export now in full swing.

 

KLS-2031 is designed to carry three complementary therapeutic genes using recombinant adeno-associated virus (rAAV) and has demonstrated its safety and tolerability in a Phase I/2a clinical trial in patients with lumbosacral radiculopathy (LSR).

 

KLS-3021 is a solid tumor therapy that incorporates three therapeutic genes into a vaccinia virus-based platform with enhanced cancer cell selectivity.

 

The candidate drug has demonstrated safety and efficacy in preclinical studies.

 

CareGen has been continuously participating in BIO USA with a standalone booth every year since 2019.

 

At this year’s event, CareGen plans to focus on introducing its main core products, including Korglutide, MyoKi, and ProGsterol, which have been commercialized based on its proprietary peptide platform technology.

 

With growing global demand for its products, Caregen aims to use this exhibition as a platform to strengthen partnerships with international distributors and pharma companies, focusing on expanding indications and diversifying its market presence.

 

CareGen also plans to showcase its major new drug pipelines, including CG-P5, a treatment for wet age-related macular degeneration, and CG-T1, a treatment for dry eye syndrome.

 

CG-P5 is being developed as a non-invasive eye drop formulation, while CG-T1 is a dry eye treatment based on a unique mechanism of action applicable to a wide range of ophthalmic conditions.

 

Aptamer Sciences plans to use BIO USA as an opportunity to initiate strategic collaboration discussions with leading ADC-focused companies in North America, Europe, and China.

 

The company aims to explore concrete partnership opportunities in joint development, clinical collaboration, expansion of new indications, and technology transfers.

 

Aptamer Sciences owns its proprietary ADC platform technology, ApDC (Aptamer Drug Conjugate).

 

ApDC is a next-generation precision drug delivery platform that uses aptamers instead of antibodies and incorporates Aptamer Sciences’ proprietary modified nucleic acid technology.

 

According to the company, anticancer drugs developed using the ApDC platform demonstrate rapid intracellular internalization and fast onset of action after binding to target cell surfaces, excellent tumor tissue penetration, swift tumor targeting in animal models post-administration, and superior antitumor efficacy—validated through comparative studies with existing ADC drugs.

 

In addition to cytotoxic drugs, Aptamer Sciences is currently expanding its platform to enable conjugation with various other therapeutic modalities such as radioisotopes, targeted protein degraders (TPDs), and immunotherapies.

 

At this year’s event, Pharos iBio will showcase research progress on its next-generation drug candidates—PHI-101 for acute myeloid leukemia (AML) and PHI-501 for refractory solid tumors—while actively seeking global partnership opportunities.

 

With both key pipelines backed by strong clinical data and advanced development stages, the company expects this conference to serve as a significant stepping stone toward global market entry.

 

PHI-101 is an innovative anticancer drug candidate discovered through Pharos iBio’s proprietary AI-driven drug discovery platform, Chemiverse.

 

It is a next-generation AML treatment designed to target a wide range of resistance mutations in the FLT3 protein.

 

The drug has demonstrated high therapeutic efficacy in global Phase 1 clinical trials and has shown favorable cardiac safety in preclinical studies through AI-based toxicity prediction, offering itself a new treatment option to patients with relapsed or refractory AML.

 

PHI-501, which is entering Phase 1 clinical trials, is a treatment candidate for hard-to-treat solid tumors.

 

In recent preclinical studies, it showed promising therapeutic effects against difficult-to-treat cancers such as refractory lung cancer, malignant melanoma, and colorectal cancer with limited treatment options.

 

Notably, PHI-501 demonstrated significant efficacy in solid tumors with BRAF, KRAS, and NRAS mutations.

 

In March, Pharos iBio submitted an IND (Investigational New Drug) application for PHI-501 to Korea’s Ministry of Food and Drug Safety, signaling its full-scale entry into the high-value KRW 40 trillion global solid anticancer drug market.