프리클리나, Preclina Inc.

30/04/2026

[좋은 약이 임상에서 사라지는 이유, 대부분 여기 있습니다]

수백억을 쏟아붓고 임상 2상에서 실패한다면?
전임상 단계에서 사용한 모델이 실제 인간 면역계와 달랐기 때문입니다.
Preclina의 PreHu™ 플랫폼은
바로 그 간극을 좁히기 위해 만들어졌습니다.

o Over 500 full-package in vivo preclinical studies
o More than $1,500 million in supported deals
o 20 years of expertise in immunology

임상 실패의 리스크, 미리 줄일 수 있습니다.
Preclina가 그 방법을 보여드립니다. 👇

12/03/2026

Meet us at BIO-Europe Spring 2026 | Booth #9 | March 23–25, Lisbon

Most immunology programs don't fail because the science is wrong.

They fail because the preclinical data wasn't predictive enough.

That's the gap Preclina was built to close — with the world's first commercialized humanized models for Psoriasis, Atopic Dermatitis, BILF, and DSS-induced Colitis. All peer-reviewed. All designed to give you data that actually translates.

20+ years in immunology. $600M+ in license-out deals. Multiple assets through to FDA approval.

If de-risking your pipeline is on your agenda in Lisbon, let's talk.
Contact Sungjong Kim at [email protected] to schedule a meeting in advance.

21/02/2026

FDA's Confirmative Evidence Standard: Why Preclinical Mechanism Matters More Than Ever

The regulatory landscape shifted with FDA's 2026 guidance on single pivotal trial approvals. The key requirement? Confirmative evidence that establishes not just efficacy, but biological plausibility and mechanistic understanding. For immunology-focused therapeutics, this creates both challenge and opportunity. Demonstrating that your therapeutic works now requires proving why it works at the immunological level. High-quality disease models and mechanistic validation have become regulatory assets, not just scientific data points.

As an immunology-specialized preclinical CRO, we've built our efficacy evaluation platform around this principle. Our rheumatoid arthritis and pulmonary fibrosis models demonstrate exceptional reproducibility with ICC (intraclass correlation coefficient) values exceeding 0.91, ensuring consistent, reliable results across studies. Each efficacy study includes comprehensive immune profiling—Th1/Th2/Th17/Treg responses, cytokine network analysis, and immune cell dynamics—generating the mechanistic depth that transforms standard efficacy data into confirmative evidence.

We validate mechanism of action through multi-parameter pathway analysis and demonstrate dose-dependent pharmacodynamic effects. This approach provides the biological inferences FDA explicitly requires: not just that your therapeutic works, but why it works and how that mechanism translates to clinical outcomes.

Sponsors can now build regulatory packages where high-quality preclinical efficacy and mechanism validation provides independent substantiation of clinical results—faster and more cost-effective than planning a second pivotal trial.

The pathway exists.
The regulatory framework supports it.
What matters now is the quality and depth of preclinical science supporting your clinical program.



FDA’s 2026 Shift in Clinical Trial Standards: [Preclina] Delivers the Confirmative Evidence.

Source:

This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.

20/01/2026

To the researcher still awake, anxious about the data.

When millions of dollars are on the line for an IND, "good enough" is never enough. We know the loneliness of that final decision. That is why Preclina aimed to deliver not just a report, but "Peace of Mind."

We didn't just conduct experiments; we delved deep into the Mechanism of Action (MoA), meticulously validating every spike so you can face regulators with absolute confidence.

Our obsession with your success has been recognized.
• ⭐2025 Best CRO Award⭐
• Trusted Partner of Daewoong Pharmaceutical, a global healthcare group with FDA-approved assets.

We successfully supported the efficacy evaluation for their new candidate (DWP213388) and various autoimmune models like MS.

"Preclina demonstrated high professionalism and responsibility in high-difficulty non-clinical efficacy evaluations, including autoimmune diseases, and left a strong impression as a reliable partner in terms of research outcomes." — Daewoong Pharmaceutical R&D Center

To further support you in sharing the weight of your challenges, Preclina is relocating to the Daegu Medical Innovation Complex this February. As a new "Global Outpost," we will offer a stable supply of Humanized Mouse models and integrated solutions.

Let Preclina help shoulder that burden. And remember to take care of yourself tonight; we will manage the proof.

Inquire about Intractable Immune Disease Models
• Website: https://www.preclina.com/
• Email: [email protected]

10/01/2026

[왜 염증을 잡아도 관절 부식은 멈추지 않을까요? RA 관절 속 ‘침묵의 파괴자’를 찾아서]

류마티스 관절염(RA) 환자들에게 가장 답답한 순간은 언제일까요? 아마 수치상 염증은 조절되는데, 관절의 구조적 파괴는 계속 진행될 때일 것입니다.

최근 Molecular Therapy(2025)에 게재된 연구는 그 해답을 ‘기질 기억(Stromal Memory)’에서 찾았습니다. 면역 세포가 진정되어도, 이미 공격적으로 변해버린 섬유아세포 유사 활막세포(FLS)가 관절에 남아 파괴를 지속하기 때문입니다.

📍 이번 연구의 핵심 포인트:

- 빌런의 정체: 단일 세포 RNA 시퀀싱(scRNA-seq)을 통해 미토콘드리아 기능 장애와 공격적인 특성을 가진 특정 'MIF-high' FLS 하위 집단을 식별했습니다.

- 새로운 차단 전략: 신규 재조합 단백질인 **sGal-9(Galectin-9)**가 CD44 차단제 역할을 수행합니다. 이는 MIF-CD44 축을 효과적으로 차단하여 FLS의 이동과 골 부식을 방지합니다.

- 검증된 효능: 콜라겐 유도 관절염(CIA) 모델에서 sGal-9은 엔브렐(Enbrel) 및 토파시티닙(Tofacitinib)과 대등한 치료 효능을 보이며 차세대 DMARD로서의 가능성을 입증했습니다.

저희 Preclina는 본 연구의 핵심인 인 비보(in vivo) 효능 시험을 수행하여 이 획기적인 연구 결과에 기여하게 된 것을 자랑스럽게 생각합니다. 연구자들은 Preclina의 최적화된 CIA 마우스 모델을 활용하여 '기질 기억'을 표적화하는 것이 강력한 치료 결과로 이어질 수 있음을 확인했습니다.

단순한 면역 억제를 넘어 관절의 '공격적 기억'을 지우는 기술, 이제 '약물 없는 관해(Drug-free remission)'가 더 이상 꿈이 아닐지도 모릅니다.

저희 프리클리나는 앞으로도 면역학 전문성을 바탕으로, 비임상과 임상을 잇는 Bridging Specialist로서 혁신 신약의 탄생을 가속화하겠습니다.

더 자세한 연구 내용이 궁금하시다면?
🔗 원문 보기: https://lnkd.in/eyeKnRqt

#류마티스관절염 #신약개발 #프리클리나 #비임상 #면역학

01/01/2026

Preclina Leads Global Commercialization of a Humanized Pulmonary Fibrosis Model

Preclina has become the first company to commercialize a humanized pulmonary fibrosis model (PreHu™-BILF), marking a significant milestone in translational preclinical research for fibrotic lung diseases.

This platform is built on human hematopoietic stem cell (HSC)–engrafted humanized mice, enabling stable reconstitution of a multi-lineage human immune system while overcoming a critical limitation of PBMC-based humanized models—pulmonary graft-versus-host disease (GvHD). By eliminating this confounding pathology, pulmonary fibrosis can be studied in a controlled and clinically relevant manner.

Pulmonary fibrosis remains a highly lethal disease with limited therapeutic options. Although the global market continues to expand, currently approved therapies such as nintedanib and pirfenidone primarily slow disease progression and are associated with safety and tolerability challenges. In parallel, human-specific biologics and cell-based therapies cannot be reliably evaluated in traditional animal models, often forcing drug developers to rely on expensive and ethically challenging non-human primate (NHP) studies.

Preclina’s humanized pulmonary fibrosis platform directly addresses these challenges. The model recapitulates key pathological hallmarks observed in patients, including immune cell infiltration and collagen accumulation, and demonstrates clinically aligned therapeutic responses to nintedanib, supporting its strong predictive value for human outcomes.

As regulatory frameworks increasingly emphasize human-relevant and alternative preclinical data, this platform provides a practical and scalable route to reduce dependence on NHP studies and to de-risk IND-enabling programs.

The scientific validation of this model has been reported in a Nature-branded journal, reinforcing its credibility. Building on this achievement, Preclina continues to expand its PreHu™ humanized mouse platform across pulmonary fibrosis, inflammatory bowel disease, and autoimmune indications, with the goal of supporting global partners developing next-generation therapeutics.

https://www.biospectator.com/news/view/27383
https://www.thebionews.net/news/articleView.html?idxno=21118
https://www.hitnews.co.kr/news/articleView.html?idxno=72441

19/06/2025

Discover the world’s first commercialized Humanized BILF [PreHu-BILF] model live at BIO 2025!

On Day 3 of the event, the Preclina booth ( # 3547) continues to draw strong interest and active engagement.

Inquiries are steadily coming in from companies developing next generation immunotherapies such as CAR-T therapies and bispecific antibodies.

Our Humanized BILF [PreHu-BILF] model anchors key conversations in fibrosis research and attracts rising demand from next-generation immunology drug developers, along with interest in our Humanized IBD [PreHu-DSS-iC] and GvHD [PreHu-GvHD, Acute] models.

Our platform for analyzing B cell depletion kinetics using CAR-T cells is also attracting significant attention.

■ Haven’t stopped by yet? Visit Booth #3547 and see for yourself.

Contact: [email protected]

https://preclina.com