Pipeline

Drug Development

Shaperon designs next-generation immunotherapies using Inflammasome inhibitors, NanoMaps, and AI.

  • Drug Development
  • Pipeline

Pipeline

Pipeline

Inflammasome Inhibitor

  • Development
  • Optimization
  • Preclinical
  • Ph1
  • Ph2

Dermatology

    • GPCR19 Agonist

      NuGel

      Atopic Dermatitis

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    NuGel

    Blocks the root cause of atopic dermatitis to restore skin health and reduce daily discomfort.

    • Competitiveness

      Demonstrated both superior efficacy and safety in clinical studies, while offering convenient topical application suitable for long-term management of chronic atopic dermatitis.

    • Market Outlook

      The global atopic dermatitis treatment market is projected to grow from approximately USD 13 billion in 2024 to USD 33 billion by 2030.

    • Unmet Needs

      Current therapies are often limited by severe side effects or suboptimal efficacy relative to cost, making them unsuitable for long-term use. There remains a strong need for new, safer, and more effective treatment options.

    • Development Status

      Completed a Phase IIa clinical trial in Korea and successfully finished Part 1 of the U.S. Phase IIb study under FDA approval. The global Phase IIb Part 2 trial is currently in progress.

    • GPCR19 Agonist

      NuDifin

      Diabetic foot ulcer

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    NuDifin

    Calms wound inflammation and accelerates the regeneration of new, healthy tissue.

    • Competitive Edge

      It promotes faster wound healing compared with existing therapies, shows superior collagen and epidermal regeneration, and can be used safely over the long term in patients with chronic conditions such as diabetes.

    • Market Opportunity

      The global market for diabetic foot ulcer treatments is projected to grow from approximately USD 8.8 billion in 2024 to USD 14.4 billion by 2032.

    • Unmet Need

      Current treatment options often show limited efficacy, frequent recurrence, and side effects, leading to delayed healing in many patients. There is a strong need for safer therapies that can restore inflammatory balance while accelerating tissue regeneration.

    • Development Status

      In preclinical studies, NuDifin has demonstrated wound contraction, de novo collagen formation, and complete epidermal restoration. Its safety profile has been confirmed in a Phase 1 clinical trial, and a Phase 2 clinical trial is currently in planning.

    • Next-generation
      GPCR19 Agonist

      NuRalin

      Atopic Dermatitis
      (Topical)

    • Next-generation
      GPCR19 Agonist

      NuAreatin

      Alopecia Areata

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    NuAreatin

    Restores immune balance to reactivate hair follicles and bring new hope to areas of hair loss.

    • Competitiveness

      Normalizes scalp immune homeostasis and promotes follicle regeneration, enabling long-term treatment durability superior to existing therapies.

    • Market Outlook

      The global alopecia areata treatment market is projected to grow from approximately USD 3.8 billion in 2025 to USD 6.9 billion by 2034.

    • Unmet Needs

      Current therapies are limited by side effects, cost, and high relapse rates, leaving major treatment gaps for severe and pediatric patients. Given the autoimmune nature of alopecia areata, there is a strong need for a long-term and safe therapy that focuses on restoring immune balance rather than broad immunosuppression.

    • Development Status

      NuAreatin was discovered using Shaperon’s AI-driven AIDEN platform and has demonstrated immunomodulatory efficacy in preclinical studies. Additional non-clinical evaluations are underway in preparation for clinical development.

Neurological Disorders

    • GPCR19 Agonist

      NuCerin

      Alzheimer’s Disease

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    NuCerin

    A smart little pill designed to reduce neuroinflammation and protect precious memories.

    • Competitiveness

      An oral therapy that simultaneously targets amyloid-β (Aβ) and neuroinflammation, the two major causes of Alzheimer’s disease. It can be administered safely for long-term use without risks of brain edema or hemorrhage.

    • Market Outlook

      The global Alzheimer’s disease treatment market is projected to grow from approximately USD 6.4 billion in 2025 to USD 31 billion by 2034.

    • Unmet Needs

      There is a high demand for a convenient and well-tolerated therapy with fewer side effects and proven efficacy not only in delaying but also in improving cognitive symptoms compared with existing treatments.

    • Development Status

      Efficacy has been validated in preclinical studies. Phase I clinical trial Part A has been completed in Korea, and Part B is currently in progress.

    • GPCR19 Agonist

      NuSepin

      CVA

Respiratory Diseases

    • GPCR19 Agonist

      NuSepin

      COVID-19

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    NuSepin

    Rapidly alleviates excessive systemic inflammation in severe patients, accelerating recovery to everyday life.

    • Competitiveness

      Effectively controls broad-spectrum inflammatory responses, enabling safe use in high-risk patients regardless of COVID-19 viral variants. Its mechanism allows potential expansion to systemic inflammatory diseases such as sepsis and ischemic stroke.

    • Market Outlook

      The global market for SIRS therapeutics is projected to grow from approximately USD 1.4 billion in 2025 to USD 3.0 billion by 2035.

    • Unmet Needs

      Current therapies for severe COVID-19 remain limited due to the lack of effective anti-inflammatory agents resilient to viral mutations and the serious side effects of existing drugs.

    • Development Status

      Received global Phase IIb/III IND approval and completed a global Phase IIb clinical trial for severe COVID-19 patients with support from the Korea Drug Development Fund (KDDF). Indication expansion is currently underway for the treatment of systemic inflammatory response syndrome (SIRS) and ischemic stroke.

    • GPCR19 Agonist

      NuPulin

      IPF

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    NuPulin

    Breaking the vicious cycle of inflammation-driven pulmonary fibrosis to help you breathe comfortably again.

    • Competitiveness

      NuPulin delivers efficacy comparable to existing therapies, while safely improving both pulmonary fibrosis and systemic inflammation without gastrointestinal adverse effects or hepatotoxicity.

    • Market Outlook

      The global idiopathic pulmonary fibrosis (IPF) treatment market is projected to grow from approximately USD 3.7 billion in 2024 to USD 5.5 billion by 2030.

    • Unmet Need

      Current therapies have limited ability to reverse advanced fibrosis and are often associated with a high risk of liver toxicity. Patients and physicians need new treatment options that can safely and effectively control fibrosis.

    • Development Status

      NuPulin has demonstrated efficacy in preclinical studies. It has completed Part A of a Phase 1 clinical trial in Korea, and Part B is currently in progress.

NanoMab

  • Development
  • Optimization
  • Preclinical
  • Ph1
  • Ph2

Hematologic Malignancy

    • Anti-PD-L1*CD47

      Papiliximab

      AML

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    Papiliximab

    A new standard in leukemia treatment — achieving both reduced anemia risk and enhanced anti-tumor efficacy.

    • Competitiveness

      Papiliximab is a NanoMab-based bispecific antibody that simultaneously blocks PD-L1 and CD47, delivering superior anti-cancer activity without the anemia and other adverse effects commonly seen with conventional antibody therapies.

    • Market Outlook

      The global bispecific antibody market is projected to grow from USD 18 billion in 2025 to USD 485 billion by 2034.

    • Unmet Need

      Current leukemia treatments face low response rates with PD-L1 monotherapy and anemia caused by CD47-targeted agents. Papiliximab is designed to overcome both challenges, offering an innovative therapeutic option for hematologic malignancies.

    • Development Status

      Preclinical studies in rodents and non-human primates have demonstrated strong anti-tumor efficacy and excellent safety, and the program is preparing for Phase I clinical trials in patients with acute myeloid leukemia and other hematologic cancers.

Solid Cancer

    • Anti-CD3*4-1BB*TAA

      Ovizumab

      NSCLC

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    Ovizumab

    A next-generation tumor-specific immunotherapy that boosts immune cell activity within the tumor microenvironment.

    • Competitiveness

      Ovizumab enhances tumor selectivity to minimize toxicity in normal tissues while improving blood-stream stability for balanced safety, potency, and durability. Its modular design enables application across multiple solid-tumor indications.

    • Market Outlook

      The immuno-oncology and multi-target antibody markets are rapidly expanding, particularly in solid tumors, driving strong demand for next-generation T-cell-activating platforms.

    • Unmet Need

      Existing therapies often suffer from cytokine-release syndrome, off-target toxicity, and limited efficacy or durability. Ovizumab is being developed to address these key limitations.

    • Development Status

      At the early preclinical stage, Ovizumab has shown robust tumor-suppressive activity in cancer cell models, demonstrating strong potential as a novel solid-tumor therapy.

    • Anti-CTLA-4*TAA

      Regtizumab

      Solid Cancer

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    Regtizumab

    Revitalizing anti-tumor immunity while minimizing systemic side effects.

    • Competitiveness

      As a precisely engineered NanoMab, Regtizumab exhibits superior tissue penetration and selectively inhibits regulatory T cell function within the tumor microenvironment, enhancing immune activation while reducing systemic toxicity. It also holds strong potential for combination therapy with other immune checkpoint inhibitors.

    • Market Outlook

      Immuno-oncology continues to expand rapidly through combination regimens, and Treg-targeted therapeutics represent a highly promising and underserved segment.

    • Unmet Need

      Current treatments carry risks of systemic immune-related toxicities and limited efficacy due to resistance. Regtizumab aims to deliver precision immune modulation with improved safety and durability.

    • Development Status

      In early preclinical development, Regtizumab has shown restoration of immune activity through selective Treg suppression with a favorable safety profile.

    • LNP-mRNA

      Rbody

      Solid Cancer

    • Development
    • Optimization
    • Preclinical
    • Ph1
    • Ph2

    Rbody

    Improving both treatment outcomes and patient quality of life by reducing dosing frequency and cost.

    • Competitiveness

      Unlike conventional antibodies, NanoMabs’ small size enables the creation of LNP-mRNA therapeutics (Rbody). Our optimized NanoMab-based Rbody maintains long in-vivo persistence and high stability even at lower doses, providing significant cost-effectiveness unattainable with traditional antibody drugs.

    • Market Outlook

      Excluding vaccines, the global mRNA-based therapeutics market is expected to grow from USD 19.6 billion in 2024 to USD 42.6 billion by 2034.

    • Unmet Need

      mRNA-based protein therapeutics still face challenges such as low expression and durability, manufacturing quality control, and safety issues—areas where Rbody offers innovative solutions.

    • Development Status

      In preclinical studies, Rbody maintained the same in-vivo half-life as antibodies at less than half the dose, demonstrating strong potential for durable and efficient mRNA-based therapy.

개인정보처리방침

회사명(이하 ‘회사’라 한다)는 개인정보 보호법 제30조에 따라 정보 주체의 개인정보를 보호하고 이와 관련한 고충을 신속하고 원활하게 처리할 수 있도록 하기 위하여 다음과 같이 개인정보 처리지침을 수립, 공개합니다.

제1조 (개인정보의 처리목적)
회사는 다음의 목적을 위하여 개인정보를 처리합니다. 처리하고 있는 개인정보는 다음의 목적 이외의 용도로는 이용되지 않으며, 이용 목적이 변경되는 경우에는 개인정보보호법 제18조에 따라 별도의 동의를 받는 등 필요한 조치를 이행할 예정입니다.

1. 홈페이지 회원 가입 및 관리
회원 가입 의사 확인, 회원제 서비스 제공에 따른 본인 식별․인증, 회원자격 유지․관리, 제한적 본인확인제 시행에 따른 본인확인, 서비스 부정 이용 방지, 만 14세 미만 아동의 개인정보처리 시 법정대리인의 동의 여부 확인, 각종 고지․통지, 고충 처리 등을 목적으로 개인정보를 처리합니다.

2. 재화 또는 서비스 제공
물품 배송, 서비스 제공, 계약서 및 청구서 발송, 콘텐츠 제공, 맞춤서비스 제공, 본인인증, 연령인증, 요금 결제 및 정산, 채권추심 등을 목적으로 개인정보를 처리합니다.

3. 고충 처리
민원인의 신원 확인, 민원사항 확인, 사실조사를 위한 연락․통지, 처리 결과 통보 등의 목적으로 개인정보를 처리합니다.

제2조 (개인정보의 처리 및 보유기간)
 회사는 법령에 따른 개인정보 보유, 이용 기간 또는 정보주체로부터 개인정보를 수집 시에 동의 받은 개인정보 보유, 이용 기간 내에서 개인정보를 처리, 보유합니다.
 각각의 개인정보 처리 및 보유 기간은 다음과 같습니다.

1. 홈페이지 회원 가입 및 관리 : 사업자/단체 홈페이지 탈퇴 시까지
다만, 다음의 사유에 해당하는 경우에는 해당 사유 종료 시까지
1) 관계 법령 위반에 따른 수사, 조사 등이 진행 중인 경우에는 해당 수사, 조사 종료 시까지
2) 홈페이지 이용에 따른 채권 및 채무관계 잔존 시에는 해당 채권, 채무 관계 정산 시까지


2. 재화 또는 서비스 제공 : 재화․서비스 공급완료 및 요금결제․정산 완료 시까지
다만, 다음의 사유에 해당하는 경우에는 해당 기간 종료 시까지
1) 「전자상거래 등에서의 소비자 보호에 관한 법률」에 따른 표시․광고, 계약내용 및 이행 등 거래에 관한 기록
- 표시․광고에 관한 기록 : 6월
- 계약 또는 청약 철회, 대금결제, 재화 등의 공급기록 : 5년
- 소비자 불만 또는 분쟁 처리에 관한 기록 : 3년
2) 「통신비밀보호법」 제41조에 따른 통신사실확인자료 보관
- 가입자 전기통신일시, 개시․종료 시간, 상대방 가입자 번호, 사용도수, 발신기지국 위치추적자료 : 1년
- 컴퓨터 통신, 인터넷 로그 기록자료, 접속지 추적자료 : 3개월


제3조 (개인정보의 제3자 제공)
 회사는 정보주체의 개인정보를 제1조(개인정보의 처리목적)에서 명시한 범위 내에서만 처리하며, 정보주체의 동의, 법률의 특별한 규정 등 개인정보 보호법 제17조에 해당하는 경우에만 개인정보를 제3자에게 제공합니다.
 회사는 다음과 같이 개인정보를 제3자에게 제공하고 있습니다.
- 개인정보를 제공받는 자 : <예) (주) OOO 카드>
- 제공받는 자의 개인정보 이용목적 : <예) 이벤트 공동개최 등 업무제휴 및 제휴 신용카드 발급>
- 제공하는 개인정보 항목 : <예) 성명, 주소, 전화번호, 이메일주소, 카드결제계좌정보>
- 제공받는 자의 보유, 이용기간 : <예) 신용카드 발급계약에 따른 거래기간동안>


제4조(개인정보처리의 위탁)
 회사는 원활한 개인정보 업무처리를 위하여 다음과 같이 개인정보 처리업무를 위탁하고 있습니다.

- 위탁받는 자 (수탁자) : (주)OOO
- 위탁하는 업무의 내용 : 쇼핑몰 호스팅 서비스의 시스템 제공, 모바일 앱 서비스, 마케팅 서비스 및 부가, 제휴서비스 제공 및 알림톡, 친구톡, 문자메시지 발송대행 서비스 등

- 위탁받는 자 (수탁자) : OOO PG
- 위탁하는 업무의 내용 : 결제 및 에스크로 업무

- 위탁받는 자 (수탁자) : OOO 택배
- 위탁하는 업무의 내용 : 상품 배송 업무

- 위탁받는 자 (수탁자) : OOO 고객센터
- 위탁하는 업무의 내용 : 고객상담 업무

- 위탁받는 자 (수탁자) : OOO
- 위탁하는 업무의 내용 : 본인확인 업무


 회사는 위탁계약 체결 시 개인정보 보호법 제25조에 따라 위탁업무 수행목적 외 개인정보 처리금지, 기술적․관리적 보호조치, 재위탁 제한, 수탁자에 대한 관리․감독, 손해배상 등 책임에 관한 사항을 계약서 등 문서에 명시하고, 수탁자가 개인정보를 안전하게 처리하는지를 감독하고 있습니다.
 위탁업무의 내용이나 수탁자가 변경될 경우에는 지체없이 본 개인정보 처리방침을 통하여 공개하도록 하겠습니다.

제5조(이용자 및 법정대리인의 권리와 그 행사 방법)

 정보주체는 회사에 대해 언제든지 다음 각 호의 개인정보 보호 관련 권리를 행사할 수 있습니다.
1. 개인정보 열람 요구
2. 오류 등이 있을 경우 정정 요구
3. 삭제요구
4. 처리정지 요구
 제1항에 따른 권리 행사는 회사에 대해 서면, 전화, 전자우편, 모사전송(FAX) 등을 통하여 하실 수 있으며 회사는 이에 대해 지체없이 조치하겠습니다.
 정보주체가 개인정보의 오류 등에 대한 정정 또는 삭제를 요구한 경우에는 회사는 정정 또는 삭제를 완료할 때까지 당해 개인정보를 이용하거나 제공하지 않습니다.
 제1항에 따른 권리 행사는 정보주체의 법정대리인이나 위임을 받은 자 등 대리인을 통하여 하실 수 있습니다. 이 경우 개인정보 보호법 시행규칙 별지 제11호 서식에 따른 위임장을 제출하셔야 합니다.
 정보주체는 개인정보 보호법 등 관계 법령을 위반하여 회사가 처리하고 있는 정보주체 본인이나 타인의 개인정보 및 사생활을 침해하여서는 아니 됩니다.


제6조(처리하는 개인정보 항목)
회사는 다음의 개인정보 항목을 처리하고 있습니다.

1. 홈페이지 회원 가입 및 관리
필수항목 : <예) 성명, 생년월일, 아이디, 비밀번호, 주소, 전화번호, 성별, 이메일주소, 아이핀번호>
선택항목 : <예) 결혼 여부, 관심 분야>

2. 재화 또는 서비스 제공
필수항목 : <예) 성명, 생년월일, 아이디, 비밀번호, 주소, 전화번호, 이메일주소, 아이핀번호, 신용카드번호, 은행계좌정보 등 결제정보>
선택항목 : <관심분야, 과거 구매내역>

3. 인터넷 서비스 이용과정에서 아래 개인정보 항목이 자동으로 생성되어 수집될 수 있습니다.
IP주소, 쿠키, MAC주소, 서비스 이용기록, 방문기록, 불량 이용기록 등

제7조(개인정보의 파기)
 회사는 개인정보 보유 기간의 경과, 처리목적 달성 등 개인정보가 불필요하게 되었을 때에는 지체없이 해당 개인정보를 파기합니다.
 정보주체로부터 동의받은 개인정보 보유 기간이 경과하거나 처리목적이 달성되었음에도 불구하고 다른 법령에 따라 개인정보를 계속 보존하여야 하는 경우에는, 해당 개인정보를 별도의 데이터베이스(DB)로 옮기거나 보관장소를 달리하여 보존합니다.
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1. 파기 절차
회사는 파기 사유가 발생한 개인정보를 선정하고, 회사의 개인정보 보호책임자의 승인을 받아 개인정보를 파기합니다.
2. 파기 방법
회사는 전자적 파일 형태로 기록․저장된 개인정보는 기록을 재생할 수 없도록 로우레밸포멧(Low Level Format) 등의 방법을 이용하여 파기하며, 종이 문서에 기록․저장된 개인정보는 분쇄기로 분쇄하거나 소각하여 파기합니다.

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1. 관리적 조치 : 내부관리계획 수립 및 시행, 정기적 직원 교육 등
2. 기술적 조치 : 개인정보처리시스템 등의 접근 권한 관리, 접근통제시스템 설치, 고유 식별정보
등의 암호화, 보안프로그램 설치
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 쿠키는 웹사이트를 운영하는데 이용되는 서버(http)가 이용자의 컴퓨터 브라우저에 보내는 소량의 정보이며 이용자들의 컴퓨터 내의 하드디스크에 저장되기도 합니다.
가. 쿠키의 사용 목적: 이용자가 방문한 각 서비스와 웹 사이트들에 대한 방문 및 이용형태, 인기 검색어, 보안접속 여부, 등을 파악하여 이용자에게 최적화된 정보 제공을 위해 사용됩니다.
나. 쿠키의 설치∙운영 및 거부 : 웹브라우저 상단의 도구>인터넷 옵션>개인정보 메뉴의 옵션 설정을 통해 쿠키 저장을 거부 할 수 있습니다.
다. 쿠키 저장을 거부할 경우 맞춤형 서비스 이용에 어려움이 발생할 수 있습니다.


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 회사는 개인정보 처리에 관한 업무를 총괄해서 책임지고, 개인정보 처리와 관련한 정보주체의 불만 처리 및 피해구제 등을 위하여 아래와 같이 개인정보 보호책임자를 지정하고 있습니다.

▶ 개인정보 보호책임자
성명 : OOO
직책 : OOO
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※ 개인정보 보호 담당부서로 연결됩니다.

▶ 개인정보 보호 담당부서
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제11조(개인정보 열람청구)
정보주체는 개인정보 보호법 제35조에 따른 개인정보의 열람 청구를 아래의 부서에 할 수 있습니다. 회사는 정보주체의 개인정보 열람 청구가 신속하게 처리되도록 노력하겠습니다.

▶ 개인정보 열람청구 접수․처리 부서
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제12조(권익침해 구제 방법)
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▶ 개인정보 침해신고센터 (한국인터넷진흥원 운영)
- 소관 업무 : 개인정보 침해사실 신고, 상담 신청
- 홈페이지 : privacy.kisa.or.kr
- 전화 : (국번없이) 118
- 주소 : (58324) 전남 나주시 진흥길 9(빛가람동 301-2) 3층 개인정보침해신고센터

▶ 개인정보 분쟁조정위원회
- 소관업무 : 개인정보 분쟁조정신청, 집단분쟁조정 (민사적 해결)
- 홈페이지 : www.kopico.go.kr
- 전화 : (국번없이) 1833-6972
- 주소 : (03171)서울특별시 종로구 세종대로 209 정부서울청사 4층

▶ 대검찰청 사이버범죄수사단 : 02-3480-3573 (www.spo.go.kr)
▶ 경찰청 사이버안전국 : 182 (http://cyberbureau.police.go.kr)


제13조(개인정보 처리방침 시행 및 변경)
이 개인정보 처리방침은 20XX. X. X부터 적용됩니다.

NuGel

Addressing the Root Cause of Atopic Dermatitis
to Restore Skin Health and Reduce Daily Burden

  • Competitiveness

    • First-in-class GPCR19-targeting anti-inflammatory therapy, offering a novel mechanism of action beyond existing PDE4 inhibitors, JAK inhibitors, and steroid-based treatments
    • Simultaneous inhibition of sensitization (Priming) and activation, demonstrating differentiated anti-inflammatory efficacy compared to existing therapies
    • Improvement in key atopic dermatitis clinical endpoints, including EASI and vIGA, with no rebound observed after treatment discontinuation
    • GPCR19-mediated immune modulation minimizes systemic toxicity and adverse effects, supporting long-term use
    • Biomarker-based approach toward personalized treatment tailored to individual patient characteristics
  • Market Outlook

    • Approximately 170 million patients worldwide with atopic dermatitis(Prevalence: ~10% in children, ~3% in adults)
    • Global market size projected at USD 13 billion by 2025, with a CAGR of 16.4%, and expected to reach USD 33 billion by 2030
    • Limitations and adverse effects of existing PDE4 and JAK inhibitors are driving demand for new therapeutic options
  • Unmet Need

    • Lack of safe and effective long-term topical therapies for patients with mild to moderate atopic dermatitis
    • NuGel is positioned as a new standard-of-care candidate addressing this unmet need
  • Development Status

    • Phase 2a clinical trial completed in Korea, demonstrating improvement in EASI and vIGA scores as well as safety
    • Phase 2b clinical trial approved by the U.S. FDA (177 patients, 12-week treatment period)-On going
    • Global Phase 2b trial expected to conclude in 2026, with active out-licensing discussions underway
    • Preparation underway for commercialization as a prescription topical therapy
  • EASI*Eczema Area and Severity Index, a composite score evaluating the extent and severity of atopic dermatitis
  • EASI-50*≥50% improvement in EASI score from baseline
  • vIGA*Investigator’s Global Assessment, a 0-4 scale evaluating overall disease severity

Precision Medicine-Based Therapeutic Development:
Identification of Biomarkers Predictive of NuGel Responders

Distinct Efficacy of NuGel Confirmed in Biomarker-Positive Patients

Based on the results of Part 1 of a Phase 2b clinical trial,

NuGel shows great efficacy with atopic dermatitis
patients achieving 100% of EASI-50 in subgroup

NuDifin

Suppressing Inflammation at the Wound Site
to Accelerate Tissue Repair and Regeneration

  • Competitiveness

    • First-in-class GPCR19-targeting anti-inflammatory therapy that fundamentally modulates chronic inflammation and immune imbalance in non-healing wounds
    • Superior tissue penetration, safety, and cost competitiveness compared to growth factor-based therapies such as EGF and PDGF
    • Promotion of wound healing in chronic inflammatory conditions through inhibition of NLRP3 inflammasome activation and NETosis
    • Preclinical data demonstrating improved wound contraction and tissue regeneration compared to EGF
  • Market Outlook

    • The global diabetic population is projected to reach 850 million by 2025 and 1.2 billion by 2050
    • Approximately 19-34% of diabetic patients are expected to experience diabetic foot ulcers (DFUs) during their lifetime, with 9-26 million new cases annually
    • High rates of amputation and mortality associated with treatment failure are driving demand for safe and effective next-generation therapies
    • Limitations of growth factor therapies (low clinical success rates and high costs) are creating opportunities for inflammation-modulating wound therapeutics
  • Unmet Need

    • Existing growth factor-based treatments show variable efficacy, limited tissue penetration, high costs, and potential cancer risk
    • Therapeutic options remain limited for infected or recurrent DFUs
    • There is a lack of treatments capable of preventing recurrence through fundamental control of chronic inflammation
    • NuDifin is being developed as a first-in-class inflammation-modulating wound therapy to address these unmet needs
  • Development Status

    • In preclinical studies, NuDifin demonstrated superior wound healing and tissue regeneration efficacy compared to EGF
    • Phase 2 clinical trial entry targeted for 2026-2027
    • Confirmed topical stability, supporting development as a locally applied wound therapy

NuCerin

A Small but Intelligent Molecule
That Reduces Neuroinflammation and Helps Preserve Memory

  • Competitiveness

    • First-in-class GPCR19-targeting oral therapy offering superior convenience and safety compared to antibody-based treatments
    • Dual mechanism of action: Reduction of neuroinflammation + Promotion of amyloid-β (Aβ) clearance
    • No observed risk of ARIA (amyloid-related imaging abnormalities), including cerebral edema, unlike anti-Aβ antibody therapies → Suitable for long-term administration due to favorable safety profile
  • Market Outlook

    • Approximately 55 million patients worldwide with Alzheimer’s disease, projected to exceed 78 million by 2030
    • Antibody-centric markets face challenges due to high costs, injection burden, and safety concerns, creating unmet demand for alternative therapies
    • Rapid growth of next-generation oral and disease-modifying therapies focused on safety and convenience (estimated CAGR ~20%)
    • Increasing demand for long-term, orally administered treatments for early-stage and prodromal patients
  • Unmet Need

    • Existing antibody therapies suffer from high costs, safety risks, and administration inconvenience, limiting accessibility
    • Lack of orally available therapies suitable for long-term use in early-stage and mild cognitive impairment patients
    • Amyloid clearance-focused approaches alone are insufficient, highlighting the need for integrated modulation of neuroinflammation
    • NuCerin is being developed as a first-in-class, neuroinflammation-modulating oral therapy to address these gaps
  • Development Status

    • Phase 1 clinical trial ongoing in Korea (Part A completed, Part B ongoing)
    • Preclinical studies demonstrated: Improved cognitive function, Neuronal regeneration, Reduction of amyloid-β levels
    • Oral formulation with confirmed safety and stability, suitable for long-term administration

Reduction of Brain Amyloid-β Plaques and Neuroinflammation
following NuCerin Administration in an Alzheimer’s Disease Animal Model

Improvement in cognitive performance was observed
following NuCerin administration in an Alzheimer’s disease animal model.

NuSepin

Rapidly Suppressing Excessive Systemic Inflammation
to Accelerate Recovery to Daily Life in Critically Ill Patients

  • Competitiveness

    • First-in-class GPCR19-targeting intravenous anti-inflammatory therapy designed to fundamentally suppress hyperinflammatory responses, including cytokine storm
    • Simultaneous blockade of inflammatory initiation and amplification pathways, demonstrating greater efficacy than existing therapies
    • Rapid clinical response confirmed in Phase 2a, with fast onset of action and no severe adverse events observed
    • Broad potential for indication expansion, including: Severe viral pneumonia, Sepsis, COVID-19, CRS (Cytokine Release Syndrome) following immunotherapy
  • Market Outlook

    • Sustained demand for high-risk, hospitalized patient anti-inflammatory therapies, even in the post-COVID-19 era
    • WHO and CDC reports indicate persistently high mortality rates among critically ill patients, highlighting continued treatment gaps
    • Applicability across systemic inflammatory response syndrome (SIRS), pneumonia, and virus-induced hyperinflammation, supporting a market potential exceeding USD 10 billion
    • Repositioning as a rapid-response therapeutic platform for future pandemics and public health emergencies
  • Unmet Need

    • Antiviral therapies alone show limited ability to reduce immune-mediated mortality
    • Continued safety concerns with JAK/IL-6 inhibitors, including increased infection risk
    • Lack of effective treatments for severe COVID-19 and other hyperinflammatory conditions
    • NuSepin is being developed as a next-generation systemic anti-inflammatory therapy applicable across infectious and immune-mediated hyperinflammatory diseases
  • Development Status

    • Selected as a Korea Drug Development Fund (KDDF)-supported project
    • Global Phase 2b clinical trial completed

Superior improvement was observed in the NuSepin plus antiviral combination group compared to placebo.

NuPulin

Breaking the Vicious Cycle of Inflammation-Driven Pulmonary Fibrosis
to Help Patients Breathe More Comfortably Again

  • Competitiveness

    • First-in-class GPCR19-targeting oral therapy designed to reduce adverse events and improve long-term treatment convenience compared to existing therapies
    • Anti-fibrotic mechanism via inhibition of inflammasome activation, addressing not only disease progression but also promoting tissue recovery
    • Demonstrated efficacy comparable to existing treatments, with improvement in Ashcroft scores and reduced expression of fibrotic marker α-SMA in preclinical models
    • Selective modulation of immune cells, minimizing systemic adverse effects and supporting long-term administration
  • Market Outlook

    • Idiopathic Pulmonary Fibrosis (IPF) shows a 5-year survival rate of approximately 20%, with a global market size estimated at USD 2.5 billion
    • Among currently approved therapies, treatment discontinuation rates due to adverse events remain high (≈18%)
    • Aging populations are driving increasing prevalence and demand for safe, long-term oral therapies
    • Emergence of a new therapeutic market focused on inflammation–fibrosis dual-modulation mechanisms
  • Unmet Need

    • Existing therapies are largely limited to slowing disease progression, with minimal improvement in survival outcomes
    • Long-term treatment adherence is challenging due to gastrointestinal and other adverse effects
    • No approved therapies capable of achieving meaningful functional recovery and quality-of-life improvement
    • NuPulin is being developed as a next-generation oral therapy that simultaneously suppresses inflammation and fibrosis to address these unmet needs
  • Development Status

    • Phase 1 clinical trial ongoing in Korea. (Part A completed,Part B ongoing)
    • In preclinical studies, NuPulin demonstrated suppression of pulmonary fibrosis and improvement in lung function (based on the bleomycin-induced fibrosis model)
    • Confirmed oral stability; under development as a once-daily oral formulation
  • Ashcroft Score* A semi-quantitative scale used to assess the severity of pulmonary fibrosis
  • α-SMA (alpha-smooth muscle actin)* A marker associated with myofibroblast activation and fibrosis progression

Reduction of Fibrosis-Related Markers
following NuPulin Treatment in Human Pulmonary Fibroblasts

Reduction in Histopathological Fibrosis Scores
following NuPulin Administration in an Idiopathic Pulmonary Fibrosis Animal Model

  • Vehicle A : Control group for comparator treatment
  • Vehicle B : Control group for NuPulin treatment
  • Bleomycin : a pulmonary fibrosis-inducing agent
  • Ashcroft Score : A semi-quantitative scale used to assess the severity of pulmonary fibrosis

Papiliximab

Setting a new standard for leukemia care by combining
enhanced anti-cancer efficacy with a reduced anemia risk.

  • Competitiveness

    • World’s first bispecific NanoMab simultaneously targeting PD-L1 and CD47
    • Maximizes tumor cell elimination by effectively neutralizing immune evasion mechanisms in cancer cells
    • Addresses anemia, the most critical adverse effect associated with conventional CD47 antibody therapies
    • Demonstrated favorable safety profile in non-human primate studies and superior tumor growth inhibition in vivo compared to existing antibodies
    • Small, high-stability nanobody format enables scalable manufacturing and reduced production costs
  • Market Outlook

    • The global bispecific antibody market is projected to grow from USD 18 billion in 2025 to USD 48.5 billion by 2034
    • The global acute myeloid leukemia (AML) market is expected to grow at a CAGR exceeding 10%, reaching approximately USD 10 billion by 2028
    • Despite strong interest, CD47-based immunotherapies have faced commercialization delays due to hematologic toxicities
    • Rapid expansion of the next-generation immuno-oncology market focused on safe immune activation
  • Unmet Need

    • Existing anti-PD-L1 monotherapies show limited response rates and resistance issues
    • Many CD47 antibodies have been discontinued due to severe anemia and hemagglutination-related toxicities
    • Strong demand for safe bispecific or novel-format immunotherapies
    • Papiliximab is positioned as a next-generation bispecific immuno-oncology candidate designed to overcome these limitations
  • Development Status

    • Preclinical development completed
    • In humanized mouse models of AML and lymphoma, Papiliximab demonstrated:
    • Superior tumor growth inhibition compared to comparator groups
    • More than five-fold improvement in overall survival
    • Non-human primate studies confirmed:
    • No red blood cell binding
    • No hemagglutination
    • Favorable pharmacokinetic (PK) stability
    • Strategically positioned as the first clinical entry candidate leveraging Shaperon’s bispecific NanoMab platform

Superior Tumor Growth Inhibition and Extended Survival
following Papiliximab Administration in a Humanized Lymphoma Mouse Model

Confirming Mitigation of Hemolytic Toxicity Associated with Conventional CD47 Antibodies

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