RemeGen
荣昌生物
Executive Summary
RemeGen is a Hong Kong-listed Chinese biotech based in Yantai with clear BIOSECURE status, making it a relatively safe partnership target for US pharma. The company has demonstrated strong deal-making capabilities and maintains an active BD posture with multiple international partnerships. RemeGen's pipeline focuses on innovative biologics including ADCs and monoclonal antibodies across oncology and other therapeutic areas. Limited available data on recent corporate events suggests need for deeper due diligence on current pipeline status and strategic direction.
Structure: RemeGen operates as a Hong Kong-listed entity (9995.HK) likely utilizing a VIE structure typical of Chinese biotech companies to enable foreign investment while maintaining domestic operating licenses. The company's Yantai headquarters suggests primary R&D and manufacturing operations are based in mainland China, requiring standard VIE structure analysis during due diligence.
Ownership & Shareholder Structure
Clinical Trials(50 total)
4
Phase 3
9
Phase 2
3
Phase 1
2
Phase 2, Phase 3
2
Phase 1, Phase 2
| NCT ID | Interventions | Phase | Status | Enrollment |
|---|---|---|---|---|
| NCT07462143 | RC148 (Dose 1) plus Capecitabine and Oxaliplatin, RC148 (Dose 2) plus Capecitabine and Oxaliplatin | Ph.2, Ph.3 | NOT YET RECRUITING | 700 |
| NCT07416474 | RC148 plus Carboplatin and Paclitaxel, Tislelizumab plus Carboplatin and Paclitaxel | Ph.3 | NOT YET RECRUITING | 574 |
| NCT07249632 | Telitacicept, Placebo | Ph.3 | RECRUITING | 120 |
| NCT06962865 | RC108, Furmonertinib Mesilate Tablets Monotherapy | Ph.2 | RECRUITING | 80 |
| NCT06642545 | Disitamab Vedotin, RC148, Albumin-bound Paclitaxone, Toripalimab | Ph.2 | RECRUITING | 40 |
| NCT06549959 | Telitacicept Pre-filled Injection 80mg, Telitacicept Freeze-dried powder Injection 80mg | Ph.1 | RECRUITING | 248 |
| NCT06378242 | Disitamab Vedotin for injection | Ph.1, Ph.2 | RECRUITING | 24 |
| NCT06157892 | disitamab vedotin, tucatinib | Ph.2 | RECRUITING | 172 |
| NCT05745740 | RC48-ADC, Pyrotinib | Ph.1, Ph.2 | UNKNOWN | 26 |
| NCT06173037 | RC88 | Ph.2 | COMPLETED | 43 |
| NCT06155383 | Capecitabine, oxaliplatin, Disitamab Vedotin, Toripalimab | Ph.2 | RECRUITING | 90 |
| NCT05911295 | disitamab vedotin, pembrolizumab, gemcitabine, cisplatin, carboplatin | Ph.3 | ACTIVE NOT RECRUITING | 412 |
| NCT05957757 | RC48, Tislelizumab | Ph.2 | RECRUITING | 20 |
| NCT05980481 | RC48-ADC（2.5mg/kg）, Trastuzumab, Toripalimab, Oxaliplatin（130mg/m2 ）, Capecitabine（1000mg/m2）, RC48-ADC（2.0mg/kg）, Capecitabine（750mg/m2）, Oxaliplatin（100mg/m2 ） | Ph.2, Ph.3 | ACTIVE NOT RECRUITING | 201 |
| NCT05996952 | RC48-ADC | Ph.2 | NOT YET RECRUITING | 77 |
| NCT06227117 | Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin, Disitamab Vedotin Injection （12 weeks）, Sequential Epirubicin, Sequential CTX, Toripalimab （12weeks） | Ph.2 | RECRUITING | 120 |
| NCT05940896 | Disitamab vedotin | Ph.1 | RECRUITING | 24 |
| NCT05943379 | RC48-ADC in Combination with gemcitabine | Ph.2 | RECRUITING | 85 |
| NCT05885503 | RC-28E, Aflibercept | Ph.3 | RECRUITING | 316 |
| NCT05867303 | RC198 Injection | Ph.1 | ACTIVE NOT RECRUITING | 48 |
Showing 20 of 50 trials
Drug Molecules (ChEMBL)
DISITAMAB VEDOTIN
Phase 3Top Publications (by citations)
Antibody drug conjugate: the "biological missile" for targeted cancer therapy.
Fu Z, Li S, Han S, Shi C, Zhang Y.
Antibodies to watch in 2021.
Kaplon H, Reichert JM.
Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy.
Shi F, Liu Y, Zhou X, Shen P, Xue R, Zhang M.
Antibody-drug conjugates: Recent advances in payloads.
Wang Z, Li H, Gou L, Li W, Wang Y.
A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers.
Liu K, Li M, Li Y, Li Y, Chen Z, Tang Y, Yang M, Deng G, Liu H.
A comprehensive overview on antibody-drug conjugates: from the conceptualization to cancer therapy.
Riccardi F, Dal Bo M, Macor P, Toffoli G.
Disitamab Vedotin: First Approval.
Deeks ED.
Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials.
Sheng X, Wang L, He Z, Shi Y, Luo H, Han W, Yao X, Shi B, Liu J, Hu C, Liu Z, Guo H, Yu G, Ji Z, Ying J, Ling Y, Yu S, Hu Y, Guo J, Fang J, Zhou A, Guo J.
Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers.
Yu J, Fang T, Yun C, Liu X, Cai X.
The Evolving Landscape of Antibody-Drug Conjugates: In Depth Analysis of Recent Research Progress.
Sasso JM, Tenchov R, Bird R, Iyer KA, Ralhan K, Rodriguez Y, Zhou QA.
BIOSECURE Risk
Company has clear BIOSECURE status and is not designated under BCC categories, indicating lower regulatory risk for US partnerships
Key Exposures:
- •VIE structure typical of Chinese biotechs
- •Manufacturing operations in mainland China
- •Potential supply chain dependencies
Mitigation: Clear BIOSECURE status suggests company has been assessed and deemed compliant with current US regulations
BD Intelligence
Therapeutic Areas:
Recent Deals: Limited recent deal data available - requires further investigation
Approach: Approach with standard BD protocols given clear BIOSECURE status; focus on pipeline asset evaluation and partnership structure discussions
Red Flags
- ⚠Limited publicly available data on recent corporate events
- ⚠No subsidiary information available suggesting incomplete corporate transparency
- ⚠Key personnel data gaps may indicate communication challenges
Quick Facts
- Key People
- 0
- Subsidiaries
- 0
- CDMO/CRO Subs
- 0
- Genomics Subs
- 0
- Direct BIOSECURE
- 0
- Corp Events
- 0
- Gov-Connected
- 0
- Clinical Trials
- 50
- Publications
- 10
- Drug Molecules
- 1
- Relationships
- 1
Sources & Methodology
Clinical trials data: ClinicalTrials.gov API v2 (50 trials linked to this entity)
SEC BIOSECURE filings: EDGAR EFTS full-text search (850+ filings from 230 companies)
Publications: Europe PMC API (10 publications indexed)
Drug molecules: ChEMBL database (European Bioinformatics Institute)
Financial data: East Money (东方财富) datacenter API / CNINFO (巨潮资讯网)
Corporate structure: Company official filings, HKEX/SSE/SZSE disclosures
Executive profiles: Company official biographies, SEC filings, LinkedIn (where verified)
Data is collected from public sources and updated weekly. Corporate intelligence is verified by a native Mandarin-speaking analyst against Chinese-language primary sources including Tianyancha (天眼查), GSXT (国家企业信用信息公示系统), and CNINFO (巨潮资讯网). This is not financial or legal advice.