CStone Pharmaceuticals
基石药业
Executive Summary
CStone is a Suzhou-based immuno-oncology biotech with a commercially approved PD-L1 inhibitor (sugemalimab) in China and proven ability to execute licensing deals with Big Pharma partners like Novartis. Founded in 2015 by Frank Jiang, the company appears well-positioned for out-licensing opportunities given their clinical development capabilities and regulatory success in China. BIOSECURE risk appears low given their clear status and focus on novel drug development rather than manufacturing services.
Structure: CStone is a Hong Kong-listed entity (2616.HK) likely structured through a Variable Interest Entity (VIE) arrangement typical for Chinese biotechs accessing international capital markets. The company appears to have a straightforward structure with headquarters in Suzhou and no complex subsidiary layers reported, which should facilitate due diligence processes.
Key People
| Name | Title | Education | Flags |
|---|---|---|---|
Frank Jiang 江宁军 | Chairman, CEO & Founder | MD, Shanghai Medical University; MBA, China Europe International Business School |
Ownership & Shareholder Structure
Clinical Trials(28 total)
5
Phase 3
1
Phase 2
9
Phase 1
1
Other
4
Phase 1, Phase 2
| NCT ID | Interventions | Phase | Status | Enrollment |
|---|---|---|---|---|
| NCT05700448 | Sugemalimab, Placebo, Pegaspargase, Gemcitabine, Oxaliplatin | Ph.3 | NOT YET RECRUITING | 150 |
| NCT06741644 | CS2009, CS2009, Pemetrexed, Carboplatin, Paclitaxel, Etoposide, Nab-paclitaxel, Oxaliplatin, Capecitabine, Docetaxel, Leucovorin, 5-FU, Irinotecan, Cisplatin | Ph.1, Ph.2 | RECRUITING | 660 |
| NCT05381753 | Avapritinib, Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al ) | COMPLETED | 61 | |
| NCT05297890 | Lorlatinib | Ph.2 | ACTIVE NOT RECRUITING | 70 |
| NCT05279300 | CS5001, Rituximab, Gemcitabine, Oxaliplatin, Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone | Ph.1 | RECRUITING | 480 |
| NCT04421352 | CS1001 | Ph.1 | COMPLETED | 11 |
| NCT04472858 | Donafenib, CS1001 | Ph.1 | UNKNOWN | 30 |
| NCT04233060 | CS3005 | Ph.1 | COMPLETED | 9 |
| NCT04162301 | CS3002 | Ph.1 | TERMINATED | 10 |
| NCT04338724 | CS1002 | Ph.1 | COMPLETED | 6 |
| NCT04187352 | CS1001+ Fluorouracil+Cisplatin, Placebo+ Fluorouracil+Cisplatin | Ph.3 | COMPLETED | 540 |
| NCT04194801 | Phase Ib: Fisogatinib (BLU-554) 400mg in combination with Sugemalimab (CS1001) 1200mg, Phase Ib: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mg, Phase II: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mg | Ph.1, Ph.2 | COMPLETED | 26 |
| NCT04200404 | CS1001, Regorafenib | Ph.1, Ph.2 | COMPLETED | 19 |
| NCT04194775 | Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib | Ph.3 | ACTIVE NOT RECRUITING | 534 |
| NCT04176393 | ivosidenib | Ph.1 | COMPLETED | 30 |
| NCT04254939 | CS3007 (BLU-285) | Ph.1, Ph.2 | COMPLETED | 65 |
| NCT03802591 | CS1001 monoclonal antibody, CS1001 placebo, Oxaliplatin, Capecitabine | Ph.3 | COMPLETED | 479 |
| NCT03789604 | CS1001 monoclonal antibody, CS1001 placebo | Ph.3 | ACTIVE NOT RECRUITING | 479 |
| NCT03744403 | CS1001 | Ph.1 | COMPLETED | 24 |
| NCT03809767 | CS1003 monoclonal antibody | Ph.1 | COMPLETED | 107 |
Showing 20 of 28 trials
Drug Molecules (ChEMBL)
SUGEMALIMAB
Phase 4BIOSECURE Risk
Company has clear BIOSECURE status and operates as a drug developer rather than a manufacturing service provider, reducing typical regulatory exposure points
Key Exposures:
- •Potential future CDMO relationships for manufacturing
- •Data sharing arrangements with Chinese research institutions
Mitigation: No specific mitigation efforts reported, but clear BIOSECURE status suggests proactive compliance management
BD Intelligence
Therapeutic Areas:
Recent Deals: Licensed canakinumab from Novartis for oncology applications in China, demonstrating active BD engagement and Big Pharma relationship management
Approach: Direct engagement with CEO Frank Jiang who appears to be the primary decision-maker; focus on out-licensing opportunities for global rights to sugemalimab or pipeline assets
Red Flags
- ⚠Limited pipeline visibility beyond sugemalimab
- ⚠No recent corporate events or news flow reported
- ⚠Lack of subsidiary structure transparency
Quick Facts
- Key People
- 1
- Subsidiaries
- 0
- CDMO/CRO Subs
- 0
- Genomics Subs
- 0
- Direct BIOSECURE
- 0
- Corp Events
- 0
- Gov-Connected
- 0
- Clinical Trials
- 28
- Publications
- 0
- Drug Molecules
- 1
- Relationships
- 2
Sources & Methodology
Clinical trials data: ClinicalTrials.gov API v2 (28 trials linked to this entity)
SEC BIOSECURE filings: EDGAR EFTS full-text search (850+ filings from 230 companies)
Publications: Europe PMC API (0 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.