Akeso
康方生物
Executive Summary
Akeso is a Chinese biotech with first-in-class ivonescimab (PD-1/VEGF bispecific) that beat Keytruda head-to-head in lung cancer trials - a historic achievement. The company has a Nov 2026 PDUFA date and represents a rare opportunity to partner with a China-originated biologic that has proven superiority over a Western blockbuster. Clear BIOSECURE status with standard Cayman/mainland structure makes it dealable for US pharma.
Structure: Standard structure with Cayman holding company (9926.HK listed) over mainland China operating entity in Zhongshan. Clean structure with no VIE complications - the Cayman entity directly owns the operating subsidiary that conducts R&D and manufacturing.
Key People
| Name | Title | Education | Flags |
|---|---|---|---|
Yu Xia 夏瑜 | Founder, Chairman & CEO | PhD, University of Alabama at Birmingham |
Ownership & Shareholder Structure
Akeso → Summit Therapeutics
Summit licensed ivonescimab ex-China ($5B+). PDUFA Nov 14, 2026.
Innovent Biologics → Akeso
Innovent and Akeso compete in PD-1/VEGF bispecific space. Innovent IBI363 vs Akeso ivonescimab.
Subsidiaries & Affiliates(2)
| Entity | Type | Jurisdiction | Scope | Flags | BIOSECURE |
|---|---|---|---|---|---|
Akeso Biopharma (Cayman) Inc. 康方生物科技(开曼)有限公司 | offshore | cayman | Holding company for Akeso group. Listed on HKEX (9926.HK). | NONE | |
Zhongshan Akeso Biopharma Co., Ltd. 中山康方生物医药有限公司 | operating | mainland china | Bispecific antibody R&D and manufacturing. Produces ivonescimab and pipeline candidates. | NONE |
Corporate Events
Ivonescimab BLA PDUFA date: November 14, 2026
FDA accepted Akeso/Summit's BLA for ivonescimab (AK112) in NSCLC. PDUFA date set for Nov 14, 2026. If approved, this would be the first China-originated biologic to beat a Western blockbuster (Keytruda) in a registrational trial.
BIOSECURE Impact: None — Akeso is a drug innovator. BIOSECURE does not affect drug approval pathway.
Clinical Trials(50 total)
5
Phase 3
7
Phase 2
4
Phase 1
4
Phase 1, Phase 2
| NCT ID | Interventions | Phase | Status | Enrollment |
|---|---|---|---|---|
| NCT07281326 | AK138D1 | Ph.1 | RECRUITING | 200 |
| NCT07023315 | Cadonilimab, SOX chemotherapy, Placebo | Ph.3 | RECRUITING | 760 |
| NCT06913218 | AK154, Cadonilimab, Ivonescimab (SMT112 or AK112) Injection, mFOLFORINOX | Ph.1 | NOT YET RECRUITING | 60 |
| NCT07052253 | TT-00420 (tinengotinib), AK104, AK112 | Ph.2 | RECRUITING | 100 |
| NCT07043283 | Ebronucimab | Ph.1 | NOT YET RECRUITING | 204 |
| NCT06953999 | Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine, Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine, Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine | Ph.3 | RECRUITING | 999 |
| NCT06767527 | AK112, Nab-paclitaxel, Placebo | Ph.3 | RECRUITING | 416 |
| NCT06767540 | Placebo, placebo | Ph.3 | NOT YET RECRUITING | 198 |
| NCT06426797 | Cadonilimab plus anlotinib | Ph.2 | NOT YET RECRUITING | 25 |
| NCT05990127 | AK104, Tislelizumab, carboplatin, Pemetrexed, Paclitaxel | Ph.3 | NOT YET RECRUITING | 642 |
| NCT06277674 | Cadonilimab plus Pemetrexed and Anlotinib | Ph.2 | RECRUITING | 20 |
| NCT05951608 | AK127 in combination with AK112 | Ph.1, Ph.2 | ACTIVE NOT RECRUITING | 216 |
| NCT06001151 | Cadonilimab, Pemetrexed, Carboplatin | Ph.2 | RECRUITING | 49 |
| NCT05256472 | AK104, axitinib | Ph.2 | ACTIVE NOT RECRUITING | 70 |
| NCT05947201 | Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil | Ph.2 | UNKNOWN | 26 |
| NCT05846867 | AK119, AK112, Oxaliplatin, Irinotecan, Calcium folinate, Fluorouracil | Ph.1, Ph.2 | ACTIVE NOT RECRUITING | 170 |
| NCT05689853 | AK119, AK112 | Ph.1, Ph.2 | RECRUITING | 87 |
| NCT05645276 | AK129 IV infusion | Ph.1 | RECRUITING | 182 |
| NCT05636267 | AK119, AK112, Pemetrexed, Carboplatin | Ph.1, Ph.2 | TERMINATED | 59 |
| NCT05227651 | AK104 | Ph.2 | COMPLETED | 14 |
Showing 20 of 50 trials
Drug Molecules (ChEMBL)
IVONESCIMAB
Phase 3PENPULIMAB
Phase 3Top Publications (by citations)
T cells in health and disease.
Sun L, Su Y, Jiao A, Wang X, Zhang B.
Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial.
HARMONi-A Study Investigators, Fang W, Zhao Y, Luo Y, Yang R, Huang Y, He Z, Zhao H, Li M, Li K, Song Q, Du X, Sun Y, Li W, Xu F, Wang Z, Yang K, Fan Y, Liu B, Zhao H, Hu Y, Jia L, Xu S, Yi T, Lv D, Lan H, Li M, Liang W, Wang Y, Yang H, Jia Y, Chen Y, Lu J, Feng J, Liu C, Zhou M, Zhou J, Liu X, Zhou N, He M, Dong X, Chen H, Chen Y, Su H, Li X, Zhang Z, Yang L, Cheng Y, Chen L, Hou X, Zhang Y, Guo J, Wang Z, Lu H, Wu D, Feng W, Li W, Huang J, Wang Y, Song X, Peng J, Liu L, Guo Y, Li W, Lu D, Hu M, Wang ZM, Li B, Xia M, Zhang L.
Antibodies to watch in 2024.
Crescioli S, Kaplon H, Chenoweth A, Wang L, Visweswaraiah J, Reichert JM.
Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China.
Xiong A, Wang L, Chen J, Wu L, Liu B, Yao J, Zhong H, Li J, Cheng Y, Sun Y, Ge H, Yao J, Shi Q, Zhou M, Chen B, Han Z, Wang J, Bu Q, Zhao Y, Chen J, Nie L, Li G, Li X, Yu X, Ji Y, Sun D, Ai X, Chu Q, Lin Y, Hao J, Huang D, Zhou C, Shan J, Yang H, Liu X, Wang J, Shang Y, Mei X, Yang J, Lu D, Hu M, Wang ZM, Li B, Xia M, Zhou C.
Antibodies to watch in 2025.
Crescioli S, Kaplon H, Wang L, Visweswaraiah J, Kapoor V, Reichert JM.
A Phase 1b Study of Ivonescimab, a Programmed Cell Death Protein-1 and Vascular Endothelial Growth Factor Bispecific Antibody, as First- or Second-Line Therapy for Advanced or Metastatic Immunotherapy-Naive NSCLC.
Wang L, Luo Y, Ren S, Zhang Z, Xiong A, Su C, Zhou J, Yu X, Hu Y, Zhang X, Dong X, Meng S, Wu F, Hou X, Dai Y, Song W, Li B, Wang ZM, Xia Y, Zhou C.
Phase 1a dose escalation study of ivonescimab (AK112/SMT112), an anti-PD-1/VEGF-A bispecific antibody, in patients with advanced solid tumors.
Frentzas S, Austria Mislang AR, Lemech C, Nagrial A, Underhill C, Wang W, Wang ZM, Li B, Xia Y, Coward JIG.
A pivotal decade for bispecific antibodies?
Surowka M, Klein C.
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, Cao Y, Niedermann G, Lu Y, Xue J.
The enhanced antitumor activity of bispecific antibody targeting PD-1/PD-L1 signaling.
Li T, Niu M, Zhou J, Wu K, Yi M.
BIOSECURE Risk
Company has clear BIOSECURE status with no BCC designation and operates standard biotech R&D/manufacturing without CDMO/CRO or genomics exposure
Mitigation: No mitigation needed - company falls outside BIOSECURE scope
BD Intelligence
Therapeutic Areas:
Recent Deals: Working with Summit Therapeutics for US development of ivonescimab
Approach: Immediate high-priority engagement given historic Keytruda-beating data and approaching PDUFA date. Focus on pipeline assets beyond ivonescimab and manufacturing capabilities.
Red Flags
- ⚠Duplicate entries in source data suggest potential data quality issues in available information
Quick Facts
- Key People
- 1
- Subsidiaries
- 2
- CDMO/CRO Subs
- 0
- Genomics Subs
- 0
- Direct BIOSECURE
- 0
- Corp Events
- 1
- Gov-Connected
- 0
- Clinical Trials
- 50
- Publications
- 10
- Drug Molecules
- 2
- Relationships
- 3
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.