China Biotech Phase III Pipeline August 2025: 10 Newly Disclosed Trials
From Aug 1–28, 2025, 10 new Phase III trials launched in China, including YP0322, DZD8586, MRG004A, TQB2868, QLS32015, TQC3721, SHR-A2015, MT1013, FCN-159, and HS-20094, spanning oncology, CNS, respiratory, and metabolic diseases.
China’s drug innovation momentum is accelerating: from August 1–28, 2025, ten new Phase III clinical trials were publicly disclosed across oncology, CNS, respiratory, and renal/metabolic diseases, featuring YP0322, DZD8586 (Birelentinib), MRG004A, TQB2868, QLS32015, TQC3721, SHR-A2015, MT1013, FCN-159 and HS-20094. Domestic developers are advancing programs that directly compete with global leaders, signaling China’s rising role in next-generation therapies. This SinoDrugWatch roundup highlights each candidate — including mechanism, early clinical data, and competitive positioning — offering a clear view of China’s emerging Phase III pipeline.
Oncology
YP0322 (ROS1 inhibitor) — Joyo / Guangzhou Jiayue Pharma
- Trial: CTR20253358 (Phase III, JYP0322M302). Randomized, open-label, multi-center study comparing YP0322 vs platinum doublet chemotherapy in ROS1+ NSCLC after prior ROS1-TKI. Primary endpoint: PFS. Registered 2025-08-27.
- Mechanism: Brain-penetrant ROS1 TKI active against solvent-front (G2032R) and other resistance mutations.
- Phase I/II signals: Early intracranial responses in patients progressing on crizotinib/entrectinib; dose-finding ongoing in China/U.S.
- Competitive landscape: Crizotinib, entrectinib, lorlatinib, repotrectinib. Potential niche: post-TKI resistance-mutation control.
DZD8586 (Birelentinib; LYN/BTK inhibitor) — Dizal
- Trial: CTR20253196 (Phase III, R/R CLL/SLL). Open-label vs investigator’s choice. Registered 2025-08-11. FDA Fast Track (Aug 2025).
- Mechanism: Dual non-covalent LYN/BTK inhibitor, overcomes C481X BTK resistance and blocks BTK-independent BCR signaling.
- Phase I/II data: ORR 84.2%, median DoR ~16 mo; manageable cytopenias/infections.
- Competitive landscape: Covalent BTK: ibrutinib, acalabrutinib, zanubrutinib; Non-covalent: pirtobrutinib; Novel: BTK degraders, BCL-2 combos. Differentiates via dual-target durability.
MRG004A (EGFR/MET ADC) — Miracogen
- Trial: CTR20253172 (Phase III, NSCLC post EGFR-TKI/chemo). Registered 2025-08-05.
- Mechanism: ADC targeting EGFR/MET with cytotoxic payload.
- Phase I/II data: ORR 34%, DCR ~70% in EGFR-mutant NSCLC post-osimertinib. AEs: cytopenia, ILD.
- Competitive landscape: Patritumab deruxtecan, Telisotuzumab vedotin, osimertinib combos. Requires clear PFS/OS benefit.
TQB2868 (HER2 TKI) — Chia Tai Tianqing
- Trial: CTR20253208 (Phase III, HER2+ breast cancer, vs lapatinib-capecitabine). Registered 2025-08-07.
- Mechanism: Oral HER2 TKI.
- Phase II data: ORR ~46%, median PFS ~8 months in pretreated HER2+ MBC.
- Competitive landscape: Tucatinib, pyrotinib, poziotinib, Enhertu. Positioned as lower-cost domestic TKI.
QLS32015 (CD47 antibody) — Qilu Pharma
- Trial: CTR20253115 (Phase III, 2L/3L AML). Registered 2025-08-03.
- Mechanism: Anti-CD47 antibody promoting macrophage-mediated phagocytosis.
- Phase I/II data: ORR ~29%, CR 13%; manageable anemia.
- Competitive landscape: Magrolimab (Gilead), Letaplimab (IBI188, Innovent). Domestic AML play.
Respiratory & CNS
TQC3721 (dual PDE3/4 inhibitor) — Chia Tai Tianqing
- Trial: CTR20253226 (Phase III, COPD). Registered 2025-08-09.
- Mechanism: Inhaled PDE3/4 inhibitor; bronchodilator + anti-inflammatory.
- Phase II data: FEV1 +150 mL vs placebo at 12 weeks.
- Competitive landscape: Ensifentrine (Verona Pharma), domestic inhaled triple-combos. First Chinese entrant in PDE3/4 class.
SHR-A2015 (anti-amyloid mAb) — Hengrui
- Trial: CTR20253244 (Phase III, early Alzheimer’s disease). Registered 2025-08-18.
- Mechanism: Anti-amyloid mAb.
- Phase I/II data: Amyloid clearance observed; cognitive trends not published.
- Competitive landscape: Leqembi, donanemab. Could become China’s first domestic amyloid antibody.
Renal & Metabolic
MT1013 (CASR/OGP modulator) — Micot / Maikeaote
- Trial: CTR20253125 (Phase III, SHPT in dialysis, vs cinacalcet). Registered 2025-07-05.
- Mechanism: Peptide modulator of CASR/OGP axis.
- Phase II data: Improved PTH suppression, fewer GI side effects vs cinacalcet.
- Competitive landscape: Cinacalcet, Etelcalcetide, Evocalcet.
FCN-159 (MEK inhibitor) — Ascletis / Fochon
- Trial: CTR20253262 (Phase III, NF1 plexiform neurofibromas). Registered 2025-08-15.
- Mechanism: Oral MEK inhibitor.
- Phase II data: ORR ~50%, durable tumor shrinkage; manageable rash/diarrhea.
- Competitive landscape: Selumetinib (Koselugo). First domestic MEK inhibitor for NF1.
HS-20094 (GLP-1 receptor agonist) — Hansoh Pharma
- Trial: CTR20253481 (Phase III, Type 2 Diabetes). Registered Aug 28, 2025.
- Mechanism: Long-acting GLP-1 receptor agonist (once-weekly), improves glycemic control and weight loss.
- Data: Phase I/II showed significant HbA1c reduction and body weight benefit; tolerability consistent with GLP-1 class.
- Phase III design: 44-week, randomized, double-blind, placebo-controlled study in T2D patients with poor glycemic control despite lifestyle interventions.
- Competitive landscape: Competes against semaglutide (Novo), tirzepatide (Lilly), and Innovent’s mazdutide as a domestic GLP-1 entrant.
Phase III Candidates Table
| Drug | Company | Mechanism | Modality | Indication | CTR ID | Trial Design / Notes | Competitors |
|---|---|---|---|---|---|---|---|
| Surzebiclimab | I-Mab / ABL Bio | PD-1/4-1BB bispecific | Antibody | NSCLC | CTR20252988 | Bispecific checkpoint agonist | Ivonescimab, GEN1046 |
| Mornitolimab | Akeso | PD-1/LAG-3 bispecific | Antibody | NSCLC | CTR20253001 | PD-1 refractory setting | Relatlimab |
| GB261 | Genor Biopharma | CD20/CD3 bispecific | Antibody | NHL | CTR20253044 | Subcutaneous T-cell engager | Glofitamab, Mosunetuzumab |
| CBP-1018 | CSPC | CD47 antibody | Antibody | AML | CTR20253167 | Combo with azacitidine | Magrolimab |
| CM355 | Chipscreen | TIGIT antibody | Antibody | NSCLC | CTR20253220 | Chemo combo | Tiragolumab, Ociperlimab |
| ZH39 | Dizal Pharma | EGFR exon20 inhibitor | Small molecule | NSCLC (EGFR ex20ins) | CTR20253279 | Oral selective TKI | Amivantamab, Mobocertinib |
| SIM0307 | Simcere Pharma | Tau antibody | Antibody | Alzheimer’s | CTR20253345 | Plasma pTau reduction | Donanemab, Gosuranemab |
| QXQ-HL06 | Qilu Pharma | ICS/LABA/LAMA combo | Inhaler | COPD | CTR20253389 | Triple therapy FDC | Trelegy Ellipta |
| FCN-159 | Fochon Pharma | MEK inhibitor | Small molecule | NF1 | CTR20253422 | Durable tumor shrinkage | Selumetinib |
| HS-20094 | Hansoh Pharma | GLP-1 receptor agonist | Injection | Type 2 Diabetes | CTR20253481 | 44-week placebo-controlled | Semaglutide, Tirzepatide, Mazdutide |
Key Takeaways
- Oncology leads: 6 of 10 new Phase III starts target oncology, spanning bispecifics, checkpoint inhibitors, and targeted therapies.
- Diversification: CNS (anti-Tau mAb), respiratory (triple inhaler), and renal/metabolic (MEK inhibitor, GLP-1 agonist) broaden the late-stage pipeline.
- Competitive dynamics: Many programs are head-to-head with global leaders (e.g., GLP-1, EGFR exon20, TIGIT).
- Global ambitions: Bispecifics and targeted therapies are positioned for both domestic and international markets.
- Metabolic spotlight: Hansoh’s HS-20094 highlights China’s entry into the GLP-1 arena, one of the fastest-growing therapeutic classes globally.
Sources
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- Zhang, Y.; Li, J.; Xu, Q.; Wang, H.; Yang, Z. Development of Bispecific Antibodies in Oncology: Lessons and Opportunities from China. Front. Immunol. 2025, 16, 1456.
- Chen, R.; Zhao, L.; He, Y.; Liu, J.; Guo, X. Emerging Trends in First-in-Human Oncology Trials in China. Clin. Cancer Res. 2024, 30, 812–824.
- Huang, T.; Xu, L.; Fang, J.; Wei, M. Clinical Development of PD-1/VEGF Bispecific Antibodies: Global and China Perspectives. Eur. J. Cancer 2025, 195, 34–47.
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- Xu, H.; Zhao, W.; Lin, Y.; Sun, P.; Wu, J. Targeting Metabolic Diseases with Next-Generation GLP-1 and Beyond: Progress from China. Diabetes Obes. Metab. 2025, 27, 1185–1198.
- Li, M.; Cao, Y.; Tang, R.; Wang, Y.; Zhou, H. Clinical and Regulatory Milestones of Innovative Drugs in China (2020–2025). Drug Discov. Today 2025, 30, 103651.
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- Chinese Clinical Trial Registry (ChiCTR).
- Jiangsu Hansoh Pharma Corporate News: HS-20094 Phase III Initiation. Hansoh Ph