Last reviewed 2026-04-23 · How we verify

MHB088C for Injection

Qilu Pharmaceutical Co., Ltd. · Phase 3 active Small molecule

MHB088C for Injection is a PD-L1 inhibitor Small molecule drug developed by Qilu Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).

MHB088C is a humanized monoclonal antibody targeting PD-L1 to enhance anti-tumor immune responses by blocking the interaction between PD-L1 and PD-1/B7-1.

MHB088C is a humanized monoclonal antibody targeting PD-L1 to enhance anti-tumor immune responses by blocking the interaction between PD-L1 and PD-1/B7-1. Used for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	MHB088C for Injection
Sponsor	Qilu Pharmaceutical Co., Ltd.
Drug class	PD-L1 inhibitor
Target	PD-L1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

MHB088C binds to programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing engagement with PD-1 and B7-1 receptors on T cells. This blockade reverses T cell exhaustion and restores anti-tumor immunity, allowing the immune system to recognize and eliminate cancer cells more effectively.

Approved indications

Non-small cell lung cancer
Other solid tumors (under investigation in Phase 3)

Common side effects

Fatigue
Decreased appetite
Immune-related adverse events (pneumonitis, hepatitis, colitis)
Infusion-related reactions

Key clinical trials

A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors (PHASE1, PHASE2)
Study of MHB088C for Patients With Advanced Solid Malignant Tumors (PHASE1, PHASE2)
A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (PHASE3)
A Trial of MHB088C in Advanced Extrapulmonary Neuroendocrine Cancer (PHASE2)
Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

MHB088C for Injection CI brief — competitive landscape report
MHB088C for Injection updates RSS · CI watch RSS
Qilu Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about MHB088C for Injection

What is MHB088C for Injection?

MHB088C for Injection is a PD-L1 inhibitor drug developed by Qilu Pharmaceutical Co., Ltd., indicated for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).

How does MHB088C for Injection work?

MHB088C is a humanized monoclonal antibody targeting PD-L1 to enhance anti-tumor immune responses by blocking the interaction between PD-L1 and PD-1/B7-1.

What is MHB088C for Injection used for?

MHB088C for Injection is indicated for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).

Who makes MHB088C for Injection?

MHB088C for Injection is developed by Qilu Pharmaceutical Co., Ltd. (see full Qilu Pharmaceutical Co., Ltd. pipeline at /company/qilu-pharmaceutical-co-ltd).

What drug class is MHB088C for Injection in?

MHB088C for Injection belongs to the PD-L1 inhibitor class. See all PD-L1 inhibitor drugs at /class/pd-l1-inhibitor.

What development phase is MHB088C for Injection in?

MHB088C for Injection is in Phase 3.

What are the side effects of MHB088C for Injection?

Common side effects of MHB088C for Injection include Fatigue, Decreased appetite, Immune-related adverse events (pneumonitis, hepatitis, colitis), Infusion-related reactions.

What does MHB088C for Injection target?

MHB088C for Injection targets PD-L1 and is a PD-L1 inhibitor.

Drug class: All PD-L1 inhibitor drugs
Target: All drugs targeting PD-L1
Manufacturer: Qilu Pharmaceutical Co., Ltd. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer
Indication: Drugs for Other solid tumors (under investigation in Phase 3)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing