APL-101

Apollomics Inc. · Phase 1 active Small molecule Quality 0/100

APL-101 is a Small molecule drug developed by Apollomics Inc.. It is currently in Phase 1 development. Also known as: Bozitinib, Vebreltinib, bozitinib, vebreltinib.

APL-101 is a programmed cell death protein 1 inhibitor used in the treatment of various cancers, including metastatic non-small cell lung cancer, hepatocellular carcinoma, and renal cell carcinoma. It is being studied in clinical trials to assess its bioequivalence and efficacy in comparison to other treatments, such as PLB-1001 and osimertinib.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 1 → approval rate +9.6pp
  Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	APL-101
Also known as	Bozitinib, Vebreltinib, bozitinib, vebreltinib, CBT-501
Sponsor	Apollomics Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (PHASE1, PHASE2)
• APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (PHASE2)
• A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants (PHASE1)
• APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC (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:

• APL-101 CI brief — competitive landscape report
• APL-101 updates RSS · CI watch RSS
• Apollomics Inc. portfolio CI

Frequently asked questions about APL-101

What is APL-101?

APL-101 is a Small molecule drug developed by Apollomics Inc..

Who makes APL-101?

APL-101 is developed by Apollomics Inc. (see full Apollomics Inc. pipeline at /company/apollomics-inc).

Is APL-101 also known as anything else?

APL-101 is also known as Bozitinib, Vebreltinib, bozitinib, vebreltinib, CBT-501.

What development phase is APL-101 in?

APL-101 is in Phase 1.

Related

• Manufacturer: Apollomics Inc. — full pipeline
• Also known as: Bozitinib, Vebreltinib, bozitinib, vebreltinib, CBT-501