Last reviewed 2026-05-25 · How we verify

CM082 combined with everolimus

AnewPharma · Phase 3 active Small molecule ✓ Verified May 2026

CM082 combined with everolimus is a Tyrosine kinase inhibitor + mTOR inhibitor combination Small molecule drug developed by AnewPharma. It is currently in Phase 3 development for Renal cell carcinoma, Other solid tumors (under investigation in Phase 3). Also known as: X-82, Affinitor.

CM082 is a tyrosine kinase inhibitor that targets multiple kinases including VEGFR and FLT3, combined with everolimus (an mTOR inhibitor) to provide dual pathway inhibition for cancer treatment.

CM082 is a small molecule inhibitor that targets FK506-binding protein 1A. It is being studied in combination with everolimus, a known inhibitor of the same target, for the treatment of metastatic renal cell carcinoma in Chinese patients.

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	CM082 combined with everolimus
Also known as	X-82, Affinitor
Sponsor	AnewPharma
Drug class	Tyrosine kinase inhibitor + mTOR inhibitor combination
Target	VEGFR, FLT3, mTOR
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

CM082 inhibits receptor tyrosine kinases involved in angiogenesis and tumor cell proliferation, while everolimus blocks mTOR signaling to suppress cell growth and survival. The combination targets both growth factor signaling and metabolic pathways to enhance anti-tumor efficacy.

Approved indications

Renal cell carcinoma
Other solid tumors (under investigation in Phase 3)

Common side effects

Hypertension
Diarrhea
Fatigue
Mucositis
Thrombocytopenia
Anemia

Key clinical trials

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:

CM082 combined with everolimus CI brief — competitive landscape report
CM082 combined with everolimus updates RSS · CI watch RSS
AnewPharma portfolio CI

Frequently asked questions about CM082 combined with everolimus

What is CM082 combined with everolimus?

CM082 combined with everolimus is a Tyrosine kinase inhibitor + mTOR inhibitor combination drug developed by AnewPharma, indicated for Renal cell carcinoma, Other solid tumors (under investigation in Phase 3).

How does CM082 combined with everolimus work?

CM082 is a tyrosine kinase inhibitor that targets multiple kinases including VEGFR and FLT3, combined with everolimus (an mTOR inhibitor) to provide dual pathway inhibition for cancer treatment.

What is CM082 combined with everolimus used for?

CM082 combined with everolimus is indicated for Renal cell carcinoma, Other solid tumors (under investigation in Phase 3).

Who makes CM082 combined with everolimus?

CM082 combined with everolimus is developed by AnewPharma (see full AnewPharma pipeline at /company/anewpharma).

Is CM082 combined with everolimus also known as anything else?

CM082 combined with everolimus is also known as X-82, Affinitor.

What drug class is CM082 combined with everolimus in?

CM082 combined with everolimus belongs to the Tyrosine kinase inhibitor + mTOR inhibitor combination class. See all Tyrosine kinase inhibitor + mTOR inhibitor combination drugs at /class/tyrosine-kinase-inhibitor-mtor-inhibitor-combination.

What development phase is CM082 combined with everolimus in?

CM082 combined with everolimus is in Phase 3.

What are the side effects of CM082 combined with everolimus?

Common side effects of CM082 combined with everolimus include Hypertension, Diarrhea, Fatigue, Mucositis, Thrombocytopenia, Anemia.

What does CM082 combined with everolimus target?

CM082 combined with everolimus targets VEGFR, FLT3, mTOR and is a Tyrosine kinase inhibitor + mTOR inhibitor combination.

Drug class: All Tyrosine kinase inhibitor + mTOR inhibitor combination drugs
Target: All drugs targeting VEGFR, FLT3, mTOR
Manufacturer: AnewPharma — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Renal cell carcinoma
Indication: Drugs for Other solid tumors (under investigation in Phase 3)
Also known as: X-82, Affinitor

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