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BioCart™II

ProChon Biotech Ltd · Phase 2 active Biologic

BioCart™II is a Viscosupplement Biologic drug developed by ProChon Biotech Ltd. It is currently in Phase 2 development for Treatment of osteoarthritis of the knee. Also known as: Autologous chondrocyte implantation, ACI.

BioCart II is a hyaluronic acid-based viscosupplement used to treat joint pain and inflammation.

BioCart II is a hyaluronic acid-based viscosupplement used to treat joint pain and inflammation. Used for Treatment of osteoarthritis of the knee.

Likelihood of approval
16.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameBioCart™II
Also known asAutologous chondrocyte implantation, ACI
SponsorProChon Biotech Ltd
Drug classViscosupplement
ModalityBiologic
Therapeutic areaRheumatology
PhasePhase 2

Mechanism of action

BioCart II works by injecting a gel-like substance into the affected joint to provide cushioning and lubrication, reducing friction and pain. This is particularly useful for treating osteoarthritis and other degenerative joint conditions.

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about BioCart™II

What is BioCart™II?

BioCart™II is a Viscosupplement drug developed by ProChon Biotech Ltd, indicated for Treatment of osteoarthritis of the knee.

How does BioCart™II work?

BioCart II is a hyaluronic acid-based viscosupplement used to treat joint pain and inflammation.

What is BioCart™II used for?

BioCart™II is indicated for Treatment of osteoarthritis of the knee.

Who makes BioCart™II?

BioCart™II is developed by ProChon Biotech Ltd (see full ProChon Biotech Ltd pipeline at /company/prochon-biotech-ltd).

Is BioCart™II also known as anything else?

BioCart™II is also known as Autologous chondrocyte implantation, ACI.

What drug class is BioCart™II in?

BioCart™II belongs to the Viscosupplement class. See all Viscosupplement drugs at /class/viscosupplement.

What development phase is BioCart™II in?

BioCart™II is in Phase 2.

What are the side effects of BioCart™II?

Common side effects of BioCart™II include Pain, swelling, or redness at the injection site.

Related

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