Last reviewed 2026-05-25 · How we verify

BH009 (Docetaxel injection)

Zhuhai Beihai Biotech Co., Ltd · Phase 3 active Small molecule Under review

BH009 (Docetaxel injection) is a Taxane; microtubule stabilizer Small molecule drug developed by Zhuhai Beihai Biotech Co., Ltd. It is currently in Phase 3 development for Metastatic breast cancer, Non-small cell lung cancer, Prostate cancer. Also known as: BH009.

Docetaxel stabilizes microtubules by binding to β-tubulin, preventing their depolymerization and disrupting cell division.

BH009 (Docetaxel injection) is a treatment for solid tumors, as studied in a bioequivalence trial (NCT04889599) conducted by Zhuhai Beihai Biotech Co., Ltd. The mechanism of action of BH009 is unknown, as per ChEMBL database information.

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	BH009 (Docetaxel injection)
Also known as	BH009
Sponsor	Zhuhai Beihai Biotech Co., Ltd
Drug class	Taxane; microtubule stabilizer
Target	β-tubulin
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Docetaxel is a taxane chemotherapy agent that binds to the β-tubulin subunit of microtubules and prevents their disassembly, leading to cell cycle arrest in the G2/M phase and apoptosis. This mechanism is effective against rapidly dividing cancer cells across multiple tumor types. BH009 is a biosimilar or generic formulation of docetaxel injection.

Approved indications

Metastatic breast cancer
Non-small cell lung cancer
Prostate cancer
Gastric cancer
Head and neck cancer

Common side effects

Neutropenia
Anemia
Thrombocytopenia
Peripheral neuropathy
Alopecia
Nausea/vomiting
Fatigue
Fluid retention

Key clinical trials

A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours (PHASE3)

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:

BH009 (Docetaxel injection) CI brief — competitive landscape report
BH009 (Docetaxel injection) updates RSS · CI watch RSS
Zhuhai Beihai Biotech Co., Ltd portfolio CI

Frequently asked questions about BH009 (Docetaxel injection)

What is BH009 (Docetaxel injection)?

BH009 (Docetaxel injection) is a Taxane; microtubule stabilizer drug developed by Zhuhai Beihai Biotech Co., Ltd, indicated for Metastatic breast cancer, Non-small cell lung cancer, Prostate cancer.

How does BH009 (Docetaxel injection) work?

Docetaxel stabilizes microtubules by binding to β-tubulin, preventing their depolymerization and disrupting cell division.

What is BH009 (Docetaxel injection) used for?

BH009 (Docetaxel injection) is indicated for Metastatic breast cancer, Non-small cell lung cancer, Prostate cancer, Gastric cancer, Head and neck cancer.

Who makes BH009 (Docetaxel injection)?

BH009 (Docetaxel injection) is developed by Zhuhai Beihai Biotech Co., Ltd (see full Zhuhai Beihai Biotech Co., Ltd pipeline at /company/zhuhai-beihai-biotech-co-ltd).

Is BH009 (Docetaxel injection) also known as anything else?

BH009 (Docetaxel injection) is also known as BH009.

What drug class is BH009 (Docetaxel injection) in?

BH009 (Docetaxel injection) belongs to the Taxane; microtubule stabilizer class. See all Taxane; microtubule stabilizer drugs at /class/taxane-microtubule-stabilizer.

What development phase is BH009 (Docetaxel injection) in?

BH009 (Docetaxel injection) is in Phase 3.

What are the side effects of BH009 (Docetaxel injection)?

Common side effects of BH009 (Docetaxel injection) include Neutropenia, Anemia, Thrombocytopenia, Peripheral neuropathy, Alopecia, Nausea/vomiting.

What does BH009 (Docetaxel injection) target?

BH009 (Docetaxel injection) targets β-tubulin and is a Taxane; microtubule stabilizer.

Drug class: All Taxane; microtubule stabilizer drugs
Target: All drugs targeting β-tubulin
Manufacturer: Zhuhai Beihai Biotech Co., Ltd — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic breast cancer
Indication: Drugs for Non-small cell lung cancer
Indication: Drugs for Prostate cancer
Also known as: BH009

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