BL-M07D1

Phase 3Small molecule

SSichuan Baili Pharmaceutical Co., Ltd.

BL-M07D1 is one of 331 small molecule programs targeting Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

330

Competitors

Pipeline

Status by Indication[3][1]

Indication

AdenocarcinomaRecruiting

Biliary Tract CancerRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerRecruiting

Colorectal CancerNot yet recruiting

Endometrial CancerRecruiting

HER2-Positive Breast CancerActive, not recruiting

Gastric or Gastroesophageal Junction AdenocarcinomaActive, not recruiting

MalignanciesRecruiting

Locally Advanced or Metastatic Digestive Tract TumorsRecruiting

AdenocarcinomaPhase 3

Recruiting

Biliary Tract CancerPhase 3

Recruiting

Non-Small Cell Lung CancerPreclinical

Active, not recruiting

Breast CancerPhase 3

Recruiting

Colorectal CancerPhase 3

Not yet recruiting

Endometrial CancerPhase 1

Recruiting

HER2-Positive Breast CancerPhase 3

Active, not recruiting

Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2

Active, not recruiting

MalignanciesPreclinical

Recruiting

Locally Advanced or Metastatic Digestive Tract TumorsPhase 1

Recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

BL-M07D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

4 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

HER2-Positive Breast Cancer

NCT06445400

Q2 2027

Phase 3Recruiting

Adenocarcinoma

NCT07152405

Q4 2027

Phase 2Recruiting

Non-Squamous NSCLC

NCT07264816

Phase 3Recruiting

First-Line Treatment

NCT07178795

Phase 3Recruiting

Breast Cancer

NCT06957886

PreclinicalRecruiting

Malignancies

NCT06131450

Clinical

Trials by Indication[1]

Breast Cancer4 trials

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06830889·1,450 enrolled

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06957886·566 enrolled

A Randomized Controlled Phase II Clinical Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT07678957·120 enrolled

Show 1 more trial

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-Positive/Negative Breast Cancer and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05461768·348 enrolled

HER2-positive Breast Cancer3 trials

A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT06891833·985 enrolled

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06445400·83 enrolled

A Randomized Controlled Phase III Clinical Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06316531·274 enrolled

Adenocarcinoma1 trial

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07152405·490 enrolled

Gastrointestinal Tumors1 trial

A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1/2·NCT06031584·42 enrolled

Non-squamous NSCLC1 trial

A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT07264816·80 enrolled

9 more indications

First-line Treatment1 trial

A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07178795·440 enrolled

Malignancies1 trial

A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With Recurrent or Metastatic Gynecologic Malignancies

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT06131450·158 enrolled

Endometrial Cancer1 trial

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Recruiting·SSystImmune Inc.·Phase 1·NCT06293898·280 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2-Overexpressing or HER2-Mutant Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT06114511·78 enrolled

Locally Advanced or Metastatic Digestive Tract Tumors1 trial

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Initial Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05631964·26 enrolled

Gastric or Gastroesophageal Junction Adenocarcinoma1 trial

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06423885·64 enrolled

Colorectal Cancer1 trial

A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07730489·130 enrolled

Biliary Tract Cancer1 trial

A Phase III Randomized Controlled Clinical Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07606599·398 enrolled

Epithelial Ovarian Cancer1 trial

A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07545460·404 enrolled

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for BL-M07D1. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BL-M07D1 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BL-M07D1. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sichuan Baili Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSichuan Baili Pharmaceutical Co., Ltd.

BL-M07D1

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Breast Cancer4 trials

HER2-positive Breast Cancer3 trials

Adenocarcinoma1 trial

Gastrointestinal Tumors1 trial

Non-squamous NSCLC1 trial

First-line Treatment1 trial

Malignancies1 trial

Endometrial Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Locally Advanced or Metastatic Digestive Tract Tumors1 trial

Gastric or Gastroesophageal Junction Adenocarcinoma1 trial

Colorectal Cancer1 trial

Biliary Tract Cancer1 trial

Epithelial Ovarian Cancer1 trial

References

Drug Info

Quick Facts

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