trastuzumab brengitecan (BL-M07D1) / Biokin Pharma - LARVOL DELTA

BL-M07D1, a novel anti-HER2 antibody-drug conjugate (ADC), in subjects with metastatic HER2-mutant non-small cell lung cancer (NSCLC) (ESMO Asia 2025) - P1/2 | "BL-M07D1 demonstrated encouraging efficacy with a manageable safety profile in previously treated pts with HER2mut NSCLC."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTSB

A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC (clinicaltrials.gov) - P3 | N=440 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 (clinicaltrials.gov) - P3 | N=490 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=280 | Recruiting | Sponsor: SystImmune Inc. | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Biliary Cancer • Breast Cancer • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Estrogen Receptor Positive Breast Cancer • Gastric Cancer • Gastroesophageal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer

Sichuan Biokin Pharmaceutical…announced today the enrollment of the first patient in its Phase III clinical trial of T‑Bren for Injection (HER2 ADC) versus pembrolizumab plus platinum‑based chemotherapy for first‑line treatment of advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC) with HER2 mutations (flcube.com)

Trial status • Lung Non-Squamous Non-Small Cell Cancer

Primary efficacy and safety of BL-M07D1 in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) (ESMO 2025) - P1, P1/2 | "No new safety signals were identified. Conclusions BL-M07D1 demonstrated encouraging efficacy with a manageable safety profile in previously treated HER2+ advanced GC/GEJ patients."

Clinical • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CTSB • HER-2

BL-M07D1, a novel HER2 antibody-drug conjugate, in subjects with locally advanced or metastatic breast cancer and other solid tumors: Results from a phase I study (ESMO 2025) - P1 | "Conclusions BL-M07D1 demonstrated encouraging efficacy in heavily pretreated breast cancers, especially in HER2+ BC. The safety profile showed adequate safety and tolerability."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTSB

Demonstrating strength of ADC platform with a second novel ADC program BL-M07D1 (PRNewswire) - "Safety and efficacy data of BL-M07D1 in patients with metastatic breast cancer and HER2-positive advance gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) will be presented."

Clinical data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer

Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Solid Tumor • HER-2

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Gynecologic Cancers • Oncology

A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC (clinicaltrials.gov) - P3 | N=440 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Gastrointestinal Cancer • Solid Tumor • HER-2

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - P3 | N=274 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

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 (clinicaltrials.gov) - P3 | N=490 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

BL-M07D1-206: A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=98 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=58 ➔ 98

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy (clinicaltrials.gov) - P3 | N=1450 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 + Pertuzumab With or Without Taxane Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer (clinicaltrials.gov) - P2/3 | N=120 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=564 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=564 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 + Pertuzumab With or Without Taxane Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer (clinicaltrials.gov) - P2/3 | N=120 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A breast cancer neoadjuvant drug from Baili Tianheng was approved for Phase II/III clinical trial [Google translation] (Sina Corp) - "On the evening of February 18, Baili Tianheng...announced that it had recently received the 'Notice of Approval for Drug Clinical Trial' officially approved and issued by the National Medical Products Administration. The Phase II/III clinical trial of the company's independently developed innovative biological drug BL-M07D1 (HER2-ADC) for injection was approved. 'After review, it is agreed that this product will be used for joint exploratory research in neoadjuvant patients with HER2-positive breast cancer'."

Trial status • HER2 Positive Breast Cancer