albumin-bound docetaxel (CPO100) / CSPC Pharma - LARVOL DELTA

Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Phase Ib/III Study of Albumin-Bound Docetaxel Combined with Oxaliplatin and 5-FU/LV (ADOF) versus FOLFOX as First-Line Treatment for Pts with Advanced HER2-Negative, PD-L1 CPS (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • HER-2 • PD-L1

Efficacy and Safety of Albumin-bound Docetaxel Plus Enlonstobart vs. Paclitaxel, Combined with Cisplatin and Concurrent Radiotherapy in Patients with Locally Advanced Unresectable Esophageal Squamous Carcinoma: Results from a Randomized Phase II Study (ASTRO 2026) - P1/2 | "HB1801 and Enlonstobart plus cisplatin with CCRT exhibits a trend toward better efficacy in unresectable LA-ESCC compared with SOC. The regimen achieved meaningful clinical responses with a tolerable safety profile, strongly supporting its further development."

Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Gleam Study Long Time Follow-up: Glumetinib + albumin-bound docetaxel (HB1801) in patients (pts) with MET overexpression (OE) non-small cell lung cancer (NSCLC) (ESMO 2026) - No abstract available

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

CSPC Pharmaceutical Group Limited…is pleased to announce that Phase III clinical trial of docetaxel for injection (albumin-bound) ('HB1801') developed by the Group for the treatment of advanced breast cancer (HB1801-017) has been officially initiated at the first centre in China recently (HKEXnews) - "The HB1801-017 study is a randomised, open-label, multicentre Phase III clinical trial, aimed at evaluating the efficacy and safety of HB1801 versus docetaxel (Taxotere) in participants with advanced breast cancer. Currently, participant recruitment and screening for the HB1801-017 study are actively underway."

Trial status • Breast Cancer • HER2 Negative Breast Cancer

Efficacy and safety of albumin-bound docetaxel vs. docetaxel in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma: A multicenter, randomized, phase II study. (ASCO-GI 2025) - P2 | " In this phase II study, eligible patients were aged 18-75 years with histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, who progressed on at least first line of combined chemotherapy of platinum and fluorouracil. Compared with Taxotere, HB1801 results in 41% reduction in risk of death with a manageable safety profile in patients with previously treated advanced G/GEJ cancer."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Neoadjuvant Anbenitamab and HB1801 in ERBB2-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "This randomized clinical trial found that neoadjuvant anbenitamab and HB1801 in patients with breast cancer significantly improved the tpCR rate compared with standard therapy with a highly manageable safety profile. This new combination may offer an improved treatment option, although long-term survival follow-up analyses are warranted."

Clinical • Journal • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of HB1801 Versus Docetaxel (Taxotere) in Patients With Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=430 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Anbenitamab plus albumin-bound docetaxel (nab-docetaxel) ± carboplatin (Cb) versus trastuzumab and pertuzumab plus docetaxel (THP) ± Cb as neoadjuvant therapy for HER2-positive early or locally advanced breast cancer: A randomized, open-label, multicenter, phase 3 trial. (ASCO 2026) - P3 | "Anbenitamab plus nab-docetaxel ± Cb significantly improved tpCR rate compared with standard of care as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer, with a manageable safety profile. These results support Anbenitamab-based regimen as a potential new standard of care."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

SPC Pharmaceutical Group Limited…is pleased to announce that the new drug application for Anbenitamab (KN026)…in combination with the Group’s self-developed docetaxel for injection (albumin-bound) ('HB1801') for neoadjuvant treatment, has been accepted by…the NMPA…and has been included in the priority review and approval procedure (HKEXnews) - "The indication for this new drug application is Anbenitamab in combination with docetaxel (albumin-bound) ± carboplatin as neoadjuvant therapy for the treatment of HER2-positive early or locally advanced breast cancer in adults....This marketing application is primarily based on a pivotal Phase III clinical trial (Study No.: KN026-004/Neo-Healer) that enrolled patients with early-stage or locally advanced HER2-positive breast cancer."

China filing • Priority review • HER2 Positive Breast Cancer

Alphamab Oncology has announced that China’s National Medical Products Administration (NMPA) granted a breakthrough therapy designation to its anti-HER2 bispecific antibody, Anbenitamab. (TipRanks) - "Co-developed with JMT-Bio, a subsidiary of CSPC Group, the drug received this designation for the first-line treatment of unresectable or metastatic HER2-positive breast cancer in combination with albumin-bound docetaxel...The decision is supported by data from a Phase III clinical trial, where the combination of Anbenitamab and HB1801 significantly improved progression-free survival compared to the standard THP regimen, while maintaining a favorable safety profile."

Breakthrough therapy • Non-US regulatory • HER2 Positive Breast Cancer

CPO-100-US-101: Dose Escalation and Dose Expansion Study of CPO-100 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=34 | Terminated | Sponsor: Conjupro Biotherapeutics, Inc. | N=126 ➔ 34 | Active, not recruiting ➔ Terminated; Business Decision

Enrollment change • Trial termination • Breast Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

PHASE III clinical study of anbenitamab (KN026) in combination with docetaxel (albumin-bound) (HB1801) for neoadjuvant treatment of HER2+ breast cancer meets primary endpoint (HKEXnews) - "In addition, beyond improving tpCR, neoadjuvant therapy also aims to facilitate earlier and more timely surgical intervention. Therefore, there is still a clinical need to explore better neoadjuvant treatment regimens that can allow for earlier surgery...Neo-Healer (KN026–004) is a randomised, controlled, open-label, multicenter Phase III clinical study, planning to enroll approximately 520 patients with early or locally advanced HER2-positive breast cancer....The detailed data of this study will be announced at an international academic conference in the near future."

P3 data • HER2 Positive Breast Cancer

Alphamab Oncology Announces the First Patient Dosed in a Phase III Clinical Study of Anbenitamab (KN026) Combined with HB1801 and Chemotherapy as Adjuvant Treatment of Breast Cancer (PRNewswire-Asia) - "KN026-007 is a randomized, controlled, open-label, multicenter Phase III clinical study, which is expected to enroll approximately 1,800 patients with resectable HER2-positive BC who have histologically confirmed involvement of four or more regional lymph nodes following surgery."

Trial status • HER2 Positive Breast Cancer

A study on the treatment of advanced gastric/gastroesophageal junction adenocarcinoma with docetaxel for injection (albumin-bound type) combined with oxaliplatin and 5-FU/LV (ADOF) (ChiCTR) - P=N/A | N=12 | Not yet recruiting | Sponsor: Fujian Cancer Hospital; CSPC Zhongqi Pharmaceutical Technology Co., Ltd.

New trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • MSI • PD-L1

Glumetinib plus albumin-bound docetaxel (HB1801) in patients with MET overexpression, actionable genetic alteration- (AGA-) negative non-small cell lung cancer (Gleam Study) (ESMO Asia 2025) - P2 | "Glumetinib plus HB1801 exhibits a tolerable safety profile and a promising efficacy in MET overexpressed, AGA-negative, locally advanced or metastatic NSCLC."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Becotatug (JMT101, Beco) combined with docetaxel (albumin-bound, HB1801) for the treatment of patients (pts) with locally advanced squamous cell non-small cell lung cancer (sqNSCLC): A randomized control phase II study (BATTLE study) (ESMO Asia 2025) - P2/3 | "This study demonstrates the potential of Beco combined with DTX or HB1801 as a novel, effective therapeutic option for pts with high EGFR expression sqNSCLC who have failed first-line therapy. These promising results, coupled with a manageable safety profile, provide strong support for further phase Ⅲ trial (NCT06319313), which may establish this combination as a new standard of care in the second-line treatment of sqNSCLC."

Clinical • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

HB1801 Combined Treatment of HER2-positive Breast Cancer (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=350 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Glumetinib for MET Overexpression and/or Amplification in Advanced Gastric Cancer: A Phase II Clinical Study‌ (ChiCTR) - P2 | N=112 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Neutropenia • Oncology • Solid Tumor • MET

A Study Comparing the Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=350 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Randomized, Controlled, Open-label Phase Ⅱ study of Becotatug (JMT101) Combined with Docetaxel (Albumin-Bound, HB1801) for Treatment of Patients (pts) with Locally Advanced/Recurrent or Distant Metastatic Squamous Cell Non-Small Cell Lung Cancer (sqNSCLC) (BATTLE study) [WITHDRAWN] (ELCC 2025) - No abstract available

Clinical • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer (clinicaltrials.gov) - P3 | N=630 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Enrolling by invitation ➔ Recruiting

Enrollment status • Gastric Cancer • Oncology • Solid Tumor

A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer (clinicaltrials.gov) - P3 | N=630 | Enrolling by invitation | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor