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Clinical Trials Medical Discoveries

Akeso's AK157D1 (B7-H3 ADC) Cleared for Phase I Trial in Solid Tumors, Adding a Third Differentiated ADC to Its Pipeline

  • By Akeso, Inc.

HONG KONG, Aug. 21, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that its investigational next-generation B7-H3-targeting antibody-drug conjugate (ADC), AK157D1, has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The clearance allows initiation of a Phase I study in patients with advanced malignant solid tumors. Development of AK157D1 in combination with Akeso's proprietary bispecific antibodies ivonescimab and cadonilimab is also planned.

Clinical Trials Medical Discoveries

Akeso Advances IO2.0 + ADC2.0 Strategy: First Patient Dosed in Phase II Study of TROP2/Nectin-4 Bispecific ADC (AK146D1) Combined with Ivonescimab in Breast Cancer

  • By Akeso, Inc.

HONG KONG, Aug. 10, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company")  announced that the first patient has been dosed in a Phase II clinical study (AK146D1-202) evaluating AK146D1, the Company's internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (bsADC), in combination with ivonescimab (the Company's PD-1/VEGF bispecific antibody), for the treatment of advanced breast cancer.

Clinical Trials Medical Discoveries

Akeso IO2.0 + ADC2.0 Strategy Makes Another Advancement: First Patient Dosed in Phase Ib/II Study of HER3 ADC (AK138D1) Combined with Ivonescimab in Lung Cancer

  • By Akeso, Inc.

HONG KONG, July 27, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that the first patient has been dosed in a Phase Ib/II clinical study (AK138D1-201) evaluating its internally developed next-generation differentiated HER3 ADC, AK138D1, as monotherapy or in combination with ivonescimab (PD-1/VEGF bispecific antibody) for advanced non-small cell lung cancer (NSCLC).

Clinical Trials Medical Discoveries

Phase II Trial of Cadonilimab(PD-1/CTLA-4) Combination Regimen Launches in the United States for Perioperative Treatment of Gastric Cancer

  • By Akeso, Inc.

HONG KONG, July 14, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that it has entered into a collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) to advance a Phase II clinical study evaluating a cadonilimab-based combination regimen for the perioperative treatment of locally advanced, resectable HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Cadonilimab is the world's first PD-1/CTLA-4 bispecific antibody developed by Akeso.

Clinical Trials Medical Discoveries

Ligufalimab (CD47)-Based Combination Achieves Deep Responses and Survival Benefit in Frontline AML: Phase II Results Presented in Oral Session at EHA 2026

  • By Akeso, Inc.

HONG KONG, June 17, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) were presented as an oral presentation at the 2026 European Hematology Association (EHA) Congress. Ligufalimab is Akeso's proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody. The study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

Clinical Trials Medical Discoveries

Akeso's Next-Generation HER3 ADC AK138D1 Combined with Ivonescimab: First Patient Enrolled in Phase Ib/II Breast Cancer Study, Advancing the IO2.0 + ADC2.0 Strategy

  • By Akeso, Inc.

HONG KONG, June 15, 2026 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926) today announced that the first patient has been enrolled in the Phase Ib/II clinical study (AK138D1-202) evaluating its internally developed next-generation HER3 antibody-drug conjugate (ADC), AK138D1, as either monotherapy or in combination with ivonescimab for the treatment of advanced breast cancer.

Clinical Trials Medical Discoveries

HARMONi-6 Demonstrates Significant Overall Survival Benefit (HR=0.66): Ivonescimab Plus Chemotherapy Superior to PD-1 Plus Chemotherapy in First-Line sq-NSCLC Landmark Results to Be Presented at ASCO 2026 Plenary Session

  • By Akeso, Inc.

CHICAGO, May 31, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that ivonescimab, the Company's first-in-class PD-1/VEGF bispecific antibody, has achieved a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment for patients with advanced squamous non-small cell lung cancer (sq-NSCLC) in the Phase III HARMONi-6 (AK112-306) study. These landmark findings will be featured in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Professor Shun Lu, Director of the Lung Cancer Center at Shanghai Chest Hospital and Principal Investigator of HARMONi-6, presented the data in an oral Plenary Session presentation.

Clinical Trials Medical Discoveries

Over 40 Studies Featuring Akeso's Innovative Oncology Agents to Be Presented at ASCO 2026: Ivonescimab's HARMONi-6 Overall Survival Data Selected for Plenary Session

  • By Akeso, Inc.

HONG KONG, May 26, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that more than 40 clinical studies of its oncology portfolio will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2 in Chicago, Illinois. Notably, the presentations include one Late-Breaking Abstract (LBA) selected for the prestigious Plenary Session, alongside four Oral or Rapid Oral presentations.