HONG KONG, Nov. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China's National Medical Products Administration (NMPA).
The Phase III multicenter, randomized, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for ivonescimab. The previous three designations include:
- Ivonescimab combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China's National Reimbursement Drug List.
- First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China.
- Ivonescimab combined with docetaxel for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing.
Receiving four Breakthrough Therapy Designations affirms ivonescimab's substantial clinical benefit across multiple major cancer types and reinforces Akeso's commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicenter studies. These large pivotal studies, backed by repeated regulatory recognition, position ivonescimab to deliver transformative, life-saving outcomes for patients worldwide.
Forward-Looking Statement of Akeso, Inc.
This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
About 依达方 ® (PD-1/VEGF Bispecific, Ivonescimab)
Ivonescimab is a first-in-class, PD-1/VEGF bispecific immuno-oncology agent developed by Akeso. In May 2024, it received approval from the China National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) after EGFR-TKI therapy. This approval made ivonescimab the world's first bispecific antibody based on a synergistic "immunotherapy plus anti-angiogenesis" mechanism. In November 2024, ivonescimab was also included in China's National Reimbursement Drug List (NRDL).
Additionally, ivonescimab has been approved as a first-line treatment for advanced NSCLC with positive PD-L1 expression. In the Phase III HARMONi-2 study, ivonescimab demonstrated superior efficacy compared to pembrolizumab, resulting in significantly improved clinical outcomes.
In 2025, the final overall survival (OS) analysis from the HARMONi-A study showed that ivonescimab met the OS endpoint, providing clinically meaningful and statistically significant OS benefits. As the first final OS analysis in a Phase III trial of ivonescimab, these results reaffirm the agent's groundbreaking value in both progression-free survival (PFS) and overall survival for patients. Moreover, a head-to-head Phase III trial comparing ivonescimab plus chemotherapy to tislelizumab plus chemotherapy in first-line treatment for squamous NSCLC also yielded promising results. These findings position ivonescimab as a substantial clinical breakthrough whether in comparison to PD-1 monotherapy in immuno-oncology, the current standard of care (SOC) of PD-1 inhibitors combined with chemotherapy, or VEGF-targeted therapies in the anti-angiogenesis field. This underscores ivonescimab's significant potential in cancer treatment.
As ivonescimab continues to demonstrate substantial clinical value and the potential to redefine treatment standards, its presence in key immuno-oncology indications is expanding rapidly. In lung cancer, the most prevalent cancer globally, ivonescimab is currently involved in 8 registrational/Phase III clinical studies, including:
- First-line NSCLC (squamous and non-squamous, compared to pembrolizumab + chemotherapy, international multicenter)
- First-line squamous NSCLC (compared to tislelizumab + chemotherapy)
- NSCLC after EGFR-TKI progression (HARMONi-A and HARMONi)
- First-line PD-L1-positive NSCLC (compared to pembrolizumab)
- First-line PD-L1-highly expressed NSCLC (compared to pembrolizumab)
- IO-resistant NSCLC
- Consolidation therapy for limited-stage small cell lung cancer post-concurrent chemoradiotherapy
In other major tumor types, ivonescimab is rapidly advancing first-line indications with ongoing Phase III trials in:
- First-line biliary tract cancer (compared to durvalumab + chemotherapy)
- First-line PD-L1–positive head and neck squamous cell carcinoma in combination with ligufalimab (CD47) (compared to pembrolizumab)
In the challenging area of cold tumors, ivonescimab has received its fourth Breakthrough Therapy Designation for first-line triple-negative breast cancer. Additionally, Phase III studies are underway for first-line MSS/pMMR colorectal cancer (which accounts for 95% of CRC cases) and first-line pancreatic cancer. Further Phase III studies are also being prepared.
With nearly 20 Phase II studies across more than 10 additional indications, ivonescimab has established a robust data foundation to support the rapid global expansion of Phase III trials.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.
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SOURCE Akeso, Inc.
