On March 30, 2025 Akeso Inc. (9926.HK) ("Akeso", "the Company") reported its 2024 annual results, emphasizing the company’s key achievements in drug research, clinical development, and commercialization (Press release, Akeso Biopharma, MAR 30, 2025, View Source [SID1234651611]).

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In 2024, Akeso achieved key success in antibody therapy research and development. The approval of new indications for cadonilimab and the launch of first-in-class drugs like ivonescimab expanded the company’s footprint in major solid tumors, including lung and gastric cancers. Akeso continues to challenge current standard of care with head-to-head trials against pembrolizumab and other therapies, while advancing novel treatments such as anti-CD47 monoclonal antibody, antibody drug conjugates ("ADCs") and bispecific ADCs. The company also achieved major milestones in commercialization and patient access, with products included in national insurance directories. Currently, over 25 registrational and Phase III clinical trials are actively progressing.

On the commercial front, Akeso’s adjustments in drug pricing and optimization of its commercial systems led to new drug sales revenue surpassing RMB 2 billion in 2024, a 25% year-on-year increase. The company continues to reduce operating losses, with an EBITDA loss of 225 million RMB in 2024.

Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso Biopharma:

"We are thrilled to have reached historic milestones in our innovative drug development in 2024. The approval of several globally competitive products and breakthroughs in advanced therapies have strengthened our global competitiveness in biopharmaceutical innovation.

Notably, our first-in-class bispecific antibodies, cadonilimab and ivonescimab, have been approved for commercial sales and included in China’s NRDL. This significantly improves drug accessibility, reduces patient burdens, and fulfills a key strategic goal in our domestic commercialization efforts. In clinical development, cadonilimab and ivonescimab are currently in over 20 registrational/Phase III clinical trials globally, establishing a strong presence in first-line treatments for a wide range of high-incidence cancers. Additionally, more than 40 Phase II trials are ongoing, further strengthening our leadership in global cancer immunotherapy.

We’ve also made key advances in novel therapies, with ligufalimab (anti-CD47 mAb) moving to Phase III for solid tumors, and progress in next-gen ADCs, bispecific ADCs, and autoimmune bispecific antibodies.

These achievements have expanded our oncology pipeline and strengthened our global expansion strategy with a comprehensive ‘IO 2.0+’ combination therapy platform."

Akeso’s Bispecific Antibody Clinical Portfolio Continues to Expand, Demonstrating Global Leadership in Next-Generation Tumor Immunotherapy

In 2024, Akeso continued to focus and make progress on research and clinical development. The accomplishments from these efforts include :

3 novel drugs approved for market
5 NDAs under review for 5 indications
24 drug candidates in global clinical development
Over 25 registrational/Phase III trials actively progressing
Notably, Akeso has focused on redefining global treatment paradigms through the development of breakthrough therapies that provide additional survival and safety benefit to current standard of care. Centered around its internally developed first-in-class bispecific antibodies—cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF)—the company has conducted over 40 clinical trials across a number of indications.

Cadonilimab

After its approval for recurrent/metastatic cervical cancer, cadonilimab reached a major milestone in 2024 with the approval for a new indication in first-line gastric cancer, addressing unmet needs in PD-L1 low/negative populations. The sNDA for first-line cervical cancer is currently under review. Cadonilimab is also currently in 8 Phase III trials and nearly 20 Phase II studies, exploring treatments for major cancers in both first- and later-line settings.

Ivonescimab

In 2024, ivonescimab was approved for the treatment of EGFR-TKI-resistant, locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). A major milestone was reached in May 2024 when the Phase III HARMONi-2 trial, comparing ivonescimab to pembrolizumab in first-line PD-L1-positive NSCLC, showed positive results. Data presented at the 2024 World Conference on Lung Cancer (WCLC) revealed a median Progression-Free Survival (mPFS) of 11.14 months for ivonescimab, compared to 5.82 months for pembrolizumab. This breakthrough highlights ivonescimab’s potential as a key therapy in next-gen immuno-oncology and boosts its global commercialization prospects.

Currently, ivonescimab is in 12 registrational/Phase III clinical trials, including 6 head-to-head studies against PD-1/L1 therapies, as well as in over 20 Phase II trials.

Key Phase III Trials in NSCLC :

Ivonescimab monotherapy vs. pembrolizumab as first-line (1L) treatment for PD-L1+ NSCLC
Ivonescimab + chemotherapy vs. pembrolizumab + chemotherapy (global multicenter trial) as 1L treatment for NSCLC
Ivonescimab + chemotherapy vs. tislelizumab + chemotherapy as 1L treatment for squamous NSCLC (sq-NSCLC)
Phase III Trials in Other Major IO Indications:

Ivonescimab + chemotherapy vs. durvalumab + chemotherapy as 1L treatment for biliary tract cancer
Ivonescimab + AK117 (CD47 mAb) vs. pembrolizumab as 1L treatment for PD-L1+ head and neck squamous cell carcinoma (HNSCC)
Ivonescimab combination as 1L treatment for triple-negative breast cancer (TNBC)
Ivonescimab in PD-(L)1-resistant NSCLC, and ivonescimab combination as 1L treatment for pancreatic cancer (preparation/initiation underway)
These trials reflect ivonescimab’s development strategy that is based on a fundamental understanding of tumor immunobiology and designing clinical studies that compares it with standard of care, encompassing both first-line and later-line treatments for high-incidence, high-mortality cancers. This positions Akeso as a key innovator in next-generation cancer immunotherapy, improving and contributing to the global IO cancer treatment landscape.

Breakthrough Bispecifics Enter NRDL, Paving the Way for the Next Stage of Commercial Growth

In 2024, Akeso Biopharma achieved commercial sales of RMB 2 billion, representing a 25% year-over-year growth.

As China’s innovative drug market transforms, clinically innovative medicines face historic development opportunities. Both cadonilimab and ivonescimab, recognized for their innovation and clinical value, were successfully included in the National Reimbursement Drug List (NRDL) during the 2024 negotiations, marking a major milestone in Akeso’s commercial franchise.

The inclusion of both cadonilimab and ivonescimab in the NRDL represents the next stage in Akeso’s market strategy, with a clear focus on hospital-based markets as the core growth area. It greatly improves the therapy accessibility, reduces patient treatment burdens, and evolves the innovative value of the company’s first-in-class bispecific antibodies into tangible social and commercial benefits.

Following the NRDL inclusion, Akeso has made key upgrades to its commercial infrastructure, aligning with its strategic priorities for accelerated growth:

Rapid Hospital Access: Prioritizing swift hospital access for cadonilimab and ivonescimab through data-driven tiering of key accounts.
Commercial Team Expansion: Enhancing coverage of core hospitals and regional hubs to ensure maximum reach and impact.
Scientific Leadership: Strengthening engagement with KOLs and generating real-world evidence to highlight the differentiated efficacy and safety profiles of its bispecifics, driving physician adoption.
These initiatives set the stage for Akeso’s growth in 2025 and beyond, while building a strong foundation for long-term, sustainable commercial growth.

Akeso’s non-oncology portfolio is also advancing with the launch of PCSK9 inhibitor ebronucimab and the potential approvals for assets like ebdarokimab and gumokimab. The company is building a dedicated commercial team to tap into the multi-billion RMB metabolic and autoimmune markets. Akeso’s strong pipeline in non-oncology indications will provide additional drivers for sales growth.

Potential Disclosure of Ivonescimab’s Topline HARMONi Clinical Data Mid-Year

International Expansion of Novel Drug Development Accelerates

Akeso’s global partner on ivonescimab, Summit Therapeutics, is advancing three international multicenter Phase III clinical trials:

The HARMONi study, a Phase III clinical trial that evaluates ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Summit has announced plans to disclose topline data in mid-2025.
Summit expanded the HARMONi-3 study cohort in 2024 to include both squamous NSCLC (sq-NSCLC) and non-squamous NSCLC (nsq-NSCLC), expanding first-line coverage for all NSCLC populations.
The HARMONi-7 study, a global Phase III trial comparing ivonescimab monotherapy with pembrolizumab monotherapy as a first-line treatment for PD-L1-high NSCLC, is expected to begin in 2025.
In February 2025, Summit has entered into a clinical collaboration with Pfizer to evaluate ivonescimab in combination with Pfizer’s antibody-drug conjugates (ADCs) across solid tumors. Pfizer will be responsible for conducting the operations of the studies. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. Akeso is responsible for the production of ivonescimab used in the clinical trial conducted globally.

Beyond bispecific antibodies

Akeso is advancing a pipeline of promising candidates beyond bispecific antibodies. The company’s first self-developed ADC, AK138D1, with the first patient enrolled in Australia for Phase I. Clinical trials for the Company’s first bispecific ADC have also begun. Additionally, the IND application for AK139, the first IL-4Rα/ST2-targeting bispecific, has been accepted.

Ligufalimab (CD47 mAb), considered a key target in immuno-oncology, advanced to Phase III in 2024. A randomized, double-blind, controlled Phase III trial (vs. pembrolizumab) is ongoing for first-line PD-L1(+) head and neck squamous cell carcinoma (HNSCC), making ligufalimab the first CD47 mAb to reach Phase III for solid tumors. A global Phase II trial combining ligufalimab with azacitidine for first-line myelodysplastic syndromes (MDS) is actively progressing across multiple countries, including the U.S.

In parallel with the accelerated global expansion of its novel drug development, Akeso’s therapies and clinical studies have also received recognition in top-tier academic journals and conferences. In 2024, the company revealed nearly 80 groundbreaking research findings in prestigious journals and academic conferences, including JAMA, Nature Medicine, and The Lancet.

On March 30, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy (Press release, Innovent Biologics, MAR 30, 2025, View Source [SID1234651609]).

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Recently, Innovent initiated and dosed the first patient for IBI363 in its first pivotal study to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab (Keytruda) monotherapy in patients with unresectable, locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. Furthermore, IBI363 has received two fast track designations (FTD) from the U.S. Food and Drug Administration (FDA), for the treatment of squamous non-small cell lung cancer and melanoma, respectively.

IBI363 has demonstrated outstanding efficacy signals in immunotherapy (IO)-naïve melanoma patients across two earlier clinical trials (Phase 1a/1b study NCT05460767 and Phase 2 study NCT06081920), which enrolled a total of 26 patients with advanced acral or mucosal melanoma:

The overall objective response rate (ORR) was 61.5%, and the disease control rate (DCR) was 84.6%—significantly higher than current domestic immunotherapy standards.
Prolonged follow-up revealed sustained tumor responses and long-term benefits, suggesting the potential superiority of IBI363 over existing standard therapies.
Dr. Hui Zhou, Senior Vice President of Innovent, said, "As Innovent’s first-in-class next-generation IO therapy, IBI363 simultaneously and selectively inhibits the PD-1/PD-L1 pathway and activates the IL-2 pathway. IBI363 has recently received multiple FTD and BTD designations, signifying regulatory recognition of its clinical value in addressing unmet medical needs. Non-cutaneous melanoma subtypes like mucosal melanoma—which are more prevalent in China—are particularly resistant to immunotherapy with limited clinical benefits[i]. We aim to validate IBI363’s potential in its first pivotal trial, through a head-to-head comparison with pembrolizumab, as a superior treatment option for melanoma patients over the current standard-of-care. We are also accelerating the global development of IBI363 across multiple tumor types, with the goal of extending the benefits of China’s innovation to patients worldwide."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly.

About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein)

IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. It is a PD-1/IL-2 bispecific antibody fusion protein designed to enhance efficiency while minimizing toxicity. The IL-2 arm of IBI363 has been engineered to optimize therapeutic effects with reduced side effects, while the PD-1 binding arm enables PD-1 blockade and selective IL-2 delivery. By simultaneously inhibiting the PD-1/PD-L1 pathway and activating the IL-2 pathway, IBI363 facilitates more precise and efficient targeting and activation of tumor specific T cells. Preclinical studies have shown that IBI363 exhibits strong anti-tumor activity across multiple tumor-bearing pharmacological models, including those resistant to PD-1 inhibitors and metastatic models. Additionally, it has demonstrated a favorable safety profile in preclinical models.

Clinical trials of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies. The first pivotal study of IBI363 has been initiated, for the treatment of IO-naive mucosal or acral melanoma.

Furthermore, IBI363 has received two fast track designations (FTD) from the U.S. FDA, for the treatment of melanoma and squamous NSCLC, respectively. IBI363 has also received breakthrough therapy designation from the NMPA of China for the treatment of melanoma.

About Melanoma

Melanoma is a malignant tumor that develops from melanocytes. Although melanoma accounts for only 3% of all types of skin cancer, it has the highest mortality rate of all types and is the most likely to metastasize. In China, the incidence and mortality rate of melanoma continue to rise. Melanoma is classified into three main subtypes: cutaneous, acral and mucosal. The characteristics of melanoma in Chinese patients differs greatly from those seen in European and American Caucasian populations in terms of pathogenesis, biological behavior, histological morphology, treatment response and prognosis[i]. For advanced cutaneous and acral melanomas, patients with the BRAF V600 mutation typically receive BRAF inhibitor combined with MEK inhibitors as the preferred molecular targeted therapy. For those without the BRAF V600 mutation, chemotherapy combined with anti-angiogenic drugs can be is a first-line treatment option. Notably, pembrolizumab has been approved as the first-line treatment indication for advanced melanoma in September 2024 in China, although clinical benefits are limited. For second-line treatment, therapies not previously used in first-line settings are recommended. Patients who have not received PD-1 monoclonal antibody in the first-line setting may be treated with PD-1 inhibitors as a second-line option. For advanced mucosal melanoma -which are more prevalent in China-are particularly resistant to immunotherapy with limited clinical benefits, in urgent need of new treatment options.

On March 28, 2025 Akeso reported the company and Transthera have entered into a strategic collaboration to jointly advance an open-label, multicenter Ph II clinical study to evaluate the combination of Akeso’s PD-1/CTLA-4 BsAb cadonilimab or PD-1/VEGF BsAb ivonescimab with Transthera’s innovative multi-target small-molecule kinase inhibitor tinengotinib (TT-00420) for the treatment of advanced HCC (Press release, Akeso Biopharma, MAR 28, 2025, View Source [SID1234654273]). The clinical protocol for this collaboration has recently received approval from China NMPA.

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Tinengotinib is an innovative, global Ph III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation and Fast Track Designation by US FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation by China NMPA.

Cadonilimab is the world’s first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Data demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% DCR with manageable safety. Furthermore, cadonilimab combined with lenvatinib as a 1L treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options.

Ivonescimab is a novel global first-in-class PD-1/VEGF bispecific immunotherapy. Ivonescimab was granted marketing approval by China NMPA for the treatment of EGFR mutated locally advanced or metastatic nsNSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including GC, HCC and CRC.

On March 28, 2025 Sihuan Pharmaceutical reported full year financial results for the year 2024 (Presentation, Sihuan Pharmaceutical, MAR 28, 2025, View Source [SID1234654104]).

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On March 28, 2025 Genor Biopharma reported its annual report for the year 2024 (Presentation, Genor Biopharma, MAR 28, 2025, View Source [SID1234654103]).

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