Akeso, Inc.

August 27, 2026 10 Min Read

Last updated: August 27, 2026

Company Overview

Akeso, Inc. (康方生物; HKEX: 9926) is a commercial-stage Chinese biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative biologic medicines. The company is particularly known for its expertise in bispecific and multispecific antibodies and has more recently expanded into antibody-drug conjugates (ADCs), T-cell engagers (TCEs), siRNA/mRNA therapeutics and cell therapies.

Akeso’s principal operating entity was established in Zhongshan, Guangdong Province, China, in March 2012 by a team of scientists with global drug-development experience. Akeso, Inc. was subsequently incorporated in the Cayman Islands in January 2019 and completed its initial public offering on the Main Board of the Hong Kong Stock Exchange in April 2020 under stock code 9926.HK. (akesobio.com)

Company	Akeso, Inc. (康方生物)
Founded	March 2012
Principal operating base	Zhongshan, Guangdong, China
Corporate domicile	Cayman Islands
Business status	Public
Stock exchange	Hong Kong Stock Exchange
Ticker	9926.HK
Industry	Biotechnology / Biopharmaceuticals
Development stage	Commercial-stage
Core focus	Innovative biologics, particularly bispecific/multispecific antibodies
Key therapeutic areas	Oncology, autoimmune/inflammatory disease, metabolic/cardiovascular disease and emerging neurological/respiratory indications
Pipeline scale	More than 50 internally developed innovative assets
Clinical-stage programs	27 candidates, according to Akeso
Commercial products	7 innovative drugs reported as commercially available
Core technology platforms	ACE, Tetrabody, Dual-Shield ADC, Dual-Lock TCE, Tissue-Smart siRNA/mRNA, cell therapy and AI-assisted drug discovery

Akeso operates an integrated model spanning target discovery, antibody engineering, clinical development, CMC, manufacturing and commercialization. Its footprint includes facilities and offices in Zhongshan, Guangzhou, Shanghai, Beijing, Nanjing, Nantong and Changsha, as well as operations in Hong Kong, the United States and Australia. (akesobio.com)

Therapeutic Focus and Technology

Oncology remains Akeso’s most important therapeutic franchise. Its strategy is increasingly centered on what the company calls “IO 2.0 + ADC 2.0”: combining next-generation immune-oncology bispecific antibodies such as ivonescimab and cadonilimab with differentiated ADCs and other targeted agents.

The company’s best-known proprietary technology is its Tetrabody platform for developing bispecific and multispecific antibodies. Akeso has subsequently built additional technology platforms covering ADCs, T-cell engagers, siRNA/mRNA and cell therapies. (akesobio.com)

Its therapeutic portfolio can broadly be divided into:

Therapeutic area	Major approaches / programs
Oncology	PD-1/VEGF, PD-1/CTLA-4 and other bispecific/multispecific antibodies; ADCs; TCEs; CD47; angiogenesis targets
Autoimmune / inflammatory diseases	IL-12/IL-23, IL-17A, IL-4Rα, IL-4Rα/ST2 and other cytokine-directed therapies
Metabolic / cardiovascular disease	PCSK9 and other metabolic targets
Respiratory disease	AK139 (IL-4Rα/ST2), including COPD and severe asthma
Neurological and other diseases	Earlier-stage programs using antibodies, siRNA/mRNA and other modalities

Akeso says its internal portfolio now exceeds 50 innovative assets, of which 27 have entered clinical development, including 15 bispecific/multispecific antibodies, bispecific ADCs and related novel modalities. (akesobio.com)

Key Products and Late-Stage Pipeline

1. Ivonescimab — Akeso’s Flagship Global Asset

Ivonescimab (AK112, 依达方®) is a PD-1/VEGF bispecific antibody and arguably Akeso’s most strategically important asset. It simultaneously blocks PD-1-mediated immune suppression and VEGF-driven angiogenesis.

Ivonescimab was first approved in China in May 2024 for EGFR-mutated, locally advanced or metastatic non-squamous NSCLC following progression on EGFR tyrosine kinase inhibitor therapy. It subsequently received a first-line approval for PD-L1-positive NSCLC in April 2025. (akesobio.com)

Most recently, on August 12, 2026, China’s NMPA approved ivonescimab plus chemotherapy for first-line advanced squamous NSCLC, giving the drug its third approved lung cancer indication in China. The approval was supported by HARMONi-6, in which the ivonescimab regimen produced statistically significant PFS and OS improvements compared with a PD-1 inhibitor plus chemotherapy. (akesobio.com)

Akeso’s global ambitions for the molecule are substantially larger. Its development program encompasses numerous Phase III trials covering NSCLC and other solid tumors.

One of the newest major developments came on August 26, 2026, when Akeso reported that the Phase III HARMONi-GI1/AK112-309 trial met its primary OS endpoint. Ivonescimab plus chemotherapy produced a statistically significant and clinically meaningful OS improvement versus durvalumab plus chemotherapy in first-line advanced biliary tract cancer. The study also met the key secondary PFS and ORR endpoints. (akesobio.com)

The global rights structure is particularly important: Akeso retains rights in China and certain other territories, while Summit Therapeutics holds development and commercialization rights to ivonescimab in the United States, Canada, Europe and Japan under a licensing transaction originally announced in 2022. (akesobio.com)

2. Cadonilimab

Cadonilimab (AK104, 开坦尼®) is Akeso’s PD-1/CTLA-4 bispecific antibody and was the company’s first major bispecific product to reach the market.

It was initially approved by China’s NMPA in June 2022 for recurrent or metastatic cervical cancer following platinum-based chemotherapy. Subsequent approvals have expanded its commercial opportunity into first-line gastric/gastroesophageal junction cancer and first-line persistent, recurrent or metastatic cervical cancer. (akesobio.com)

Akeso reported in March 2026 that it was advancing 12 registrational or Phase III studies involving cadonilimab across more than 10 cancer types. The program includes international development, including a head-to-head Phase III study against nivolumab in first-line gastric cancer and a registrational study in immunotherapy-resistant hepatocellular carcinoma. (akesobio.com)

3. Penpulimab

Penpulimab (AK105, 安尼可®) is an anti-PD-1 monoclonal antibody developed with Chia Tai Tianqing.

The drug has multiple approvals in China, including indications in classical Hodgkin lymphoma, nasopharyngeal carcinoma, squamous NSCLC and hepatocellular carcinoma.

An important international milestone came in April 2025, when the U.S. FDA approved penpulimab-kcqx for advanced nasopharyngeal carcinoma, including first-line combination treatment and later-line monotherapy. (akesobio.com)

4. Ebronucimab

Ebronucimab (AK102, 伊喜宁®) is Akeso’s anti-PCSK9 monoclonal antibody and its first commercialized non-oncology medicine.

China’s NMPA approved the therapy in September 2024 for primary hypercholesterolemia/mixed hyperlipidemia and heterozygous familial hypercholesterolemia. (akesobio.com)

Akeso has subsequently moved toward a partnership-based commercialization model for the product, granting commercialization rights in China to Jumpcan Pharmaceutical in 2026. The transaction allows Akeso to leverage an established domestic commercial network while concentrating resources on its innovative pipeline. (www1.hkexnews.hk)

5. Ebdarokimab

Ebdarokimab (AK101, 爱达罗®) is an IL-12/IL-23-targeting monoclonal antibody developed for inflammatory and autoimmune diseases.

The NMPA approved ebdarokimab in April 2025 for adults with moderate-to-severe plaque psoriasis, making it Akeso’s first Class 1 innovative drug approved in the autoimmune field. (akesobio.com)

6. Gumokimab

Gumokimab (AK111) is an IL-17A-targeting monoclonal antibody.

The NMPA approved gumokimab for moderate-to-severe plaque psoriasis in June 2026, further expanding Akeso’s commercial immunology portfolio. A second regulatory application covering active ankylosing spondylitis is under NMPA review following positive Phase III results. (akesobio.com)

Selected Pipeline Overview

Drug / Code	Target / Modality	Principal area	Development status*
Ivonescimab (AK112)	PD-1 × VEGF bispecific	Oncology	Marketed / multiple Phase III
Cadonilimab (AK104)	PD-1 × CTLA-4 bispecific	Oncology	Marketed / multiple Phase III
Penpulimab (AK105)	PD-1 mAb	Oncology	Marketed in China; FDA approved
Ebronucimab (AK102)	PCSK9 mAb	Cardiovascular/metabolic	Marketed
Ebdarokimab (AK101)	IL-12/IL-23 mAb	Autoimmune	Marketed
Gumokimab (AK111)	IL-17A mAb	Autoimmune	Marketed for psoriasis; additional NDA under review
Manfidokimab (AK120)	IL-4Rα mAb	Atopic dermatitis	Phase III / regulatory-stage
Ligufalimab (AK117)	CD47 mAb	Oncology/hematology	Phase II/III development
AK129	PD-1 × LAG-3 bispecific	Oncology	Clinical
AK130	TIGIT × TGF-β bispecific	Oncology	Clinical
AK131	PD-1 × CD73 bispecific	Oncology	Clinical
AK132	Claudin18.2 × CD47 bispecific	Oncology	Clinical
AK139	IL-4Rα × ST2 bispecific	Immunology/respiratory	Phase II
AK138D1	HER3 ADC	Oncology	Phase I/II
AK146D1	TROP2 × Nectin-4 bispecific ADC	Oncology	Phase II
AK157D1	B7-H3 ADC	Oncology	Phase I cleared
AK150	ILT2 × ILT4 × CSF1R trispecific	Oncology	Phase I / clinical-stage

*Status reflects publicly disclosed development through August 27, 2026 and is simplified because many assets are being studied simultaneously across multiple indications and trial phases.

Expansion Into ADCs and Multispecific Antibodies

Akeso’s pipeline is increasingly moving beyond conventional antibodies and bispecific checkpoint inhibitors.

Its AK146D1, a TROP2/Nectin-4 bispecific ADC, entered Phase II combination development with ivonescimab in advanced breast cancer in August 2026. The study includes HR-positive/HER2-negative breast cancer and triple-negative breast cancer. (akesobio.com)

AK138D1, a HER3 ADC, is being evaluated as monotherapy and in combination with ivonescimab in lung and breast cancers. (akesobio.com)

On August 21, 2026, Akeso announced that AK157D1, its B7-H3 ADC, had received Chinese regulatory clearance to enter Phase I development in advanced solid tumors. This made AK157D1 the company’s third next-generation ADC to reach clinical development. (akesobio.com)

Akeso is also expanding into trispecific antibodies. AK150, targeting ILT2, ILT4 and CSF1R, received clearance to enter clinical trials in March 2026 and represents the company’s first trispecific antibody to enter the clinic. (akesobio.com)

These programs illustrate an important strategic shift: Akeso is attempting to build an oncology franchise in which ivonescimab and cadonilimab function as immunotherapy backbones that can be combined with internally developed ADCs, multispecific antibodies and other targeted therapies.

Autoimmune and Non-Oncology Pipeline

Although oncology remains the company’s primary business, Akeso has increasingly developed a diversified immunology franchise.

The clinical portfolio includes ebdarokimab, gumokimab and manfidokimab as well as AK139, an IL-4Rα/ST2 bispecific antibody.

In February 2026, AK139 received clearance for seven Phase II studies covering COPD, severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, chronic rhinosinusitis with nasal polyps, moderate-to-severe atopic dermatitis and prurigo nodularis. (akesobio.com)

The diversification provides Akeso with potential long-term growth drivers outside the increasingly competitive Chinese oncology market.

Latest Clinical and Commercial Developments

Several developments in 2026 have materially strengthened Akeso’s position:

Date	Development	Significance
Aug. 26, 2026	HARMONi-GI1 met OS, PFS and ORR endpoints in 1L biliary tract cancer	Potential major new indication for ivonescimab
Aug. 21, 2026	AK157D1 cleared for Phase I	Third Akeso next-generation ADC enters clinical development
Aug. 12, 2026	Ivonescimab + chemotherapy approved for 1L squamous NSCLC	Third China lung cancer indication for ivonescimab
Aug. 10, 2026	First patient dosed in AK146D1 + ivonescimab Phase II breast cancer study	Advances IO 2.0 + ADC 2.0 strategy
Jun. 2026	Gumokimab approved for plaque psoriasis	Expands commercial immunology franchise
Mar. 2026	AK150 entered clinical development	First Akeso trispecific antibody in clinic
2025–26	Multiple ivonescimab and cadonilimab Phase III programs advance globally	Expands Akeso beyond China

Perhaps the most important near-term driver remains ivonescimab. Akeso reported in March 2026 that its development program comprised 15 Phase III studies, including five global studies and seven head-to-head trials against PD-1/PD-L1 therapies. (akesobio.com)

Commercial Performance

Akeso has transitioned from a clinical-stage biotechnology company into a substantial commercial biopharmaceutical business.

For 2025, commercial sales reached approximately RMB3.03 billion, an increase of 51.5% year over year. Total reported revenue was approximately RMB3.06 billion. Growth was primarily driven by cadonilimab and ivonescimab, alongside expansion of Akeso’s other marketed medicines. (akesobio.com, financialfilings.com)

Another important commercial development was reimbursement. By the end of 2025, approved indications for Akeso’s five independently commercialized innovative medicines had entered China’s National Reimbursement Drug List, significantly expanding patient access. (akesobio.com)

Financial/Commercial Metric	FY2025
Commercial sales	RMB3.033 billion
YoY commercial-sales growth	51.5%
Total revenue	RMB3.056 billion
Cash, cash equivalents, time deposits & financial products	RMB9.172 billion
Commercial-stage status	Fully integrated commercial biopharma

Financing and Funding Status

Unlike an early-stage biotechnology company dependent primarily on venture financing, Akeso is now funded through a combination of commercial product revenue, public equity, licensing income and bank financing.

The company went public in Hong Kong in April 2020.

Akeso subsequently strengthened its balance sheet through additional equity placements. An October 2024 share placement generated approximately HK$1.92 billion in net proceeds, primarily earmarked for global and Chinese clinical development, commercialization and general corporate purposes. (hkexnews.hk)

A substantially larger placement followed in 2025. Akeso issued 23.55 million new shares at HK$149.54 per share. The transaction represented approximately 2.6% of the company’s pre-placement issued share capital. (hkexnews.hk)

By December 31, 2025, Akeso reported approximately RMB9.17 billion in cash, cash equivalents, time deposits and financial products, providing substantial resources for its expanding global Phase III program and next-generation pipeline. (financialfilings.com)

Accordingly, Akeso can now be characterized as a well-capitalized, revenue-generating public biotechnology company, rather than a venture-backed development-stage biotech.

Major Partnerships and Licensing Agreements

Akeso has pursued partnerships both to globalize its pipeline and to increase commercial reach.

Partner	Asset / Relationship	Structure / Status
Summit Therapeutics	Ivonescimab (AK112)	Exclusive development/commercial rights in U.S., Canada, Europe and Japan; deal value originally announced at up to US$5 billion
Pfizer / Summit	Ivonescimab + Pfizer ADCs	Clinical collaboration evaluating combinations across multiple solid tumors
Merck & Co.	AK107 / CTLA-4 antibody	Out-licensed in 2015; potential consideration up to US$200 million
Sino Biopharmaceutical / Chia Tai Tianqing	Penpulimab (AK105)	Co-development/co-commercialization; CTTQ-Akeso joint venture
Jumpcan Pharmaceutical	Ebronucimab	Exclusive commercialization arrangement announced in 2026
INOVIO	Oncology combination research	Clinical collaboration involving combination treatment for glioblastoma

The most economically and strategically important partnership is the Summit Therapeutics–ivonescimab agreement. Akeso out-licensed ivonescimab rights in the United States, Canada, Europe and Japan in December 2022 in a transaction with potential consideration of up to US$5 billion. (akesobio.com, akesobio.com)

The partnership effectively gives Akeso exposure to ivonescimab’s global commercial opportunity while allowing Summit to lead development and commercialization across major Western markets.

Summit subsequently entered a clinical collaboration with Pfizer in 2025 to study ivonescimab together with several Pfizer ADCs across multiple solid tumors. (akesobio.com)

Competitive Position and Outlook

Akeso has evolved from a China-focused antibody biotechnology company into one of the country’s more internationally visible innovative biopharmaceutical companies.

Its competitive position rests on three major pillars.

First is its bispecific antibody franchise, led by ivonescimab and cadonilimab. Both drugs reached the market ahead of many competing next-generation immunotherapies and are being expanded through large registrational programs.

Second is its increasingly diversified IO 2.0 + ADC 2.0 pipeline. Instead of relying solely on its existing checkpoint bispecifics, Akeso is building internally controlled ADC, trispecific and TCE technologies that could generate both standalone medicines and combination regimens.

Third is its growing commercial and financial scale. More than RMB3 billion in 2025 commercial sales and a balance of more than RMB9 billion in cash, deposits and financial products provide considerably greater internal funding capacity than is typical for a development-stage Chinese biotechnology company. (financialfilings.com)

Ivonescimab remains the company’s most important value driver. Its head-to-head development strategy against established checkpoint inhibitors is unusually ambitious, and success across additional tumor types could establish the PD-1/VEGF mechanism as an important new immuno-oncology class.

At the same time, Akeso is deliberately reducing its dependence on a single platform. ADCs such as AK146D1, AK138D1 and AK157D1, the AK150 trispecific antibody, immunology programs such as AK139, and the expanding commercial autoimmune portfolio create additional potential growth engines.

Overall, Akeso has moved beyond the traditional definition of a China biotech startup. It is increasingly operating as a fully integrated global biopharmaceutical company, with internally discovered products, commercial infrastructure, substantial product revenue, a large late-stage pipeline and international licensing and clinical-development partnerships.

COMPANY NEWS

References

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