Akeso Biopharma

What Akeso Biopharma does

Akeso Biopharma (康方生物, HKEX: 9926) is a Chinese biopharmaceutical company founded in 2012 by Dr. Michelle Xia in Zhongshan, Guangdong, and listed on the Hong Kong Stock Exchange since April 2020. The company operates an end-to-end drug discovery and development platform branded as the ACE Platform, which integrates AI-driven drug discovery with multiple proprietary technology stacks including Tetrabody bispecific/multispecific antibody technology, Dual-Shield ADC technology, Dual-Lock TCE, Tissue-Smart siRNA, cell therapy, and Flex-Nano mRNA. Across oncology, autoimmune/inflammatory, metabolic, and neurological disease areas, Akeso has advanced more than 50 innovative drug candidates into development, with 24 in clinical stage and 7 approved for marketing: cadonilimab (PD-1/CTLA-4 bispecific, world's first approved tumor immunotherapy bispecific), ivonescimab (PD-1/VEGF bispecific, world's first in class), penpulimab (PD-1 monoclonal antibody with FDA approval for nasopharyngeal cancer), ebdarokimab (PCSK9 inhibitor for hypercholesterolemia), yiruqizimab (IL-12/IL-23 bispecific for psoriasis), gumokimab (IL-17A for psoriasis), and mandokimab (IL-4R for atopic dermatitis).

The company's commercial model is dual-track. In China, Akeso sells directly through a hospital sales force covering all provinces, with all five commercialized oncology products listed on the National Reimbursement Drug List (NRDL), driving RMB 3,033.1 million in FY2025 sales revenue (a 51.48% YoY increase). Internationally, the company out-licenses assets to global partners — most notably Summit Therapeutics for ivonescimab in a deal worth up to $5 billion plus double-digit royalties, which is funding the HARMONi global Phase III program and an FDA BLA with a November 14, 2026 PDUFA date. Additional strategic partnerships include Pfizer (ADC combination clinical trials via Summit), INOVIO (glioblastoma combination with cadonilimab), Shanghai Pharmaceuticals (China distribution), and multiple Chinese collaborators for combination therapy development.

Akeso's lead clinical assets have produced differentiated data, including a head-to-head Phase III win against Merck's pembrolizumab (Keytruda) in first-line NSCLC (PFS HR=0.51, 49% reduction in disease progression/death risk), 34% reduction in death risk versus tislelizumab combinations in squamous NSCLC, and 80% objective response rates in AML with ligufalimab combinations. The pipeline further extends into next-generation modalities including the trispecific antibody AK150, bispecific ADCs (AK146D1 Trop2/Nectin4, AK138D1 HER3), a personalized mRNA cancer vaccine (AK154 for pancreatic cancer), and disease-modifying Alzheimer's bispecific (AK152). Akeso's value proposition rests on first-in-class bispecific antibodies addressing PD-L1 low/negative patients and IO-resistant tumors where conventional PD-1 monotherapy has limited efficacy.

Name

Akeso Biopharma

Legal name

中山康方生物医药有限公司 (Zhongshan Akeso Biopharmaceutical Co., Ltd.)

Website

https://akesobio.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Akeso Biopharma is a Chinese biopharmaceutical company (HKEX: 9926) that discovers, develops, and commercializes innovative antibody therapeutics in oncology, autoimmune, and metabolic diseases, with two globally first-in-class approved bispecific antibodies — cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF) — sold in China via hospitals and NRDL and licensed internationally.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals / Oncology Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Bispecific & Multispecific Antibodies (HLAAAAAF)

akta.pro secondary industries

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI), Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE)

Keywords

• Bispecific antibodies
• Oncology therapeutics
• Antibody-drug conjugates
• Autoimmune therapeutics
• Immunotherapy drugs

Headquarters

HQ city

Zhongshan

HQ country

China

HQ region

Asia

Offices7 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Product Sales (China): Direct commercial sales of approved innovative drugs in China including cadonilimab (开坦尼), ivonescimab (依达方/依沃西), penpulimab (安尼可), and non-oncology drugs like inulizumab (伊喜宁) and yiruoximab (依若奇). Products are sold through hospital channels and covered under China's National Reimbursement Drug List (NRDL).
2. Licensing and Partnership Revenue: Revenue from out-licensing deals including the $500 million upfront payment from Summit Therapeutics for ivonescimab (up to $5 billion total potential deal value), and potential milestone payments and royalties from international partners.
3. Milestone Payments: Potential future revenue from regulatory and commercial milestone payments tied to clinical development progress, FDA approvals, and sales performance under partnership agreements.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Akeso Biopharma is a biopharmaceutical company that discovers, develops, manufactures, and commercializes innovative antibody-based therapeutics. Its portfolio centers on first-in-class bispecific antibodies (ivonescimab, cadonilimab) and antibody-drug conjugates (ADCs) for oncology, autoimmune, inflammatory, and metabolic diseases, built on the proprietary ACE Platform combining Tetrabody bispecific technology, Dual-Shield ADC, AI-driven drug discovery, and mRNA capabilities. The company sells approved products directly through hospitals in China under NRDL reimbursement and out-licenses international rights to partners like Summit Therapeutics.

Product overview

Akeso Biopharma is a biopharmaceutical company developing innovative antibody drugs across oncology, autoimmune, inflammatory, metabolic, and neurological diseases. The company's portfolio centers on two approved tumor immunotherapy bispecific antibodies: ivonescimab (PD-1/VEGF) and cadonilimab (PD-1/CTLA-4), both representing first-in-class global innovations. Akeso has expanded into ADC technology (AK146D1, AK138D1), mRNA therapeutics (AK154), and novel bispecific/trispecific antibodies (AK150, AK139, AK130). The non-oncology portfolio includes approved products ebdarokimab (PCSK9), yiruqizimab (IL-12/IL-23), gumokimab (IL-17), and mandokimab (IL-4R), with multiple candidates in late-stage development. The company operates through its ACE Platform combining AI-powered drug discovery, Tetrabody bispecific technology, ADC platforms, and mRNA capabilities.

Differentiator

Problem solved

Functional benefit

Brands

• 开坦尼® (Kaitanni®): Brand name for cadonilimab (卡度尼利单抗), the world's first approved PD-1/CTLA-4 bispecific antibody for tumor immunotherapy
• 依达方® (Yidafang®)
• 安尼可® (Annike®)
• 伊喜宁® (Yixinin®)
• 爱达罗® (Aidaluo®)

Products and services

• Ivonescimab (依沃西 / 依达方)
• Cadonilimab (开坦尼 / 卡度尼利)
• Penpulimab (安尼可 / 派安普利)
• Ebdarokimab (伊喜宁 / 伊努西)
• Yiruqizimab (依若奇 / 爱达罗)
• Gumokimab (古莫奇)

Quantifiable outcome

• Reduced disease progression/death risk by 49% (PFS HR=0.51) vs Keytruda in first-line NSCLC
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature4 records

Partnerships

Seven partnerships are on record, tiered minor and core.

• INOVIO PharmaceuticalsminorStrategic or Co-development Partner · 4 March 2026Akeso and INOVIO announced clinical trial collaboration to evaluate cadonilimab (PD-1/CTLA-4 bispecific) combined with INO-5412 (DNA immunotherapy) for glioblastoma treatment. The combination will be studied in the INSIGhT Phase II adaptive platform trial at Dana-Farber Cancer Institute, with dosing expected to begin in H2 2026.
• Zhengzhou University First Affiliated HospitalminorStrategic or Co-development Partner · 17 September 2025Akeso and Zhengzhou University First Affiliated Hospital entered strategic cooperation focusing on medical research, talent development, and clinical collaboration. The partnership aims to accelerate clinical trial execution and research translation.
• Yaopharma (药捷安康)minorStrategic or Co-development Partner · 16 April 2025Akeso entered strategic cooperation with Yaopharma to jointly advance cadonilimab/ivonescimab combined with Tinengotinib (VEGFR/PDGFR/c-Met inhibitor) for treatment of advanced liver cancer. Akeso provides clinical trial supply of bispecific antibodies and clinical operation support.
• Genovac (复诺健)minorStrategic or Co-development Partner · 16 April 2025Akeso partnered with Genovac to advance ivonescimab in combination with VG201 (oncolytic virus) for treatment of colorectal cancer liver metastasis. This combination explores synergistic mechanisms between immunotherapy and oncolytic virus therapy.
• Shanghai Pharmaceuticals (上药控股)minorChannel Partner/ Reseller/ Distributor · 10 April 2025Akeso partnered with Shanghai Pharmaceuticals to promote high-quality commercialization of innovative drugs including cadonilimab and ivonescimab. The partnership leverages Shanghai Pharma's distribution network for improved market access.
• PfizercoreStrategic or Co-development Partner · 1 February 2025Summit Therapeutics (Akeso's partner) entered clinical trial collaboration with Pfizer to evaluate ivonescimab in combination with Pfizer's antibody-drug conjugates (ADCs) across multiple solid tumor types. This collaboration leverages Akeso's bispecific antibody with Pfizer's ADC portfolio.
• Summit TherapeuticscoreOEM/ Whitelabel/ Licensing Partner · 6 December 2022Akeso out-licensed ivonescimab (PD-1/VEGF bispecific antibody) to Summit Therapeutics for development and commercialization outside Greater China. Summit paid $500 million upfront with potential total deal value of up to $5 billion plus double-digit royalties on sales. Summit is conducting multiple global Phase III trials (HARMONi, HARMONi-3, HARMONi-7) and filed BLA with FDA (PDUFA Nov 14, 2026).

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Innovent Biologics: Leading Chinese biopharmaceutical company developing innovative oncology biologics including PD-1 inhibitor sintilimab (Tyvyt) and bispecific antibodies. Directly comparable to Akeso as a China-based, oncology-focused biologics innovator with NRDL-covered commercial products and out-licensing partnerships.
• BeiGene: Global oncology-focused Chinese biopharmaceutical company with approved PD-1 inhibitor tislelizumab and BTK inhibitor zanubrutinib. Directly comparable given China origin, PD-1 franchise, NRDL access, and US/global commercialization footprint that overlaps with Akeso's ivonescimab launch through Summit.
• Junshi Biosciences: Chinese biopharma that developed toripalimab, one of China's first approved PD-1 antibodies. Direct competitor in the Chinese PD-1/IO space with shared NRDL dynamics and overlapping oncology indications relevant to Akeso's cadonilimab and ivonescimab.

Broad incumbents

• Regeneron Pharmaceuticals: Global leader in bispecific antibodies (Dupixent via Sanofi partnership, linvoseltamib) and antibody platform technologies. Comparable as a mature global benchmark for the bispecific antibody commercial opportunity Akeso is pursuing, particularly in immunology and oncology.
• Eli Lilly: Global pharmaceutical leader with strong bispecific antibody pipeline and competing oncology/immunology programs. Comparable as a global pharma incumbent whose commercial scale Akeso's Summit-partnered ivonescimab will compete against in NSCLC and other indications.
• Merck & Co. Maker of Keytruda (pembrolizumab), the global PD-1 standard-of-care against which Akeso's ivonescimab has demonstrated head-to-head superiority. Critical competitor whose commercial response to ivonescimab approval will shape the PD-1/VEGF commercial opportunity.
• Pfizer: Global pharma with major oncology and ADC franchises (Padcev, Adcetris). Directly relevant as Akeso's clinical collaboration partner (ivonescimab + ADC combinations) and as a benchmark for ADC commercial potential through AK146D1 and AK138D1 programs.

Emerging players

• Genmab: Differentiated bispecific antibody platform company (DuoBody technology) with multiple partnered programs including epcoritamab and talquetamab. Comparable as a pure-play bispecific antibody innovator and platform licensor, though smaller and more partnered than Akeso.
• MacroGenics: Clinical-stage biopharma specializing in bispecific antibodies (DART platform) in oncology. Comparable as a focused bispecific antibody developer targeting similar IO mechanisms, though at earlier commercialization stage than Akeso.

Regional players

• Hansoh Pharmaceutical: Major Chinese pharmaceutical company with oncology and biologics franchises including innovative antibodies. Comparable as a China-domestic innovative drug developer with overlapping therapeutic areas (lung cancer, autoimmune) and NRDL commercial dynamics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/AkesoInc
• LinkedInlinkedin.com/company/akeso-biopharma-inc.

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries3 records

Funding overview

Funding rounds6 records

Investors16 records

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M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Akeso Biopharma