Chinese biotech company Akeso has emerged as a global leader in bispecific antibody development, transforming from a modest $3 million startup in 2012 to a $15 billion enterprise that symbolizes China's biotech sector evolution. Founded by CEO Michelle Xia and three co-founders, Akeso has grown to over 3,400 employees across drug discovery, development, manufacturing, and commercialization.
Breakthrough Bispecific Portfolio
Akeso has achieved a significant milestone as the only biopharma company to have two approved immuno-oncology bispecifics. Cadonilimab, targeting PD-1 and CTLA-4 pathways, became "the world's first cancer immunotherapy bispecific antibody" when China's health authority approved it for cervical cancer patients in June, with insurance coverage included. The drug has also received approval for gastric cancer treatment.
The company's second bispecific, ivonescimab, targets both PD-1 signaling and the VEGF cascade. This dual mechanism blocks cancer cells from evading the immune system while inhibiting tumor blood vessel formation. In April, ivonescimab won Chinese approval as a first-line treatment for patients with PD-L1-positive non-small cell lung cancer (NSCLC), marking it as the first-ever PD-1/VEGF therapy to reach market.
Global Partnership and Clinical Success
Akeso's international recognition peaked with its December 2022 partnership with California-based Summit Therapeutics, which paid $500 million upfront plus up to $5 billion in potential milestones. This collaboration centers on ivonescimab, which demonstrated superiority over Merck's Keytruda in a Phase III NSCLC study announced in September.
Despite this clinical success, ivonescimab faced regulatory challenges in the U.S. after missing the overall survival target in a global Phase III study, which the FDA deemed crucial for approval. Summit continues development with ongoing HARMONi-3 and HARMONi-7 studies comparing the bispecific against Keytruda, expected to complete in 2028 and 2029, respectively.
Expanding Pipeline and U.S. Presence
Beyond its bispecific portfolio, Akeso has achieved U.S. market entry with penpulimab, approved in April for recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. The approval covers both combination therapy with cisplatin or carboplatin and gemcitabine as first-line treatment, and monotherapy for patients who progressed after platinum chemotherapy.
The company's pipeline includes AK146D1, a bispecific antibody-drug conjugate (ADC) that simultaneously targets two cancer markers while carrying a toxic payload, currently being studied in advanced cancers both in China and internationally. Additional assets include bispecific antibodies targeting PD-1/LAG-3 and TIGIT/TGFβ, along with dual-payload ADCs.
Beyond Oncology Innovation
Akeso is leveraging its bispecific technology beyond cancer into autoimmune and neurodegenerative diseases. In February, Chinese regulators accepted the investigational new drug application for AK139, described as "the world's first IL-4R/ST2 bispecific antibody" to enter clinical testing for respiratory and skin conditions.
Looking ahead, Xia revealed plans to expand beyond bispecifics into other modalities including mRNA and siRNA therapies, as well as cell and gene editing technologies.
China's Biotech Transformation
Akeso's journey reflects the broader transformation of China's pharmaceutical industry. When the company launched in 2012, China's biopharmaceutical sector was "still in its infancy," dominated by generic drug manufacturing with "very few engaged in innovative drug discovery," according to Xia.
The early years proved challenging, with limited talent, capital, and infrastructure. Xia and her team faced skepticism from doctors, investors, and regulators, working from a small rented office space and occasionally going without salary.
The transformation accelerated after 2015 when the Chinese government updated drug regulations to meet international standards, enabling domestic companies to compete globally. Private equity and venture capital investment grew substantially, providing crucial financial support for innovation.
Today, China offers what Xia describes as a "conducive ecosystem for biopharma innovation," with an expanded talent pool, mature capital markets, and a large patient population supporting clinical trials. The country provides "rich clinical resources essential for drug development" with "clinical outcomes as well as regulatory reviews that meet the rigorous requirements of markets such as the United States and Europe."
