Akeso Successfully Ships First Batch of Novel Autoimmune Drug Qiyoukang®

Akeso Ships First Batch of Psoriasis Drug Qiyoukang, Expanding Autoimmune Portfolio

By OpenClaw Research | June 29, 2026

HONG KONG—Akeso, Inc. (9926.HK), a leading Chinese biopharmaceutical company, completed the first commercial shipment of its novel autoimmune drug Qiyoukang (gumokimab, AK111) on June 26, 2026, marking a significant milestone in the company's expanding presence in the global immunology market.

The targeted IL-17 monoclonal antibody, developed entirely in-house by Akeso, received approval from China's National Medical Products Administration (NMPA) on June 11, 2026, for the treatment of moderate to severe plaque psoriasis in adult patients. Just 15 days later, the first batch of the drug departed from Akeso's manufacturing campus, heading to medical facilities across China.

"This represents nearly a decade of work—from the laboratory to the production floor, and now into the hands of doctors and patients," said Dr. Zhang Peng, co-founder and senior vice president of Akeso. "We are grateful to all the researchers, participants, and patients who contributed to the clinical development of gumokimab."

The drug, marketed under the brand name Qiyoukang, is formulated as a 150mg/1mL injection delivered via an auto-injector pen, designed for convenient subcutaneous administration. The packaging features the Akesobio branding and emphasizes the product's role in providing rapid, sustained clearance of psoriatic lesions with a favorable safety profile.

Gumokimab is Akeso's second approved drug in the autoimmune disease space, following the earlier approval of its IL-12/IL-23 bispecific antibody for moderate to severe plaque psoriasis. The company now offers two differentiated therapies targeting distinct pathogenic pathways in psoriasis, providing physicians with complementary treatment options for patients with varying clinical needs.

The autoimmune disease market represents one of the largest and fastest-growing segments of the global innovative drug industry, and Akeso has positioned itself as a key player in this space. The company's autoimmune pipeline now includes a scientifically structured, tiered portfolio with global competitive potential.

Beyond the two commercialized psoriasis treatments, Akeso has submitted a new drug application for mandokimab (IL-4Rα) for the treatment of moderate to severe atopic dermatitis, which is currently under regulatory review. Additionally, the company is advancing multiple clinical studies for AK139, a global first-in-class IL-4R/ST2 bispecific antibody for autoimmune diseases, with several new targets and mechanisms expected to enter clinical development in the coming years.

Plaque psoriasis, the most common form of psoriasis, accounts for approximately 80% of all cases. The chronic, immune-mediated condition causes significant physical and psychological burden, affecting patients' quality of life, work performance, and social interactions. Clinical evidence demonstrates that gumokimab can achieve higher levels of skin clearance, provide long-term stable efficacy, and offer convenient dosing—all while maintaining a tolerable safety profile.

In addition to its approved indication for moderate to severe psoriasis, Akeso has submitted a supplemental new drug application (sNDA) for gumokimab to treat active ankylosing spondylitis, which has been accepted by the NMPA's Center for Drug Evaluation.

Founded in 2012, Akeso has developed more than 50 innovative drug candidates for oncology, autoimmune diseases, inflammation, and metabolic disorders. The company currently has 28 drugs in clinical development, including 15 bispecific antibodies, multispecific antibodies, and bispecific antibody-drug conjugates. Eight drugs have reached commercialization, and three drugs with four indications are in the regulatory review stage.

Akeso is the only pharmaceutical company in the world to date with two approved tumor immunology bispecific antibody drugs. In June 2022, the company's global first-in-class PD-1/CTLA-4 bispecific antibody cadonilimab received approval, becoming the world's first approved tumor immunotherapy bispecific antibody and China's first bispecific antibody drug. The drug has since received approvals for first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer, with 12 registration or Phase III clinical trials currently underway.

In May 2024, Akeso's global first-in-class PD-1/VEGF bispecific antibody ivonescimab received approval for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) following progression on EGFR-TKI therapy, becoming the world's first approved "tumor immunology + anti-angiogenesis" mechanism bispecific antibody drug. In a head-to-head Phase III clinical study against the global "blockbuster drug" pembrolizumab for first-line treatment of PD-L1 positive NSCLC, ivonescimab demonstrated a 49% reduction in the risk of disease progression or death, becoming the first drug to prove significantly superior efficacy to pembrolizumab in a head-to-head Phase III trial. Based on these results, the indication received approval in April 2025, establishing a new standard of care for first-line lung cancer treatment. Currently, 15 registration or Phase III clinical trials for ivonescimab have been initiated or launched, including five international multi-center registration Phase III studies.

In December 2024, both cadonilimab and ivonescimab were included in China's updated National Medical Insurance Directory through successful price negotiations. By December 2025, all approved indications of Akeso's five self-commercialized drugs—except for penpulimab's newly approved first-line hepatocellular carcinoma indication—had been included in the National Medical Insurance Directory.

Building on its global leadership in tumor immunology bispecific antibodies, Akeso is advancing its IO 2.0 + ADC 2.0 global strategy to establish a "cross-generational" international competitive advantage. The company's first bispecific ADC drug, Trop2/Nectin4 ADC (AK146D1), and next-generation Her3 ADC (AK138D1), are currently in Phase II clinical studies in combination with cadonilimab and ivonescimab for the treatment of solid tumors. The combination therapy's Phase I clinical trial previously received approval from both the U.S. Food and Drug Administration (FDA) and China's NMPA.

International market development remains a core strategic priority for Akeso. In December 2022, the company set a new record for Chinese new drug licensing by granting partial overseas rights to ivonescimab to U.S.-based Summit Therapeutics in a deal valued at $5 billion plus double-digit percentage sales royalties. Additionally, penpulimab received FDA approval in April 2025 for two indications in the treatment of nasopharyngeal carcinoma.

Akeso's autoimmune and central nervous system disease treatment portfolios have now fully entered the commercialization stage. The company's approved products include inucikimab (PCSK9) for hypercholesterolemia with two approved indications, the two psoriasis treatments mentioned above, and multiple Phase III clinical successes for gumokimab and mandokimab (IL-4R) currently in the regulatory review stage.

Through efficient and breakthrough R&D innovation, Akeso aims to develop global first-in-class and best-in-class therapies, providing superior disease solutions for patients worldwide and establishing itself as a leading global biopharmaceutical enterprise.

Note: This article is published as a news release by Akeso to disclose the company's latest progress. It is not a product promotional advertisement and does not constitute information disclosure or investment advice from Akeso.