On March 27 , 2026 , Zhejiang Bioray Bio-Pharmaceutical Co., Ltd. (hereinafter referred to as "Bioray Bio-Pharmaceutical") and UCB, a global biopharmaceutical company, jointly announced that their biologic * (trade name: Bejule® ) , was approved by the National Medical Products Administration ( NMPA ) of China on the same day for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy , and for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne paradoxica) who have not responded well to conventional systemic therapy . This approval marks the official expansion of this first-line IL-17A/F dual-target biologic agent , the world's first and currently the only one approved in China, from the field of rheumatology and immunology to the field of dermatology, bringing new treatment options to millions of patients in China suffering from these two chronic, relapsing, and often physically and mentally exhausting inflammatory skin diseases.

Continuously promote the improvement of psoriasis treatment standards and help patients achieve deep skin lesion clearance.

Currently, there are over 7 million psoriasis patients in China [1] . Among them, plaque psoriasis is the most common type [2] . Patients not only suffer from physical symptoms such as itching, scaling, and pain, but the stigma and social barriers brought about by the disease also have a profound impact on their quality of life, work ability, and mental health. [3][4]

Professor Jianzhong Zhang , Director of the Department of Dermatology at Peking University People's Hospital and Leading PI of the Phase III BE SHINING study of bicizumab ( PsO) in China, stated: "Psoriasis is a chronic, relapsing, systemic inflammatory disease. Although the application of biologics has brought significant improvements, some patients still face the challenge of incomplete clearance of skin lesions or difficulty in maintaining efficacy. Especially for many moderate to severe patients, existing treatments still have limitations in achieving and maintaining deep clearance of skin lesions. Therefore, we need innovative options that can control inflammation more precisely and persistently."

Global multicenter phase III clinical trial data showed that with bicizumab treatment, about 90% ( 85%-91% ) of patients achieved clear or nearly cleared skin lesions at week 16 ; of these, about 60% ( 59%-68% ) of patients achieved the goal of complete clearing of skin lesions ( PASI 100 ), and the response was rapid and could last for up to one year [5][6] . Long-term data also showed that the vast majority of patients maintained a high level of clinical response over four years. [7]

Professor Yang Bin , Dean of the Dermatology Hospital of Southern Medical University and Chief Physician of the Department of Dermatology pointed out: "The unique IL-17A/F dual-target mechanism of bicizumab directly targets the core of inflammation, bringing new treatment options to the clinic. In clinical trials, we observed that bicizumab not only has a rapid onset of action, with significant improvement visible after a single dose, but more importantly, its ability to deeply clear skin lesions is expected to help more psoriasis patients achieve and maintain the treatment goal of complete lesion clearance. This is of great significance for improving patients' quality of life and reducing the long-term burden of the disease."

Breaking the deadlock in the treatment of hidradenitis suppurativa and filling long-standing unmet needs.

Hidradenitis suppurativa ( HS ) is a chronic, relapsing, painful and potentially disabling inflammatory skin disease. The main symptoms include nodules, abscesses and purulent fistulas, which usually appear in the armpits, groin and buttocks. Patients experience disease flare-ups and severe pain, which seriously affect their quality of life [8][9][10] . In September 2023 , the National Health Commission of China included HS in the second batch of rare disease catalogs in China. According to statistics, there are currently about 500,000 HS patients in China [11] , with the peak incidence concentrated in young adults aged 20 to 40 [12] . In Asia, the male-to-female ratio of HS patients is ( 1.6 to 2.5 ) :1 [13] .

Professor Gao Xinghua, Director of the Institute of Dermatology and Cosmetic Dermatology at China Medical University, said: " The treatment of HS has long been a tough nut to crack in the field of dermatology. It takes an average of 10.2 years from the onset of symptoms to diagnosis. More than 70 % of patients have already progressed to moderate to severe disease when diagnosed, resulting in irreversible scarring and destruction of body structure [14] . Repeated abscesses, pain and purulent discharge not only bring great physical suffering, but also seriously damage the mental health and social life of patients. Traditional treatment methods are difficult to meet the needs of long-term disease control. Clinically, there is an urgent need for innovative treatment plans that can accurately target the core pathways of the disease and achieve long-term effective control."

Global multicenter phase III clinical trial data * showed that, compared with placebo, a higher proportion of patients treated with bicizumab achieved a 50% or greater improvement in signs and symptoms of HS at week 16 ( HiSCR50 ), and the efficacy continued until week 48 [15] . The latest three-year follow-up data further showed that bicizumab can sustainably improve patients' clinical response and continuously promote the healing of purulent sinus tracts, bringing patients stable and continuously improving clinical benefits.

Professor Wang Baoxi, Chief Physician of the Department of Dermatology at the Plastic Surgery Hospital of the Chinese Academy of Medical Sciences, pointed out: "As the world's first and currently the only approved IL-17A/F dual-target inhibitor for hepatitis B (HS) , the approval of bicizumab marks a new stage in HS treatment with dual-target anti-inflammatory therapy. International clinical data show that bicizumab can not only rapidly control acute inflammation such as abscesses and nodules, but more importantly, long-term follow-up results have confirmed its sustained effects in relieving pain and promoting sinus tract healing. This in-depth and sustained clinical response brings real hope for long-term control and improved quality of life to patients who have long suffered from recurrent disease."

Focusing on empowerment , delivering on promises through innovation and accessibility.

With the continued expansion of Bejugal® 's indications in the immunotherapy field, Bory Biotech's foundation in the domestic market is becoming increasingly solid. This approval of a new indication further enriches the company's product portfolio in the field of immunotherapy. The value of innovation lies in benefiting patients; Bory Biotech will always be committed to promoting the clinical application of immunotherapy achievements, working with UCB to effectively improve patient access to medication, and ensuring that cutting-edge immunotherapy results can truly reach and serve more Chinese patients.

Mr. Liu Min, CEO of BioBio, stated, “Congratulations on the approval of Bejule® for two new indications in the immunology field. Following the collaboration between BioBio and UCB in December 2024 regarding the commercialization of bicizumab, this approval will further enhance BioBio’s product portfolio in the field of autoimmune and inflammatory diseases. It also provides new treatment options for millions of psoriasis patients in China and offers a breakthrough solution for patients with hidradenitis suppurativa, who have long faced limited treatment options and a heavy disease burden. BioBio will fully leverage its core advantages in commercial operations to accelerate market access and clinical application of this innovative therapy, effectively improve drug accessibility, and enable more patients with autoimmune diseases in urgent need of treatment to access and afford this globally leading innovative drug.”

UCB China General Manager Ma Yajun stated: “ The simultaneous approval of Bezoar® for both indications marks another significant milestone in UCB China’s development. This not only confirms the enormous potential of the IL-17A/F dual-target mechanism in various immune-mediated diseases, but also demonstrates our firm commitment to ‘deepening our presence in China’ and accelerating the introduction of global innovative achievements. Enabling Chinese patients to access globally leading innovative drugs simultaneously has always been our goal. We deeply understand that diseases bring not only physical suffering to patients and their families, but also immense emotional and life pressures. Facing the vast population of dermatology patients in China and their urgent needs, we hope that the arrival of Bezoar® will bring more patients and their families the joy of clean skin and the confidence to return to a normal life. ”

* In December 2024 , BioBio signed a commercial promotion cooperation agreement with UCB for bicizumab injection ( trade name : Bejule® ) in the Chinese market.

* Two global multicenter phase III clinical trials included data from 1,014 participants from countries and regions including Europe, the United States, and Japan.

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• Bimekizumab ( Bimekizumab® ) is approved in China for the following purposes: adult patients with active ankylosing spondylitis ( AS ) who have not responded to or are intolerant of conventional therapy ; adult patients with active radionegative axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (as indicated by elevated C- reactive protein ( CRP ) and / or magnetic resonance imaging ( MRI )) who have not responded to or are intolerant of nonsteroidal anti-inflammatory drugs (NSAIDs ) ; adult patients with moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy; and adult patients with moderate to severe hidradenitis suppurativa (acne paradoxica) who have not responded to conventional systemic therapy.

For complete prescription information and safety instructions, please refer to the individual product instructions.
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