Innovent Biologics announced that China's National Medical Products Administration (NMPA) has approved PECONDLE (picankibart injection), a recombinant anti-interleukin-23p19 subunit (IL-23p19) antibody, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systematic therapy.

This approval was based on a pivotal registrational Phase 3 clinical trial, CLEAR-1 (NCT05645627), which evaluated the efficacy and safety of picankibart in Chinese participants with moderate-to-severe plaque psoriasis. The study results showed that at week 16, the proportion of participants achieving PASI 90 (80.3%) and sPGA 0/1 (93.5%) was higher in the picankibart group than in the placebo group (2.0% and 13.1%, p < 0.0001 for both).

At week 52, the proportions of participants achieving PASI 90 and sPGA 0/1 in the picankibart 100 mg and 200 mg q12w maintenance treatment groups were stable and maintained at a high level. The proportion of participants who achieved PASI 75, PASI 100, sPGA 0, and DLQI 0/1 was higher in the picankibart group than in the placebo group (p < 0.0001), and picankibart showed varying degrees of improvement in psoriasis in special areas (scalp, nail, palmoplantar and perineal).

The overall safety of picankibart was favourable. The most common Adverse Event (AE) was upper respiratory tract infection, which was consistent with the safety profile of other IL-23p19 agents. No new safety signals were identified.

Professor Shi Yuling, Principal Investigator, CLEAR-1, Shanghai Skin Disease Hospital, stated, "Psoriasis is a lifelong disease that has a profound impact on patients' physical and mental health and quality of life. Although there is no radical cure, it is crucial to select more effective and individualised treatment options for patients to control the disease, reduce the risk of comorbidities, maintain long-term efficacy, and comprehensively improve quality of life. Current evidences have suggested that antibodies targeting IL-23p19 have significant advantages in long-term efficacy maintenance and treatment convenience. As the first IL-23 p19 monoclonal antibody independently developed by a Chinese enterprise, picankibart has shown significant short-term efficacy and maintained long-term efficacy in CLEAR-1; administration once every 12 weeks during the maintenance period further improves the medication convenience and compliance of patients; while bringing significant clinical benefits and improvement in quality of life, it also shows favourable safety. The investigators of this study and I are pleased that picankibart's pivotal clinical study results in psoriasis have received approval from national regulatory authorities, leading to its market authorisation. This brings a promising new treatment option for patients with psoriasis in China."

In recent years, the treatment of moderate-to-severe plaque psoriasis has evolved from traditional systemic therapies to a new era of precision therapy driven by biological agents and small molecule-targeted drugs. The treatment goal has shifted from achieving a PASI improvement of ≥ 75% (PASI 75) to achieving PASI 90/100, along with a marked improvement in quality of life (DLQI 0/1). At the same time, more attention has been paid to the long-term maintenance and efficacy in special areas (scalp, nail, palmoplantar and perineal). PECONDLE (picankibart injection) is a next?generation, domestically developed IL-23p19 monoclonal antibody with an innovatively engineered Fc region that extends its half-life. It has demonstrated superior efficacy in skin lesions clearness and supports longer maintenance dosing intervals than currently available biologics in China, delivering a new treatment option for patients with plaque psoriasis.

Dr Lei Qian, Chief R&D Officer, General Biomedicine, Innovent Biologics, stated, "We are honoured that with the dedication of participants, investigators and regulatory authorities, picankibart (picankibart) has been officially approved, and has become the first approved IL-23p19 antibody drug independently developed by Chinese enterprises. The pivotal registration study CLEAR-1 showed that picankibart can rapidly clear skin lesions, significantly improve quality of life, maintain stable efficacy for a long time, and has a favourable safety profile. With its balance of efficacy and safety and convenient long-interval maintenance dosing, picankibart demonstrates strong potential as the best-in-class treatment. As the first and backbone drug of Innovent's innovative pipeline in the field of autoimmunity, picankibart will provide a new treatment option for the majority of psoriasis patients. We are also promoting lifecycle management and building comprehensive clinical evidence by exploring outcomes after randomised withdrawal and switching to picankibart from other biological products, aiming to address unmet clinical needs such as drug resistance and disease recurrence. Innovent will continue to expand its innovative portfolio in ophthalmology, autoimmune diseases, and cardiovascular and metabolic with the aim to help more people achieve healthier lives."