San Francisco, China, October 29, 2024/PRNewswire/ -- Cinda Biopharmaceuticals Group (HKSE stock code: 01801), a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for major diseases such as tumors, autoimmunity, metabolism, cardiovascular, and ophthalmology, recently announced picontibimab injection (recombinant anti-interleukin 23p19) antibody, R&D code: IB112) A multi-center, open phase II clinical study ( ClinicalTrials.gov, NCT05970978)'s latest clinical results have observed good efficacy and safety in psoriatic subjects who have not responded well to previous treatments with other biologics. Previously, the first NDA for treating moderate to severe plaque psoriasis with picontibimab was reviewed by the NMPA.

Biologics have become the main systemic drug for psoriasis treatment, yet a significant proportion of patients still fail in treatment with biologics. This study is the first clinical study of treating IL-23p19 antibodies with other biologics in the field of psoriasis in China. The study showed that in patients with previous poor response to treatment with other biologics (targeting IL-17 antibodies as the main group), 64.6% of patients achieved skin lesion removal/almost elimination (overall assessment of SPgA 0/1 score by static physicians). This study is expected to provide new evidence for long-term treatment options for patients with moderate to severe psoriasis. Cinda Biotech will actively promote phase III clinical research on biologic transfer to piconcibalizumab treatment.

The first clinical study in China to convert IL-23p19 antibodies from other biologics in the field of psoriasis treatment

The study aims to evaluate the efficacy and safety of previous biologics in the treatment of patients with plaque psoriasis with trans-piconcibalizumab. A total of 152 subjects were enrolled in the study (previously using marketed biologics to treat plaque psoriasis, including biologics targeting IL-17 and TNF-α), and those with poor response (SpGA≥2, or 3% BSA of cumulative skin lesion surface area) received 200 mg of concibalimab subcutaneously at weeks 0, 4, and 8, and were followed up every 12 weeks until the end of the 44th week; the responders (SPgA 0 or 1 point, and BSA <) Received a 200 mg subcutaneous injection of picontibimab in week 0, and thereafter The drug was given every 12 weeks until week 36 and followed up until the end of week 44 treatment. The main end point of the study was the proportion of subjects who reached sPgA 0 or 1 and BSA < 3% at week 16, which is more strict compared to similar clinical studies that mostly use sPgA 0 or 1 as the primary endpoint.

Enrolled patients had a long course of illness, and previous treatment with biological agents targeting IL-17 did not meet expectations

Of the 152 subjects enrolled in the study, 83 (54.6%) were subjects with poor response. The median course of psoriasis was 12.0 years, 80 (96.4%) were treated with biological agents targeting IL-17, 90.4% of subjects had baseline SpGA≥2 points, and 86.7% of subjects had baseline BSA ≥ 3%.

The primary end point was reached, the effect was rapid, and the subjects' skin damage removal effectiveness indicated that it was the best in its class

Week 16:

• Nearly half (48.2%, 40/83) of subjects with poor responses reached the primary endpoint, that is, sPgA of 0 or 1 and BSA < 3%.
• Regarding the secondary endpoint, most (64.6%, 42/65) of subjects (n=65) with a baseline spGa of at least 2 and a BSA of 3% achieved sPgA 0 or 1, and 16.9% (11/65) of subjects achieved complete removal of skin damage, that is, 0 points of spGa.
• Among subjects with poor response at baseline and DLQI > 1 in the baseline dermatological disease quality of life index, 38.0% (27/71) of patients achieved DLQI 0 or 1.

Good safety, long-term data follow-up

• In terms of safety, the overall safety of the test subjects was good, and no new safety signals were found, similar to previous studies and the safety characteristics of similar products.
• The efficacy results of the responding subjects are still being followed up; after completing the study, complete efficacy and safety data are planned to be submitted and published in future academic conferences or journals.

Professor Zhang Furen of the Dermatology Hospital Affiliated to Shandong First Medical University, said, “Psoriasis is a lifelong disease that has a huge impact on patients' physical and mental health and quality of life. Currently, biologics have become the main systemic drugs for psoriasis, and play a positive and effective role in the treatment of severe, refractory and specific types of psoriasis. Despite the remarkable curative effect, a significant proportion of patients still experience treatment failure during biologics treatment, and there is an urgent need for a reasonable conversion of medication from alternative treatment methods. I am very happy to see that picontibimab has shown good efficacy and safety in psoriatic subjects who have not responded well to previous biologic treatments, suggesting that piconcipeimab can be a potential alternative to drug conversion. I look forward to further proving the efficacy and safety of picontibimab in future phase III studies in psoriatic patients who have not responded well to previous biologics to benefit more psoriatic patients.”

Dr. Qian Lei, senior clinical vice president of Cinda Biopharmaceutical Group, said, “As the first IL-23p19 monoclonal antibody independently developed by a Chinese company, the key registration phase III study carried out in patients with moderate to severe plaque psoriasis has been successful, and a marketing application has been submitted to the Chinese regulatory authorities and accepted. We have also initiated full-life cycle management of picontibimab to expand the development of indications based on unmet clinical needs. The results of the phase II study on biologics converted to piconcibizumab are encouraging. With the widespread use of biologics, the problem of biologics treatment failure is gradually becoming clinically prominent and needs to be addressed urgently. However, in this study, for psoriatic patients with poor response to previous biologics (with IL-17 antibodies as the main population), it was confirmed that initiating piconchibimab treatment can bring excellent skin removal benefits and will greatly meet clinical needs. We will actively promote phase III clinical research on biologic transpicontibimab treatment based on existing data, enrich clinical evidence with picontibimab to treat psoriasis, and strive to provide more treatment options for psoriatic patients as soon as possible.”

About psoriasis

Psoriasis is a chronic, recurrent, inflammatory, and systemic disease mediated by genetics and environment. It can occur in all age groups without gender differences. Typical clinical symptoms are scaly erythema or plaques, limited or widespread, non-infectious, difficult to treat, and often lifelong. Psoriasis can be divided into psoriasis vulgaris (including pitted psoriasis and plaque psoriasis), pustular psoriasis, erythrodermal psoriasis, and arthropathic psoriasis. Among them, plaque psoriasis accounts for 80 to 90%, and about 30% is moderate to severe. There are significant differences in the prevalence of psoriasis around the world, with more than 7 million patients in China. Currently in China, the main systemic drug treatments include methotrexate (MTX), cyclosporine A (Cyclosporine A), tretinoin, and biologics. Since 2019, psoriatic treatment in China has gradually entered the era of biologics. Innovative biologics, represented by IL-23 inhibitors, have characteristics such as high accuracy, fast efficacy, good safety, and long-lasting effects, and are more advantageous in thoroughly removing skin damage and extending the time without recurrence.

About Pikontibimab (IBI112)

Picontibimab (IBI112) is a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection. It is a monoclonal antibody independently developed by Cinda Biotech and has independent intellectual property rights. It specifically binds to IL-23p19 subunit. By blocking IL-23 from binding to cell surface receptors, it blocks IL-23 receptor-mediated signaling pathways to exert anti-inflammatory effects. IBI112 is expected to provide more effective and longer dosage cycles for patients with psoriasis, ulcerative enteritis, and other autoimmune diseases.

Pikontibimab is currently undergoing a number of clinical studies, including:

• The registered phase III clinical study (CLEAR-1) in patients with moderate to severe psoriasis reached an end in May 2024;
• A phase III clinical study of random withdrawal and retreatment in patients with moderate to severe psoriasis;
• A phase II clinical study of biologics to treat transpiconcibalizumab in patients with moderate to severe psoriasis;
• Phase II clinical study in patients with moderate to severe active ulcerative colitis;

In September 2024, the first NDA for picontibimab was accepted by the NMPA to treat moderate to severe plaque psoriasis.

About Cinda Biotech

“Beginning with faith, achieving action” is the mission and goal of Cinda Biotech to develop high-quality biopharmaceuticals that ordinary people can use. Founded in 2011, Cinda Biotech is committed to developing, producing and selling innovative drugs in major diseases such as oncology, autoimmunity, metabolism, and ophthalmology, so that our work can benefit more lives. The company has been approved for marketing of 11 products, namely Cindilizumab Injection (Daberzumab), Bevacizumab Injection (Dayoutong), Adalimumab Injection (Sulixin), Rituximab Injection (Dabroximab), Pemitinib (Dabbotan), Olebatinib Tablets (Nelic), Remosilizumab Injection (Cyranzil), Ceptinib Capsules (Rituil), Iquiolenxide Injection (Foz Sul) Lacizumab injections (Cipilac) and fluzalecide tablets (Dabert). Currently, there are also 5 varieties in the NMPA review. 3 new drug molecules have entered phase III or key clinical research, and 17 new drug types have entered clinical research.

The company has reached more than 30 strategic partnerships with international partners such as Eli Lilly, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center. While continuously developing innovative drugs and seeking its own development, Cinda Biotech adheres to the people-centered development philosophy of economic construction. Over the years, we have always been scientific and kind, adhering to the “patient-centered” approach, caring for patients and their families, and actively fulfilling social responsibilities. The company has successively initiated and participated in a number of drug charity aid projects, so that more and more patients can benefit from advances in life science and can buy and use high-quality biopharmaceuticals. Up to now, the Cinda Biotech Patient Assistance Program has benefited more than 170,000 ordinary patients, with a total value of 3.4 billion yuan in drug donations. Cinda Biotech hopes to work with everyone to raise the level of development of China's biopharmaceutical industry to meet people's accessibility to medicine and people's pursuit of a better life and health.

For more information, please visit the company's website: or the company's LinkedIn account.

Disclaimer: Cinda does not recommend the use of any unapproved drugs/indications.

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