On October 29, 2024, in San Francisco, USA, and Suzhou, China / PRNewswire/ -- Innovent Bio (Hong Kong Stock Exchange Code: 01801), a biopharmaceutical company dedicated to the research, development, production, and sales of innovative drugs in the areas of oncology, autoimmunity, metabolism, cardiovascular, ophthalmology, and other major disease fields, recently announced the latest clinical results of a multicenter, open Phase II clinical study (Clinicaltrials.gov, NCT05970978) of Piclannqui (recombinant anti-interleukin-23p19 subunit (IL-23p19) antibody, research code: IB112) Injection in Chinese patients with plaque psoriasis who responded poorly to previous biologic therapy, showing good efficacy and safety. The first NDA for the treatment of severe plaque psoriasis with Piclannqui is already under review by the NMPA.

Biologic therapy has become the main systemic treatment for psoriasis, yet a considerable proportion of patients experience treatment failure during biologic therapy. This study is the first clinical research in China to transition from other biologic agents in the field of psoriasis to treatment with IL-23p19 antibodies. The study shows that after 16 weeks of treatment with Piclannqui in patients who had inadequate responses to previous other biologic agents (targeting mainly the IL-17 antibody population), 64.6% of patients achieved complete/near complete skin lesion clearance (static physician global assessment sPGA 0/1 score). This study is expected to provide new evidence for the long-term treatment of moderate to severe psoriasis patients, and Innovent Bio will actively advance to Phase III clinical trials of transitioning from biologic agents to Piclannqui treatment.

The first clinical study in China to transition from other biologic agents in the field of psoriasis to IL-23p19 antibody treatment

The study aims to evaluate the efficacy and safety of transitioning patients with plaque psoriasis previously treated with other biologic agents to Piclannqui treatment. A total of 152 subjects were enrolled in the study (previously treated with biologic agents on the market for plaque psoriasis, including those targeting IL-17 and TNF-α), with inadequate responses (sPGA≥2, or BSA≥3%) receiving 200 mg subcutaneous injections of Piclannqui every 12 weeks up to week 32 and followed until the end of week 44; responders (sPGA 0 or 1, and BSA<3%) received 200 mg subcutaneous injections of Piclannqui at week 0, then every 12 weeks until week 36 and followed until the end of week 44. The primary endpoint of the study was the proportion of subjects achieving sPGA 0 or 1 and BSA<3% at week 16, which is more stringent compared to similar clinical studies that often use sPGA 0 or 1 as the primary endpoint.

The enrolled patients had a long disease course, and previous treatment with targeted IL-17 biologics did not achieve the expected results.

Among the 152 subjects enrolled in the study, 83 cases (54.6%) were non-responders. The median course of psoriasis in these non-responders was 12.0 years. 80 cases (96.4%) had received treatment with targeted IL-17 biologics, with 90.4% of subjects having a baseline sPGA score of ≥2 and 86.7% having a baseline BSA of ≥3%.

Meeting the primary endpoint, with rapid onset of action, the efficacy of skin clearance in non-responders suggests optimal performance in its class.

At week 16:

• Nearly half (48.2%, 40/83) of the poorly responding subjects reached the primary endpoint, sPGA 0 or 1 and BSA <3%.
• Regarding secondary endpoints, the majority (64.6%, 42/65) of subjects with baseline sPGA ≥2 and BSA ≥3% achieved sPGA 0 or 1, with 16.9% (11/65) of subjects achieving complete clearance of skin lesions, sPGA 0.
• Among subjects with poor response at baseline and baseline Dermatology Life Quality Index DLQI >1, 38.0% (27/71) of patients achieved DLQI 0 or 1.

Good safety profile observed in long-term follow-up data.

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

The primary investigator of the study, Professor Zhang Furen of the First Medical University of Shandong affiliated Skin Disease Hospital, stated: "Psoriasis is a lifelong disease with a huge impact on the physical and mental health and quality of life of patients. Currently, biologics have become the main systemic treatment for psoriasis, playing a positive and effective role in the treatment of severe, refractory, and special types of psoriasis. Although the efficacy is significant, there is still a considerable proportion of patients experiencing treatment failure during biologic treatment, urgently requiring rational switching of medications. I am pleased to see that Picokinebeimab has shown good efficacy and safety in psoriasis subjects who had poor responses to previous biologic treatments, suggesting Picokinebeimab as a potential choice for switching therapy. I look forward to further demonstrating the effectiveness and safety of Picokinebeimab in Phase III studies for psoriasis patients with poor responses to previous biologic treatments, benefiting more psoriasis patients in the future."

Dr. Qian Lei, Senior Vice President of Clinical Research at Innovent Bio, stated: "Picokinebeimab, as the first IL-23p19 monoclonal antibody independently developed by a Chinese company, has successfully conducted key Phase III registration studies in moderate to severe plaque psoriasis patients, submitted a marketing application to the Chinese regulatory agency, which has been accepted. We have also initiated full life-cycle management of Picokinebeimab, expanding the development of indications based on unmet clinical needs. The Phase II study results of switching from biologics to Picokinebeimab treatment are encouraging. With the widespread use of biologics, the problem of biologic treatment failure is gradually becoming prominent in clinical practice and needs to be addressed. In this study, for psoriasis patients with poor responses to previous biologic treatments (predominantly target IL-17 antibody users), it was confirmed that initiating Picokinebeimab treatment can bring outstanding benefits in clearing skin lesions, which will greatly meet clinical needs. We will actively advance Phase III clinical studies of switching from biologics to Picokinebeimab treatment based on existing data, enrich the clinical evidence of Picokinebeimab in treating psoriasis, and strive to provide more treatment options for psoriasis patients soon."

关于银屑病

银屑病是一种遗传与环境共同作用，免疫介导的慢性、复发性、炎症性、系统性疾病，可发生于各年龄段，无性别差异。典型临床表现为鳞屑性红斑或斑块，局限或广泛分布，无传染性，治疗困难，常罹患终身。银屑病可以分为寻常型银屑病（包括点滴状银屑病和斑块型银屑病）、脓疱型银屑病、红皮型银屑病及关节病型银屑病。其中斑块型银屑病占80~90%，30%左右为中重度。银屑病患病率在世界各地有显著差异，中国患者约在7 million以上。目前在中国，主要系统性药物治疗方法包括甲氨蝶呤（Methotrexate，MTX）、环孢素（Cyclosporine A）、维A酸类、生物制剂类。自2019年开始，中国银屑病治疗逐渐进入生物制剂时代。以IL-23抑制剂为代表的创新生物制剂具有精准度高、起效快、疗效高、安全性好、作用持久等特点，在全面深度清除皮损、延长无复发时间方面更具优势。

关于匹康奇拜单抗（IBI112）

匹康奇拜单抗（IBI112）为重组抗白介素23p19亚基（IL-23p19）抗体注射液，是由信达生物自主研发，具有自主知识产权的一种单克隆抗体，特异性结合IL-23p19亚基。通过阻止IL-23与细胞表面受体结合，阻断IL-23受体介导信号通路发挥抗炎作用。IBI112有望为银屑病、溃疡性肠炎和其他自身免疫性疾病患者提供更有效、更长给药周期的治疗方案。

Pikanchi monoclonal antibody is currently conducting multiple clinical studies, including:

• Phase III clinical studies (CLEAR-1) conducted in patients with moderate to severe psoriasis have reached the endpoint in May 2024;
• Phase III clinical studies of random withdrawal and retreatment in patients with moderate to severe psoriasis;
• Phase II clinical studies of biologic treatment switching from conventional treatment to Pikanchi monoclonal antibody therapy in patients with moderate to severe psoriasis;
• Phase II clinical study conducted in patients with moderate to severe active ulcerative colitis.

In September 2024, the first NDA for Pikanchiqibai monoclonal antibody was accepted by NMPA for the treatment of moderate to severe plaque psoriasis.

"Starting with trust and ending with action", developing high-quality biopharmaceuticals that the general public can afford is the ideal and goal of Innovent Biologics. Innovent Biologics was established in 2011 and is committed to the development, production, and sales of innovative drugs to treat major diseases such as tumors, metabolic diseases, and autoimmune diseases. On October 31, 2018, Innovent Biologics went public on the Main Board of the Hong Kong Stock Exchange with stock code: 01801. Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model. It has established a product chain including 23 new drug varieties, covering multiple disease areas such as tumors, metabolic diseases, and autoimmune diseases, of which 6 varieties have been selected for the national "Major New Drug Creation" special project, and 3 products (Sintilimab Injection, brand name: Tyvyt, English trademark: TYVYT; Bevacizumab Injection, brand name: Duligotong, English trademark: BYVASDA; Camrelizumab Injection, brand name: Sulinno, English trademark: SULINNO) have been approved.

"Starting from trust and reaching accomplishment", developing high-quality biopharmaceuticals affordable for lbx pharmacy chain joint stock is the mission and goal of Innovent Bio. Innovent Bio was established in 2011, dedicated to researching, developing, producing, and selling innovative drugs in major disease areas such as oncology, autoimmunity, metabolism, and ophthalmology, benefiting more lives with our work. The company has obtained approval for 11 products, namely, sintilimab injection (Tyvyt), camrelizumab injection (AiRuiJian), tislelizumab injection (BeiLieXin), toripalimab injection (Tuoyi), pemigatinib tablets (Tabrecta), avapritinib tablets (Ayvakit), lefitolimod injection (Levac), septrinib capsules (Ruituo), iclusig injection (Fusosu), toripalimab injection (Innovent Biologics) and fluzoparib tablets (Elunate). Currently, there are additional 5 varieties under NMPA evaluation, 3 new drug molecules entering phase III or pivotal clinical studies, and another 17 new drug varieties in clinical research.

The company has reached more than 30 strategic cooperation agreements with international partners such as Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. While seeking self-development through independent research and development of innovative drugs, Innovent adheres to the development concept of economic construction centering on the people. Over the years, it has always had a scientific and kind heart, stuck to the principle of "patient-centered," concerned about the patients and their families, and actively fulfilled its social responsibilities. The company has launched and participated in a number of drug public welfare assistance projects, enabling more and more patients to benefit from the progress of life sciences and buy and afford high-quality biological drugs. Up to now, Innovent's patient assistance project has benefited more than 170,000 ordinary patients, and the total value of drug donations is 3.4 billion yuan. Innovent hopes to work together with everyone to improve the development level of China's biopharmaceutical industry, to meet the accessibility of the people's medication and the pursuit of a better life and health.

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Innovent Bio does not recommend the use of any unapproved drugs/indications.

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