San Francisco, USA and Suzhou, China, September 26, 2024 / PRNewswire / - Innovent Bio (Hong Kong Stock Exchange stock code: 01801), a biopharmaceutical company dedicated to the research, production, and sales of innovative drugs in the fields of oncology, autoimmunity, metabolism, cardiovascular, ophthalmology, and other major diseases, announced that the new drug application (NDA) for Tykrinab Monoclonal Antibody Injection (recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, research code: IBI112) has been accepted by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of moderate to severe plaque psoriasis. Tykrinab Monoclonal Antibody is the world's first IL-23p19 antibody drug to achieve PASI 90 in more than 80% of subjects reaching primary study endpoints in the 16th week of Phase III clinical registration, with the longest dosing interval among similar biologics (every 12 weeks), offering comprehensive benefits such as skin lesion clearance, improvement in quality of life, and enhanced drug convenience for Chinese patients with moderate to severe plaque psoriasis.

This NDA acceptance is based on positive results from Phase III registration clinical trial CLEAR-1 (NCT05645627) conducted in Chinese subjects with moderate to severe plaque psoriasis. The study successfully met primary and all key secondary endpoints in May 2024, showing that the Tykrinab Monoclonal Antibody group achieved significantly better proportions of subjects with skin lesion clearance (PASI 90, PASI 75, PASI 100, sPGA 0/1, and sPGA 0) and quality of life improvement (DLQI 0/1) compared to the placebo group. Throughout the study treatment period, Tykrinab Monoclonal Antibody demonstrated good overall safety without any new safety signals. Detailed data from the CLEAR-1 study are planned to be disclosed at future academic conferences and in academic journals.

Professor Shi Yuling, the principal investigator of this study and from Shanghai Skin Disease Hospital, stated: "Psoriasis is a lifelong disease that has a significant impact on patients' physical and mental health and quality of life. Currently, psoriasis is an incurable disease, and having more effective treatment options suitable for patients is crucial for disease control, reducing comorbidities, maintaining long-term efficacy, and overall improving patients' quality of life. Existing research evidence indicates that the IL-23p19 targeted antibody has clear advantages in maintaining long-term efficacy and drug convenience. Tykrinab Monoclonal Antibody is the first IL-23p19 monoclonal antibody independently developed by a Chinese enterprise, demonstrating excellent short-term and long-term efficacy in clinical trials. The dosing interval of once every 12 weeks for maintenance treatment also enhances drug convenience and compliance for patients. Patients can achieve significant clinical benefits and quality of life improvements while maintaining good safety. As the lead investigator of the Phase III clinical trial for Tykrinab Monoclonal Antibody, leading researchers from national research centers successfully completed the clinical study and supported the successful submission of this new drug application. I am proud of this accomplishment and hope that Tykrinab Monoclonal Antibody can be approved soon, providing more treatment options for Chinese psoriasis patients.

Dr. Qian Lei, Clinical Vice President of Innovent Bio, stated: "We are honored that with the support of regulatory agencies, researchers, and participants, the first NDA for Tykrinab Monoclonal Antibody has been accepted, making it the first IL-23p19 antibody drug independently developed by a Chinese enterprise to submit an NDA. Tykrinab Monoclonal Antibody has shown outstanding efficacy in rapid skin lesion clearance and quality of life improvement in key registration studies, maintaining high stable levels in the long term with good safety. Balancing efficacy, safety, and long-interval maintenance dosing, Tykrinab Monoclonal Antibody has demonstrated the best potential among similar treatments. We will actively cooperate with regulatory authorities, looking forward to providing effective and safe treatment options for Chinese psoriasis patients as soon as possible. Meanwhile, we are engaging in comprehensive lifecycle management and enriching clinical evidence on multiple dimensions, exploring clinical outcomes of dose withdrawal and retreatment and transitioning from biologic treatments to Tykrinab Monoclonal Antibody therapy, with the aim of further addressing unmet clinical needs for psoriasis resistance, relapse, and more. Innovent Bio will continue to innovate in the fields of oncology, autoimmunity, cardiovascular and metabolism (CVM), and ophthalmology, continuously meeting the good life pursuit of the people and serving more patients."

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 with trust and implementing through actions", developing affordable high-quality biopharmaceuticals for the public is the mission and goal of LBX pharmacy chain joint stock. Innovent Bio was established in 2011, dedicated to the research and development, production, and sales of innovative drugs in major disease areas such as oncology, autoimmunity, metabolism, ophthalmology, and more, benefiting more lives through our work. The company has obtained approvals for 11 products, namely: sintilimab injection (Tyvyt), camrelizumab injection (AiRui), tislelizumab injection (Suli Xin), ropidoxuridine injection (Tyvys), pemigatinib tablets (Dabutan), alectinib tablets (Nailike), lembrucizumab injection (Xiranze), sepetinib capsules (Rutu), icotinib mesylate injection (Fucosyl), toripalimab injection (Xinbile), and fuzuresinib tablets (Dabet). Currently, there are 4 varieties undergoing NMPA review, 3 new drug molecules entering Phase III or pivotal clinical trials, and an additional 18 new drug varieties in clinical studies.

Innovent Biologics has reached more than 30 strategic cooperation agreements with international partners such as Eli Lilly and Co, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center. While constantly innovating and researching and developing new drugs, Innovent adheres to the concept of people-centered economic development. Over the years, Innovent has always aimed to fulfill the social responsibility of science and technology while advocating the idea of "patient-centered," caring about patients and their families, and actively fulfilling social responsibility. The company has launched and participated in multiple drug public welfare assistance projects, enabling more and more patients to benefit from the progress of life science and to buy and afford high-quality biological drugs. By the end of 2023, Innovent Biologics' patient assistance projects had benefited more than 170,000 ordinary patients, with a total drug donation value of 3.4 billion RMB. Innovent Biologics hopes to work together with everyone to improve the development level of China's biopharmaceutical industry and to meet the people's demand for accessible and affordable medicine and their pursuit of good health and well-being.

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

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

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