Chongqing's First Class 1 Biological Innovative Drug, Xeligekimab Injection, Achieves Mass Distribution to Benefit Psoriasis Patients Nationwide

VCBeat has learned that on September 3, Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. (hereinafter referred to as “Zhixiang Jintai”), located in the Chongqing International Bio-City, announced that its self-developed Class 1 new drug, selikimab injection (brand name: Jinlixi®), for the treatment of psoriasis, has achieved batch supply following its market approval, thereby meeting market demand.

At the shipment launch ceremony held that morning, refrigerated trucks loaded with secukinumab injection slowly departed from the Zhixiang Jintai facility. This batch of products will depart from Banan, Chongqing, and be distributed to multiple cities including Beijing, Shanghai, Guangzhou, and Wuhan, bringing hope to more patients with psoriasis.

It is reported that secukinumab injection, a fully human anti-human IL-17A monoclonal antibody independently developed by Zhixiang Jintai, was approved for marketing by the National Medical Products Administration (NMPA) on August 27 for the indication of moderate-to-severe plaque psoriasis. As the first domestically produced innovative biologic drug for psoriasis approved in China, it has broken the monopoly of foreign pharmaceutical companies on anti-IL-17A monoclonal antibodies, filled the gap in the field of domestic biologic agents for psoriasis, and provided patients with new treatment options. On August 29, just two days after its approval, the first prescription in China was issued by Professor Zhang Jianzhong, Chief Expert of the clinical study and Director of the Department of Dermatology at Peking University People's Hospital.

Psoriasis (commonly known as “niupixuan”) is a chronic, relapsing, inflammatory, systemic immune-mediated disease triggered by the interplay of genetic and environmental factors, which significantly impairs patients’ quality of life. Due to its prolonged course and propensity for frequent relapses, it imposes substantial psychological and economic burdens on patients and their families.

In recent years, the prevalence of psoriasis in China has shown a gradual upward trend, with the total number of patients currently exceeding 7 million. Among them, more than half (57.3%) of psoriasis patients have moderate-to-severe disease, and 43% suffer from pruritus. For patients, the top three treatment goals are alleviating itching, controlling symptoms, and clearing skin lesions. However, conventional therapies have limitations in efficacy and safety, failing to meet the diverse treatment needs of patients. There is an urgent need for novel therapeutic agents that are safe, highly effective, and capable of significantly improving symptoms.

Clinical data for secukinumab demonstrate that it achieves a 96.5% efficacy rate in patients with 75% psoriasis lesion area, representing a leading position in China and exhibiting excellent efficacy and safety.

“We will spare no effort in optimizing production organization and quality control to accelerate the delivery of secukinumab to patients, thereby alleviating their suffering with efficient, high-quality, and accessible new medicines,” said a representative from Zhixiang Jintai.

The approval of secukinumab for market launch is merely the “opening salvo” in the commercialization of Zhixiang Jintai’s product portfolio. The company currently operates antibody drug R&D centers in Beijing, Shanghai, and Chongqing, with 15 products in development and nine approved to enter clinical trials, all of which are Class 1 innovative drugs. Among these, three products have advanced to Phase III clinical trials, including treatments for moderate-to-severe atopic dermatitis, as well as the world’s first monoclonal antibodies for passive immunization against rabies and tetanus. Furthermore, the New Drug Application (NDA) for a second indication of secukinumab—ankylosing spondylitis—was accepted in January this year, with market approval expected in 2025.

“The approval of secukinumab for market launch represents a significant breakthrough in the field of biologic agents for psoriasis in China, filling a domestic gap. We will continue to uphold our patient-centric philosophy, relentlessly develop more high-quality innovative drugs, and bring greater benefits to patients worldwide,” stated Jiang Rensheng, Chairman and President of Zhifei Biological Products and actual controller of ZhiXiang JinTai.

It is understood that the Chongqing International Bio-City serves as the core park in Chongqing Municipality’s “1+5+N” pharmaceutical industry layout system. Its biopharmaceutical technological innovation has consistently remained at the forefront of the city, with 56 innovative drugs under development, 23 having entered clinical trials, and 10 reaching Phase III clinical trials. Notably, it is rapidly advancing into the national forefront in the field of high-end biologics, particularly in antibodies, insulin, and vaccines. As the first Class I biological innovative drug in Chongqing to complete registration approval and achieve mass supply, Selicikimab represents a significant milestone in the history of Chongqing’s pharmaceutical production. It holds substantial importance for boosting confidence in the development of the city’s biopharmaceutical industry, accelerating the enhancement of its scale and capacity, and cultivating and strengthening new quality productive forces in the biopharmaceutical sector.