Sino Biopharm (01177): TRD221 "complement protein regulator" clinical trial application approved by NMPA.

SINO Biopharm (01177) announced that its subsidiary, Beijing Tide Pharmaceutical Co., Ltd. (Beijing Tide), has received clinical trial approval from the China National Medical Products Administration (NMPA) for the innovative drug TRD221 "Complement Protein Regulator," developed for the treatment of osteoarthritis. Injectable TRD221 is a globally innovative (First-in-class) complex polysaccharide drug developed jointly by Beijing Tide and the Institute of Materia Medica, Chinese Academy of Medical Sciences. Polysaccharides have good biocompatibility and safety, but due to their complex mechanism of action, research in pharmacy, quality control, and pharmacological evaluation present many challenges, which have long hindered the development of polysaccharide-based innovative drugs. TRD221, as a key protein regulator of the complement system cascade activation, can inhibit the release of inflammatory factors activated by the complement system, prevent direct damage to chondrocytes, regulate the metabolic status of chondrocytes, promote cartilage repair, and delay the progression of the disease. Osteoarthritis (OA) is a degenerative disease caused by various factors that lead to fibrosis, fissures, ulcers, and loss of joint cartilage. Clinical manifestations of OA include joint pain, deformity, and functional impairment. OA not only significantly affects the quality of life of patients but also increases the risk of cardiovascular events, deep vein thrombosis, and hip fractures. In 2020, there were approximately 595 million OA patients worldwide, with the knee joint being the most common site, followed by the hands, hips, and other joints. It is estimated that by 2050, the global number of patients will increase to 642 million. The prevalence of primary OA in the Chinese population over the age of 40 has reached 46.3%, and with the aging population, the prevalence continues to rise. Current treatment for OA mainly focuses on pain relief, with commonly used drugs including non-steroidal anti-inflammatory drugs (oral or topical) and intra-articular injections of steroids, hyaluronic acid, etc. However, there are still significant clinical needs for delaying disease progression and improving joint function. The pathogenesis of OA is complex and involves multiple factors such as cartilage destruction, inflammatory reactions, and immune regulation, with the complement system playing a crucial role in the occurrence and development of OA. TRD221 has shown a dual effect of relieving pain symptoms and improving structural damage in various mechanistically-induced OA animal models, with good safety, and has the potential to become a new treatment option for OA. The clinical approval of this trial will further enrich the innovative pipeline of the group in the field of surgery/pain management, and it is expected to fill existing treatment gaps and bring new treatment options for a large number of OA patients.