SINO BIOPHARM (01177) announced that its subsidiary, Beijing Tide Pharmaceutical Co., Ltd., has obtained clinical trial approval from the National Medical Products Administration (NMPA) for TRD221, a first-in-class complement protein modulator intended for the treatment of osteoarthritis. TRD221 for injection is a globally innovative complex polysaccharide drug co-developed by Beijing Tide and the Institute of Materia Medica, Chinese Academy of Medical Sciences. Polysaccharides offer excellent biocompatibility and safety, but their complex mechanisms of action pose significant challenges in pharmaceutical research, quality control, and pharmacological evaluation, which have long hindered the development of innovative polysaccharide drugs. As a key regulator of the complement system cascade activation, TRD221 can inhibit the release of inflammatory factors triggered by complement activation, block direct damage to chondrocytes, and regulate metabolic homeostasis in cartilage cells, thereby promoting cartilage repair and slowing disease progression. Osteoarthritis (OA) is a degenerative joint disease characterized by cartilage fibrosis, fissuring, ulceration, and loss, primarily causing joint pain, deformity, and functional impairment. OA not only severely impacts patients' quality of life but also significantly increases the risk of cardiovascular events, deep vein thrombosis, and hip fractures. Globally, approximately 595 million people suffered from OA in 2020, with knee OA being the most common, followed by hand and hip OA. This number is projected to rise to 642 million by 2050. In China, the prevalence of primary OA among individuals aged 40 and above has reached 46.3%, and the rate continues to climb due to an aging population. Current OA treatments mainly focus on pain relief, using medications such as nonsteroidal anti-inflammatory drugs (oral or topical) and intra-articular injections of corticosteroids or hyaluronic acid. However, there remains a significant unmet clinical need for therapies that can slow disease progression and improve joint function. The pathogenesis of OA is complex, involving cartilage destruction, inflammatory responses, and immune regulation. The complement system, a key component of innate immunity, plays a critical role in OA development. In various OA animal models, TRD221 has demonstrated dual benefits in alleviating pain symptoms and improving structural damage, along with a favorable safety profile, indicating its potential as a new treatment option for OA. This clinical approval will further enrich the Group's innovative pipeline in the surgical/analgesia field and is expected to address existing treatment gaps, offering new hope for OA patients.