Recently, TRD221 for injection, a Class 1 innovative drug developed by Beijing Tide Pharmaceutical, a core member company of Sino Biopharmaceutical Limited (1177.HK), in collaboration with the Institute of Materia Medica, Chinese Academy of Medical Sciences, has received implied permission for clinical trials from the Center for Drug Evaluation (CDE), NMPA, for the proposed treatment of osteoarthritis. TRD221 is a First-in-Class (FIC) complex polysaccharide drug with a novel structure, expected to offer a new treatment option for over 100 million osteoarthritis patients in China. 

The pathogenesis of osteoarthritis (OA) is complex, involving multiple factors such as cartilage destruction, inflammatory responses, and the immune system. The complement system, as a crucial component of innate immunity, plays a key role in the onset and progression of osteoarthritis. Polysaccharide drugs have always been a key research focus in new drug development due to their excellent biocompatibility and safety. However, complex mechanisms of action, pharmaceutical research, quality control, and pharmacological characteristics polysaccharide drugs have long been major challenges hindering their clinical translation.

TRD221 for injection is a new polysaccharide drug with a novel structure developed by Beijing Tide Pharmaceutical in collaboration with the Institute of Materia Medica, Chinese Academy of Medical Sciences. As a key protein modulator of complement system cascade activation, it can inhibit the production of inflammatory factors activated by the complement system, blocking the direct attack and injury to chondrocytes at the source. In animal models of osteoarthritis induced by various mechanisms, TRD221 has demonstrated a dual effect of alleviating pain symptoms and improving structural injury, along with a favorable safety profile.

It is expected to fill the unmet clinical needs in the field of osteoarthritis treatment. Osteoarthritis is a degenerative disease primarily characterized by joint pain, caused by multiple factors leading to articular cartilage fibrosis, fissures, ulcers, and loss. It not only severely affects patients' quality of life but also significantly increases the risk of cardiovascular events, deep vein thrombosis and embolism in the lower limbs, hip fractures, and all-cause mortality. The number of osteoarthritis patients worldwide reached 595 million in 2020 and is projected to increase to 642 million by 2050^[1]. Epidemiological surveys show that there are over 100 million osteoarthritis patients in China^[2], with the overall prevalence of primary osteoarthritis among people over 40 reaching as high as 46.3%^[3]. As the population continues to age, the prevalence and disability rates of osteoarthritis will continue to rise. Currently, the clinical treatment for osteoarthritis primarily focuses on pain relief, mainly involving oral and topical non-steroidal anti-inflammatory drugs, as well as intra-articular injections of hormones and sodium hyaluronate. There remain significant unmet needs in terms of delaying disease progression and improving joint function.

The clinical approval of TRD221 for injection will further expand Sino Biopharm's product pipeline in the surgery/analgesia field. The company will continue to advance the clinical development of TRD221 for injection, aiming to bring new hope to the vast number of osteoarthritis patients. 

References:
[1] Global, regional, and national burden of osteoarthritis, 1990–2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021.The Lancet Rheumatology, 2023.
[2] Epidemiological Survey Report on Osteoarthritis in China [3] Qingyun Xue, Kunzheng Wang, Fuxing Pei, et al.  Investigation on the prevalence of primary osteoarthritis in people over 40 years old in China [J]. Chinese Journal of Orthopaedics, 2015, 35(12):1206-1212. DOI: 10.3760/cma.j.issn.0253-2352.2015.12.005.

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1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes.

2. The company does not recommend any drugs and/or indications.

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific information about disease diagnosis and treatment, please follow the advice or guidance of a doctor or other healthcare professional. 

Forward-looking Statements:

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expected clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities for [TRD221]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.