On December 30, Beijing Tide Pharmaceutical, a subsidiary of Sino Biopharmaceutical Limited (1177.HK), announced that the first patient has been enrolled in the Phase III clinical trial of its independently developed TDI01 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). TDI01 is the world's first highly selective ROCK2 inhibitor to enter Phase III clinical trials for IPF, marking a major breakthrough for China in the field of innovative drugs for IPF and is expected to bring better treatment options to IPF patients worldwide. 

Innovative Mechanism: A Highly Selective ROCK2 Inhibitor for Multidimensional Intervention in IPF

TDI01 is a highly selective ROCK2 kinase inhibitor achieved through structural innovation. It can precisely target the core hub that regulates multiple pathological processes such as vascular leakage, fibrosis, inflammation, and immune disorders—the Angiocrine System—intervening in the complex pathogenesis of IPF from multiple dimensions. At the same time, the selective inhibition of ROCK2 can effectively improve the drug's safety window. This unique mechanism of action is expected to achieve clinical benefits superior to existing standard therapies. 

Data from the previously completed Phase II clinical trial have preliminarily validated the outstanding potential of TDI01. After 24 weeks of treatment, the improvement in forced vital capacity (FVC) in the TDI01 400mg group was 89 mL greater than in the placebo group. It significantly reduced the risk of all-cause mortality while also lowering the risk of acute exacerbation and progression of IPF. In terms of safety, the incidence of serious adverse events and the rate of discontinuation due to adverse events in the TDI01 treatment group were both lower than those of similar standard-of-care drugs, demonstrating that TDI01 has good safety and tolerability. 

Treatment Dilemma: Existing Therapies Have Limitations, and Clinical Needs Are Far from Met

IPF is a progressive, chronic fibrotic interstitial lung disease with an unknown etiology and pathogenesis. As the disease progresses, patients gradually lose lung function and may eventually die from respiratory failure due to extensive scarring of lung tissue, affecting approximately 3 million people worldwide^[1]. The incidence and prevalence of IPF are increasing year by year. The disease primarily affects the elderly, and the median survival time for patients is only 2-3 years^[2]. Because its biological behavior and mortality rate are close to those of malignant cancers, and it is even more dangerous than many cancers, it is also known as "the cancer that is not a cancer".
In terms of drug therapy, only Pirfenidone, Nintedanib, and a PDE4B inhibitor approved this year are authorized for the treatment of IPF. Clinical trials of investigational products targeting other targets have repeatedly failed.

However, existing drugs and treatment methods cannot control or reverse damaged lung function. Pirfenidone and Nintedanib have prominent adverse reactions such as photosensitivity, liver injury, and diarrhea. There is an urgent clinical need for novel therapies that can comprehensively intervene in the complex mechanisms of the disease and have a better safety profile. 

TDI01: Designated as a Major New Drug Creation Project with Value in Multi-Indication Expansion

TDI01 is a national "13th Five-Year" Major New Drug Creation project, directly addressing the unmet clinical needs of IPF, and has received high recognition from international peers. In addition to the IPF indication, TDI01 is also being developed for the chronic Graft-versus-Host Disease (cGVHD) indication. Based on excellent efficacy and safety data from the Phase Ib study, TDI01 was included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE), NMPA in June this year. 

The successful enrollment of the first patient in this Phase III clinical trial for IPF marks a key stage in the clinical development of TDI01. The company will fully advance this study, striving to provide a more effective and safer new treatment option for IPF patients as soon as possible. 

References:
[1] Nalysnyk L., et al. Incidence and Prevalence of Idiopathic Pulmonary Fibrosis: Review of the Literature. Eur Respir Rev. 2012; 21(126): 355-361.
[2] Raghu G., et al. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. Am J Respir Crit Care Med. 2011; 183: 788–824.

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Forward-Looking Statements:
This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expected clinical benefits and advantages, commercialization prospects, the possibility of clinical benefit to patients, and potential commercial opportunities for [TDI01]. 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.