Recently, Chia Tai Tianqing, a core enterprise of Sino Biopharmaceutical (1177.HK), announced that the first patient has been enrolled in a Phase III clinical trial of the Class 1 new drug TQ-B3234 capsules (a MEK1/2 inhibitor) at Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine (abbreviated as Shanghai Ninth People’s Hospital). Previously, TQ-B3234 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation of the National Medical Products Administration for the treatment of adult plexiform neurofibromas (PN) associated with neurofibromatosis type I (NF1). 

This study (TQ-B3234-III-01) is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial. Professor Li Qingfeng from the Department of Plastic and Reconstructive Surgery at Shanghai Ninth People’s Hospital serves as the principal investigator at the leading site. The study aims to scientifically evaluate the efficacy and safety of TQ-B3234 capsules in treating patients with symptomatic, inoperable plexiform neurofibromas (PN) associated with neurofibromatosis type I (NF1), to provide a superior clinical treatment option. 

NF1 is a rare genetic disorder affecting multiple systems and has been included in China's "Second List of Rare Diseases". About 30%-60% of NF1 patients develop PN, leading to pain, disfigurement, and even malignant transformation. Currently, clinical treatment options are extremely limited. Traditional surgery faces challenges of high recurrence rates and significant injury due to unclear lesion boundaries and rich blood supply, representing a huge unmet clinical need. 

As an oral selective MEK1/2 inhibitor, TQ-B3234 inhibits tumor growth by suppressing the activity of the RAS-regulated RAF/MEK/ERK pathway. Preliminary Phase I clinical data showed an objective response rate (ORR) of 68.4% at a dose of 50 mg once daily, which is significantly superior to that of currently marketed drugs in the same class. The safety profile is manageable, with most adverse reactions being Grade 1-2. 

The current Phase III clinical study plans to enroll 177 subjects, who will be assigned to the experimental and control groups at a 2:1 ratio. The treatment duration will be up to approximately 36 cycles. During the study, the sponsor will provide the investigational product and related examinations free of charge, and will provide subjects with corresponding compensation for transportation, blood collection, etc. Clinical trial insurance has also been purchased to fully protect the rights and interests of the subjects. 

As the first activated study site, Shanghai Ninth People's Hospital is currently conducting subject recruitment and enrollment, and multiple sites nationwide will be launched successively. With the successive launch of multiple sites nationwide, Chia Tai Tianqing will work with investigators to provide safe and effective innovative treatment options for Chinese patients with the rare disease NF1, filling the clinical treatment gap with rigorous and scientific trial data. 

Declaration:

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 disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

Forward-Looking Statements:

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities for [T-QB3234]. 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.