JumpCan Pharmaceutical's Class 1.1 Innovative TCM Drug Xiao'er Biantong Granules Has Marketing Application Accepted

2025.07.08

Recently, JumpCan Pharmaceutical received the "Acceptance Notice" from the National Medical Products Administration (NMPA) for the marketing application of its Class 1.1 innovative traditional Chinese medicine (TCM) drug Xiao'er Biantong Granules. Derived from a renowned physician's proven formula, Xiao'er Biantong Granules are designed to strengthen the spleen and stomach, promote qi movement, and relieve stagnation. They are indicated for the treatment of constipation in children diagnosed with food accumulation syndrome according to TCM principles.

 

 

According to public information, no drug with an identical formulation has been submitted for registration or marketed in mainland China (excluding Hong Kong, Macao, and Taiwan). This product is expected to become the first Class 1.1 TCM drug specifically developed for pediatric constipation following the release of the "Technical Guidelines for Clinical Development of TCM New Drugs for Pediatric Constipation (Trial)" (2024).

 

 

As one of the pharmaceutical companies in China with the most extensive portfolio of pediatric varieties and formulations, JumpCan Pharmaceutical has deep expertise in the pediatric field, having developed branded products such as Pudilan Xiaoyan Oral Liquid, Xiao'er Chiqiao Qingre Granules (Tonpei), Jianwei Xiaoshi Oral Liquid, Huanglong Zhike Granules, and lron Proteinsuccinylate Oral Solution (Shengxueyuan). The company continues to strengthen the secondary development of marketed products and the R&D of innovative TCM drugs and high-end chemical drugs. It has achieved milestones such as the approval of Xiao'er Chiqiao Qingre Syrup (K-tonpei), the first improved TCM new drug under the new drug Registration Management Measures, and has become the first company in China to gain approval for Fexofenadine Hydrochloride for Suspension (Minfeile) and Pediatric Faropenem Sodium Granules (Beiluonan), enhancing its core competitiveness in pediatrics.

 

Furthermore, JumpCan Pharmaceutical enables expansive growth through business development, establishing an R&D system that combines independent innovation and collaborative research. In partnership with Zenshine Pharmaceuticals, the company developed Sebaloxavir Marboxil Tablets, a Class 1 innovative drug with global independent intellectual property rights. As a next-generation polymerase acidic protein (PA) endonuclease inhibitor, it requires only a single dose for a full treatment course. Its New Drug Application (NDA) has been accepted by the Center for Drug Evaluation (CDE) of the NMPA. Additionally, the Biologics License Application (BLA) for a Class 1 innovative fusion protein-based long-acting growth hormone, developed in collaboration with TJ Biopharma, has been accepted by the NMPA. Administered once weekly, this innovative therapy is expected to provide an effective and convenient treatment option for children with growth hormone deficiency.

 

 

Moving forward, guided by its purpose of "Build a joyful and vibrant life together" and adhering to the R&D philosophy of "Leading the Frontier, Innovating Fine Products", JumpCan Pharmaceutical will continue to stay attuned to changes in the pharmaceutical market, prioritize patient needs, focus on medium to long-term development strategies, and drive high-quality and sustainable growth through scientific innovation. The company remains committed to fulfilling its social responsibilities as a listed pharmaceutical enterprise and safeguarding public health.