Recently, Tianjin Tasly Saint Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Tasly Pharmaceutical Group Co., Ltd. (Stock Code: 600535), received the Notice of Approval for Drug Clinical Trial (No. 2026LP02559) for TSL2402 Tablets issued by the National Medical Products Administration (NMPA), authorizing the initiation of clinical trials for the drug.
As Tasly’s partner, Medicilon has received a letter of appreciation from Tasly. This recognition acknowledges Medicilon’s pharmacodynamic research services, compliant delivery standards and the expertise of its project team, proving the value of Medicilon’s integrated service platform.
Meeting Unmet Clinical Demands: TSL2402 Tablets Bridge the Treatment Gap in PBC
Primary Biliary Cholangitis (PBC) is a common refractory liver disease. Current baseline treatments leave substantial unmet medical needs, as a subset of patients show suboptimal therapeutic responses. There is an urgent clinical need for differentiated, optimized therapeutic agents. TSL2402 Tablets, the newly approved Class 2.3 Modified New Combination Pharmaceutical, is Tasly’s differentiated innovative drug developed for precision PBC treatment. Globally, no comparable combination product has gained marketing approval yet, highlighting its unique clinical value.
TSL2402 Tablets target PBC patients with Scheuer stage S2 or higher liver fibrosis who can tolerate UDCA baseline treatment. With an innovative formulation ratio to improve conventional therapies, the drug addresses major drawbacks of existing regimens. It is expected to provide a new, superior clinical intervention for refractory PBC patients and fill the unmet medical gap in this niche area. The successful advancement of this project reflects Tasly’s deep commitment and robust innovation strength in liver disease R&D with keen perception of clinical needs.
Tackling Difficulties in PBC Model Assessment: Specialized Pharmacodynamic Studies Safeguard IND Submission
Various animal models are available for PBC, yet most suffer from poor stability and homogeneity, creating hurdles for pharmacodynamic evaluation of test materials. For this joint project, Medicilon quickly formed a dedicated research team. Following strict scientific standards and leveraging a mature quality control system, the team efficiently completed pharmacodynamic studies for TSL2402 Tablets to support the IND filing.
More than 290 Non-Tumor Pharmacodynamic Models: Medicilon Builds Systematic Drug Evaluation Capacity
The clinical trial approval of this PBC project serves as solid proof of Medicilon’s comprehensive expertise in non-tumor pharmacodynamic assessment. Medicilon owns over 290 animal models for non-tumor drug pharmacodynamic studies, covering neuropsychiatric, cardiovascular, metabolic, inflammatory and immune, digestive and other disease systems. Our portfolio features industry-leading, highly stable models for technically challenging indications: inflammatory immune disorders, stroke, renal ischemia-reperfusion injury, myocardial ischemia, liver fibrosis, pulmonary fibrosis, osteoarthritis, diabetic foot, diabetic nephropathy, renal failure, alopecia areata, lupus and other autoimmune diseases, and endometriosis. We deliver full systematic evaluation for test articles of diverse formulations and administration routes, including small-molecule and large-molecule novel drugs with various targets, ADCs, nucleic acid therapeutics, exosomes, radiopharmaceuticals and cell therapies.
Keeping pace with cutting-edge drug discovery, Medicilon continuously develops novel and effective evaluation models, and advances non-rodent large-animal pharmacodynamic models (monkeys, Bama miniature pigs, dogs) to assess pharmacodynamic effects for stem cell therapy for type 1 diabetes, weight management, postoperative analgesia and anticoagulation.
Recognition brings both honor and accountability, encouragement and motivation. Moving ahead, Medicilon will keep focusing on preclinical innovative drug R&D, continuously refine its one-stop preclinical R&D service platform, target unresolved clinical challenges, and fuel high-quality, sustainable growth of the global biopharma sector.
