According to disclosures from the Hong Kong Stock Exchange on September 29, Shaanxi MacroAir Technology Co., Ltd. (MacroAir) has submitted its listing application to the HKEx Main Board, with CCB International and CMB International Securities serving as joint sponsors.
The prospectus reveals that MacroAir operates as a platform-type biotechnology company dedicated to accelerating the innovation and development of next-generation bispecific/multispecific peptide drugs globally. The company's core product is currently in Phase III clinical trials.
Since its establishment in 2007, the company has focused on metabolic diseases (particularly kidney-related conditions) and cardiovascular diseases. MacroAir has independently developed: (i) one core product MT1013, primarily indicated for secondary hyperparathyroidism (SHPT), with potential expansion to additional indications including chronic kidney disease-mineral and bone disorder (CKD-MBD) with osteoporosis and non-dialysis SHPT; and (ii) three key products: XTL6001, MT1002, and MT200605. The company is also advancing three additional clinical-stage pipeline candidates.
MacroAir's core product MT1013 represents the world's first dual-target receptor agonist peptide drug capable of simultaneously targeting CaSR and OGP receptors. MT1013 is primarily developed for SHPT treatment, with plans to expand to additional indications including CKD-MBD with osteoporosis and non-dialysis SHPT.
As of September 22, 2025, MT1013 completed its Phase II clinical trial (MT1013-II-C01) for SHPT treatment in May 2025 and has entered a Phase III clinical trial using cinacalcet as the positive control drug. Clinical trials of MT1013 have demonstrated significant improvement in the comprehensive achievement rate of iPTH/serum calcium/serum phosphorus indicators, with rapid onset, strong and sustained iPTH reduction effects, cardiovascular benefit prospects, good safety and tolerability, and significant bone density improvement and bone metabolism enhancement.
Given the positive Phase II results showing beneficial effects on bone density improvement, the company is actively expanding MT1013's indications to include CKD-MBD with osteoporosis and non-dialysis secondary hyperparathyroidism.
Additionally, MacroAir's key product XTL6001 is the world's first and only GLP-1R/GCGR/MasR triple-target agonist to receive approval for investigational new drug clinical research and enter clinical trial stages in both China and the United States. The introduction of the innovative MasR target into the GLP-1R/GCGR combination represents a global first among current GLP-1 drugs, with potential applications in chronic weight management for obese or overweight populations, treatment of chronic kidney disease with proteinuria, and metabolic dysfunction-associated steatohepatitis.
Regarding financial performance, for the years 2023 and 2024, and the six months ended June 30, 2025, the company's R&D expenses were RMB 87.013 million, RMB 107 million, and RMB 40.432 million, respectively. During the same periods, annual/period losses were approximately RMB 195 million, RMB 157 million, and RMB 49.901 million, respectively.