IPO News | McCool sprints to HKEx's core product MT1013 in phase III clinical trials

The Zhitong Finance App learned that, according to the Hong Kong Stock Exchange's disclosure on September 29, Shaanxi McAuto Technology Co., Ltd. (abbreviation: McAuto) submitted a listing application to the main board of the Hong Kong Stock Exchange, with CCB International and China Merchants Securities International as co-sponsors.

According to the prospectus, Micot is a platform-based biotechnology company dedicated to accelerating the innovation and development of next-generation bispecific/polypeptide drugs around the world. The company's core products are in phase III clinical trials.

Since its establishment in 2007, the company has focused on metabolic diseases (especially kidney related diseases) and cardiovascular and cerebrovascular diseases, and has independently developed (i) a core product, MT1013. Its main indication is secondary hyperparathyroidism (SHPT), and has the potential to expand to additional indications such as abnormal mineral and bone metabolism (CKD-MBD) with osteoporosis and SHPT without dialysis; and (ii) three key products, namely XTL6001, MT1002, and MT200605. The company is also promoting three additional clinical-stage product candidates in the pipeline.

Among them, the core product of Micot, MT1013 is the world's first dual-target receptor agonist polypeptide drug, which can simultaneously target CasR and OGP receptors. MT1013 was mainly developed to treat SHPT and is planned to be extended to additional indications including CKDMBD with osteoporosis and SHPT without dialysis. As of September 22, 2025, MT1013 has completed its phase II clinical trial (MT1013-II-C01) for the treatment of SHPT in May 2025, and has entered a phase III clinical trial using cinacalcet as a positive control drug.

Clinical trials of MT1013 have shown that it can significantly improve the overall compliance rate of the three iPTH/blood calcium/blood phosphorus indicators. The effect of reducing iPTH is fast, the curative effect is strong and long-lasting. It has the potential for cardiovascular benefits, good safety and tolerability, and can significantly increase bone density and improve bone metabolism. In view of the phase II clinical trial results showing that it has a positive effect in improving bone density, the company is actively expanding the indications of the core product MT1013 to fields such as CKD-MBD with osteoporosis and non-dialysis secondary hyperparathyroidism.

In addition, McCool's key product, xTL6001, is the world's first and only GLP-1r/GCGR/MasR triple target agonist that has obtained clinical research approval for a new drug in both China and the US and has entered the clinical trial stage. The introduction of the innovative target MASR into the GLP-1r/GCGR target combination is the first in the world among current GLP-1 drugs. It has potential applications for chronic weight management in obese or overweight people, treatment of chronic kidney disease with proteinuria, and steatohepatitis associated with metabolic dysfunction.

In terms of performance, in 2023, 2024, and 2025 for the six months ended June 30, the company's R&D expenses were 87.013 million yuan, 107 million yuan, and 404.32 million yuan respectively; during the same period, the annual/period losses were approximately 195 million yuan, 157 million yuan, and 49.901 million yuan.