HC-1119 (deuterated enzaluamide) is about to be commercialized, with potential BIC varieties and huge market growth space. HC-1119 for end-line treatment of metastatic castration-resistant prostate cancer (mCRPC) NDA was accepted in March 2023 and is expected to be approved for market in 2024; in addition, a global multicenter III phase of mCRPC treatment is under way. HC-1119 is deuterated enzaluamide, which has better efficacy and safety than Enzaluamide. It is a potential BIC product. With the continuous improvement of domestic AR inhibitor permeability, HC-1119 future sales growth space is huge, the sales peak is expected to be nearly 3 billion yuan.
HP501 is about to enter the third phase of clinical practice, and its safety advantage is obvious. HP501 is a highly active and highly selective URAT1 inhibitor independently developed by the company for the treatment of hyperuricemia / gout. There are a large number of patients with hyperuricemia and gout in China, and the mainstream drugs on the market have obvious deficiencies in terms of safety. Based on the existing phase I and II clinical trial data, HP501 has a good efficacy, especially in terms of safety significantly better than similar products. At present, HP501 monotherapy for hyperuricemia / gout has completed a number of phase Ⅰ and Ⅱ clinical studies, and preparations for phase III clinical trials are being carried out. The domestic progress is leading and the future market space is huge. It is expected that the long-term sales peak will exceed 1 billion yuan.
Deuterium and PROTAC technology platforms help the company to innovate and develop and build differentiated product lines in the areas of cancer and metabolism. The company condenses the outstanding technical advantages in the field of deuterium and PROTAC, and gradually builds and improves the four core technology platforms independently. At present, four core products have entered the clinical stage. In addition to HC-1119 and HP-501, HP518 is an oral PROTAC drug for prostate cancer, and it is also the first oral PROTAC drug for prostate cancer in China to enter the clinical stage. Phase I clinical trials are progressing smoothly in Australia, which has more advantages than similar products.
Profit forecast and investment advice. The company has unique technological advantages, and its blockbuster products are about to be commercialized. It is estimated that the operating income from 2023 to 2025 will be 0,1.3 and 490 million yuan respectively. Calculated by the DCF method, assuming a sustainable growth rate of 2% and 10.58%, the reasonable equity value of the company is 7.8 billion yuan, and the corresponding share price is 78.86 yuan. The company is given a "buy" rating for the first time.
Risk hints: risks related to preclinical and clinical studies of new drugs, risks of drug registration and approval, risks of technology upgrading and product iteration, risks of loss of core technical personnel, etc.