Incident: The company released its semi-annual report for 2023, and net profit for the first half of 2023 was 165 million yuan. Net profit to parent was 90 million yuan in the second quarter of 2023.
The deuterium-enzalutamide NDA has been accepted and is expected to be the first drug approved for second-line treatment of metastatic castration-resistant prostate cancer (mCrPC) in China. The phase III clinical trial of deuterium-enzalutamide was assessed by IDMC in June 2022. The data was selected for ASCO 2023, and the marketing application was accepted by the CDE in March 2023. Deuteronzalutamide is a new class 1 drug intended for use in mCRPC patients who have failed treatment with abiraterone acetate or docetaxel and are intolerable or unsuitable for docetaxel treatment. It is also the first innovative drug for this type of treatment to apply for marketing of a new drug. It is expected to be approved for marketing in 2024. Additionally, its global multicenter phase III clinical trial for the treatment of first-line mCrPC is being enrolled.
HP518 China IND has been accepted, and HP501 is undergoing phase III clinical preparations. HP501 has completed multiple HP501 phase I and phase II clinical trials. Currently, preparations for the HP501 phase III clinical trial in China are being carried out. At the same time, US clinical trial plan design and IND application preparation are also being carried out. The HP518 clinical Ia dose climbing study was enrolled in the first patient group in Australia in January 2022. Currently, multiple dose group phase A clinical studies have been completed. The application for the dose extension Ib study submitted in the US was approved by the FDA in January 2023, and the Chinese IND was accepted by the NMPA in August 2023.
Technology platforms such as PROTAC have established continuous independent innovation capabilities, and many clinical-stage products are worth looking forward to. The company has 13 products in its research pipeline. The disease field is mainly tumors and metabolic diseases, and 4 products have entered the clinical stage. Tumor pipelines mainly include HC-1119, HP558, and HP518, covering multiple targets such as AR, SHP2, CBP/p300, BET, and FAK; the field of metabolic diseases mainly includes HP501 and HP515. Various clinical-stage products are worth looking forward to. For example, HP501 is a potentially safer and more effective anti-hyperuricemia/gout URAT1 inhibitor, and HP518 is the first oral PROTAC molecule in China to enter clinical treatment for drug-resistant prostate cancer. The IND for HP530S tablets intended for use in solid tumors was accepted by the NMPA in February 2023.
Profit forecasts and investment recommendations. The company is expected to achieve revenue of about 0.02, 160 and 380 million yuan respectively in 2023-2025. Considering Haichuang Pharmaceutical's strong R&D capabilities and outstanding deuteride and PROTAC technology platforms, the first innovative drug, dernulamide NDA, has been accepted, maintaining the “buy” rating.
Risk warning: R&D or review and approval progress falls short of expected risks, increased market competition risks, policy risks in the pharmaceutical industry, etc.