Incident: Recently, the company received the “Notice of Acceptance” approved and issued by the China Drug Administration for the marketing application of a new drug called denlutamide (HC-1119 softgels).
Denlutamide NDA has been accepted and is expected to be the first drug approved for second-line treatment of metastatic casting-resistant prostate cancer (mCRPC) in China. Denlutamide (HC-1119 softgel) is a new class 1 drug intended for 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. It is expected to be approved for marketing in late 2023 or early 2024. Additionally, the global multi-center phase III clinical trial of denlutamide for the treatment of first-line mCRPC is being enrolled, and it is expected that phase III clinical trials will be completed in 2024/2025.
Denlutamide is a deuterium drug of enzalutamide, an AR inhibitor with BIC potential. Comparing enzalutamide test data horizontally, dernulamide was more effective. The efficacy of 80 mg of denalutamide was comparable to 160 mg of enzalutamide, and patient compliance was better; safety was better, and no epilepsy had occurred in clinical subjects. According to phase I clinical data of denlutamide, the PSA response rate in the dose escalation and dose extension cohort (≥ 50% lower than baseline) was 77% and 75%, respectively; the overall disease control rate (22 cases that can be radiologically analyzed) was 72.7%, 4 cases of PR, 12 cases of SD; the 2-year OS rate of patients in the dose extension cohort was 56.8%. It is safe and well tolerated, and no dose-limiting toxicity has been observed. Fatigue was the most common treatment-related adverse event, and no seizures were observed. Enzalutamide had global sales of approximately US$4.39 billion in 2020, ranking in the top 20 global drug sales rankings.
High-quality research pipelines are advancing at an accelerated pace, and many clinical-stage products are worth looking forward to. The company has developed 10 products in the pipeline, 9 of which are new drugs developed by the company itself. The field of diseases is mainly tumors and metabolic diseases. There are 8 types of tumor pipelines, including HC-1119, HP558, and HP518, covering various targets such as AR, SHP2, CBP/p300, BET, FAK, etc.; the field of metabolic diseases mainly includes HP501, HP515, etc. Many 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 to enter clinical treatment of drug-resistant prostate cancer in China.
Profit forecasts and investment recommendations. It is estimated that the company will achieve operating income of about 0, 0 and 160 million yuan respectively in 2022-2024. 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.