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海创药业(688302):核心产品商业化在即 研发管线获多个里程碑

Haichuang Pharmaceutical (688302): The commercialization of core products is imminent, and the R&D pipeline has achieved many milestones

東方財富證券 ·  May 16, 2023 00:00  · Researches

Continuously increase investment in research and development, and have rich technical reserves. In 2022, the company achieved pharmaceutical intermediates sales revenue of 1,6508 million yuan, and the company has not yet achieved a profit; net profit of the mother returned to the mother was -302 million yuan; net profit after deducting the return of the mother was -341 million yuan, a year-on-year loss of 5.3611 million yuan, a decrease of 1.55%. In 2022, the company invested 251 million yuan in R&D, a decrease of 5.12% over the previous year.

The company has a unique PROTAC targeted protein degradation technology platform, deuterated drug development platform, targeted drug discovery and verification platform, translational medicine technology platform, etc. Among them, PROTAC technology uses bifunctional small molecules to target target proteins. It is considered a revolutionary technology in the biomedical field, which can target non-generic drug targets and solve drug resistance problems.

The core product HC-1119 is about to be commercialized, and PROTAC HP518 is the first product in China to enter the clinical stage. The company has 13 innovative drug research projects, 4 of which are under NDA review and different clinical stages (HC-1119, HP518, HP501 and HP558). The core product HC-1119 is an androgen receptor (AR) inhibitor independently developed based on the company's core deuterogenesis drug development platform for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Its registered clinical phase III trial reached the end point of the protocol, and the data was selected for the 2023 American Society of Clinical Oncology Annual Meeting (ASCO); The marketing application for HC-1119 in March 2023 has been accepted by the Drug Evaluation Center (CDE), and HC-1119 is expected to be the first domestically produced innovative drug approved to be marketed to treat metastatic casting-resistant prostate cancer (mCRPC) after abirtrone/chemotherapy.

HP518, the first drug on the PROTAC platform, is the first oral ARPROTAC drug under development to enter clinical trials in China, and is expected to become a new generation of treatment for prostate cancer.

The company has international competitiveness and simultaneously develops international clinical and commercial cooperation. The company adopted a simultaneous global development strategy to anchor the world's major pharmaceutical markets. At present, the company has established global branches in China, the United States, Australia, etc.; it has set up experienced global clinical teams in China and the United States, and is carrying out global multi-center clinical trials in the US, Europe, Australia and other countries and regions. The HC-1119 phase III clinical trial for first-line treatment of casting-resistant prostate cancer is underway at various centers around the world; the application for the HP518 clinical Ib study has been approved by the US FDA. The company actively engages in global business and business cooperation to achieve international drug development.

The translation is provided by third-party software.


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