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海创药业上半年同比减亏 首款新药获批上市

Core Viewpoint - Haichuang Pharmaceutical (688302) reported significant revenue growth in the first half of 2025, achieving operating income of 13.17 million yuan, a year-on-year increase of 11,899.08%, while reducing net losses to 61.85 million yuan from 100 million yuan in the same period last year [1] Group 1: Financial Performance - The company achieved a substantial increase in revenue compared to previous years, where it had minimal revenue, with 2020, 2021, and 2023 annual revenues being zero and only 366,800 yuan in 2024 [1] - The net profit loss decreased significantly from 100 million yuan in the previous year to 61.85 million yuan in the current reporting period [1] Group 2: Product Development - Haichuang Pharmaceutical's first core product, HC-1119, a deuterated enzalutamide soft capsule for prostate cancer, received NMPA approval in May 2025 [1] - The drug is a first-class new drug developed for treating metastatic castration-resistant prostate cancer (mCRPC) and has received support from the National Major New Drug Creation Technology Major Project [1] Group 3: Commercialization Strategy - The company has established a four-pronged commercialization strategy focusing on "medical-market-access-sales" and has built a commercial channel network [2] - By June 2025, the company achieved national product launch and the first prescription issuance [2] - Haichuang is actively preparing for market access and medical insurance inclusion, aiming for inclusion in the 2025 national negotiations to enhance product accessibility [2] Group 4: Research and Development Progress - The company disclosed progress on several in-development drugs, including HP518, which targets advanced prostate cancer and has received NMPA approval for clinical trials [3] - HP518's clinical trial application was approved by the FDA in the U.S., and results from Australian trials will be presented at major oncology conferences [3] - HP515, another drug for non-alcoholic fatty liver disease, has completed its Phase I clinical trial in China, showing promising safety and efficacy results [4] Group 5: Intellectual Property and Global Strategy - Haichuang Pharmaceutical has a global development strategy, with 334 invention patents filed globally, of which 129 have been granted [4] - The company has established global branches and clinical teams in China, the U.S., and Australia to enhance management and execution of overseas clinical trials [4] Group 6: Market Performance - The innovative drug sector has seen significant interest in the capital market, with Haichuang's stock price increasing over 100% since the beginning of the year [5] - New institutional investors have entered the top ten circulating shareholders, while the two largest shareholders slightly reduced their holdings in the second quarter [5]