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海创药业(688302):研发进展顺利,氘恩扎鲁胺软胶囊上市顺利
CAITONG SECURITIES· 2025-08-18 11:01
Investment Rating - The investment rating for the company is "Accumulate" (maintained) [2] Core Views - The company has made significant progress in innovative drug development, with the successful launch of Deutetrabenazine soft capsules, which are approved for treating metastatic castration-resistant prostate cancer (mCRPC) [9] - The company is expected to achieve revenue of 0.8 billion, 3.0 billion, and 5.0 billion RMB in 2025, 2026, and 2027 respectively, indicating a strong growth trajectory [9] Financial Performance - For the first half of 2025, the company reported total revenue of 0.13 million RMB and a net profit of -0.62 billion RMB, showing a reduction in losses compared to the same period last year [9] - Revenue growth rates are projected to be 21,708.1% in 2025, 275.0% in 2026, and 66.7% in 2027 [7][10] - The company is expected to continue incurring losses, with net profits projected at -221 million RMB in 2025, -85 million RMB in 2026, and -9 million RMB in 2027 [7][10] Research and Development Progress - The company has developed HP518, the first oral AR PROTAC drug in clinical trials in China, with clinical trial applications approved by both the NMPA and FDA [9] - HP515, another drug for treating MASH, has also progressed well, with clinical trial applications approved and ongoing patient enrollment [9] Market Performance - The company's stock has shown a performance of -7% over the last 12 months, compared to a 25% increase in the chemical pharmaceutical sector [4]
海创药业:上半年营收增11899%,多款在研药有进展
Sou Hu Cai Jing· 2025-08-14 11:51
Core Viewpoint - Haichuang Pharmaceutical reported significant revenue growth in the first half of 2025, with a revenue of 13.17 million yuan, marking a year-on-year increase of 11,899.08% [1] Financial Performance - The company recorded a net profit attributable to shareholders of -61.85 million yuan, an improvement from -100 million yuan in the same period last year [1] - Previous years (2020-2023) showed zero revenue, with only 366,800 yuan in revenue for 2024 [1] Product Development - The company achieved a breakthrough with its core product, Deuteroenzalutamide soft capsule, which was approved for market release in May 2025 for the treatment of metastatic castration-resistant prostate cancer [1] - The product is a first-class new drug developed independently by the company and supported by a national major new drug creation technology project [1] Market Strategy - During the reporting period, the company initiated commercialization preparations and established a four-wheel drive strategy [1] - In June, the product was first shipped nationwide, and the first prescription was issued, with ongoing efforts for market access and medical insurance inclusion planned for 2025 [1] Research and Development Progress - The company disclosed progress on multiple drugs in development, including HP518, which has commenced Phase I/II clinical trials in China and completed Phase I trials in Australia [1] - HP515 tablets have completed Phase I clinical trials in China, with preliminary data indicating good safety [1] - The company has adopted a global synchronized development strategy, establishing global branches and clinical teams, with a product pipeline that includes 334 patent applications, of which 129 have been authorized [1] Investment and Market Performance - The company acknowledged the high costs and long cycles associated with innovative drug development, expecting R&D expenses to remain elevated, and the unprofitable status may continue, potentially increasing cumulative unrecouped losses [1] - The innovative drug sector has been favored this year, with Haichuang Pharmaceutical's stock price increasing by over 100% [1] - As of June 30, three institutions entered the top ten circulating shareholders, while the top two shareholders slightly reduced their holdings in the second quarter [1]
海创药业上半年同比减亏 首款新药获批上市
Zheng Quan Shi Bao Wang· 2025-08-14 10:20
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]