Core Viewpoint - HaiChuang Pharmaceutical (688302) has made significant progress in commercialization, medical insurance access, and research pipeline, with revenue growth and reduced losses as indicated in its performance forecast [1] Group 1: Project Advancement - The company announced on February 1, 2026, that its soft capsule production line for the anti-tumor drug has passed GMP compliance inspection, indicating the core product, Deuteroenzalutamide soft capsules, is now capable of large-scale production, completing the "R&D - Production - Sales" full industry chain [2] Group 2: Business Progress - Deuteroenzalutamide soft capsules were included in the national medical insurance catalog on December 2025, effective from January 1, 2026, which is expected to enhance patient accessibility through a "direct sales + agency" dual-track model; the product was previously approved for market launch in May 2025 and included in the CSCO Prostate Cancer Diagnosis and Treatment Guidelines [3] Group 3: Product Development Progress - The company is focusing on prostate cancer and metabolic diseases, with the oral AR PROTAC drug HP518 having completed Phase I clinical trials, while Phase II trials in China and combination therapy studies are ongoing; HP515, aimed at treating metabolic-associated fatty liver disease (MASH), has entered Phase II clinical trials, with preclinical data on its combination with GLP-1 presented at international conferences [4] Group 4: Performance and Operations - The 2025 performance forecast indicates the company expects revenue between 19 million and 22 million, representing a significant year-on-year increase, with losses narrowing by 24.81% to 37.34%, primarily due to the sales of Deuteroenzalutamide [5] Group 5: Institutional Research - In January 2026, the company hosted a research meeting with 29 institutions, including Foresight Investment and Western Securities, reflecting market interest in its innovative drug pipeline [6]

Core Viewpoint - The strong trend in the mainland healthcare sector from last year is expected to continue into this year, with investors needing to consider the value of more R&D pipelines when evaluating valuations [1] Group 1: Investment Strategy - Companies are now trading based on actual execution capabilities rather than solely on licensing deal expectations [1] - Achieving returns that exceed the industry will rely more on key data releases, actual transactions, and visibility on earnings realization or turning points [1] Group 2: Sector Insights - The outlook for CDMO companies is becoming more constructive due to accelerated growth, strong product cycles, limited geopolitical risks, and reasonable valuations [1] - The ratings for WuXi AppTec and WuXi AppTec Holdings have been upgraded to "Buy" [1] Group 3: Selective Strategy in Biotech and Pharma - A selective strategy is adopted for biotech and pharmaceutical companies, favoring those with key data releases and early data showing potential, along with actual transaction expectations [1] - Companies such as Kelun-Biotech, Junshi Biosciences, and Hansoh Pharmaceutical are viewed positively [1] Group 4: Medical Devices Sector - The medical devices sector is maintained with a neutral outlook, indicating that while the industry has bottomed out, recovery will take time [1] - Recommended stocks include Angelalign Technology and Weigao Group [1]

Hot Topics - Jia Mei Packaging's stock trading suspension review has concluded, and the stock will resume trading tomorrow [1] - Fenglong Co., Ltd.'s stock trading suspension review has concluded, and the stock will resume trading tomorrow [2] - Hongbaoli does not produce epoxy propylene products, and its subsidiary's related project has entered the preliminary preparation stage for trial production [2] - Hunan Gold's future market price for gold products has uncertainty regarding whether it can continue to rise or maintain high levels [2] - Tongding Interconnection's current operating conditions are normal, with no significant changes in the internal and external operating environment [3] - Tiandi Online's recent operating conditions and internal and external operating environment show no significant changes [4] - Dayue City reports no significant changes in its recent operating conditions and internal and external environment [5] - Huangtai Liquor Industry is not involved in hot concept matters, and its current operating conditions are normal [6] Performance - Leshan Electric Power reported a net profit of 23.4023 million yuan for 2025, an increase of 3.68% year-on-year [7] - Great Wall Motors sold 90,300 vehicles in January, a year-on-year increase of 11.59% [8] - Seres sold 45,900 vehicles in January, a year-on-year increase of 104.85% [9] - GAC Group sold 116,600 vehicles in January, a year-on-year increase of 18.47% [10] - BAIC Blue Valley's subsidiary sold 8,073 vehicles in January, a year-on-year increase of 11.83% [11] Shareholding Changes - Chipone Technology's shareholders plan to reduce their holdings by no more than 1.95% of the company's shares [30] Share Buybacks - Chuzhou Dongfeng's controlling shareholder proposed to repurchase shares worth 50 million to 100 million yuan [31] - GoerTek has increased the total amount for share repurchase from no less than 500 million yuan (inclusive) and no more than 1 billion yuan (inclusive) to no less than 1 billion yuan (inclusive) and no more than 1.5 billion yuan (inclusive) [31] Contract Awards - Jerry Holdings' wholly-owned subsidiary signed a sales contract for gas turbine generator sets worth approximately 1.265 billion yuan with a U.S. client [32] - Fulongma is expected to win four sanitation service projects in January, with a total first-year service fee of 83.5364 million yuan [34] Equity Changes - Yanzhou Coal Mining is transferring 100% equity of Xintai Coal [33] Mergers and Acquisitions - BGI Genomics plans to acquire 100% equity of Sanjian Qifa and 100% equity of BGI Xufeng to integrate two cutting-edge technology platforms in spatial omics and nanopore sequencing [34] Refinancing - Sanjia Technology (rights protection) plans to issue shares to its controlling shareholder to raise no more than 300 million yuan for working capital and repaying bank loans [35] Other - Fushikong's actual controller, chairman, and general manager Chen Yongliang has been placed under detention [36] - China Mobile's VAT tax category adjustment will change the applicable VAT rate from 6% to 9% [37] - China Telecom's VAT tax category adjustment will impact the company's revenue and profits [38] - China Unicom's VAT tax category adjustment will change the applicable VAT rate from 6% to 9% [39] - Nanwang Energy's price policy adjustment for pumped storage and new energy storage will increase uncertainty in revenue and profits from pumped storage power stations [39] - Wanbangde has completed the enrollment of 100 subjects for the clinical trials of Shishan Jianjia controlled-release tablets phases II and III [39] - Penghui Energy has submitted an application for issuing H-shares and listing on the Hong Kong Stock Exchange [40] - Haichuang Pharmaceutical has passed the GMP compliance inspection for drugs [41]

Core Viewpoint - Haichuang Pharmaceutical has received the GMP compliance inspection notice from the Sichuan Provincial Drug Administration, confirming that its soft capsule production line for the anti-tumor drug, Deutetrabenazine, meets the required quality management standards [1] Group 1 - The company announced the receipt of the GMP compliance inspection notice (No. 川许2026035) [1] - The inspection covered the soft capsule production line for the anti-tumor drug Deutetrabenazine (National Drug Approval No. H20250029) [1] - The company has completed the necessary changes to its drug production license following the successful inspection [1]

Core Insights - Haichuang Pharmaceutical's innovative drug, Deutetrabenazine (brand name: Hainan'an®), has successfully passed GMP compliance inspection, enabling large-scale commercial production [1] - The drug has been included in the 2025 National Medical Insurance Directory, providing a solid payment foundation for market expansion [1] - The combination of GMP certification and insurance inclusion creates a synergistic effect, completing the company's full industry chain from R&D to production and sales [1] Group 1: Product and Market Potential - Deutetrabenazine is the first domestic AR inhibitor approved for metastatic castration-resistant prostate cancer (mCRPC), filling a clinical gap in this area [2] - The domestic AR inhibitor market is rapidly growing, expected to reach 23.9 billion yuan by 2030, with the overall prostate cancer market exceeding 50 billion yuan [2] - The current market is dominated by foreign products, which hold 75% of the market share, indicating significant potential for domestic alternatives [2] Group 2: Pipeline Development - The activation of commercial production capacity will support not only the core product but also the pipeline reserves, ensuring scalable implementation [3] - The oral ARPROTAC drug HP518 is in clinical trials, showing potential for synergy with Deutetrabenazine in treating resistant prostate cancer [3] Group 3: Metabolic Disease Research - The drug HP515 for treating MASH has completed Phase I clinical trials, with Phase II trials ongoing, showcasing promising preclinical data in combination with GLP-1 drugs [4] - The combination therapy addresses the core issue of muscle loss associated with traditional weight loss drugs, catering to the needs of over 400 million overweight/obese individuals in China [5] - The global weight loss market is projected to reach $554.9 billion by 2030, indicating substantial growth potential in this sector [5] Group 4: Strategic Positioning - The dual breakthroughs of GMP certification and core product insurance inclusion signify the company's comprehensive capabilities in innovative R&D, large-scale production, and market promotion [5] - The company aims to leverage its mature production management system and full industry chain layout to enhance market penetration of core products and clinical transformation of pipeline products [5]

证券代码：688302 证券简称：海创药业 公告编号：2026-002 海创药业股份有限公司 关于公司通过药品 GMP 符合性检查暨 药品生产许可证变更的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 海创药业股份有限公司（以下简称"公司"）于近日收到四川省药品监督管 理局核准签发的《药品 GMP 符合性检查告知书》（编号：川许 2026035），认定 公司本次检查范围及相关车间、生产线"软胶囊剂（抗肿瘤药）[氘恩扎鲁胺软 胶囊（国药准字 H20250029）],软胶囊车间，软胶囊生产线"符合《药品生产质 量管理规范（2010 年修订）》及相关附录规定。本次检查通过后，公司相应完 成了《药品生产许可证》的变更工作。现将相关情况公告如下： 一、《药品 GMP 符合性检查告知书》相关信息 企业名称：海创药业股份有限公司 住所：四川省成都市双流区凤凰路 558 号 检查范围及相关车间、生产线：软胶囊剂（抗肿瘤药）[氘恩扎鲁胺软胶囊 （国药准字 H20250029）],软胶囊车间，软胶囊生产线 检查结论：符合《药品生产质量管 ...

Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has received approval from the Sichuan Provincial Drug Administration for its GMP compliance inspection, allowing the company to expand its production capabilities in the oncology drug sector [1] Group 1: Regulatory Approval - The company has been issued a GMP compliance inspection notice (No. 川许2026035) confirming that its soft capsule production line for the anti-tumor drug Deutetrabenazine meets the required standards [1] - Following the inspection, the company has completed the necessary changes to its Drug Production License [1] Group 2: License Changes - The changes to the Drug Production License include a new registered address located at 558 Phoenix Road, Shuangliu District, Chengdu, Sichuan Province [1] - The production scope has been expanded to include soft capsules for anti-tumor drugs, with the classification code changing from "Bh" to "AhBh" [1]

Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has received approval from the Sichuan Provincial Drug Administration for its GMP compliance inspection, allowing the company to expand its production capabilities in the oncology drug sector [1] Group 1: Regulatory Approval - The company has been issued a GMP compliance inspection notice (No. 川许2026035) confirming that its soft capsule production line for the oncology drug Deutetrabenazine meets the required standards [1] - Following the inspection, the company has completed the necessary changes to its Drug Production License [1] Group 2: License Changes - The changes to the Drug Production License include a new registered address located at 558 Phoenix Road, Shuangliu District, Chengdu, Sichuan Province [1] - The production scope has been expanded to include soft capsules for oncology drugs, with the classification code changing from "Bh" to "AhBh" [1]

Core Viewpoint - The company, Haichuang Pharmaceutical, anticipates a reduction in losses for the fiscal year 2025, with projected net losses between 150 million to 125 million yuan, representing a year-on-year decrease in losses of approximately 24.81% to 37.34% [2][6]. Group 1: Performance Forecast - The company expects a total profit loss of 150 million to 125 million yuan for 2025, a reduction in losses compared to the previous year by 49.48 million to 74.48 million yuan [2]. - The projected net profit attributable to the parent company is also expected to be between 150 million to 125 million yuan, with a similar reduction in losses compared to the previous year [2]. - The anticipated operating revenue for 2025 is estimated to be between 19 million to 22 million yuan, with the same range applicable for revenue excluding non-core business income [2]. Group 2: Previous Year Performance - In 2024, the company reported an operating revenue of 366,800 yuan, with a total profit loss of 199.48 million yuan and a net profit loss attributable to the parent company of 199.49 million yuan [4]. Group 3: Reasons for Performance Changes - The approval and market launch of the company's first Class 1 new drug, Deuteroenzalutamide soft capsule, in May 2025 is expected to contribute to increased sales revenue compared to the previous year [5]. - The inclusion of Deuteroenzalutamide soft capsule in the National Medical Insurance Drug List is anticipated to lead to a significant price reduction, affecting revenue projections due to inventory adjustments and changes in marketing strategies [5]. - The company plans to reduce research and development expenses for 2025 to between 105 million to 125 million yuan, a decrease from the previous year [5].

Core Viewpoint - The company expects to reduce its losses significantly in 2025, with projected total profits ranging from -150 million to -125 million yuan, indicating a year-on-year loss reduction of 24.81% to 37.34% [1] Financial Projections - The company anticipates a net profit attributable to shareholders of the parent company for 2025 to be between -150 million and -125 million yuan, reflecting a decrease in losses by 49.49 million to 74.49 million yuan compared to the previous year [1] - The expected net profit after deducting non-recurring gains and losses is projected to be between -185 million and -155 million yuan, which represents a reduction in losses by 32.51 million to 62.51 million yuan year-on-year, equating to a decrease of 14.95% to 28.74% [1] Product Development - The company’s first Class 1 new drug, Deutetrabenazine soft capsules (Project No: HC-1119), is expected to be approved for market sale in May 2025, which will contribute to revenue growth despite the current limited sales from materials and intermediates [1]