智通财经APP讯，海思科(002653.SZ)发布公告，公司子公司辽宁海思科制药有限公司于近日收到国家药 品监督管理局下发的《受理通书》，涉及药品："HSK46575"。本次获得受理的为本品联合奥拉帕利片 或联合多西他赛和泼尼松片用于前列腺癌的治疗适应症的临床试验申请。 HSK46575片是公司自主研发的一种口服、强效和高选择性的小分子抑制剂，拟用于前列腺癌的治疗。 临床前研究结果表明，本品靶点明确、疗效确切、安全性好，是一款极具开发潜力的小分子药物，临床 应用的效益/风险比高，具有广阔的临床应用前景，有望成为前列腺癌的有效治疗药物并解决目前临床 用药匮乏的难题。根据国家药品监督管理局关于发布《化学药品注册分类及申报资料要求》的通告 (2020年第44号)中化学药品注册分类的规定，本品属于化学药品1类。 ...

HSK46575片是公司自主研发的一种口服、强效和高选择性的小分子抑制剂，拟用于前列腺癌的治疗。 临床前研究结果表明，本品靶点明确、疗效确切、安全性好，是一款极具开发潜力的小分子药物，临床 应用的效益/风险比高，具有广阔的临床应用前景，有望成为前列腺癌的有效治疗药物并解决目前临床 用药匮乏的难题。根据国家药品监督管理局关于发布《化学药品注册分类及申报资料要求》的通告 (2020年第44号)中化学药品注册分类的规定，本品属于化学药品1类。 海思科（002653）(002653.SZ)发布公告，公司子公司辽宁海思科制药有限公司于近日收到国家药品监 督管理局下发的《受理通书》，涉及药品："HSK46575"。本次获得受理的为本品联合奥拉帕利片或联 合多西他赛和泼尼松片用于前列腺癌的治疗适应症的临床试验申请。 ...

格隆汇12月22日｜海思科公告，子公司辽宁海思科制药有限公司于近日收到国家药品监督管理局下发的 《受理通知书》，HSK46575片联合奥拉帕利片或联合多西他赛和泼尼松片用于前列腺癌的治疗适应症 的临床试验申请获受理。HSK46575片是公司自主研发的一种口服、强效和高选择性的小分子抑制剂， 拟用于前列腺癌的治疗。临床前研究结果表明，本品靶点明确、疗效确切、安全性好，具有广阔的临床 应用前景。 ...

Core Insights - The new National Medical Insurance Directory has added 114 new drugs, surpassing last year's addition of 91, with 50 being first-class innovative drugs, achieving an overall success rate of 88%, an improvement from 76% in 2024 [1][2] Group 1: New Drug Additions - The total number of drugs in the directory has increased to 3,253, significantly enhancing coverage for key areas such as oncology and chronic diseases [2] - The directory includes 38 global innovative drugs and 50 first-class innovative drugs, marking a historical high for new additions [2] - Notable inclusions are the first globally approved red blood cell maturation agent, Rotecip, for treating lower-risk myelodysplastic syndromes, and the first domestically developed IL-4Rα antibody drug, Kangyueda, for multiple indications [3][4] Group 2: Oncology Innovations - Several innovative oncology drugs have been added, including Tagolizumab, the first PD-L1 monoclonal antibody approved for nasopharyngeal carcinoma, and non-covalent BTK inhibitor, Jebatib, for relapsed mantle cell lymphoma [4][5][6] - ADCs (antibody-drug conjugates) have gained attention, with new entries like Lukanasatuzumab and Ruikangquzuzumab, targeting advanced breast cancer and non-small cell lung cancer [7][8] Group 3: Chronic Disease Treatments - The directory has included innovative drugs for chronic diseases, such as Novartis' PCSK9 mRNA interference drug for cholesterol management, addressing patients who cannot reach LDL-C targets [14] - AstraZeneca's biologic drug Benralizumab for severe eosinophilic asthma has also been added, providing targeted treatment options for patients [15][16] Group 4: Influenza Treatments - The new directory has incorporated two domestic antiviral drugs for influenza, Masurashave and Angladiv, which have shown promising clinical results in reducing symptoms and viral load [17]

Core Insights - The company reported a revenue of 331 million yuan and a net profit of 63.46 million yuan for the first three quarters of 2025, with a quarterly revenue of 112 million yuan and a net profit of 17.88 million yuan in Q3 [1] - The company is accelerating product commercialization and expanding its global market presence, with its product Olaparib tablets expected to be selected in the recent national centralized drug procurement [1] - The company received FDA approval for its product Tocilizumab sustained-release tablets in October, marking a significant milestone in its product portfolio [1] Product Development - The company made breakthroughs in the diabetes sector, with the approval of new specifications for Sitagliptin Metformin sustained-release tablets by the National Medical Products Administration in September [2] - The product Sitagliptin Metformin sustained-release tablets also received temporary approval from the FDA in October, enhancing the company's international presence in diabetes treatment [2] - The company has established a solid foundation for entering the U.S. market with two products receiving temporary FDA approval in the first half of the year [2] High-end Generic Drugs - The company follows a "first generic, high activity" strategy, achieving global first-generic breakthroughs for several products, including Posaconazole enteric-coated tablets and Macitentan tablets [3] - The company has also received approvals for high-activity formulations such as Olaparib tablets and Exemestane tablets, establishing market barriers [3] - The company's self-developed modified new drug project XT-0043 has shown excellent safety and efficacy in Phase II clinical trials [3] Future Outlook - The company plans to continue driving innovation and steadily advancing its international layout strategy, focusing on enhancing its high-end generic and modified new drug pipeline [3] - The company aims to improve its production quality system and service capabilities while strengthening international cooperation to commercialize more products globally [3]

Core Viewpoint - The company, Shanghai Xuantai Pharmaceutical Co., Ltd., has reported significant developments in its product approvals and market strategies, which are expected to enhance its competitive position and market share in both domestic and international markets [7][9]. Financial Data - The financial statements for the third quarter are unaudited, and the report period covers three months from the beginning to the end of the quarter [3][9]. - The company has not reported any non-recurring gains or losses that are significant enough to be classified differently from regular financial metrics [4][9]. Shareholder Information - As of the end of the reporting period, the company holds 4,336,109 shares in its repurchase account, representing 0.96% of the total share capital [5]. Product Approvals and Market Expansion - The company received approval from the National Medical Products Administration (NMPA) for a new specification of its product, Sitagliptin Metformin Sustained-Release Tablets 50/500mg, which is expected to better meet patient needs and enhance market competitiveness [7]. - The product, Tocilizumab Sustained-Release Tablets 11mg, has received formal approval from the U.S. Food and Drug Administration (FDA), while Sitagliptin Metformin Sustained-Release Tablets have received temporary approval from the FDA, indicating potential for expanded sales in the U.S. market [7]. - The company’s product, Olaparib Tablets, is set to be included in the 11th batch of national centralized drug procurement, which could lead to increased sales and market share if procurement contracts are signed and executed [7].

Core Viewpoint - The company has demonstrated significant progress in its high-end generic drug and CRO/CMO businesses, achieving substantial revenue growth and regulatory approvals for key products in both domestic and international markets [1][2][3] Financial Performance - For the first three quarters of 2025, the company reported a revenue of 331 million yuan and a net profit attributable to shareholders of 63.46 million yuan [1] - In Q3 2025, the company achieved a revenue of 112 million yuan and a net profit of 17.88 million yuan [1] - R&D expenses reached 17.19 million yuan in Q3, accounting for 15.36% of total revenue, reflecting the company's commitment to innovation [2] Product Development and Approvals - The company received approval for new specifications of its Sitagliptin Metformin Extended-Release Tablets from the National Medical Products Administration in September 2025, enhancing its product matrix in the diabetes sector [1] - In October 2025, the same product received tentative approval from the FDA, marking a significant milestone in the company's internationalization efforts [1] - The company’s Tofacitinib Citrate Extended-Release Tablets 11mg specification received formal approval from the FDA in October [2] - The company’s Olaparib Tablets are expected to be selected in the recent national drug centralized procurement, which will help expand sales and market share [2] R&D and Innovation Strategy - The company focuses on a "first-to-market" strategy in high-end generics, achieving multiple first-generic breakthroughs globally [2] - The company has developed three proprietary R&D technology platforms: "Poorly Soluble Drug Solubilization Technology," "Controlled Release Drug Formulation R&D Platform," and "Fixed-Dose Combination Formulation R&D Platform" [2] - The first self-developed modified new drug project, XT-0043, has shown excellent safety and efficacy in Phase II clinical trials [2] CRO/CMO Business Development - The company leverages its dual-platform in China and the U.S. and multiple GMP certifications to deepen collaborations with domestic and international innovative drug companies [3] - The company has advanced over 100 innovative drug formulation development projects and has established a stable CMO production service model for several successfully launched innovative drugs [3] Future Outlook - The company plans to continue its innovation-driven strategy and steadily advance its international layout, focusing on enhancing its high-end generic and modified new drug pipelines [3] - The controlling shareholder has committed not to reduce its stake in the company for two years starting from August 25, 2025, reflecting confidence in the company's long-term development [3]

Core Insights - The company reported a revenue of 331 million yuan and a net profit of 63.46 million yuan for the first nine months of 2025, with a quarterly revenue of 112 million yuan and a net profit of 17.88 million yuan in Q3 [1] Group 1: Product Development and Market Expansion - The company achieved significant progress in its internationalization strategy, with the FDA approving its 11 mg formulation of tofacitinib citrate in October [1] - The diabetes pipeline saw breakthroughs, with the approval of a new specification for sitagliptin and metformin extended-release tablets by the National Medical Products Administration (NMPA) in September, enhancing the product matrix [2] - The company’s products are now available in multiple countries, including China, the USA, Australia, Canada, and Southeast Asia, creating a diversified global sales structure [2] Group 2: Regulatory Approvals and Quality Certifications - The company’s solid dosage form workshop received GMP certification from the European Medicines Agency (EMA) in July, maintaining a "zero-defect" record in inspections by major global regulatory agencies [3] - The company was awarded the highest information disclosure rating of "A" by the Shanghai Stock Exchange for the 2024-2025 information disclosure evaluation, reflecting its commitment to investor relations and transparency [3] Group 3: Strategic Commitments - The controlling shareholder, Shanghai Lianhe Investment Co., Ltd., voluntarily committed not to reduce its shareholding for two years starting from August 25, 2025, indicating confidence in the company's long-term development strategy [3]

Economic News - The largest offshore emergency drill in northern China's waters commenced on October 28, 2025, testing the country's deep-sea wind power emergency rescue capabilities [1] - The Ministry of Finance reported that from January to September, state-owned enterprises generated total revenue of 613,290.5 billion yuan, a year-on-year increase of 0.9% [1] - The China Logistics and Purchasing Federation indicated that the total social logistics cost for the first three quarters reached 14.2 trillion yuan, growing by 4.3% year-on-year [1] - The Xiamen government announced a new household registration policy effective November 1, 2025, aimed at optimizing residency conditions [1] Company News - Three squirrels announced a price adjustment for certain products effective November 1, with price increases ranging from 0.2 yuan to 10 yuan across 35 products [4] - Tongrentang made significant progress in liquid preparation capacity, with a new production line expected to submit GMP compliance checks by the end of the year [4] - BYD launched its first K-car model, Racco, designed specifically for the Japanese market, with pre-sales planned for summer 2026 [4] - The company Guokai Military Industry signed a contract worth 4.66 billion yuan for military trade products, expected to positively impact its performance [4] Industry Insights - The "Fifteenth Five-Year Plan" outlines clear economic and social development goals, including achieving a per capita GDP at the level of moderately developed countries by 2035 [5][6] - The plan emphasizes the importance of enhancing the financial sector, improving capital market functions, and supporting emerging industries [6][7] - It highlights the need for a strong domestic market and increased consumer spending, with policies aimed at boosting consumption and enhancing public service spending [8] - The plan also focuses on accelerating the development of new energy systems and increasing the share of renewable energy supply [8][9] Investment Recommendations - The release of the planning document is expected to enhance market understanding of China's economic direction, boosting confidence in Chinese assets [9][10] - The report suggests focusing on the technology sector, particularly in areas of innovation, as a key investment opportunity [10] - It also indicates that sectors such as cyclical industries, new energy, and military industries are expected to maintain high levels of activity, presenting good investment prospects [10]

Core Viewpoint - XuanTai Pharmaceutical (688247.SH) has participated in the 11th national centralized procurement organized by the National Organization for Drug Procurement Office, with its product Olaparib tablets expected to be selected in this procurement process [1] Group 1 - The company announced its involvement in the national centralized procurement bidding [1] - The procurement results were published on October 28, 2025, indicating the potential selection of Olaparib tablets [1] - The procurement document number for this process is GY-YD2025-1 [1]