| CYHS2401192 | 棕榈酸帕利哌酮注射 | 湖南科伦制药有限公司 | 国药准字 | 2025年11月12日 | | --- | --- | --- | --- | --- | | | 液 | | H20255925 | | | CYHS2401193 | 棕榈酸帕利哌酮注射 | 湖南科伦制药有限公司 | 国药准字 | 2025年11月12日 | | | 液 | | H20255926 | | | CYHS2401194 | 棕櫚酸帕利哌酮注射 | 湖南科伦制药有限公司 | 国药准字 | 2025年11月12日 | | | 液 | | H20255927 | 目開發 | 截图来源：NMPA 棕榈酸帕利哌酮注射液作为第二代抗精神病药的代表，以帕利哌酮前体形式经肌肉注射后形成长效药物储库，持续缓释并转化为活性成分，通过精准拮抗多 巴胺D2受体与5-羟色胺2A（5-HT2A）受体，实现症状的稳定控制。 11月14日，据NMPA官网显示，湖南科伦制药提交的4类注册仿制药棕榈酸帕利哌酮注射液获批上市并视同通过一致性评价。今年以来，科伦药业（含子公 司）已经拿下6款首仿。 其独特的每月一次给药方案显著降低患者住 ...

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. has received drug registration approval from the National Medical Products Administration for its injectable drug Paliperidone Palmitate, which is expected to enhance the company's competitiveness in the central nervous system field [1][2][3]. Group 1: Drug Information - The drug name is Paliperidone Palmitate, available in injection form with specifications of 75mg, 100mg, and 150mg per 0.75ml, 1.0ml, and 1.5ml respectively [1]. - It is classified as a Class 4 chemical drug and has been approved for domestic production [1]. - The drug was developed by Janssen Pharmaceuticals and was first approved in the U.S. in 2009, with China approving its import in 2011 [2]. Group 2: Advantages and Market Potential - Paliperidone Palmitate is the first long-acting atypical antipsychotic approved for monthly administration, offering advantages such as improved patient compliance, reduced risk of disease relapse, and enhanced safety [2]. - The drug is widely recommended in various authoritative guidelines and is included in the national essential drug list and Class B medical insurance [2]. - The global sales forecast for 2024 is approximately $3.5 billion [2]. Group 3: Company Technology and Pipeline - The long-acting microcrystal injection platform of the company has independent intellectual property rights and addresses stability issues in microcrystal formulations [3]. - Paliperidone Palmitate is the first product approved from this microcrystal platform, with multiple other products under development [3]. - The approval of this drug is expected to enhance the company's pipeline competitiveness in the central nervous system disease sector [3].

Core Viewpoint - Kolun Pharmaceutical's subsidiary, Hunan Kolun Pharmaceutical Co., Ltd., has received drug registration approval from the National Medical Products Administration for its chemical drug "Paliperidone Palmitate Injection," which is used for the treatment of acute and maintenance phases of schizophrenia [1] Group 1 - The approved drug is specifically indicated for the treatment of schizophrenia, addressing both acute and maintenance phases [1] - The approval marks a significant milestone for Kolun Pharmaceutical, enhancing its product portfolio in the psychiatric treatment segment [1]

Core Viewpoint - Kolun Pharmaceutical's subsidiary, Hunan Kolun Pharmaceutical Co., Ltd., has received drug registration approval from the National Medical Products Administration for its chemical drug "Paliperidone Palmitate Injection" [1] Group 1: Product Approval - The "Paliperidone Palmitate Injection" was developed by Janssen Pharmaceuticals and was first approved in the United States in 2009 [1] - The drug was imported into China in 2011 and utilizes long-acting microcrystal technology, allowing for administration once a month [1] Group 2: Indications - The injection is indicated for the treatment of acute and maintenance phases of schizophrenia [1]

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook for its stock performance [4]. Core Views - The company reported a stable performance in its 2025 semi-annual report, achieving a revenue of RMB 6.272 billion, a slight decrease of 0.17% year-on-year, while the net profit attributable to shareholders increased by 9.4% to RMB 1.281 billion [1]. - The growth in the company's profit was driven by the formulation segment and high-margin specialty raw material exports, despite a slight decline in revenue from certain segments due to market fluctuations [1][2]. - The company is entering a harvest period for its innovative research and development, with several products progressing through clinical trials and receiving regulatory approvals [2]. Financial Summary - The projected net profit for the company from 2025 to 2027 is expected to be RMB 2.268 billion, RMB 2.534 billion, and RMB 2.799 billion, reflecting growth rates of 10%, 11.7%, and 10.5% respectively [2]. - The company's earnings per share (EPS) is projected to increase from RMB 2.51 in 2025 to RMB 3.10 in 2027, indicating a positive trend in profitability [3]. - The price-to-earnings (P/E) ratio is expected to decrease from 16.6 in 2025 to 13.4 in 2027, suggesting that the stock may become more attractive relative to its earnings [3].

Core Viewpoint - Lijun Group reported a slight decline in revenue but a significant increase in net profit for the first half of 2025, indicating strong operational efficiency and growth in specific product segments [2][3]. Financial Performance - The company achieved a revenue of 6.272 billion yuan, a year-on-year decrease of 0.17% - Net profit attributable to shareholders was 1.281 billion yuan, a year-on-year increase of 9.4% - Basic earnings per share stood at 1.43 yuan [2]. Product and R&D Development - Major product revenues in the digestive, psychiatric, reproductive, and traditional Chinese medicine sectors all experienced year-on-year growth - R&D investment was approximately 491 million yuan, accounting for 7.82% of total revenue - The company has 39 products in the research pipeline, with 13 in the registration phase and 4 in Phase III clinical trials [2][3]. Business Development and Collaboration - The company introduced 6 projects through business development (BD) in 2024, with 5 successfully entering clinical transformation - The focus for BD in the first half of 2025 included core therapeutic areas such as digestive, psychiatric, metabolic, and anti-infection fields [3]. AI and Patent Strategy - Lijun Group enhanced the application of AI technology throughout the R&D process, including drug design and clinical research - In the first half of 2025, the company submitted 23 patent applications and received 19 domestic patent authorizations, totaling 936 effective patents [3]. International Revenue Growth - The company achieved overseas revenue of approximately 1.004 billion yuan, a year-on-year increase of 18.4% - Overseas revenue accounted for about 16.01% of total revenue, an increase of 2.51 percentage points from the previous year [3].

Core Viewpoint - Lijun Group reported a slight decline in revenue but an increase in net profit for the first half of 2025, indicating strong performance in specific segments and effective cost management [1] Financial Performance - The company achieved operating revenue of 6.272 billion yuan, a year-on-year decrease of 0.17% [1] - Net profit attributable to shareholders reached 1.281 billion yuan, reflecting a year-on-year growth of 9.4% [1] - Basic earnings per share were 1.43 yuan [1] R&D and Pipeline Development - R&D investment amounted to approximately 491 million yuan, accounting for 7.82% of total revenue [1] - The company has 39 products in the research pipeline, with 13 in the listing application stage and 4 in Phase III clinical trials [1] - Significant progress in clinical trials includes JP-1366 tablets completing Phase III and submitting for market approval [2] AI Integration in R&D - The company has integrated AI technology throughout the R&D process, enhancing efficiency in drug design and clinical research [3] - AI applications have improved the efficiency of the quadrivalent influenza vaccine project, reducing development time and increasing yield [3] Patent and Intellectual Property - In the first half of 2025, the company submitted 23 patent applications and received 19 domestic and 4 foreign patent grants [3] - The total number of effective patents held by the company is 936, including 490 invention patents [3] International Revenue and Market Expansion - Overseas revenue reached approximately 1.004 billion yuan, a year-on-year increase of 18.4%, accounting for 16.01% of total revenue [3] - The company’s raw material exports generated 974 million yuan, reflecting a year-on-year growth of 19.68% [4] - The company is expanding its high-end antibiotic and veterinary drug markets, with new product approvals expected in Europe and the U.S. [4]

R&D Strategy - The company has initiated a comprehensive review of its R&D strategy since 2024, focusing on clear objectives in disease areas and technology platforms [2] - Key areas of focus include gastrointestinal, reproductive health, and mental health, with a complete product pipeline and treatment plans [2][3] - In the gastrointestinal field, the company is advancing P-CAB products, with the tablet in phase III clinical trials expected to launch this year [2] - In reproductive health, the company has successfully launched a water-soluble progesterone injection and is working on recombinant human follicle-stimulating hormone injection, expected to be approved by Q1 2027 [2][3] Key Product Developments - The NS-041 project for epilepsy is in phase II clinical trials, showing superior selectivity and efficacy compared to similar products [4] - The IL-17A/F monoclonal antibody for psoriasis has completed phase III clinical enrollment, with plans to submit for approval in 2025 [5] - The company has a strong market position in reproductive health, holding over 90% of the u-FSH market in China since 2005 [5][6] Financial Performance and Projections - The company expects a slight growth in traditional Chinese medicine sales, driven by policy changes and new product developments [7] - In 2024, the revenue from APIs and intermediates is projected to be CNY 3.25 billion, with a 7.9% increase in exports [8] - The company plans to balance dividends, share buybacks, and R&D investments, with 88% of net profit allocated to shareholder returns in 2024 [11] Business Development Strategy - The business development strategy focuses on gastrointestinal, mental health, and reproductive health, while expanding into chronic disease areas [10] - The company aims to leverage its technology platforms to enhance its product pipeline and market competitiveness [10] Market Outlook - The market for psoriasis and ankylosing spondylitis treatments is expected to grow significantly, with high demand for effective therapies [5] - The company is preparing to optimize sales channels and promotional teams for upcoming product launches [5]