证券研究报告 | 半年报点评 gszqdatemark 2025 08 27 年 月 日 研发管线方面，2025 年上半年，JP-1366 片完成Ⅲ期临床，现已提交上市 申请并获受理；重组抗人 IL-17A/F 人源化单克隆抗体注射液基本完成中 重度银屑病Ⅲ期临床、司美格鲁肽注射液减重适应症推进到Ⅲ期临床后 期；复达那非片、抗癫痫药物 NS-041 片、抗感染药物 SG1001 片均从Ⅰ 期临床推进到Ⅱ期临床，小核酸痛风药物 LZHN2408、注射用 JP-1366 获 得临床批件并推进至Ⅰ期临床。上半年注射用阿立哌唑微球及黄体酮注射 液获得上市批件；重组人促卵泡激素注射液、棕榈酸帕利哌酮注射液及注 射用阿立哌唑两款长效微晶等主要产品已申报上市。 盈利预测与投资评级。基于公司优秀的管理层、销售团队、研发进度等， 公司长期投资价值凸显。我们预计 2025-2027 年归母净利润分别为 22.68 亿元、25.34 亿元、27.99 亿元，增长分别为 10%、11.7%、10.5%。公 司业绩增速确定性高，估值较低，创新研发进入收获期。我们看好公司长 期发展，维持"买入"评级。 风险提示：研发失败的风险，产品商业 ...

Core Viewpoint - The company reported a slight decrease in revenue but a significant increase in profit for the first half of 2025, indicating a stable operational performance despite market challenges [7][8]. Financial Performance - The company achieved a revenue of RMB 6,271.91 million, a decrease of 0.17% compared to RMB 6,282.35 million in the same period last year [7]. - The total profit reached RMB 1,828.11 million, reflecting a year-on-year increase of 13.66% from RMB 1,608.39 million [7]. - The net profit attributable to shareholders, excluding non-recurring gains and losses, was RMB 1,258.46 million, up 8.91% from RMB 1,155.47 million in the previous year [7]. Business Segments - The company’s various business segments showed mixed results, with growth in digestive, psychiatric, reproductive, and traditional Chinese medicine sectors, while the raw materials and diagnostic segments faced slight declines [8]. - The company’s focus on improving operational efficiency contributed to the increase in total profit and net profit [8]. R&D and Pipeline Development - The company invested approximately RMB 491 million in R&D, accounting for 7.82% of total revenue, supporting its strategic initiatives [8]. - As of July 31, 2025, the company had 39 products in the pipeline, with 13 in the registration phase and 4 in Phase III clinical trials [8][9]. - Key projects include innovative drugs targeting various conditions, with significant progress reported in clinical trials for several products [10][11][12]. Market Expansion and Sales Strategy - The company reported overseas revenue of approximately RMB 1.004 billion, an increase of 18.40%, accounting for 16.01% of total revenue [22]. - The company is actively expanding its presence in international markets, with a focus on local operations and tailored marketing strategies [22][23]. - The company aims to enhance its sales channels and market penetration through a comprehensive approach involving hospitals, grassroots medical institutions, and retail [19][20]. ESG and Sustainability Initiatives - The company has been recognized for its commitment to ESG principles, achieving high ratings in sustainability assessments [29]. - Efforts include enhancing employee welfare, promoting green manufacturing practices, and engaging in community support initiatives [32][31].

Core Insights - Lijun Group is undergoing a transformation from a traditional pharmaceutical company to an innovative international pharmaceutical enterprise, with a focus on steady growth and internationalization [1][2] Financial Performance - In the first half of 2025, the company reported revenue of 6.272 billion yuan, a slight decrease of 0.17% year-on-year, while net profit attributable to shareholders reached 1.281 billion yuan, an increase of 9.4% year-on-year [1] - The stable profit growth is attributed to the collaborative efforts across various business segments and structural optimization, with significant contributions from the high-margin specialty raw materials exports [1] R&D Innovation - R&D investment amounted to approximately 491 million yuan, accounting for 7.82% of total revenue, leading to significant advancements in the product pipeline [2] - Multiple key products received approval or are nearing market launch, including injectable aripiprazole microspheres and progesterone injection [2] - Clinical progress has been made in several major disease areas, with notable achievements in the development of IL-17A/F inhibitors and other treatments [2] Globalization Strategy - The company achieved overseas revenue of approximately 1.004 billion yuan, a year-on-year increase of 18.40%, representing 16.01% of total revenue [3] - Growth in overseas revenue is primarily driven by the global competitiveness of the raw materials business, with exports of high-end antibiotics and veterinary drugs showing significant increases [3] - The company is also expanding its international presence through acquisitions and partnerships, including plans to acquire a controlling stake in a Vietnamese company to enhance operational capabilities in Southeast Asia [4]

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].

Group 1 - The core viewpoint of the articles highlights the rapid development of China's innovative drug industry, supported by government policies, leading to a significant increase in the number of approved innovative drugs [1][2] - Guangdong Zhongsheng Pharmaceutical Co., Ltd. announced the approval of its innovative drug, Anladiwei Tablets, marking a major breakthrough in respiratory system treatment and enhancing the company's market competitiveness [2][3] - The approval of Anladiwei Tablets is expected to contribute positively to the company's future performance, as it expands the product line and strengthens its leading position in the respiratory drug market [2][3] Group 2 - Health元药业集团 announced the approval of its long-acting injectable Aripiprazole Microspheres, which is the first of its kind globally, targeting adult schizophrenia [3] - Sichuan Kelun Pharmaceutical Co., Ltd. made progress in international collaboration by entering into an exclusive licensing agreement for the development of SKB378/HBM9378/WIN378, indicating a strategic move in the innovative drug sector [3] - The overall demand for innovative drugs is expected to grow due to aging populations, changing disease patterns, and increased health awareness, suggesting a significant market opportunity for domestic companies [3]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Viewpoints - The GLP-1 weight loss drugs are experiencing explosive growth globally and in China, with significant sales figures expected for the year [7] - The pharmaceutical and biotechnology industry index increased by 1.50%, ranking 16th among 31 primary industries, underperforming the CSI 300 index [5][15] - The industry PE (TTM) as of May 9, 2025, is 26.77x, showing an upward trend but still below the average [20] Industry Review - The pharmaceutical and biotechnology industry index increased by 1.50%, ranking 16th among 31 primary industries, underperforming the CSI 300 index which increased by 1.56% [5][15] - The medical equipment and pharmaceutical distribution sectors showed the highest gains, with increases of 3.92% and 2.38% respectively, while medical research outsourcing saw a decline of 0.65% [5][15] - As of May 9, 2025, the PE (TTM) for the pharmaceutical and biotechnology industry is 26.77x, up from 26.34x in the previous period, indicating a valuation increase [20] Investment Suggestions - The current trend in GLP-1 weight loss drugs indicates a golden development period for the industry, with significant sales growth expected both globally and in China [7] - The report suggests focusing on companies with solid clinical data, sufficient production capacity, and integrated supply chain capabilities [7] Important Industry News - The NMPA has released new regulations for the quality management of online sales of medical devices, effective from October 1, 2025 [25] - The approval of the first long-acting analgesic new drug in China, "Meloxicam Injection," marks a significant milestone in the industry [31] - Johnson & Johnson's "Guselkumab Injection" has been approved as the first IL-23 inhibitor for treating ulcerative colitis in China [33] - The investment of 2.04 billion RMB by Roche in a new biopharmaceutical production base in Shanghai highlights the ongoing commitment to local production and supply chain enhancement [43]

Investment Rating - The report indicates a positive long-term outlook for the weight loss drug industry, particularly focusing on GLP-1 medications, suggesting to maintain a long-term focus on the weight loss drug industry chain [3]. Core Insights - The importance of weight loss drugs has been reaffirmed, with the WHO developing new guidelines for obesity prevention and treatment, expected to be finalized by August or September 2025. This is anticipated to standardize the use of GLP-1 drugs, enhancing their application in weight management [3][13]. - The FDA has expanded its inspections of overseas manufacturing facilities, which is expected to benefit leading CDMO companies in China that have established quality systems meeting global standards [3][16]. - The pharmaceutical and biotechnology sector saw a weekly increase of 1.5%, underperforming compared to the overall A-share market and the CSI 300 index, with offline pharmacies and medical devices showing the highest gains [3][8]. Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector rose by 1.5% from April 28 to May 9, lagging behind the overall A-share market (2.32%) and the CSI 300 index (1.56%). Offline pharmacies (5.64%), medical devices (4.49%), and medical R&D outsourcing (2.78%) led the gains, while vaccines (-0.45%), blood products (-0.43%), and in vitro diagnostics (-0.17%) saw declines [3][8]. Industry News and Key Company Announcements - Significant events include the WHO's ongoing development of obesity guidelines, which will clarify the clinical applications of GLP-1 drugs [3][13]. - The FDA's announcement on May 6 regarding expanded inspections of foreign manufacturers aims to ensure equal regulatory oversight for foreign companies [3][16]. - Notable company announcements include the approval of new indications for various drugs and the financial performance of companies like BeiGene, which reported a 50.2% year-on-year revenue increase in Q1 [3][12][17].

Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests a long-term focus on the weight-loss drug industry chain due to the increasing importance of weight-loss medications [3]. Core Insights - The importance of weight-loss drugs has been reaffirmed, with the WHO developing new guidelines for obesity prevention and treatment, expected to be finalized by August or September 2025. This includes the use of GLP-1 medications for adult obesity management, which may standardize their application and increase their usage in weight-loss populations [3][13]. - The FDA has expanded surprise inspections of overseas manufacturing facilities, particularly in India and China, to ensure foreign companies meet the same regulatory standards as U.S. companies. This is expected to benefit leading CDMO companies in China that have established quality systems compliant with global standards [3][16]. Market Weekly Review - The pharmaceutical and biotechnology sector rose by 1.5% from April 28 to May 9, underperforming the Wind All A index (2.32%) and the CSI 300 index (1.56%). The best-performing segments included offline pharmacies (5.64%), medical devices (4.49%), and medical research outsourcing (2.78%), while vaccines (-0.45%), blood products (-0.43%), and in vitro diagnostics (-0.17%) lagged [3][8]. - Notable individual stock performances included Changshan Pharmaceutical (26.28%) and Haichuang Pharmaceutical (25.85%), both linked to the weight-loss drug concept [3][11]. Industry News and Key Company Announcements - On May 9, the NMPA approved a new indication for Hansoh Pharmaceutical's Amivantamab, targeting specific mutations in non-small cell lung cancer [12]. - The report highlights significant developments in the industry, including the approval of new drug applications and clinical trials by various companies, indicating a dynamic and evolving market landscape [16][17].

Major Events - Jin'an Industrial (02292) received a privatization offer from its controlling shareholder at a premium of approximately 30%, with resumption of trading on May 12 [1] - Jingtai Holdings (02228) plans to acquire 90% of Shanghai Siwei Medical for 250 million yuan, aiming to create an AI-enabled remote electrocardiogram diagnosis platform [1] - China Investment and Financing (01226) is in contact with MCHKI to explore several potential corporate activities following unusual stock price movements [1] - Qiu Tai Technology (01478) reported camera module sales of 33.229 million units in April, an increase of 8.4% month-on-month but a decrease of 20.1% year-on-year [1] - Stone Pharmaceutical Group (01093) received approval for clinical trials of SYH2046 in the United States [1] - Fosun Pharma (02196) subsidiary Junji Health obtained FDA approval for drug clinical trials [1] - Rongchang Bio (09995) received approval for the marketing of Aidiqi® for treating HER2-positive advanced breast cancer with liver metastasis in China [1] - Livzon Pharmaceutical (01513) received approval for the marketing of injectable aripiprazole microspheres [1] - GAC Group (02238) reported April automobile production of 108,600 units, a year-on-year decline of 25.74% [2] - China Overseas Development (00688) reported contract property sales of approximately 20.164 billion yuan in April, a year-on-year decrease of 7.5% [2] Share Buybacks/Reductions - China Hongqiao (01378) repurchased 19.667 million shares for 273 million HKD on May 9 [1] - AIA Group (01299) repurchased 1.5 million shares for 92.1915 million HKD on May 9 [1] - Cathay Securities (02611) repurchased 1.6906 million A-shares for 29.3356 million yuan on May 9 [1] - Times Electric (03898) repurchased 610,300 shares for 19.7008 million HKD on May 9 [1] - East Asia Bank (00023) acquired 52.8 million shares from Sumitomo Mitsui Banking Corporation [1] - Shandong Molong (00568) saw shareholder Zhimo Holdings reduce its holdings by 28.81 million H-shares [1] Operating Performance - Longyuan Power (00916) achieved a power generation volume of 6.9064 million MWh in April, a year-on-year increase of 4.85% [2] - New天绿色能源 (00956) reported a power generation volume of 1.4778 million MWh in April, a year-on-year increase of 16.91% [2] - Jianye Real Estate (00832) achieved a total property contract sales amount of 2.71 billion yuan in the first four months, a year-on-year increase of 4.8% [2] - China Overseas Hongyang Group (00081) reported a cumulative contract sales amount of 9.556 billion yuan in the first four months, a year-on-year decrease of 14.1% [2] - Times China Holdings (01233) reported a cumulative contract sales amount of approximately 1.81 billion yuan in the first four months, a year-on-year decrease of 29.87% [2] - Agile Property Holdings (01813) reported a pre-sale amount of 509 million yuan in April, a year-on-year decrease of 47.5% [2] - Greenland Hong Kong (00337) reported contract sales of approximately 880 million yuan in the first four months, a year-on-year decrease of 69.3% [2]

Core Viewpoint - The approval of the novel drug Amivantamab by Hansoh Pharmaceutical marks a significant breakthrough in the treatment of non-small cell lung cancer (NSCLC) in China, addressing a critical unmet medical need for postoperative patients with EGFR mutations [1][4]. Group 1: Drug Approval and Market Impact - On May 9, 2025, Hansoh Pharmaceutical announced that its self-developed class I new drug, Amivantamab, received approval from the National Medical Products Administration for use in adult patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations after tumor resection [1]. - The approval allows Amivantamab to break the monopoly of imported drugs in this field, achieving parallel coverage with imported drugs and marking a significant advancement for domestic innovative targeted drugs in the comprehensive treatment of NSCLC [3]. Group 2: Clinical Significance and Expert Opinions - Professor Cheng Ying from the Chinese Society of Clinical Oncology highlighted that the high recurrence rate of operable NSCLC patients post-surgery indicates a substantial unmet treatment need, and the approval of Amivantamab provides new hope for long-term survival [4]. - The third-generation EGFR-TKI has become the standard treatment for EGFR-mutated NSCLC, and the rapid development of innovative targeted drugs in China has allowed them to catch up with international drugs [4]. - Since its approval in 2020, Amivantamab has made significant progress in the treatment of NSCLC, and the new indication expands its use from first-line and second-line treatments to adjuvant therapy, solidifying its position in the treatment landscape [4].