众生药业（002317.SZ）8月19日在投资者互动平台表示，ZSP1601片是具有全新作用机制的治疗代谢功 能障碍相关脂肪性肝炎（MASH）的一类创新药，为国家重大新药创制项目，该项目正在开展IIb期临 床试验。 每经AI快讯，有投资者在投资者互动平台提问：董ZSP1601具体是治疗什么，现在到什么进度了？ （文章来源：每日经济新闻） ...

Investment Rating - The report maintains a "Buy" rating for the company [4] Core Views - The company has established a multi-mode positive cycle research and development ecosystem, focusing on metabolic diseases and respiratory diseases, with two innovative drug projects already approved for market and several others in clinical trials [1] - The negative impacts on the company's main business have been largely digested, and it is expected to achieve steady growth in the future, with a projected net profit of 170-210 million yuan in the first half of 2025, representing a year-on-year growth of 94%-140% [2] - The company is expected to see a rebound in its main business, with innovative results gradually contributing to performance elasticity, projecting net profits of 351 million yuan, 435 million yuan, and 513 million yuan for 2025-2027, with corresponding growth rates of 217.4%, 23.8%, and 17.9% [2][3] Financial Summary - The company's revenue for 2023 is reported at 2,611 million yuan, with a year-on-year decline of 2.5%. It is expected to recover to 2,810 million yuan in 2025, reflecting a growth rate of 13.9% [3] - The net profit for 2023 is 263 million yuan, with a significant decline of 18.3%. However, it is projected to turn positive in 2025 with a net profit of 351 million yuan [3] - The earnings per share (EPS) is expected to improve from -0.35 yuan in 2024 to 0.41 yuan in 2025, indicating a recovery trend [3] Market Position and Product Development - The company’s core product, the brain thrombus capsule, is unique in the market, and the company is enhancing its product competitiveness through a combination of evidence-driven and market-driven cultivation models [2] - The innovative drug RAY1225 is progressing smoothly in clinical trials, showing significant potential for weight loss and improvement in metabolic indicators [7] - The company’s flu drug, Angladiwei, has a substantial market potential, with the global flu treatment market reaching 68.738 billion yuan in 2023, and it is expected to achieve rapid market penetration following its approval [7]

Group 1: Basic Information - The surveyed company is Zhongshan Biologics Co., Ltd., belonging to the traditional Chinese medicine industry. The survey was conducted on July 17, 2025, and the company's receptionists included the board secretary, the president of Zhongrui Innovation, and the securities business manager [8]. - Participating survey institutions include Zheshang Securities Co., Ltd., Tianfeng Securities Co., Ltd., Caitong (a fund management company), Beijing Dingsa Investment Co., Ltd., and individual investors [2][9]. Group 2: R & D Pipeline Layout - The company has established a multi - mode R & D ecosystem, focusing on metabolic and respiratory diseases. It has 2 approved innovative drugs and multiple projects in clinical trials [14]. - In the metabolic disease R & D pipeline, ZSP1601 tablets for MASH are in Phase IIb clinical trials, and RAY1225 injection for T2DM and obesity/overweight has completed Phase II trials and is entering Phase III [14][15]. - In the respiratory disease R & D pipeline, Lairetrievir tablets have been approved and included in the national medical insurance, and Angladivir tablets have been approved in May 2025. Angladivir granules have obtained Phase II clinical trial top - line data [15][16]. Group 3: RAY1225 Injection Phase II Clinical Trial Results - RAY1225 injection has dual - receptor agonistic activity. Its Phase II trials for obesity/overweight and T2DM patients reached the primary endpoints [17]. - In the REBUILDING - 1 trial for obesity/overweight patients, 3mg, 6mg, and 9mg groups showed dose - dependent weight loss, with better results than the placebo group and numerically higher weight - loss达标 rates than Tirzepatide [17][18]. - In the SHINING - 1 trial for T2DM patients, 3mg, 6mg, and 9mg groups showed dose - dependent reduction in HbA1c, with better results than the placebo group and numerically higher glycemic - control达标 rates than Tirzepatide [20][21]. - RAY1225 injection has significant comprehensive advantages in improving cardiovascular - kidney - metabolic indicators and has good safety [22]. Group 4: Angladivir Project R & D Status - Angladivir tablets were approved in May 2025, with better efficacy than the placebo and Oseltamivir in clinical trials, and strong inhibitory effects on various influenza virus strains [24]. - Angladivir granules for 2 - 17 - year - old patients with influenza A have obtained Phase II clinical trial top - line data, showing positive efficacy and good safety [25][26]. Group 5: Marketing Plan for Angladivir Tablets - The company deepens marketing innovation in three dimensions: academic ecosystem construction, data - service upgrade, and key project implementation [27]. Group 6: R & D Investment - The company's annual R & D investment has exceeded 8% of its revenue for many years, and over 10% in the past three years. It will continue to invest in R & D to build a diversified R & D matrix [27][28]. Group 7: Overseas Progress of Innovative Drugs - The company values overseas market opportunities for innovative drugs and will seek international cooperation to create long - term value [28].

R&D Pipeline and Innovations - The company has established a multi-modal, positive cycle R&D ecosystem focusing on metabolic diseases and respiratory diseases, with 2 innovative drug projects approved for market and several in clinical trials [1][2] - ZSP1601 tablets, targeting metabolic dysfunction-related fatty liver disease (MASH), are the first domestic innovative drug project to complete clinical trials for safety and pharmacokinetics, showing significant potential in reducing liver inflammation markers [1][2] - RAY1225 injection, a long-acting GLP-1 analog, has shown promising results in Phase II trials for obesity and Type 2 diabetes, achieving primary endpoints in both REBUILDING-1 and SHINING-1 trials [2][5] Clinical Trial Results - In the REBUILDING-1 trial, RAY1225 injection demonstrated a dose-dependent weight loss: 3mg, 6mg, and 9mg groups showed weight reductions of -10.05%, -12.98%, and -15.05% respectively, compared to -3.55% in the placebo group [5][7] - The SHINING-1 trial indicated significant reductions in HbA1c levels: -1.68%, -2.06%, and -2.16% for the 3mg, 6mg, and 9mg groups respectively, with the placebo group at -0.33% [8][10] - RAY1225 injection also showed superior results in cardiovascular and metabolic indicators, with significant reductions in uric acid levels compared to the placebo [8] Product Approvals and Market Strategy - The oral antiviral drug, Lai Ruitewei tablets (乐睿灵®), received conditional approval in March 2023 and is included in the national medical insurance directory, enhancing patient access [3] - The company’s innovative drug Angladiwei tablets (安睿威®) was approved in May 2025, showing significant efficacy in alleviating flu symptoms compared to the placebo [4][11] - The company is focusing on building an academic ecosystem and enhancing digital services to improve healthcare delivery and patient trust [14][15] Investment and Future Directions - The company has consistently invested over 10% of its revenue in R&D over the past three years, emphasizing the importance of innovation in its growth strategy [15] - Plans for international collaboration on innovative drugs are underway to expand market opportunities and enhance global brand influence [16][18]

Group 1: Innovative Drug Development - The company has established a multi-mode, positive cycle research and development ecosystem, focusing on metabolic diseases and respiratory diseases, with two innovative drug projects approved for market and several in clinical trials [2][4]. - ZSP1601 tablets, targeting metabolic dysfunction-related fatty liver disease (MASH), have shown significant reduction in liver inflammation markers after four weeks of treatment, indicating potential for improving liver inflammation and fibrosis [2][4]. - RAY1225 injection, a long-acting GLP-1 class drug, has completed Phase II clinical trials for obesity and type 2 diabetes, achieving primary endpoints and demonstrating significant weight loss and metabolic improvements [4][14][18]. Group 2: Clinical Trial Results - RAY1225 injection demonstrated a weight loss of -10.05%, -12.98%, and -15.05% for 3mg, 6mg, and 9mg doses respectively, significantly outperforming the placebo group [14][16]. - The RAY1225 injection also showed a reduction in HbA1c levels of -1.68%, -2.06%, and -2.16% for the same doses, with a notable percentage of participants achieving target HbA1c levels [16][18]. - The clinical trial for the oral antiviral drug, Liratewe tablets, has been approved and included in the national medical insurance directory, providing accessible treatment options for patients [5][6]. Group 3: Safety and Efficacy - The clinical trials for RAY1225 injection reported good safety and tolerability, with low incidence of gastrointestinal adverse effects, similar to previous GLP-1 drug profiles [18]. - The clinical trial for Anglave tablets showed a median flu symptom relief time of 31.72 hours, with no serious adverse events reported, indicating good safety and efficacy in children and adolescents [10][11]. - Anglave tablets demonstrated a significant reduction in flu symptoms compared to placebo, achieving statistical significance in symptom relief and viral load reduction [10][11]. Group 4: Research and Development Investment - The company has consistently invested over 8% of its annual revenue in R&D, with the last three years exceeding 10%, reflecting a commitment to innovation and development [19]. - The R&D strategy includes a diversified matrix of traditional Chinese medicine, innovative drugs, modified new drugs, chemical generics, and raw materials, transitioning from a traditional to an innovative pharmaceutical enterprise [19].

Core Viewpoint - The innovative drug sector is experiencing a bull market, with funds seeking low-priced stocks for potential gains. Zhongsheng Pharmaceutical's stock has seen significant fluctuations, with a recent increase of 9.99% to 16.84 CNY per share, resulting in a market capitalization of 14.33 billion CNY [1][2]. Group 1: Stock Performance - Zhongsheng Pharmaceutical's stock price has increased by over 61% since April 9, 2023, after a decline of more than 70% from its historical high of 40.7 CNY per share in November 2022, reaching a low of 9.65 CNY [8][10]. - The company announced an abnormal stock trading fluctuation, with a cumulative price deviation exceeding 20% over two consecutive trading days [2]. Group 2: Drug Development Pipeline - Zhongsheng Pharmaceutical has two innovative drug projects approved for market, with several others in clinical trials. The RAY1225 injection, a long-acting GLP-1 drug, is undergoing Phase III clinical trials for treating obesity and type 2 diabetes [4]. - The small molecule innovative drug, Anladiwei (安睿威®), for treating influenza A, has been approved by the National Medical Products Administration and is the first drug targeting the PB2 new target, developed under the leadership of academician Zhong Nanshan [4][6]. - The innovative drug ZSP1601 for treating metabolic dysfunction-related fatty liver disease has completed Phase Ib/IIa clinical trials and is moving into Phase IIb trials [8]. Group 3: Financial Performance - In 2024, Zhongsheng Pharmaceutical reported a revenue of 2.467 billion CNY, a year-on-year decline of 5.48%, and a net loss of 299 million CNY, a year-on-year decrease of 213.63% [10]. - For the first quarter of 2024, the company achieved a revenue of 634 million CNY, a slight decline of 1.03%, while net profit increased by 61.06% to 82.61 million CNY [10]. Group 4: Future Outlook - Guangfa Securities projects Zhongsheng Pharmaceutical's EPS for 2025-2027 to be 0.36, 0.45, and 0.54 CNY per share, maintaining a positive outlook on its core business and the progress of its innovative drugs [10].

Group 1: Company Overview and R&D Pipeline - Guangdong Zhongsheng Pharmaceutical Co., Ltd. has established a multi-modal and healthy R&D ecosystem focusing on metabolic diseases and respiratory diseases, with two innovative drug projects approved for market and several in clinical trials [1] - The innovative drug ZSP1601 for treating metabolic dysfunction-related fatty liver disease (MASH) has completed Phase Ib/IIa clinical trials, showing significant reduction in liver inflammation markers [3][15] - The oral antiviral drug Lurivon (brand name: Le Ru Ling®) received conditional approval in March 2023 and is included in the national medical insurance directory, providing affordable treatment options for patients [3] Group 2: Clinical Trial Results - ZSP1601 has shown potential in improving liver inflammation and fibrosis, with results published in Nature Communications [3][15] - The clinical trial for Lurivon demonstrated effectiveness and safety, particularly for elderly and patients with liver and kidney dysfunction, without requiring dosage adjustments [3] - The innovative drug Anglave (brand name: An Rui Wei®) has shown statistically significant improvement in flu symptom relief compared to placebo, with a median symptom relief time of 38.83 hours [4][8] Group 3: Financial and Asset Management - In 2024, the company recorded an asset impairment loss of CNY 546.68 million, impacting the net profit attributable to shareholders by CNY 484.10 million [12] - The company has made provisions for inventory and goodwill impairment losses totaling CNY 201.68 million due to market conditions and policy impacts [12][14] Group 4: Strategic Initiatives and Future Plans - The company plans to enhance its marketing strategy by integrating academic resources and building a network of experts in respiratory and infectious diseases [11] - The company has increased its stake in its subsidiary Zhongsheng Ruichuang to 74.26%, enhancing control over its operations and R&D capabilities [27] - A change in the use of raised funds has been proposed to accelerate the R&D of innovative drugs, specifically RAY1225 injection and Anglave granules [28][30]

Core Viewpoint - The approval of Angladevir tablets marks a significant breakthrough for the company in the innovative drug sector, with potential for rapid market penetration in the billion-level influenza market [2][3]. Group 1: Product Approval and Clinical Data - Angladevir tablets, developed by the company's subsidiary, have received approval from the National Medical Products Administration for the treatment of adult uncomplicated influenza [1]. - The Phase III clinical trial results indicate that Angladevir significantly outperformed the placebo group in key endpoints, including the time to relief of seven influenza symptoms [2]. - The company is also developing a granule formulation of Angladevir for children and adolescents aged 2-17, with promising Phase II trial results showing shorter symptom relief times compared to adult data [2]. Group 2: Market Potential - The influenza drug market in China exceeded 10 billion yuan in 2023 and is projected to reach 22.39 billion yuan by 2027 [3]. - Current leading antiviral drugs include Oseltamivir and Marbofloxacin, with Oseltamivir sales exceeding 8 billion yuan in 2023 [3]. - Angladevir, as a PB2-targeting RNA polymerase inhibitor, shows superior efficacy against various influenza strains compared to existing treatments, including those resistant to Oseltamivir and Marbofloxacin [3]. Group 3: Financial Forecast - The company anticipates accelerated revenue growth following the commercialization of Angladevir, projecting revenues of 2.765 billion yuan, 3.216 billion yuan, and 3.774 billion yuan for 2025-2027 [9]. - Expected net profits for the same period are 300 million yuan, 391 million yuan, and 517 million yuan, with corresponding EPS of 0.35 yuan, 0.46 yuan, and 0.61 yuan [9].

Investment Rating - The report assigns a "Buy" rating for the stock of Zhongsheng Pharmaceutical (002317) based on its strong market potential and recent product approvals [1]. Core Insights - The approval of Anglavei (Anruiwei®) marks a significant breakthrough for the company in the innovative drug sector, with expectations for rapid market penetration in the over 10 billion RMB influenza market [2][3]. - The company is advancing its innovative drug pipeline, including RAY1225, which has shown promising results in clinical trials for obesity and type 2 diabetes, and ZSP1601, targeting MASH, which is progressing well in clinical trials [4][5][8]. Financial Summary - The projected revenue for Zhongsheng Pharmaceutical is expected to grow from 27.65 billion RMB in 2025 to 37.74 billion RMB by 2027, with net profit forecasts of 3.00 billion RMB and 5.17 billion RMB respectively [11]. - The company’s gross margin is projected to improve from 56.5% in 2025 to 60.6% by 2027, indicating enhanced profitability [10][11]. - The earnings per share (EPS) is expected to increase from 0.35 RMB in 2025 to 0.61 RMB in 2027, reflecting strong growth potential [11].

Financial Performance - In 2024, the company reported a revenue of CNY 246,741.84 million, with a net loss attributable to shareholders of CNY 29,915.71 million, and a net loss of CNY 26,031.27 million after excluding non-recurring gains [2][4] - The decline in performance was attributed to the impact of centralized procurement pricing on the company's core product, the Compound Thrombus-Resolving Series [2] - Non-recurring gains decreased the net profit attributable to shareholders by CNY 3,884.44 million due to litigation-related provisions [2] Asset Impairment - The total asset impairment loss for 2024 was CNY 54,668.07 million, reducing the net profit attributable to shareholders by CNY 48,409.79 million [5][7] - Major impairment factors included inventory write-downs of CNY 5,472.75 million and goodwill impairment of CNY 20,167.71 million related to subsidiaries [5][7] - The company also recognized an impairment loss of CNY 7,916.66 million on intangible assets [5][7] Q1 2025 Performance - In Q1 2025, the company achieved a revenue of CNY 63,426.14 million, a year-on-year decrease of 1.07% [8] - The net profit attributable to shareholders was CNY 8,261.18 million, a year-on-year increase of 61.06% [8] - The net profit after excluding non-recurring gains was CNY 7,843.48 million, reflecting an increase of 8.60% year-on-year [8] R&D Pipeline - The company has established a multi-mode R&D ecosystem focusing on metabolic and respiratory diseases [9] - The innovative drug ZSP1601 for treating metabolic dysfunction-related fatty liver disease has completed Phase Ib/IIa clinical trials, showing significant reductions in liver inflammation markers [9][14] - The oral antiviral drug, Lai Rui Te Wei (乐睿灵®), has been approved for conditional marketing and included in the national medical insurance directory [10] New Drug Developments - The influenza drug Angrawei (安睿威®) has shown positive results in Phase III clinical trials and is under review for market approval [20] - The GLP-1 receptor agonist RAY1225 has completed Phase II trials, demonstrating significant weight loss and glycemic control in participants [15][18] - RAY1225 is expected to be a bi-weekly administered treatment for type 2 diabetes and obesity, with ongoing Phase III trials [15][18]