Core Viewpoint - The National Medical Products Administration (NMPA) of China has mandated the addition of warnings regarding neuropsychiatric adverse reactions in the instructions for Montelukast formulations, including serious reactions such as depression and suicidal tendencies, with a deadline for compliance set for March 12, 2026 [1][4]. Group 1: Regulatory Changes - The NMPA requires all Montelukast product license holders in China to revise their product instructions to include warnings about neuropsychiatric adverse reactions [1]. - The revisions must be submitted to the NMPA or provincial drug regulatory departments by March 12, 2026, and all existing product labels must be updated within nine months after the submission [1]. Group 2: Market Context - Montelukast sodium, originally developed by Merck (brand name: Singulair), is a potent selective leukotriene receptor antagonist used for asthma prevention and treatment in children aged 2 to 14 [3]. - Following the expiration of Merck's patent, domestic companies have begun to produce generic versions, with 62 approvals found on the NMPA website from various manufacturers [3]. Group 3: Adverse Reactions and Clinical Implications - The revision of Montelukast's instructions is based on adverse reaction assessments, with the FDA in the U.S. having previously issued a black box warning for similar neuropsychiatric adverse reactions [4][5]. - Reports of adverse reactions, including depression and suicidal behavior, have been documented, with a study indicating that 86.12% of Montelukast prescriptions in a certain hospital were for off-label uses [5][8]. Group 4: Sales and Competitive Landscape - Montelukast ranked third in sales among asthma medications in China for the first three quarters of 2024, with total sales reaching 1.33 billion yuan [9]. - The competitive landscape includes 24 companies with 42 formulations of Montelukast available, with significant market shares held by companies like Eurofarma and Shanghai Anbisen [9]. Group 5: Emerging Treatments - The emergence of biologic therapies is changing the treatment landscape for pediatric asthma, with several new biologics approved for use in children [10]. - The NMPA's revisions to Montelukast's labeling serve as a reminder for the need for safe and effective prescribing practices as new treatment options become available [10].

该疫苗靶向一种名为免疫球蛋白E（IgE）的抗体。正常情况下，IgE随血液流动，会与体内免疫细胞结 合，在遭遇病毒、寄生虫等威胁时触发免疫应答，释放组胺，引发咳嗽、喘息或荨麻疹等症状。在过敏 人群中，IgE会对花生、猫毛屑等原本无害的蛋白过度反应，甚至可能诱发致命的全身性过敏反应，导 致喉头水肿、呼吸衰竭甚至休克。 新疫苗能够促使机体生成可与IgE结合的抗体，从而阻止IgE与免疫细胞受体结合。这一机制显著降低了 接触过敏原后可能启动过敏反应的游离IgE水平。 法国图卢兹感染与炎症研究所科学家在新一期《科学·转化医学》杂志发表论文称，他们研发出一种新 的实验性疫苗，名为"IgE-K"，能使小鼠在长达一年时间内免于严重过敏反应。这一最新进展显示，疫 苗接种在预防过敏领域具有广阔前景。 该研究证实了疫苗可激发抗IgE抗体的产生。新疫苗的作用机制与已获批准的抗过敏单抗药物奥马珠单 抗类似，但后者需每两周注射一次以维持效果，而新疫苗有望提供更持久的保护。 不过团队也提醒，仍需进一步验证该疫苗是否会在人体内引发意外过敏反应，以及IgE长期降低是否会 削弱机体对抗寄生虫感染的能力。 （文章来源：科技日报） 在动物实验中，团队 ...

Group 1: Company Research - The company, CSPC Pharmaceutical Group (01093), is rated as "Buy" with a target price of HKD 10.03, representing a potential upside of 31.3% from the current price of HKD 7.64[5][6]. - The market capitalization of CSPC Pharmaceutical Group is HKD 880.32 billion, with 11.522 billion shares issued[5]. - The adjusted net profit for the first three quarters of 2025 decreased by 15.2%, with revenue at HKD 19.89 billion, down 12.3% year-on-year[6]. Group 2: Financial Performance - The gross profit margin for the company is 65.6%, with a decrease in sales and administrative expense ratios by 4.4 and 0.8 percentage points to 31.1% and 3.1%, respectively[6]. - R&D expenses as a percentage of revenue increased by 6.3 percentage points to 27.1%[6]. - The net profit attributable to shareholders was HKD 3.51 billion, down 7.1%, with a net profit margin of 15.5%, a decrease of 2.1 percentage points[6]. Group 3: Segment Performance - The revenue from the finished drug segment was HKD 15.45 billion, down 17.2%, with a 25.5% decline in drug revenue to HKD 13.91 billion[6][7]. - The raw material drug segment saw revenue of HKD 1.79 billion, up 22.3%, while the functional food segment reported revenue of HKD 1.43 billion, up 11.2%[6][7]. - The profit margin for the finished drug segment was 20.9%, down 1.8 percentage points, while the vitamin C segment's profit margin increased by 3.6 percentage points to 11.0%[6][7]. Group 4: Future Outlook - The company plans to maintain dividends in the second half of the year at least at the same level as the first half, which was HKD 0.14 per share[6]. - The target market value for CSPC Pharmaceutical Group is estimated at HKD 116.5 billion, with a corresponding price-to-earnings ratio of 25.2 times for 2025 and 29.4 times for 2026[9].

Core Viewpoint - Haitong International maintains an "outperform" rating for CSPC Pharmaceutical Group (01093) with a target price of HKD 11.34, noting a revenue decline in the first three quarters but signs of recovery in Q3, with a 10% quarter-on-quarter growth in prescription drug revenue and a 27% year-on-year increase in net profit attributable to shareholders [1][2]. Financial Performance - For the first nine months of 2025, CSPC achieved revenue of CNY 19.9 billion, a 12% year-on-year decline, with prescription drug revenue at CNY 15.5 billion (down 17%), API revenue at CNY 3 billion (up 10%), and functional foods and other businesses at CNY 1.4 billion (up 11%) [2]. - The gross margin was 65.6%, down 4.9 percentage points year-on-year; R&D expenses were CNY 4.2 billion (up 8%), with an R&D expense ratio of 21.0% (up 3.9 percentage points); the sales expense ratio was 24.1% (down 5.1 percentage points) [2]. - In Q3 2025, CSPC reported revenue of CNY 6.6 billion, a 3% year-on-year increase and a 6% quarter-on-quarter increase, with prescription drug revenue at CNY 5.2 billion (up 2% year-on-year, up 10% quarter-on-quarter) [2]. Prescription Drug Business - In Q3 2025, all segments of the prescription drug business showed improvement, confirming the bottom of the fundamentals, with total prescription drug revenue of CNY 4.7 billion and drug revenue of CNY 4.7 billion (up 8% quarter-on-quarter) [3]. - Specific revenue breakdown includes: - Neurological system: CNY 1.91 billion (down 4% year-on-year, up 4% quarter-on-quarter) - Oncology: CNY 590 million (down 47% year-on-year, up 19% quarter-on-quarter) - Anti-infection: CNY 830 million (down 9% year-on-year, up 12% quarter-on-quarter) - Cardiovascular: CNY 470 million (up 18% year-on-year, up 4% quarter-on-quarter) - Respiratory: CNY 320 million (up 73% year-on-year, up 28% quarter-on-quarter) - Metabolism: CNY 250 million (up 14% year-on-year, up 8% quarter-on-quarter) - Other therapeutic areas: CNY 360 million (up 26% year-on-year, down 4% quarter-on-quarter) [3]. - The company expects a 5% revenue growth in the second half of the year for the prescription drug segment (excluding authorized revenue) [3]. Asset Expansion and R&D Progress - The SYS6010 (EGFRADC) clinical trial is progressing well, with significant potential for external licensing; multiple technology platforms and products are also expected to expand internationally [4]. - Management plans to present clinical data for SYS6010 at major conferences next year and publish data in top academic journals [5]. - The small RNA platform has five assets entering clinical stages, focusing on liver-targeted and multi-target products, with plans for new products in weight loss and muscle gain to enter clinical trials next year [6]. - The PD-1/IL15 pipeline is a key focus, with over 90 patients enrolled in dose-exploration trials, showing promising safety and efficacy results [6].

Core Viewpoint - Haitong International maintains an "outperform" rating for CSPC Pharmaceutical Group (01093) with a target price of HKD 11.34, noting a revenue decline in the first three quarters but signs of recovery in Q3, with a 10% quarter-on-quarter growth in traditional medicine revenue and a 27% year-on-year increase in net profit attributable to shareholders [1]. Financial Performance - For the first nine months of 2025, CSPC achieved revenue of CNY 19.9 billion, a 12% year-on-year decline, with traditional medicine revenue at CNY 15.5 billion (down 17%), API revenue at CNY 3 billion (up 10%), and functional foods and other businesses at CNY 1.4 billion (up 11%) [1]. - The gross margin was 65.6%, down 4.9 percentage points year-on-year; R&D expenses were CNY 4.2 billion (up 8%), with an R&D expense ratio of 21.0% (up 3.9 percentage points); the sales expense ratio was 24.1% (down 5.1 percentage points) [1]. - The net profit attributable to shareholders for the first three quarters was CNY 3.5 billion, a 7% year-on-year decline [1]. Q3 Performance - In Q3 2025, CSPC reported revenue of CNY 6.6 billion, a 3% year-on-year increase and a 6% quarter-on-quarter increase, with traditional medicine revenue at CNY 5.2 billion (up 2% year-on-year, up 10% quarter-on-quarter) [2]. - The gross margin was 65.6%, down 2.1 percentage points year-on-year; R&D expenses were CNY 1.5 billion (up 12.3%), with an R&D expense ratio of 22.7% (up 1.8 percentage points); the sales expense ratio was 26.4% (down 2.4 percentage points) [2]. - The net profit attributable to shareholders for Q3 was CNY 960 million, a 27% year-on-year increase but a 10% quarter-on-quarter decline [2]. Traditional Medicine Business - In Q3, all segments of the traditional medicine business showed improvement, indicating a bottoming out of fundamentals, with traditional medicine revenue of CNY 4.7 billion and drug revenue of CNY 4.7 billion (up 8% quarter-on-quarter) [3]. - Specific revenue breakdown includes: - Neurological system: CNY 1.91 billion (down 4% year-on-year, up 4% quarter-on-quarter) - Oncology: CNY 590 million (down 47% year-on-year, up 19% quarter-on-quarter) - Anti-infection: CNY 830 million (down 9% year-on-year, up 12% quarter-on-quarter) - Cardiovascular: CNY 470 million (up 18% year-on-year, up 4% quarter-on-quarter) - Respiratory: CNY 320 million (up 73% year-on-year, up 28% quarter-on-quarter) - Metabolism: CNY 250 million (up 14% year-on-year, up 8% quarter-on-quarter) - Other therapeutic areas: CNY 360 million (up 26% year-on-year, down 4% quarter-on-quarter) [3]. - The company expects a 5% revenue growth in the traditional medicine segment (excluding authorized revenue) in the second half of the year compared to the first half [3]. Asset Expansion and R&D Progress - The SYS6010 (EGFRADC) clinical trial is progressing well, with significant potential for external licensing; multiple technology platforms and products are expected to expand internationally [4]. - Management plans to present clinical data for SYS6010 at major academic conferences next year and publish lung cancer clinical data in top journals [5]. - The small RNA platform has five assets entering clinical stages, focusing on liver-targeted and multi-target products, with plans for new products in weight loss and muscle gain to enter clinical trials next year [6]. - The PD-1/IL15 pipeline is a key focus, with over 90 patients enrolled in dose-exploration trials, showing promising safety and efficacy results [6].

Investment Rating - The report maintains an "Outperform" rating for CSPC Pharmaceutical Group [2][12][23] Core Insights - In 9M25, CSPC achieved revenue of CNY 19.9 billion, a year-on-year decrease of 12%, with finished drug revenue at CNY 15.5 billion, down 17% year-on-year [3][16] - The gross profit margin (GPM) was reported at 65.6%, a decline of 4.9 percentage points year-on-year [3][16] - Management anticipates a return to positive growth in finished drug sales by 2026, despite uncertainties surrounding the renewal rules for generic drug procurement [3][16] Financial Performance Summary - Revenue projections for FY25 and FY26 have been adjusted to CNY 27.3 billion and CNY 30.1 billion, respectively, reflecting slower-than-expected out-licensing income recognition [9][23] - Net profit attributable to shareholders is forecasted at CNY 5.0 billion for FY25 and CNY 5.1 billion for FY26, down from previous estimates [9][23] - The company reported a net profit of CNY 3.5 billion in 9M25, a decrease of 7% year-on-year [3][16] Segment Performance - In 3Q25, all segments of finished drugs showed quarter-on-quarter improvement, with total finished drug revenue reaching CNY 4.7 billion, an increase of 8% quarter-on-quarter [5][18] - Notable revenue contributions in 3Q25 included CNY 1.91 billion from the nervous system segment and CNY 0.32 billion from the respiratory system, which saw a 73% year-on-year increase [21][18] Research and Development - R&D expenses for 9M25 were CNY 4.2 billion, an increase of 8% year-on-year, with an R&D expense ratio of 21.0% [3][16] - The company is advancing multiple clinical pipelines, including SYS6010, with clinical data expected to be released in 2026 [20][22] Out-Licensing Opportunities - The report highlights significant potential for out-licensing multiple assets, including SYS6010, which is progressing well in clinical trials [6][19] - The company's business development strategy is entering a phase of tangible results, with expectations for continuous deals that will enhance net profit [6][19]

Core Viewpoint - Zhongyin International reports that CSPC Pharmaceutical Group (01093) experienced a 6% quarter-on-quarter revenue growth in Q3 2025, reaching 6.6 billion RMB, primarily due to the absorption of negative impacts on traditional oncology products. However, net profit decreased by 10% to 964 million RMB due to a significant increase in operating expenses. The target price is adjusted to HKD 8.5, maintaining a "Hold" rating, which corresponds to a 20x P/E ratio for 2026 [1]. Revenue and Profit Analysis - Q3 2025 revenue reached 6.6 billion RMB, reflecting a 6% quarter-on-quarter increase [1] - Net profit for Q3 2025 decreased by 10% to 964 million RMB, attributed to rising operating expenses [1] Management Guidance - Management maintains guidance for a mid-single-digit recovery in H2 2025 compared to H1 2025, despite uncertainties from the upcoming national centralized procurement renewal and strict control of medical insurance fund expenditures [1] - Anticipated product launches in H1 2026 include innovative products (e.g., Bai Zi II, KN026) and biosimilars (e.g., Omadubmab, Pertuzumab), although management remains cautious about the domestic market outlook for 2026 [1] Strategic Focus - To address domestic uncertainties, internationalization is emphasized as a key strategic priority [1] - R&D expenses are expected to increase by 15% to 20% year-on-year in 2026 [1] Revenue Forecast Adjustments - Zhongyin International maintains its 2025 revenue forecasts due to Q3 performance meeting expectations, but lowers revenue forecasts for 2026 and 2027 by 5.8% and 8.5%, respectively, due to uncertainties from national centralized procurement and potentially slower new product sales growth [1]

Core Insights - Zhongjin International reported that CSPC Pharmaceutical Group (01093) achieved a quarterly revenue growth of 6% to 6.6 billion RMB in Q3 2025, primarily due to the absorption of negative impacts on traditional oncology products [1] - However, net profit decreased by 10% to 964 million RMB, mainly due to a significant increase in operating expenses [1] - The target price has been adjusted down to 8.5 HKD, maintaining a "Hold" rating, which corresponds to a 20x P/E ratio for 2026 [1] Revenue and Profit Analysis - All core therapeutic areas experienced sales growth, indicating a positive trend in the company's product performance [1] - The management maintains guidance for a mid-single-digit recovery in performance for the second half of 2025 compared to the first half [1] - The anticipated uncertainty from the upcoming national centralized procurement renewal and strict control of medical insurance fund expenditures has led to a cautious outlook for the domestic market in 2026 [1] Strategic Focus and R&D - The management emphasized that internationalization is a key strategic focus to address domestic uncertainties [1] - R&D expenses are expected to increase by 15% to 20% year-on-year in 2026, reflecting the company's commitment to innovation [1] - Despite the expected launch of innovative products and biosimilars in the first half of 2026, the management remains cautious about the growth rate of new product sales [1] Forecast Adjustments - Zhongjin International has maintained its 2025 forecasts due to Q3 performance meeting expectations [1] - However, revenue forecasts for 2026 and 2027 have been reduced by 5.8% and 8.5%, respectively, due to uncertainties surrounding the first to eighth batches of national centralized procurement and potential slower-than-expected sales growth of new products [1]

Core Viewpoint - The report from Zhongyin International indicates that the revenue of CSPC Pharmaceutical Group increased by 6% quarter-on-quarter to 6.6 billion yuan, primarily due to the recovery from negative impacts on traditional oncology products, with sales growth across all core therapeutic areas [1] Financial Performance - Revenue for the third quarter reached 6.6 billion yuan, reflecting a 6% increase compared to the previous quarter [1] - Net profit decreased by 10% to 964 million yuan, attributed to a significant rise in operating expenses [1] Management Guidance - Management maintains guidance for a mid-single-digit recovery in performance for the second half of 2025 compared to the first half [1] - Despite the anticipated launch of innovative products and biosimilars in the first half of 2026, management expresses caution regarding the domestic market outlook due to uncertainties from upcoming national procurement renewals and strict control of medical insurance fund expenditures [1] Forecast Adjustments - The firm has kept its 2025 revenue forecast unchanged, but has lowered the revenue projections for 2026 and 2027 by 5.8% and 8.5% respectively, due to uncertainties surrounding the national procurement renewals and potentially slower-than-expected sales growth of new products [1] - The target price has been adjusted down to 8.5 HKD, while maintaining a "Hold" rating [1]

Investment Rating - The report does not explicitly state an investment rating for the chronic spontaneous urticaria (CSU) drug industry in China. Core Insights - The chronic spontaneous urticaria drug market in China is projected to grow from CNY 12.4 billion in 2019 to CNY 16.9 billion in 2024, with a compound annual growth rate (CAGR) of 6.4%. It is expected to further increase at a CAGR of 16.2%, reaching CNY 41.7 billion by 2030 [5][12][14]. - The existing treatment landscape for CSU primarily includes second-generation antihistamines, with varying sales performance among different drugs. Innovative monoclonal antibody therapies are emerging, with several companies focusing on IL-4R and IgE targets [5][24][30]. Summary by Sections Market Overview - The report focuses on the chronic spontaneous urticaria drug industry in China, exploring disease mechanisms, drug patterns, and research and development progress to understand the current market size and future growth [3][4]. Treatment Patterns - The first-line treatment for CSU is standard-dose second-generation antihistamines. If symptoms are uncontrolled, combination therapy or increased dosage may be considered. If still ineffective, omalizumab can be added [5]. Market Size and Growth - The CSU drug market in China is expected to grow significantly, with a market size of CNY 12.4 billion in 2019, increasing to CNY 16.9 billion by 2024, and projected to reach CNY 41.7 billion by 2030 [12][14]. Drug Sales Performance - Sales of second-generation antihistamines show varied trends: - Loratadine has faced sales fluctuations due to generic competition. - Cetirizine maintains stable sales due to formulation innovations. - Ebastine has seen a significant decline due to national procurement policies. - Desloratadine has experienced continuous growth due to new formulations and market expansion [5][17][20]. Innovation in Drug Development - The report highlights a rich pipeline of innovative monoclonal antibody therapies for CSU treatment, with companies like Sanofi and others focusing on IL-4R and IgE targets, some of which are in clinical phases [5][24][30]. Epidemiology - The number of CSU patients globally and in China is on the rise, with projections indicating 73.5 million cases worldwide and 29.7 million in China by 2030 [8][11]. Competitive Landscape - The competitive landscape for second-generation antihistamines in China is characterized by significant disparities in sales among leading companies, with a clear market hierarchy [20][21]. Monoclonal Antibody Market - In the global CSU monoclonal antibody market, Sanofi's Dupixent shows strong performance, while Novartis's Omalizumab faces challenges and needs optimization to maintain its leading position [24][25][27]. Candidate Drugs in China - The Chinese market for CSU monoclonal antibodies features multiple candidates with diverse targets and clinical stages, indicating a dynamic and competitive environment [30].