Core Viewpoint - The company reported a decline in revenue and profit for the first nine months of 2025, primarily due to industry policy impacts such as centralized procurement and price adjustments in the national medical insurance drug list [1][2]. Financial Performance - The company recorded revenue of RMB 19.891 billion and a profit attributable to shareholders of RMB 3.511 billion, representing a decrease of 12.3% and 7.1% respectively compared to the same period last year [1]. - The basic earnings per share attributable to shareholders was RMB 0.3072, down 4.1% year-on-year [1]. - The revenue from the pharmaceutical business was RMB 15.450 billion, including licensing fee income of RMB 1.540 billion, which decreased by 17.2% year-on-year [1]. - The raw material products business achieved sales revenue of RMB 3.006 billion, an increase of 10.3% compared to the previous year [1]. - The functional food and other businesses reported sales revenue of RMB 1.435 billion, up 11.2% year-on-year, mainly due to stable growth in sales of Guo Weikang [1]. Research and Development - R&D expenses increased by 7.9% to RMB 4.185 billion, accounting for 27.1% of the pharmaceutical business revenue [2]. - The company has nearly 90 products in various stages of clinical trials, with 14 submitted for market approval and over 30 key products in the registration clinical stage [2]. - The company is enhancing its internal innovation capabilities and increasing R&D investment, resulting in a rich pipeline of innovative assets [2]. - The company is actively promoting the internationalization of its R&D pipeline through licensing innovative products and strategic collaborations with multinational pharmaceutical companies [2].

Financial Performance - For the nine months ended September 30, 2025, the company reported total revenue of RMB 19.89 billion, a decrease of 12.3% compared to RMB 22.69 billion in the same period last year[5]. - The company's profit attributable to shareholders was RMB 3.51 billion, down 7.1% from RMB 3.78 billion year-on-year[5]. - Basic earnings per share based on profit attributable to shareholders was RMB 30.72, reflecting a decrease of 4.1% from RMB 32.03 in the previous year[5]. - The gross profit for the same period was RMB 13,048,937,000, down from RMB 15,985,244,000, indicating a decrease of about 18.3%[49]. - The company reported total other income of RMB 541,844,000, an increase from RMB 401,531,000 in the previous year, marking a growth of about 34.8%[49]. - The basic earnings per share for the period was RMB 30.72, down from RMB 32.03 in the same period of 2024, indicating a decrease of about 4.0%[49]. - The total sales cost for the nine months was RMB 6,842,138,000, compared to RMB 6,700,907,000 in 2024, reflecting an increase of approximately 2.1%[49]. - The company’s operating profit before tax for the nine months was RMB 4,302,523,000, down from RMB 4,745,513,000 in the previous year, indicating a decrease of about 9.3%[49]. - The company reported a total income from sales of goods of RMB 18,351,066,000 for the nine months, down from RMB 22,686,151,000 in 2024, representing a decline of approximately 19.3%[51]. - Total revenue for the nine months ended September 30, 2025, was RMB 19,891,075,000, with a breakdown of RMB 18,351,066,000 from merchandise sales and RMB 1,540,009,000 from licensing fees[55]. Segment Performance - The pharmaceutical segment generated revenue of RMB 15.45 billion, a decline of 17.2% from RMB 18.67 billion in the prior year, primarily due to centralized procurement and price adjustments in the national medical insurance drug list[6]. - Revenue from raw materials increased by 10.3% to RMB 3.01 billion, compared to RMB 2.73 billion in the previous year[4]. - Revenue from functional foods and others rose by 11.2% to RMB 1.43 billion, up from RMB 1.29 billion year-on-year[4]. - The neurological system treatment area saw a revenue drop of 21.6%, from RMB 7.23 billion to RMB 5.67 billion[6]. - The oncology segment experienced a significant decline of 56.8%, with revenue falling from RMB 3.81 billion to RMB 1.65 billion[6]. - The anti-infective segment's revenue decreased by 22.7%, from RMB 3.21 billion to RMB 2.48 billion[6]. Research and Development - R&D expenses increased by 7.9% year-on-year to RMB 4.185 billion, accounting for 27.1% of pharmaceutical business revenue, with nearly 90 products in various stages of clinical trials[12]. - The R&D pipeline is being accelerated through diverse models including licensing, independent development, and collaborative research[12]. - The company is committed to a dual-driven strategy of "innovation + internationalization" to strengthen its long-term competitive advantage[7]. - The company is focusing on enhancing product quality and expanding its overseas sales network to increase market share[9]. - The company is actively pursuing collaborations and partnerships to accelerate its research and development efforts in oncology[34][36]. Clinical Trials and Product Development - Three new products were approved for market launch in China, and eight products received acceptance for market applications from the beginning of the year[13]. - The company has received 10 clinical trial approvals for innovative drugs in North America and one qualification for expedited review[13]. - The company is developing SYH2070 injection (ANGPTL3 siRNA) for high triglycerides or mixed dyslipidemia, expected to be available by September 2025[20]. - The company is advancing SYS6043 (B7-H3 ADC) for late-stage or metastatic solid tumors, with clinical trials initiated in January 2025[20]. - The company has initiated a Phase III clinical trial in China for JSKN003, targeting positive control treatment for depression, with patient enrollment currently ongoing[22]. - The company is also developing SYS6010 (CPO301) for late or metastatic non-squamous non-small cell lung cancer, with fast track designation granted in May 2025[21]. - The company plans to launch SYH2061 injection (C5 siRNA) for IgA nephropathy and other complement-mediated diseases by October 2025[19]. - The company is conducting a Phase III clinical trial for JMT101 in combination with chemotherapy for HER2 low-expressing recurrent or metastatic breast cancer, with the first patient enrolled in January 2025[23]. - A Phase III clinical trial for the treatment of type 2 diabetes using JMT101 in combination with dapagliflozin commenced in China, with the first patient enrolled in July 2025[26]. - The company completed the enrollment of the last patient in a Phase III clinical trial for the treatment of primary hypertension in August 2025[32]. Strategic Initiatives and Collaborations - The group entered a strategic research collaboration with AstraZeneca, with an upfront payment of $110 million and potential milestone payments of up to $5.2 billion[45]. - The group has signed exclusive licensing agreements for SYS6005 (ADC) and received an upfront payment of $15 million, with potential milestone payments of up to $1.575 billion[43]. - The group has retained rights to develop and commercialize other oral GLP-1 receptor agonist products in China while granting exclusive rights for SYH2086 globally, with a total potential value of up to $2.075 billion[46]. - The group is actively promoting the internationalization of its R&D pipeline through licensing innovative products and strategic collaborations with multinational pharmaceutical companies[42]. - The company aims to enhance its market presence through strategic partnerships and collaborations in drug development[37][38]. Intellectual Property and Patents - The group submitted a total of 249 PCT international patent applications and 2,409 patent applications (1,542 domestic and 867 foreign) as of October 31, 2025, with 1,040 patents granted (666 domestic and 374 foreign)[41]. - The group has submitted 41 PCT international patent applications and 324 patent applications (187 domestic and 137 foreign) from January to October 2025, with 62 patents granted[41].

Financial Performance - Revenue for 1-9/2025 was RMB 19,891 million, a decrease of 12.3% compared to RMB 22,686 million in 1-9/2024[27] - Gross profit for 1-9/2025 was RMB 13,049 million, down 18.4% from RMB 15,985 million in 1-9/2024[27] - Gross profit margin decreased by 4.9 percentage points, from 70.5% in 1-9/2024 to 65.6% in 1-9/2025[27] - R&D expenses increased by 7.9%, from RMB 3,880 million in 1-9/2024 to RMB 4,185 million in 1-9/2025[27] - Reported profit attributable to shareholders decreased by 7.1%, from RMB 3,778 million in 1-9/2024 to RMB 3,511 million in 1-9/2025[27] - Underlying profit attributable to shareholders decreased by 23.0%, from RMB 3,999 million in 1-9/2024 to RMB 3,079 million in 1-9/2025[27] - Finished drugs revenue decreased by 17.2%, from RMB 18,670 million to RMB 15,450 million[28] - Revenue from oncology decreased significantly by 56.8%, from RMB 3,809 million to RMB 1,645 million[29] - Revenue from nervous system decreased by 21.6%, from RMB 7,234 million to RMB 5,669 million[29] - License fee revenue was RMB 1,540 million in 1-9/2025, compared to no revenue in 1-9/2024[29] R&D and Regulatory Updates - 3 new drugs were approved[5] - 5 breakthrough therapy designations were received[5] - 12 new pivotal clinical trials were initiated[7] - 52 IND approvals were obtained, including 42 in China and 10 in North America[7] BD and Shareholder Returns - License-out agreements were made for SYS6005, Irinotecan Liposome Injection, SYH2086 and strategic collaboration with AstraZeneca[9, 115] - A total of HK$300 million worth of shares have been repurchased this year[8] - The 2025 interim dividend is HK14 cents per share[8] R&D Pipeline Highlights - Anbenitamab injection co docetaxel treatment of 1L HER2+ relapse/metastasis breast cancer was published in Cancer Communications, with ORR of 76.4% and mPFS of 27.7m[37] - SYS6091 for injection has been granted as BTD by NMPA for the treatment of platinum resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or whole population of patients with fallopian tube cancer and HER2-positive advanced colorectal cancer[45] - JMT101+ Irinotecan has been granted as BTD by NMPA for the treatment of RAS, RAF, EGFR ECD and PIK3CA exon 20 wild-type advanced colorectal cancer after failure of standard treatment in second-line or beyond[51] - The company has approximately 200 innovative drugs and new formulations[4, 96]

Core Viewpoint - The cooperation framework agreement between Xinlong Holdings and Shiyao Group has automatically terminated after the agreed cooperation period expired, following amicable negotiations between both parties [1] Summary by Relevant Sections - **Cooperation Agreement** - The cooperation framework agreement between Xinlong Holdings and Shiyao Group has reached its expiration date [1] - The termination of the agreement was a result of friendly negotiations between the two companies [1] - **Investor Advisory** - Investors are advised to pay attention to investment risks related to the termination of the cooperation agreement [1]

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 1.12% with a trading volume of 2.214 billion yuan on November 14, 2024 [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 13, 2024, the fund's latest share count was 9.665 billion shares, with a total size of 8.579 billion yuan, reflecting a year-to-date increase of 2344.51% in shares and 2170.81% in size [1] Fund Performance - The current fund manager, Ma Jun, has achieved a return of 69.74% since taking over on January 3, 2024 [2] - The fund's top holdings include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant weightings in the portfolio [2] Trading Activity - Over the past 20 trading days, the ETF has accumulated a trading volume of 28.057 billion yuan, averaging 1.403 billion yuan per day [1] - Year-to-date, the ETF has recorded a total trading volume of 251.214 billion yuan, with an average daily trading volume of 1.196 billion yuan [1]

Core Insights - The insider trading incident involving the executive director of Shiyao Group has raised significant concerns regarding the company's governance structure and internal controls [2] - Shiyao Group is facing severe challenges in its business transformation, with a notable decline in revenue and a shift in its business structure [3][5] Governance and Compliance - Executive director Pan Weidong was fined 5 million yuan by the China Securities Regulatory Commission for insider trading, having purchased 2.74258 million shares of Xinnuowei during a sensitive period, resulting in a transaction amount of approximately 999.88 million yuan [2] - The investigation revealed Pan's lack of cooperation during the regulatory inquiry, and three other former directors and executives were also penalized for the same restructuring event, raising concerns about the company's internal controls [2] Financial Performance - Shiyao Group reported an 18.5% year-on-year decline in revenue for the first half of 2025, with the traditional medicine segment experiencing a significant 24.4% drop [3][5] - The oncology drug revenue plummeted by 60.8%, falling to 1.051 billion yuan, down from approximately 2.681 billion yuan in the same period of 2024 [5] - The revenue contribution from the oncology segment decreased from 18.6% in 2024 to 10.3% in 2025 [5] Product Challenges - Key products such as Duomeisu® and Jinyouli® faced severe price reductions due to national procurement policies, leading to substantial revenue losses [6][8] - The revenue from the neurology segment, which is the largest source of income for Shiyao Group, declined by 28.3% in the first half of 2025 [7] - The company’s traditional strengths in the anti-infection and cardiovascular sectors also saw double-digit declines in revenue [8] Innovation and R&D - Shiyao Group has been increasing its R&D investment, which rose from 2 billion yuan in 2019 to 5.19 billion yuan in 2024, with a 5.5% increase in the first half of 2025 [9][11] - The company achieved some progress in innovative drug development, with three new drugs approved for market in the first half of 2025 [11] - Despite these efforts, the innovative drug business has not yet compensated for the decline in traditional business, with many products still in various stages of clinical trials [13][14]

Healthcare Policy - National Healthcare Security Administration held a series of discussions on the adjustment of the disease-based payment grouping scheme 3.0, involving over 70 representatives from medical institutions and industry associations [1] Drug and Medical Device Approvals - Shijiazhuang Pharmaceutical Group's application for the listing of Pertuzumab injection has been accepted by the National Medical Products Administration, targeting HER2-positive breast cancer [1] - Huason Pharmaceutical received a registration certificate for its special medical purpose formula food, Ganyimei®, designed for patients over 10 years old with strict fat restrictions and digestive absorption disorders [2] - United Imaging Healthcare's subsidiary obtained a medical device registration certificate for its color Doppler ultrasound diagnostic system, enhancing its product range across various market segments [3] - Yiling Pharmaceutical's application for the listing of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, has been approved [4] - Zhifei Biological's clinical trial application for a freeze-dried varicella inactivated vaccine has been accepted by the National Medical Products Administration [10] - Changchun High-tech's subsidiary received approval for a clinical trial of an acellular pertussis-diphtheria-tetanus combined vaccine for adolescents and adults [11] Capital Market Activities - Peking University Pharmaceutical announced the release of 34,615,386 shares from pledge, representing 51.52% of the pledged shares and 5.81% of the total share capital [5] - Kelun Pharmaceutical received approval for a registration of 4 billion yuan in ultra-short-term financing bonds, with a validity period of 2 years [6][7] - Baili Tianheng decided to delay its global offering and listing of H-shares due to current market conditions [8] - Aipeng Medical announced a plan for a shareholder to reduce holdings by up to 1% of total shares, citing personal funding needs [12] - Hendi Pharmaceutical's shareholders plan to collectively reduce their holdings by up to 2.33% of total shares for personal financial planning [13] Financial Adjustments - Baihua Pharmaceutical plans to use 1.91 billion yuan from its capital reserve to cover losses, primarily due to goodwill impairment from a previous major asset restructuring [14]

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose over 4% following the acceptance of a new drug application for its product, a monoclonal antibody injection for HER2-positive breast cancer, by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed a monoclonal antibody injection, Pertuzumab, which has received regulatory acceptance for marketing [1] - The product is classified as a Class 3.3 therapeutic biological product and is indicated for HER2-positive breast cancer [1] - Pertuzumab is a recombinant humanized anti-HER2 monoclonal antibody injection that requires administration every three weeks [1] Group 2: Product Mechanism and Clinical Trials - The product works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The application is primarily based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that Pertuzumab is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, with comparable safety and tolerability [1]

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose over 4% following the acceptance of a listing application for its drug, trastuzumab injection, by the National Medical Products Administration of China, aimed at treating HER2-positive breast cancer [1] Company Summary - CSPC Pharmaceutical Group's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed trastuzumab injection, which is a recombinant humanized anti-HER2 monoclonal antibody [1] - The drug is administered once every three weeks and works by specifically binding to the extracellular dimerization domain II of HER2, blocking dimerization with other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The application is based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients, demonstrating that the drug is equivalent to the reference drug in terms of efficacy [1] Clinical Trial Summary - The clinical trial results indicate that trastuzumab injection is effective for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, showing equivalence to the reference drug [1] - The safety and tolerability of the drug are reported to be good and comparable to the reference drug [1]

Group 1 - Public funds have significantly increased their allocation to Hong Kong stocks, with the investment market value reaching 1.362211 trillion yuan by the end of Q3 2025, a 43.09% increase from 951.985 billion yuan at the end of Q2 2025 [1] - The market value of equity and index funds in Hong Kong stocks reached 1.231653 trillion yuan and 701.284 billion yuan, reflecting increases of 45.02% and 73.07% respectively [1] - The surge in public fund holdings in Hong Kong stocks indicates a structural transformation in asset allocation, driven by the attractiveness of technology and value stocks [1] Group 2 - The influx of funds into Hong Kong ETFs is attributed to three main reasons: valuation advantages compared to A-shares, the convenience and low cost of ETF trading, and risk diversification benefits [2] - The top Hong Kong stocks that public funds increased their holdings in include SenseTime-W, Alibaba Health, China Biologic Products, and others, primarily in the information technology and healthcare sectors [2] - A total of 38 cross-border ETFs attracted a net inflow of 49.561 billion yuan in Q3, with a year-to-date net inflow of 72.642 billion yuan as of November 12 [2]