Core Viewpoint - The recent surge in drug notification letters from the National Medical Products Administration (NMPA) indicates a tightening of approval processes for generic drugs in China, with a significant increase in rejected or withdrawn applications in December 2023 compared to previous months [3][9]. Summary by Sections Drug Application Status - In December 2023, 167 drug notification letters were issued, with 102 related to generic drug applications, marking a doubling of rejections or withdrawals compared to November [3][4]. - The rejected or withdrawn applications include a variety of therapeutic areas such as cardiovascular, metabolic diseases, and oncology, with notable drugs like Sacubitril/Valsartan and Levofloxacin involved [6][8]. Industry Response - Some companies, like Jiutian Pharmaceutical, have publicly stated reasons for their withdrawal, citing the need for further data improvement after discussions with the NMPA [7]. - Issues primarily stem from raw material quality rather than the formulations themselves, as reported by some rejected applicants [7]. Regulatory Environment - The approval process for chemical generic drugs is tightening, as indicated by new drafts released by the NMPA that outline stricter criteria for approval, including the rejection of applications based on existing documentation without the need for additional submissions [9][10]. - The new guidelines aim to clarify significant deficiencies in bioequivalence studies, which have been a common reason for application failures [10]. Market Dynamics - China remains a major player in the generic drug market, but increasing competition and the inclusion of more innovative drugs in the medical insurance catalog are pressuring profit margins for generics [12][13]. - The market for chemical generics is projected to maintain a 50% share of the overall pharmaceutical market in 2024, with a notable increase in the number of approved generic varieties [13]. Competition and Industry Trends - The number of generic drug varieties has surged, leading to intensified competition and market saturation, with a significant rise in the number of products with five or more manufacturers [13]. - Concerns about low-level duplication in the generic drug sector have prompted calls for regulatory reforms to enhance the quality and efficiency of the approval process [15].

Core Viewpoint - The recent surge in drug notification letters from the National Medical Products Administration indicates a tightening of approval processes for generic drugs in China, with a significant increase in rejected or withdrawn applications in December compared to November [1][5]. Group 1: Drug Approval Trends - As of December 19, 2023, a total of 167 drug notification letters were issued, with 102 related to generic drug applications, marking a doubling in rejections or withdrawals compared to November [1]. - The therapeutic areas affected include cardiovascular, metabolic diseases, nervous system, respiratory, anti-infection, oncology, ophthalmology, dermatology, and digestive systems, with specific drugs like sacubitril/valsartan and sitagliptin/metformin among those impacted [1]. - Multiple manufacturers faced challenges with the same drug, such as the allergy treatment bilastine, which had six companies involved in unsuccessful applications [2]. Group 2: Reasons for Rejections - Some companies, like Jiutian Pharmaceutical, have publicly stated that their withdrawal was due to the need for further data refinement after discussions with the National Drug Review Center [3]. - Manufacturers of rejected generic drugs indicated that the primary issues were related to raw materials rather than the formulations themselves [3]. Group 3: Regulatory Changes - The approval process for generic drugs is tightening, as indicated by the recent drafts of guidelines from the National Medical Products Administration, which outline significant deficiencies in pharmaceutical research and bioequivalence studies [5][6]. - The new guidelines suggest that applications with major deficiencies will not be allowed to supplement their materials, leading to more rejections based on existing documentation [5]. Group 4: Market Dynamics - The Chinese generic drug market is facing increased competition, with a significant number of companies vying for approval of similar products, leading to market saturation [7]. - The report from the Chinese Academy of Medical Sciences indicates that by 2024, generic drugs will still account for 50% of the overall pharmaceutical market, with a notable increase in the number of approved generic varieties [7]. - The market concentration remains low, with the top ten companies holding around 22% of the market share, indicating ongoing challenges for profitability in the generic sector [7]. Group 5: Industry Insights - Industry experts have noted that the increasing number of generic drug projects, often with lower development costs compared to innovative drugs, contributes to market saturation and competition [8]. - Concerns about "internal competition" in the generic drug sector have prompted calls for regulatory adjustments to optimize the approval process and reduce unnecessary resource expenditure [8].

目前国内医药生产企业众多，竞争较为激烈，昂利康始终坚持将研发作为企业的核心发展动力，注重业 内合作，立足于开发具有临床价值的优质产品。经过多年的发展，在口服头孢类抗生素原料药、alpha 酮酸原料药、心血管类制剂、吸入用麻醉原料药、抗雄性激素中间体及植物源胆固醇系列产品上均具有 显著优势。公司是国内最早掌握酶法技术的口服头孢类原料药生产厂家之一；公司是国内最大的alpha 酮酸原料药生产厂家，也是费森尤斯卡比的核心原料药供应商之一；公司是国内钙拮抗剂类抗高血压制 剂的主要生产企业之一，苯磺酸左氨氯地平片在国内市场具有较高的市场占有率；公司是国内主要的吸 入用麻醉原料药和制剂一体化的生产企业；公司是国内较早以植物甾醇生物发酵所得产品为起始原料生 产甾体药物中间体的企业，是国内首家实现植物源胆固醇规模化生产的企业，在抗雄性激素中间体、植 物源胆固醇、植物源维生素D系列等细分领域已取得行业领先地位。 此次入选两项榜单，既是对昂利康创新工作的肯定，也将激励企业继续前进。未来，昂利康将继续坚持 研发投入，加强专利布局，推动更多优质医药产品上市，为浙江省民营经济高质量发展贡献力量，助力 公众健康事业发展。 昂利康主要从事 ...

Core Viewpoint - Recently, Shijiazhuang Four Drug Group announced the approval of its generic version of Benidipine Hydrochloride Tablets, which is considered equivalent to the original product. According to MoSheng Pharmaceutical data, over 20 pharmaceutical companies have received approval for this product so far [1][10]. Group 1: Product Overview - Benidipine Hydrochloride Tablets are calcium channel blockers that selectively inhibit calcium ion influx across vascular smooth muscle cell membranes, thereby reducing peripheral vascular resistance, which helps in lowering blood pressure and alleviating angina [4]. - The total sales of Benidipine Hydrochloride Tablets in the full terminal hospital market are expected to exceed 2 billion yuan in 2024, making it one of the top 10 cardiovascular system drugs in terms of sales [4][5]. Group 2: Market Competition - In the 2024 full terminal hospital market, Benidipine Hydrochloride Tablets exhibit a three-way competitive landscape. Yangtze River Pharmaceutical holds the leading market share at 27.61%, followed by North China Pharmaceutical with 25.24%, and Nanchang Hongyi Pharmaceutical at 16.31% [6]. Group 3: Industry Participation - Currently, 22 companies, including Shijiazhuang Four Drug, North China Pharmaceutical, and Yangtze River Pharmaceutical Group, have received approval for Benidipine Hydrochloride Tablets, with 4 companies participating in the eighth batch of centralized procurement [10]. - In terms of generic drug development, over 30 companies, including Jiangsu Wango Pharmaceutical and Hunan Jiudian Pharmaceutical, are in the process of applying for the generic version under category 4 [10][13].

Core Viewpoint - The company has obtained the drug production registration approval from the National Medical Products Administration of China for Amlodipine Besylate Tablets (5mg and 2.5mg), classified as a Category 4 chemical drug, indicating it has passed the consistency evaluation [1] Group 1 - Amlodipine Besylate Tablets are primarily used for the treatment of hypertension, chronic stable angina, and vasospastic angina, and can be used alone or in combination with other medications [1]

Core Viewpoint - The company has obtained production registration approval from the National Medical Products Administration of China for Amlodipine Besylate Tablets (5mg and 2.5mg), classified as Category 4 chemical drugs, indicating successful consistency evaluation [1] Group 1: Product Information - Amlodipine Besylate Tablets are primarily used for the treatment of hypertension, chronic stable angina, and vasospastic angina, and can be used alone or in combination with other medications [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不會就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致之任何損失承擔任何責任。 苯磺酸左氨氯地平片主要用於高血壓、慢性穩定性心絞痛及血管痙攣性心絞痛的治療，可單獨 應用或與其他藥物聯合應用。 本公告為本公司自願發佈，目的是使股東及潛在投資者瞭解本集團最新業務發展情況。 承董事局命 執行董事兼公司秘書 周興揚 香港，二零二五年十月十七日 自願公告 產品開發的最新進展 石四藥集團有限公司（「本公司」，連同其附屬公司，「本集團」）董事局（「董事局」）欣然公告， 本集團已取得中國國家藥品監督管理局有關苯磺酸左氨氯地平片(5mg 及2.5mg)的藥品生產註 冊批件，均屬於化學藥品第4類，視同通過一致性評價。 於本公告日期，董事局成員包括執行董事曲繼廣先生、蘇學軍先生、孟國先生、周興揚先生及 曲婉蓉女士，非執行董事劉文軍先生，以及獨立非執行董事王亦兵先生、周國偉先生及姜廣策 先生。 ...

Core Viewpoint - The company, Anglikang, has announced a share buyback plan, indicating confidence in its business and future growth potential, while also focusing on enhancing employee incentives through stock ownership [1][2] Group 1: Share Buyback and Financials - Anglikang has repurchased a total of 3,599,700 shares, accounting for approximately 1.78% of its total share capital, with a total transaction amount of 50,001,275.28 yuan [1] - The buyback price range was between 12.17 yuan and 17.00 yuan per share, with a planned total expenditure of no less than 50 million yuan and no more than 70 million yuan [1] - The company aims to use the repurchased shares for future employee stock ownership plans or equity incentives [1] Group 2: Business Operations and Market Position - Anglikang primarily engages in the production and manufacturing of pharmaceuticals, including chemical raw materials, formulations, and specialized intermediates [1] - The company has established a comprehensive industrial chain in the production of oral cephalosporins and other pharmaceutical products, enhancing its market competitiveness [1] - The customer structure is clear, with domestic sales accounting for 75.85% and international sales for 24.15%, focusing on large pharmaceutical and chemical companies [2] Group 3: Research and Development - In the first half of 2025, the company's R&D investment reached 85.6 million yuan, representing 11.82% of its operating revenue, resulting in the acquisition of 4 invention patents and 5 utility model patents [3] - The product line includes core products with high market share and new formulations that have won centralized procurement bids, aiding market expansion [3] - The company is developing innovative drugs, with several candidates entering clinical trials, establishing a complete product pipeline from generics to innovative drugs [3] Group 4: Strategic Growth and Future Prospects - The acquisition of Keri Bio has strengthened Anglikang's cash flow and market position, with Keri Bio expected to achieve a net profit margin of 40% in 2024 [4] - The company is focusing on the pet medicine sector, with ambitious sales targets and numerous projects in the pipeline, which are anticipated to become new growth drivers [4] - Anglikang has implemented environmentally friendly production techniques and established a comprehensive quality management system, aligning with industry standards [3]

Core Viewpoint - The company, Anglikang, reported a revenue of 724 million yuan in the first half of 2025, with significant contributions from its formulation, API, and specialty intermediates businesses, indicating a positive growth trajectory despite market fluctuations [1][2]. Financial Performance - In H1 2025, the company achieved revenues of 315 million yuan from formulations, 288 million yuan from APIs, and 90.12 million yuan from specialty intermediates, with gross margins of 46.67%, 21.94%, and 70.20% respectively [1]. - The company's R&D investment reached 85.6 million yuan, accounting for 11.82% of its revenue, highlighting its commitment to innovation [1][4]. Business Structure and Market Strategy - The company maintains a diversified business structure, with domestic sales accounting for 75.85% and international sales for 24.15%, focusing on large pharmaceutical and feed enterprises [2]. - Through a combination of direct sales and deep distribution, the company has established a stable market foundation in the chemical API and formulation sectors [2]. R&D and Innovation - The company is advancing its innovation strategy, with multiple new drug projects entering clinical stages, including ALK-M001/BM2216 and ALK-N001/QHL-1618 [1][4]. - In H1 2025, the company secured four invention patents and five utility model patents, reflecting its strong focus on R&D [4]. Strategic Collaborations - The company signed a licensing agreement with Yafei Biopharmaceutical and Qinhuli Biopharmaceutical to develop the innovative drug ALK-N002/IMD-1005, which targets CD47 for cancer treatment [5][6]. - This collaboration aims to enhance the company's product portfolio in the oncology sector, leveraging unique drug design for improved therapeutic outcomes [6][7]. Market Expansion in Emerging Sectors - The company is actively expanding into the pet medicine and nutrition market, which is projected to grow significantly, with the pet medicine market expected to increase from 9.39 billion yuan in 2020 to 20.95 billion yuan by 2024, reflecting a compound annual growth rate of 22.2% [8]. - The company has made progress in its pet medicine R&D projects, completing several product registrations and enhancing market recognition through initiatives like the "Angmai Cup" veterinary anesthesia case competition [8]. Future Outlook - Anglikang aims to continue its growth trajectory by integrating resources to optimize product layout and transitioning from a focus on generic drugs to a model that includes specialty generics, modified new drugs, and innovative drugs [9]. - The company is committed to sustainable development and enhancing its brand recognition in the modern pharmaceutical industry [9].

Financial Performance - In the first half of 2025, the company achieved a total revenue of 72,435.50 million RMB and a net profit attributable to shareholders of 6,592.51 million RMB, with a non-recurring net profit of 4,369.69 million RMB [3] - The company experienced growth due to increased sales from products entering centralized procurement, stabilizing the previously declining formulation business [3] Business Segments API and Specialty Intermediates - The API business faced fluctuations primarily due to a sluggish antibiotic market and reduced demand from downstream formulations [3] - The specialty intermediates segment saw a decline in revenue, particularly in the 25-hydroxyvitamin D3 series, influenced by customer demand fluctuations and global policy changes [3] Innovative and Improved Drugs - The company is focusing on innovative drugs, with ALK-N001/QHL-1618 currently in Phase I clinical trials, and plans to explore various solid tumor types [4][11] - The company aims to increase investment in innovative drug development, with a projected total investment of around 300 million RMB for 2024, covering two innovative drug pipelines [6] R&D and Team Development - The R&D team is being optimized to support innovative drug development, with plans to recruit clinical and medical teams [6] - The company is currently prioritizing the introduction of external innovative drug pipelines while maintaining an open collaboration approach [6] Capital Expenditure and Future Projects - The largest anticipated capital expenditure is for the construction of an 8,000-ton amoxicillin and 2,000-ton ampicillin production project, with a total investment of approximately 336 million RMB [7] - The company plans to gradually advance existing projects while considering new R&D pipeline introductions based on operational conditions [7] Market Outlook - The orders for 25-hydroxyvitamin D3 are expected to be lower than initial projections due to demand fluctuations and global policy impacts [8] - The sales of formulation products like benazepril and ketone acid tablets are showing stabilization, with significant growth from selected products due to centralized procurement [8] Future Strategies - The company is committed to enhancing its innovative drug pipeline and commercializing products based on clinical research outcomes [13] - The pet medicine sector is progressing as planned, with multiple new veterinary drug products being registered, although overall sales remain modest [13]