Core Viewpoint - The financial performance of Shuangcheng Pharmaceutical (002693.SZ) is deteriorating, with significant declines in revenue and profits, raising concerns about its future viability and potential delisting from the Shenzhen Stock Exchange [2][6][7]. Financial Performance - In the first half of 2025, Shuangcheng Pharmaceutical reported total revenue of 84.12 million yuan, a year-on-year decrease of 11.35% [2]. - The net profit attributable to shareholders was -18.47 million yuan, down 8.97% year-on-year, while the net profit after deducting non-recurring items was -21.02 million yuan, a decline of 18.34% [2]. - The company's cash reserves plummeted by over 70% compared to the same period last year, leaving only 4.78 million yuan, insufficient to cover even one month of operating expenses [5]. Product Performance - Revenue from peptide products, other products, and entrusted business all experienced declines in the first half of 2025, with entrusted business revenue dropping by 41.04% [2][4]. - The revenue from peptide products was 40.07 million yuan, a decrease of 3.95%, and accounted for 47.64% of total revenue, with a gross margin of 46.5%, down 13.87 percentage points from the previous year [3]. Market Challenges - The decline in gross margin is attributed to price reductions for core products, particularly the injection of thymosin alpha-1, which saw a significant drop in sales profits due to new procurement pricing [3]. - The company has faced challenges in expanding its entrusted business, with revenue from this segment only accounting for 13.90% of total revenue, and slow progress in external CMO collaborations [4]. Legal and Financial Issues - Shuangcheng Pharmaceutical has initiated legal action against Zhongrong Trust due to overdue financial products, seeking repayment of 21.05 million yuan in principal and interest [8][9]. - The company has reported cumulative losses exceeding 700 million yuan over the past nine years, raising concerns about its financial sustainability [6]. Future Outlook - The company has proposed several measures to improve performance, including increasing R&D investment, expanding sales channels, and optimizing operational processes [7]. - However, the revenue trend from 2022 to 2025 shows a consistent decline, indicating significant challenges ahead in meeting the revenue threshold to avoid delisting [7].

Group 1 - The company expects a net loss attributable to shareholders in the range of 13 million to 19 million yuan for the current reporting period, compared to a loss of 16.9462 million yuan in the same period last year, indicating a potential decrease of 12.12% to an increase of 23.29% [1] - The expected operating income for the current period is projected to be between 75 million and 95 million yuan, down from 94.8926 million yuan in the previous year [1] - The company attributes the performance changes to significant price reductions in key products due to market reforms and competitive bidding, particularly affecting domestic sales profits [2] Group 2 - The company has received FDA approval for the abbreviated new drug application (ANDA) for injectable paclitaxel (albumin-bound), which has begun to generate export sales, contributing positively to export profits [2] - Non-recurring gains are expected to contribute approximately 2.55 million yuan to net profit, primarily from government subsidies and investment income [2] - The company is actively taking measures to address the delisting risk warning imposed by the Shenzhen Stock Exchange due to financial performance concerns [3]

Core Viewpoint - *ST Shuangcheng (002693.SZ) expects a net loss of 13 million to 19 million yuan for the first half of 2025, compared to a loss of 16.9462 million yuan in the same period last year [1] Company Summary - The company attributes the expected loss to significant changes in market supply and pricing due to ongoing reforms in the pharmaceutical industry, with a notable decline in sales volume for non-winning bid products and a substantial drop in prices for winning bid products [1] - The company's main product, Thymosin Alpha 1 injection, experienced a price reduction during the new bidding period, leading to decreased domestic sales profits [1] - However, the company achieved a milestone with the approval of the abbreviated new drug application (ANDA) for Paclitaxel Injection (albumin-bound) by the U.S. Food and Drug Administration (FDA) in May 2025, which has begun to generate export sales [1] - Additionally, there was an increase in export revenue from the injection of Bivalirudin, contributing to improved export profits [1] - Overall, these factors resulted in minimal changes to the company's overall performance [1]

Core Viewpoint - The company has received marketing authorization for injectable bivalirudin from the Therapeutic Goods Administration (TGA) of Australia, indicating its capability to sell the product in Australia, which is expected to positively impact the company's overseas market expansion and performance [1][2]. Group 1: Product Information - Product Name: Injectable Bivalirudin [1] - Dosage Form: Injection [1] - Specification: 250mg [1] - Indication: Used as an anticoagulant for patients with high-risk acute coronary syndrome (ACS) undergoing early invasive treatment and those receiving percutaneous coronary intervention (PCI) [1]. Group 2: Regulatory Approvals and Milestones - In January 2019, the company received a drug registration certificate from the National Medical Products Administration (NMPA) for injectable bivalirudin [2]. - In May 2019, the company obtained a GMP certificate from the Hainan Provincial Drug Administration for the active pharmaceutical ingredient [2]. - In June 2019, the company successfully challenged the patent of the original holder of injectable bivalirudin [2]. - In October 2019, the ANDA for injectable bivalirudin received final approval from the FDA, leading to its market launch in the U.S. in 2020 [2]. - In December 2022, injectable bivalirudin passed the consistency evaluation for generic drug quality and efficacy by the NMPA [2]. - In February 2024, the product received registration approval from the Saudi Food and Drug Authority (SFDA) [2]. Group 3: Company Strategy and Product Portfolio - The company has extensive experience in the research, registration, production, and marketing of chemically synthesized peptide drugs, having developed multiple products including injectable thymosin alpha-1 and various other therapeutic drugs [3]. - The internationalization strategy aims to obtain drug approvals and market sales in developed countries such as the U.S. and EU to increase revenue and profit [3].

Core Viewpoint - The direct thrombin inhibitors (DTIs) market is poised for growth driven by innovation in drug development, expansion of indications, breakthroughs in biotechnology, and reshaping of market dynamics towards safer, more precise, and accessible treatments [1][25]. Group 1: Industry Definition and Classification - Direct thrombin inhibitors are small molecules that directly inhibit thrombin activity without the need for auxiliary factors, capable of inhibiting both free and clot-bound thrombin [2]. - They are categorized into bivalent and non-bivalent inhibitors based on their mechanism of action [2]. Group 2: Current Industry Status - Thrombotic diseases are a leading cause of death in China, with over 300,000 deaths annually from myocardial infarction and stroke, accounting for 40% of total deaths [4]. - The market has several approved products, including Dabigatran etexilate, Lepirudin, Bivalirudin, Desirudin, and others, with ongoing clinical trials for new drugs [4][6]. - As of mid-2024, the number of companies selling Dabigatran etexilate capsules is 7, with sales of 340.83 million yuan; 15 companies sell Argatroban injection with sales of 140.57 million yuan; and 5 companies sell Bivalirudin injection with sales of 64.67 million yuan [6][8]. Group 3: Market Sales Data - In 2023, Dabigatran etexilate capsules generated sales of 706.14 million yuan, accounting for 53.58% of the DTI market; Argatroban injection sales were 482.25 million yuan (36.59%); and Bivalirudin injection sales were 129.63 million yuan (9.84%) [8]. - In the first half of 2024, Dabigatran etexilate sales reached 340.83 million yuan (62.41%); Argatroban sales were 140.57 million yuan (25.74%); and Bivalirudin sales were 64.67 million yuan (11.84%) [8]. Group 4: Competitive Landscape - The DTI market in China is characterized by a high concentration of multinational pharmaceutical companies, with significant competition from generic and biotech firms [12][15]. - Major players include Boehringer Ingelheim, Chengdu Baitai Pharmaceutical, Tianjin Institute of Pharmaceutical Research, and others, with Boehringer Ingelheim leading with a market share of 21.43% [15][12]. Group 5: Future Development Trends - The DTI industry is expected to focus on innovative drug development, expanding indications, and technological breakthroughs, driven by policy, technology, and patient needs [25]. - The market will likely see increased competition among multinational companies, generics, and biosimilars, aiming for safer and more effective treatments [25].

Group 1: Development Direction and Progress - The company focuses on high-end complex formulations, particularly in markets with large scale, high technical difficulty, and few competitors, to establish a unique competitive advantage [2][3] - Currently, the company has three peptide injection products (including APIs) approved for market in the U.S., with four more under FDA review [2] - The company aims to accelerate the registration process in Europe and expand into other global markets, leveraging approvals obtained in the U.S. [2] Group 2: Internationalization Efforts - The company has consistently pursued an internationalization strategy, successfully passing GMP inspections from the U.S. FDA, EU EMA, Philippines FDA, and Saudi Arabia SFDA [3] - Products such as thymosin alpha-1 and other injections have received FDA approval and have been exported to the U.S. [3] - The company plans to continue submitting DMF and ANDA applications in the U.S. and EU to further its internationalization efforts [3] Group 3: Raw Material Development - The company's thymosin alpha-1 has passed technical review by the Italian Medicines Agency (AIFA), and its somatostatin API has obtained a CEP certificate [3] - Other raw material businesses are being developed as a key focus for future growth [3] Group 4: Quality Management and CMO Cooperation - The subsidiary Ningbo Shuangcheng has passed the U.S. FDA CGMP inspection, ensuring compliance with quality management standards [3] - The company is actively pursuing CMO collaborations, particularly with major clients, while ensuring the production of its proprietary products [3]

Group 1 - The company will participate in the "2024 Annual Performance Briefing and Investor Reception Day" on May 13, 2025, to enhance communication with investors regarding its annual report and other key topics [1] - The company has received marketing authorization from the Therapeutic Goods Administration (TGA) in Australia for its injectable drug Bivalirudin, which is indicated as an anticoagulant for high-risk acute coronary syndrome patients [3][4] - The injectable Bivalirudin has previously received approvals from various regulatory bodies, including the FDA in the United States and the Saudi Arabian SFDA [5] Group 2 - The company's stock has experienced abnormal trading fluctuations, with a cumulative price deviation exceeding 12% over two consecutive trading days [9] - The company has confirmed that there are no undisclosed significant matters that could affect its stock price, and it has conducted a thorough review of its recent trading activity [10][11] - The company has been placed under a delisting risk warning due to negative financial results, with the lowest of its audited profit total, net profit, and net profit after non-recurring gains and losses being negative, and revenue below 300 million [12]

Core Viewpoint - ST Longjin is facing delisting due to a net profit loss in the recently disclosed 2024 annual report and revenue falling below 300 million, triggering delisting conditions [2][14]. Company Overview - Longjin Pharmaceutical was established in September 1996, focusing on the research, production, and sales of modern traditional Chinese medicine and high-end chemical generics [2]. - The company’s representative products include injection of Ligusticum Chuanxiong, injection of fibrinolytic enzyme, and injection of Bivalirudin, with Ligusticum Chuanxiong being the core product [2]. Stock Performance - Longjin Pharmaceutical was listed in 2015 during a bull market, with its stock price peaking at 135 yuan before experiencing a significant decline, dropping to around 6 yuan within two years [2]. - In 2019, the company invested 15 million yuan to acquire a 51% stake in Yunnan Muya Agricultural Technology Co., which focuses on large-scale industrial hemp cultivation, leading to a stock price surge from 5 yuan to 23.5 yuan in two months [4]. - The stock was heavily speculated upon due to the industrial hemp concept, achieving multiple trading halts in 2021, earning the title of the "first industrial hemp stock" [4]. Financial Performance - From 2021 to 2024, Longjin Pharmaceutical's revenue showed a drastic decline: 702.5 million, 123 million, 86.62 million, and 66.48 million respectively, with net profits of 3.093 million, -56.12 million, -70.94 million, and -41.44 million, indicating three consecutive years of losses [7]. - The company was placed under delisting risk warning by the Shenzhen Stock Exchange in the previous year due to a negative net profit and revenue below 100 million [8]. Recent Developments - Following the delisting risk warning, Longjin Pharmaceutical's stock faced a series of trading halts, with the price plummeting to around 1 yuan after multiple trading suspensions [9][11]. - Currently, there are nearly 30,000 shareholders, many of whom are stuck with high-priced shares and reluctant to sell [14]. Industry Context - The number of listed companies in A-shares has exceeded 5,000, with an increasing number of delistings each year, highlighting the importance of avoiding poorly performing stocks [16].