格隆汇12月8日丨科兴制药(688136.SH)公布，近日，公司全资子公司深圳科兴收到国家药监局签发的 《药物临床试验批准通知书》，国家药监局批准同意深圳科兴开展"GB10注射液"的临床试验。产品名 称：GB10注射液，受理号：CXSL2500841。 GB10注射液是深圳科兴自主研发、拥有全球知识产权的抗VEGF/Ang-2双靶点抗体高浓度眼科专用蛋白 药物制剂。GB10注射液浓度达到140mg/mL，可减少注射体积或提高给药量，延长给药周期，预期实现 每4个月给药一次，极大提高患者依从性。 临床前数据显示，其生物活性和动物药效均达到国际竞品水平，在激光诱导的猴CNV（脉络膜新生血 管, choroidal neovascularization）药效模型中能够有效抑制眼底血管新生。 公司GB10注射液的临床试验获得国家药监局的批准，是公司创新药研发过程中的重要一步，标志着科 兴基于自主技术平台的双抗研发战略取得关键进展，若该药品研发未来实现成功上市，能够为满足市场 需求提供更加多元的产品，有利于丰富公司产品布局，进一步提高公司市场竞争力。 ...

Core Viewpoint - Company Sihuan Pharmaceutical (688136.SH) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its self-developed GB10 injection, marking a significant step in its innovative drug development process [1] Group 1: Product Development - GB10 injection is a high-concentration ophthalmic protein drug formulation targeting both VEGF and Ang-2, with a concentration of 140 mg/mL, which can reduce injection volume or increase dosage, allowing for administration every four months [1] - Preclinical data indicates that GB10 injection's biological activity and animal efficacy meet international competitive standards, effectively inhibiting choroidal neovascularization in laser-induced monkey models [1] Group 2: Strategic Importance - The approval for GB10 injection's clinical trial represents a key advancement in the company's dual-antibody research strategy based on its proprietary technology platform [1] - Successful future commercialization of GB10 injection could diversify the product offerings in the market, enhancing the company's competitive position [1]

科兴制药公告，全资子公司深圳科兴药业有限公司收到国家药品监督管理局签发的《药物临床试验批准 通知书》，国家药监局批准同意开展"GB10注射液"的临床试验，产品名称为GB10注射液，受理号为 CXSL2500841，审批结论为同意本品开展治疗新生血管性年龄相关性黄斑变性的临床试验。 ...

Core Insights - Company Kexing Pharmaceutical has submitted its prospectus to the Hong Kong Stock Exchange, marking a significant step in its "A+H" dual-platform strategy following its listing on the STAR Market in December 2020 [3] - Kexing Pharmaceutical is distinct from Kexing Biotech, focusing on recombinant protein drugs and microbiome preparations, primarily in antiviral and oncology treatments, while Kexing Biotech specializes in preventive vaccines [3][4] - The company has faced declining growth momentum due to domestic price reductions and increased international competition, leading to a period of losses [3][10] - The actual controller, Deng Xueqin, has raised over 1 billion yuan through share reductions, raising market concerns about the company's stock price volatility [3][19] Company Background - Kexing Pharmaceutical and Kexing Biotech share a common origin dating back to 1989, but have since become completely independent entities with no substantial ties [4] - The company was established as a result of asset and business separations that began in 2001, with Kexing Pharmaceutical focusing on therapeutic biopharmaceuticals [4][5] Financial Performance - Kexing Pharmaceutical's revenue has fluctuated between 1.2 billion to 1.3 billion yuan from 2020 to 2023, with a net loss of 190 million yuan in 2023 [10][9] - The company expects revenue to recover to 1.4 billion yuan in 2024, with a net profit of 31 million yuan, and further growth in 2025 [9][10] - Approximately 90% of the company's revenue comes from four core products, all of which have been on the market for over 15 years, facing challenges such as price reductions and increased competition [10][11] Product Portfolio - The four main products contributing to revenue include Epoetin (依普定), Interferon (赛若金), Granulocyte Colony-Stimulating Factor (白特喜), and Clostridium Butyricum (常乐康), which collectively accounted for 89% of revenue in 2024 [10][11] - Despite strong historical performance, these products are now encountering growth ceilings, impacting overall revenue stability [10][12] Cost Management and Efficiency - The company has implemented cost-cutting measures, reducing R&D expenses by 51% and sales expenses by 13.4% in 2024 [15][14] - Employee numbers have decreased from 1,407 at the end of 2022 to 971 by mid-2025, indicating a significant reduction in workforce [15] Financial Health - Kexing Pharmaceutical's debt levels have increased, with a debt-to-asset ratio rising from 43% at the end of 2022 to 49% by mid-2025, alongside a significant increase in bank loans [17] - The company's liquidity position has also deteriorated, with the current ratio dropping from 2.6 in 2022 to 1.6 in mid-2025, indicating a tightening of short-term financial flexibility [17] Market Strategy - The submission for H-share listing aims to enhance the company's "innovation + internationalization" strategy and diversify financing channels [18] - The market is observing the implications of Deng Xueqin's share reductions, which may reflect either a lack of confidence or a strategic move to optimize the share structure ahead of the H-share issuance [19][22]

科兴生物制药股份有限公司 关于以集中竞价交易方式回购公司股份的进展公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： | 回购方案首次披露日 | 2025/3/19 | | | | | | --- | --- | --- | --- | --- | --- | | 回购方案实施期限 | 2025 年 3 月 3 月 | 17 | 日~2026 | 年 | 16 日 | | 预计回购金额 | 3,000万元~6,000万元 | | | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 □用于转换公司可转债 | | | | | | 累计已回购股数 | □为维护公司价值及股东权益 1,319,333股 | | | | | | 累计已回购股数占总股本比例 | 0.66% | | | | | | 累计已回购金额 | 4,924.18万元 | | | | | | 实际回购价格区间 | 23.14元/股~43.50元/股 | | | | | 一、回购股份的基本情况 科兴生物制药股份有限公司（以下简称" ...

Core Viewpoint - Kexing Biopharmaceutical Co., Ltd. (referred to as "Kexing Pharmaceutical") has officially listed in Hong Kong after nearly five years of being on the A-share market, marking the beginning of its "A+H" dual-platform financing strategy. However, the company faces multiple challenges, including operational bottlenecks, increasing debt pressure, and governance issues that have raised market confidence concerns [1][2]. Financial Performance - Kexing Pharmaceutical's revenue has shown limited growth in recent years, with significant fluctuations in net profit. The operating revenues for 2022, 2023, 2024, and the first half of 2025 were 1.316 billion, 1.259 billion, 1.407 billion, and 700 million respectively, while net profits were -93 million, -195 million, 27 million, and 79 million respectively. Notably, in the first three quarters of 2025, the revenue reached 1.148 billion, a year-on-year increase of 10.54%, with a net profit of 111 million, marking a staggering year-on-year growth of 547.7% [3][5]. Product and Market Dynamics - The sustainability of Kexing Pharmaceutical's growth is questioned, as 80% of its revenue comes from four core products. The revenue from these products has remained stagnant between 1.2 billion and 1.3 billion from 2022 to 2024. The company's gross margin has also been declining, from 75.4% in 2022 to 63.6% in the first half of 2025 [7][8]. Governance and Compliance Issues - Kexing Pharmaceutical has faced significant governance and compliance issues, including receiving a regulatory warning for inaccurate information disclosure. The company had discrepancies in its earnings forecasts and failed to maintain consistent voluntary disclosures. Additionally, it mismanaged raised funds by investing in non-principal-protected products, which is against regulatory guidelines [9][10]. Shareholder Actions - Prior to the IPO, Kexing Pharmaceutical's controlling shareholder, Deng Xueqin, significantly reduced his holdings, cashing out over 1 billion in just five months. This raised concerns about shareholder intentions and market trust, especially as the company's total market value is only 6.78 billion [11][15].

Core Viewpoint - The article discusses the recent IPO of Kexing Pharmaceutical Co., Ltd. in Hong Kong, highlighting the challenges it faces in gaining market trust due to governance issues, financial performance, and the actions of its controlling shareholder [1][5][19]. Financial Performance - Kexing Pharmaceutical's financial data shows a transition from continuous losses to a turnaround, with revenues of 1.316 billion, 1.259 billion, 1.407 billion, and 700 million yuan for the years 2022, 2023, 2024, and the first half of 2025 respectively, while net profits fluctuated from -93 million to 79 million yuan during the same period [6][7]. - In the first three quarters of 2025, the company reported a revenue of 1.148 billion yuan, a year-on-year increase of 10.54%, and a net profit of 111 million yuan, reflecting a significant growth of 547.7% [7]. - The growth in revenue is attributed to the expansion into overseas markets, with overseas revenue increasing from 160 million yuan in 2022 to 224 million yuan in 2024, and reaching 177 million yuan in the first three quarters of 2025, accounting for 25.9% of total revenue [8]. Product and Market Challenges - Kexing Pharmaceutical's core products, which account for 80% of its revenue, are facing growth limitations, with a significant reliance on four main products that contributed 98.9%, 96.1%, 89.5%, and 79.5% of revenue from 2022 to the first half of 2025 [9][10]. - The overall gross margin has been declining, with rates of 75.4%, 70.8%, 68.7%, and 63.6% from 2022 to the first half of 2025 [11]. Governance and Compliance Issues - The company has faced regulatory scrutiny, receiving a warning letter for issues related to information disclosure and improper use of raised funds, including investing in non-principal-protected products [13][17]. - There were significant discrepancies in performance forecasts, with the 2023 annual profit forecast being significantly off from the actual results, leading to regulatory concerns about the accuracy of disclosures [14][15]. Shareholder Actions - Prior to the IPO, the controlling shareholder, Deng Xueqin, sold shares worth over 1 billion yuan, raising concerns about potential shareholder cash-out and its impact on market confidence [19][22][23].

Core Insights - The article highlights the successful international approval of Liraglutide injection by Tonghua Dongbao Pharmaceutical Co., Ltd. in Peru, marking a significant milestone in the company's global expansion strategy in the GLP-1 product category [4] - Liraglutide, a GLP-1 analog, is recognized for its efficacy in improving blood sugar levels, cardiovascular protection, and weight loss, gaining global acceptance [4] Market Growth and Strategy - The International Diabetes Federation (IDF) projects that the number of adults aged 20-79 with diabetes will reach 589 million in 2024, with a prevalence rate of 11.1%, and is expected to rise to 853 million by 2050, indicating a growing market for diabetes treatments [6] - The company, in collaboration with Sinovac Biotech, is targeting emerging markets with high diabetes prevalence, covering 17 countries across Latin America, the Middle East and North Africa, Southeast Asia, and South Africa [6] Product Development and Internationalization - The company has achieved significant progress in international registrations for multiple products, including Liraglutide and insulin formulations, with approvals in Indonesia, Uzbekistan, and other emerging markets [7] - The internationalization strategy is set to accelerate, aiming to expand overseas sales and provide accessible diabetes treatment options to a broader patient base [7]

Core Viewpoint - The successful completion of the GMP audit for the liraglutide injection by Tonghua Dongbao and its partner Sinovac Biotech marks a significant step in the company's internationalization strategy and paves the way for market entry in Brazil and expansion in South America [1][2]. Group 1: Company Developments - Tonghua Dongbao and Sinovac Biotech have collaborated to obtain exclusive commercialization rights for liraglutide injection in 17 emerging markets [1]. - The GMP audit conducted by Brazil's ANVISA was based on PIC/S guidelines, covering the entire production and quality management chain, and resulted in a "zero defect" outcome [1][2]. - The successful audit is seen as a key breakthrough for the company's international strategy, facilitating rapid entry into the Brazilian market [2]. Group 2: Market Context - Brazil has seen an increase in diabetes prevalence, with 16.62 million patients aged 20-79 and a prevalence rate of 10.7% [2]. - The country has established itself as a benchmark in the emerging pharmaceutical market since joining PIC/S in 2021, known for its stringent GMP standards [2]. - The company plans to accelerate the commercialization of more high-value products globally, enhancing treatment options for patients and driving long-term growth [2].

Core Viewpoint - The stock of Kexing Pharmaceutical has shown significant fluctuations, with a year-to-date increase of 57.84% and a recent decline over the past 20 and 60 days, indicating volatility in its market performance [1]. Financial Performance - For the period from January to September 2025, Kexing Pharmaceutical achieved a revenue of 1.148 billion yuan, representing a year-on-year growth of 10.54% [2]. - The net profit attributable to shareholders for the same period was 111 million yuan, reflecting a substantial year-on-year increase of 547.70% [2]. Shareholder and Market Activity - As of September 30, 2025, the number of shareholders for Kexing Pharmaceutical increased by 25.03% to 11,800, while the average circulating shares per person decreased by 19.37% to 17,102 shares [2]. - The stock has appeared on the "龙虎榜" (a list of stocks with significant trading activity) six times this year, with the most recent appearance on July 3 [1]. Dividend Distribution - Since its A-share listing, Kexing Pharmaceutical has distributed a total of 51.5446 million yuan in dividends, with 15.7785 million yuan distributed over the past three years [3]. Institutional Holdings - As of September 30, 2025, notable changes in institutional holdings include a decrease in shares held by the second-largest shareholder, E Fund Medical Care Industry Mixed A, by 1.6069 million shares, while the fifth-largest shareholder, Fortune Tianhui Growth Mixed A/B, increased its holdings by 10,000 shares [3].