证券日报网讯康缘药业（600557）11月27日在互动平台回答投资者提问时表示，公司始终坚定研发创 新，目前在研产品管线丰富，中药聚焦呼吸与感染疾病、心脑血管疾病、妇科疾病、骨伤科疾病等中医 优势领域，化药、生物药在心脑血管疾病、代谢性疾病、消化系统疾病、自身免疫疾病、神经系统疾病 等治疗领域积极布局。其中，治疗超重或肥胖、2型糖尿病生物药1类创新药ZX2021注射液于2025年6月 完成II期首例受试者入组，低剂量组、中剂量组、高剂量组已全部完成受试者入组，盲态下已呈现减重 效果，计划2026年三季度进入III期临床；治疗2型糖尿病、超重或肥胖生物药1类创新药ZX2010注射液 于2025年7月完成II期首例受试者入组，已开展3个剂量组入组(共4个剂量组)，计划2026年三季度进入III 期临床；治疗神经营养性角膜炎生物药1类创新药ZX1305E滴眼液于2025年6月完成II期首例受试者入 组，计划2026年三季度进入III期临床；治疗视神经损伤生物药1类创新药ZX1305注射液正在开展IIb期临 床。公司各项在研管线均按临床计划和方案有序推进，争取实现早日上市。对于临床试验进展、审评结 果等关键信息，公司 ...

康缘药业公告，全资子公司江苏中新医药有限公司近日收到国家药品监督管理局签发的关于ZX2021注 射液新增用于治疗代谢功能障碍相关脂肪性肝病适应症的《药物临床试验批准通知书》。 ...

Core Viewpoint - Kangyuan Pharmaceutical (600557.SH) has reported its 2025 semi-annual results, showing pressure on performance but significant advancements in R&D innovation, attracting attention from major securities firms for potential value reassessment [1] Group 1: Company Overview - Kangyuan Pharmaceutical is a leading enterprise in the Chinese traditional medicine sector, with core products including Re Du Ning Injection, Jin Zhen Oral Liquid, and Ginkgo Biloba Diterpene Glycoside Injection [1] - The company follows a strategic framework of "one body and two wings," focusing on traditional Chinese medicine while expanding into chemical and biological drugs [1] Group 2: R&D Innovations - The company has expanded its innovative business layout, acquiring 100% of Zhongxin Pharmaceutical for 270 million yuan to enhance its biological drug portfolio, particularly in the metabolic field [1] - Zhongxin Pharmaceutical is developing ZX2021, a long-acting weight loss (anti-diabetic) fusion protein targeting three pathways, which has shown promising results in clinical trials [1][2] Group 3: Market Potential - The market for type 2 diabetes and obesity drugs in China is projected to reach 109.8 billion yuan and 47.2 billion yuan by 2032, with GLP-1 drugs becoming mainstream [2] - Kangyuan Pharmaceutical aims to enter the lucrative metabolic sector with its dual-target and tri-target drugs from Zhongxin Pharmaceutical [2] Group 4: Clinical Development - The company has made significant progress in its self-developed products, with five drugs approved for IND and nine drugs in clinical phases III and above, all being traditional Chinese medicine [3] - In the chemical and biological drug sector, a key product targeting Alzheimer's disease has completed phase II clinical trials and is expected to start phase III trials within the year [3] Group 5: Institutional Support - The company has received recommendations from approximately 10 securities firms, with 16 research reports published this year, emphasizing its innovative R&D pipeline [3] - Despite facing complex internal and external challenges, the company is enhancing its professional and compliant marketing strategies, which are expected to support its long-term healthy development [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company's operating performance is under short-term pressure, with a focus on the growth potential of its innovative pipeline [5] - For the first half of 2025, the company achieved revenue of 1.642 billion yuan (down 27.29% year-on-year) and a net profit attributable to shareholders of 142 million yuan (down 40.12%) [5] - The gross margin for the first half of 2025 was 70.88% (down 3.66 percentage points), and the net margin was 9.06% (down 2.95 percentage points) [5] - The company has adjusted its profit forecasts for 2025-2026 and added a new forecast for 2027, expecting net profits of 380 million, 431 million, and 491 million yuan respectively [5] Financial Performance Summary - Revenue for 2025H1 was 1.642 billion yuan, with a year-on-year decline of 27.29% [5] - The net profit attributable to shareholders for 2025H1 was 142 million yuan, down 40.12% year-on-year [5] - The company's revenue breakdown shows that injection liquid revenue was 506 million yuan (down 39.73%), while tablet revenue increased by 12.26% to 190 million yuan [6] - The company has completed the acquisition of 100% equity in a biopharmaceutical company, enhancing its innovative drug pipeline [7] Financial Projections - The company expects revenues of 3.529 billion yuan in 2025, 3.750 billion yuan in 2026, and 4.035 billion yuan in 2027, with corresponding net profits of 380 million, 431 million, and 491 million yuan [8] - The projected EPS for 2025, 2026, and 2027 is 0.67, 0.76, and 0.87 yuan per share respectively [8] - The current stock price corresponds to a P/E ratio of 26.8 for 2025, 23.6 for 2026, and 20.8 for 2027 [5][8]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Views - The company is advancing its innovative drug pipeline, with a focus on three target areas, and has updated its key product pipeline [1] - The acquisition of 100% equity in Zhongxin Pharmaceutical for 270 million yuan will enhance the company's portfolio with four innovative products, including a three-target weight loss drug [1] - The company is expected to face performance pressure in 2024 due to external pharmaceutical environment and internal reforms, but is projected to enter a recovery phase in 2025, with steady growth anticipated from 2026 to 2027 [2] Financial Summary - Revenue is projected to decline from 4.86 billion yuan in 2023 to 3.90 billion yuan in 2024, with a growth rate of -19.9% [4] - Net profit attributable to the parent company is expected to decrease from 464 million yuan in 2023 to 392 million yuan in 2024, reflecting a -15.6% year-on-year change [4] - The company’s R&D expenses are projected to be 638 million yuan in 2024, indicating a strong commitment to innovation despite short-term profit pressures [2][4] - Forecasted net profits for 2025, 2026, and 2027 are 400 million yuan, 462 million yuan, and 530 million yuan, respectively, with corresponding growth rates of 2%, 15.7%, and 14.6% [2] Product Pipeline - The company is developing multiple products across various therapeutic areas, including: - SIPI-2011 for treating ventricular arrhythmias, currently in Phase II clinical trials [2] - AAPB injection for acute ischemic stroke, in Phase I clinical trials [2] - KYS202002A, a CD38 monoclonal antibody for multiple myeloma and lupus, with dual submissions in China and the US [2] - KYS2301 gel, a first-in-class peptide inhibitor targeting CCR8 for atopic dermatitis [2]