Market Performance - The China Securities Xinhua National Brand Engineering Index rose by 0.94% last week, closing at 1950.25 points, amidst market fluctuations [1][2] - The Shanghai Composite Index fell by 1.18%, while the Shenzhen Component Index decreased by 0.83%. In contrast, the ChiNext Index increased by 2.35% [2] Strong Stock Performances - Key stocks in the index showed strong performance, with EVE Energy rising by 36.39%, followed by Sungrow Power Supply at 35.52%, and Xinlitai at 15.87% [2] - Other notable performers included Zhongji Xuchuang (14.67%), Hengrui Medicine (9.42%), and Ningde Times (6.18%) [2] Year-to-Date Stock Gains - Since the beginning of the second half of the year, Zhongji Xuchuang has surged by 179.03%, while Sungrow Power Supply and EVE Energy have increased by 99.70% and 70.27%, respectively [3] - Several other stocks, including Kewo and Wu Biological, have also seen gains exceeding 50% [3] Market Outlook - According to Xing Shi Investment, there are currently no negative signals in market liquidity or macroeconomic factors, indicating a healthy upward trend in the market [4] - Daily market transactions have consistently remained above 2 trillion yuan, suggesting active capital seeking investment opportunities [4] Capital Inflow and Market Dynamics - Pingjing Investment notes that the key driver of market growth is the accumulation of profit-making effects leading to continuous capital inflow [5] - The market is expected to experience adjustments due to increased profit-taking by investors, but these adjustments are typically short-lived [5]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Viewpoints - The pharmaceutical sector is experiencing a transformation, with traditional Big Pharma companies accelerating their innovation and research investments, leading to a potential revaluation of their market value [3][8] - The report emphasizes the importance of innovative drugs as a key growth driver, with a focus on companies that have shown significant improvements in their operational trends and clinical pipelines [5][35] Summary by Sections Industry Performance - From September 1 to September 5, the pharmaceutical index rose by 1.40%, outperforming the CSI 300 index by 2.21% [5] - Notable stock performances included Haichen Pharmaceutical (+29%), Changchun High-tech (+24%), and Baihua Pharmaceutical (+21%) [5] Traditional Pharma Revaluation - Since the implementation of drug procurement policies in 2018, traditional Big Pharma has faced revenue and profit pressures, prompting a shift towards innovation and increased R&D spending [8] - Key factors for the improvement in Big Pharma include rapid revenue/profit growth, increased R&D investment, and a decline in sales/administrative expenses [9][16] Innovation as a Growth Engine - The transition from generic to innovative drugs is becoming the core internal growth driver for Big Pharma, with significant increases in innovative revenue and its proportion of total income [22][27] - For instance, Heng Rui Medicine reported innovative drug sales of 95.61 billion RMB in the first half of 2025, accounting for 60.66% of total revenue [22] Clinical Pipeline and Global Competitiveness - The long-term R&D investments have resulted in a robust clinical pipeline for Big Pharma, with many products in advanced stages of development, enhancing their global competitiveness [29] - The report highlights the potential for business development (BD) opportunities abroad, which could serve as a second growth curve for these companies [29] Investment Recommendations - The report suggests focusing on innovative drugs, manufacturing, and companies with low valuations that are positioned to benefit from aging populations and increased healthcare consumption [35] - Specific companies to watch include Heng Rui Medicine, Xinlitai, and China National Pharmaceutical Group [35]

Core Viewpoint - Shenzhen Xinlitai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the drug Enarodustat (恩那度司他片) to treat anemia in chronic kidney disease (CKD) patients undergoing dialysis, marking a significant expansion of its therapeutic applications [1][2]. Group 1: Drug Information - The drug Enarodustat is a new generation hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved for treating anemia in both dialysis and non-dialysis adult CKD patients [2]. - Enarodustat is available in tablet form with specifications of 1mg, 2mg, and 4mg, and is classified as a chemical drug of category 3 [1][2]. - The drug's approval number includes National Drug Approval Codes H20233662, H20233663, and H20233664 [1]. Group 2: Clinical Significance - Anemia is a common complication in CKD patients, significantly affecting their quality of life and increasing the risk of cardiovascular events and mortality [2]. - Enarodustat selectively targets the PHD1 enzyme, promoting endogenous EPO production closer to physiological levels, thereby improving iron metabolism and effectively increasing hemoglobin (Hb) levels with a high achievement rate and low thrombosis risk [2]. - The drug offers advantages such as once-daily oral administration, good adherence, no need for weight adjustment, and low risk of drug interactions [2]. Group 3: Future Prospects - The approval of the new indication for Enarodustat is expected to positively impact the company's future performance and long-term development [3]. - The company is also conducting clinical research for other indications of Enarodustat, including treatment for chemotherapy-induced anemia in non-myeloid malignancy patients, currently in various stages of clinical trials [2].

Core Viewpoint - The company, Xinlitai, has received approval from the National Medical Products Administration for the registration certificate of Ennadustat tablets, which are indicated for the treatment of anemia in chronic kidney disease (CKD) patients undergoing dialysis [1] Company Summary - Xinlitai announced the approval of Ennadustat tablets on the evening of September 5 [1] - The drug is specifically approved for use in patients with chronic kidney disease who are undergoing both hemodialysis and peritoneal dialysis [1]

Core Viewpoint - The company, Xinlitai, has received approval from the National Medical Products Administration for its clinical trial application of the innovative small molecule drug SAL0139 tablets [1] Group 1 - The company announced on the evening of September 5 that it has received a notice of acceptance for its clinical trial application [1] - The drug SAL0139 is developed independently by the company [1]

Core Viewpoint - The company, Sinopharm (002294.SZ), has received a notice of acceptance from the National Medical Products Administration for its innovative small molecule drug SAL0139, which targets hyperlipidemia and aims to provide new treatment options for patients with high cholesterol levels [1] Group 1: Drug Development - SAL0139 is an innovative small molecule drug developed by the company, with the project code SAL0139 [1] - The clinical trial application for SAL0139 has been accepted, indicating progress in the drug development process [1] - Preclinical studies suggest that SAL0139 has the potential to lower low-density lipoprotein cholesterol (LDL-C), a key risk factor for cardiovascular diseases [1] Group 2: Market Implications - If successfully developed and approved, SAL0139 could offer new medication options for patients with hyperlipidemia, addressing unmet clinical needs [1] - The introduction of SAL0139 is expected to enhance patient compliance and expand the company's innovative product pipeline in the chronic disease sector [1]

Core Viewpoint - The approval of Enarodustat (恩那度司他片) by the National Medical Products Administration marks a significant advancement in the treatment of anemia in chronic kidney disease (CKD) patients undergoing dialysis, providing a new therapeutic option that addresses unmet clinical needs [1] Company Summary - Xintai (信立泰) has received the drug registration certificate for Enarodustat, a new generation HIF-PHI drug, which selectively targets PHD1 enzyme, leading to a more rational regulation of HIF targets [1] - The drug promotes the production of endogenous EPO (erythropoietin) closer to physiological concentrations, improving iron metabolism trends and effectively increasing hemoglobin (Hb) levels [1] Industry Summary - Enarodustat is characterized by high achievement rates, low exceedance rates in elevation speed, and reduced thrombotic risks, making it a safer option for patients [1] - The drug offers advantages such as once-daily oral administration, good medication adherence, no need for weight adjustment, and low risk of drug interactions [1] - The launch of this new indication will provide CKD patients with anemia a novel treatment choice, better meeting the clinical demands in this area [1]

信立泰（002294）(002294.SZ)公告，公司收到国家药品监督管理局核准签发的恩那度司他片(恩那罗)药 品注册证书，其用于治疗透析(包括血液透析和腹膜透析)慢性肾脏病(CKD)患者的贫血适应症获批。 ...

人民财讯9月5日电，信立泰（002294）9月5日晚间公告，近日，公司收到国家药监局核准签发的恩那度 司他片(恩那罗)药品注册证书，其用于治疗透析(包括血液透析和腹膜透析)慢性肾脏病(CKD)患者的贫 血适应症获批。 恩那罗是国内上市的新一代缺氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI)药物，2023年已获批用于非透 析的成人慢性肾脏病(CKD)患者的贫血治疗，并于同年被纳入国家医保目录；此次获批的适应症为治疗 透析CKD患者的贫血(统称"肾性贫血")。 ...

Core Viewpoint - The approval of Enarodustat (恩那度司他片) by the National Medical Products Administration marks a significant advancement in the treatment of anemia in chronic kidney disease (CKD) patients undergoing dialysis, providing a new therapeutic option that addresses unmet clinical needs [1] Company Summary - Xintai (信立泰) has received the drug registration certificate for Enarodustat, a new generation HIF-PHI drug, which selectively targets PHD1 enzyme, leading to a more rational regulation of HIF targets [1] - The drug promotes the production of endogenous EPO (erythropoietin) closer to physiological concentrations, improving iron metabolism trends and effectively increasing hemoglobin (Hb) levels [1] Industry Summary - Enarodustat is characterized by high achievement rates, low exceedance rates in elevation speed, and reduced thrombotic risks, making it a safer option for patients [1] - The drug offers advantages such as once-daily oral administration, good medication adherence, no need for weight adjustment, and low risk of drug interactions [1] - The launch of this new indication will provide a novel treatment choice for more patients with renal anemia, better meeting the clinical demands in this field [1]