Core Viewpoint - Huahai Pharmaceutical's stock has experienced fluctuations, with a recent decline of 2.05% and a total market capitalization of 25.738 billion yuan. The company has seen a year-to-date stock price increase of 1.30%, but a decline of 4.92% over the last five trading days [1]. Financial Performance - For the period from January to September 2025, Huahai Pharmaceutical reported a revenue of 6.409 billion yuan, representing a year-on-year decrease of 11.57%. The net profit attributable to shareholders was 380 million yuan, down 63.12% compared to the previous year [2]. Shareholder Information - As of September 30, 2025, the number of shareholders for Huahai Pharmaceutical increased to 68,400, up by 1.58%. The average number of circulating shares per shareholder rose to 21,889 shares, an increase of 1.23% [2]. Dividend Distribution - Since its A-share listing, Huahai Pharmaceutical has distributed a total of 2.989 billion yuan in dividends. Over the past three years, the cumulative dividend payout has been 1.016 billion yuan [3]. Institutional Holdings - As of September 30, 2025, the top ten circulating shareholders of Huahai Pharmaceutical include notable entities such as China Europe Medical Health Mixed A, which holds 28.785 million shares, a decrease of 4.4618 million shares from the previous period. Hong Kong Central Clearing Limited increased its holdings to 21.2462 million shares, up by 0.23487 million shares [3].

Group 1 - The core point of the news is that Huahai Pharmaceutical's stock has experienced a decline, with a 5.65% drop over the last three days, closing at 17.55 yuan per share on January 14, with a total market capitalization of 26.277 billion yuan [1] - Huahai Pharmaceutical, established on February 28, 2001, and listed on March 4, 2003, specializes in the research, production, and sales of various dosage forms of generic drugs, biological drugs, innovative drugs, and specialty raw materials [1] - The company's revenue composition includes finished drug sales at 61.86%, raw materials and intermediates sales at 36.75%, other sales at 0.78%, and technical services at 0.62% [1] Group 2 - From the perspective of major fund holdings, one fund under Qianhai United Fund holds Huahai Pharmaceutical as its eighth largest position, with 40,000 shares representing 3.38% of the fund's net value [2] - The fund, Qianhai United National Health Mixed A (003581), has incurred a floating loss of approximately 5,600 yuan today and a total floating loss of 42,000 yuan during the three-day decline [2] - The fund was established on December 29, 2016, with a latest scale of 15.6476 million yuan, and has achieved a year-to-date return of 9.78% [2]

Market Overview - The Shanghai Composite Index fell by 0.64% on January 13, with six industries experiencing gains, led by the oil and petrochemical sector (up 1.62%) and the pharmaceutical and biotechnology sector (up 1.21%) [1] - The defense and military industry and the electronics sector saw the largest declines, down 5.50% and 3.30% respectively [1] Capital Flow Analysis - The net outflow of capital from the two markets was 162.743 billion yuan, with only four industries seeing net inflows [1] - The pharmaceutical and biotechnology sector had the highest net inflow of capital at 4.348 billion yuan, followed by the oil and petrochemical sector with a net inflow of 586 million yuan [1] - The electronics industry experienced the largest net outflow, totaling 37.010 billion yuan, followed by the computer industry with a net outflow of 23.107 billion yuan [1] Pharmaceutical and Biotechnology Sector Performance - The pharmaceutical and biotechnology sector rose by 1.21%, with a total of 478 stocks in the sector, of which 329 stocks increased in value and 16 stocks hit the daily limit [2] - A total of 256 stocks in the sector saw net capital inflows, with 21 stocks receiving over 100 million yuan in net inflows; leading was Mindray Medical with a net inflow of 372 million yuan [2] - The stocks with the highest net outflows included Hainan Haiyao, Huahai Pharmaceutical, and Sanbo Brain Science, with net outflows of 204 million yuan, 164 million yuan, and 153 million yuan respectively [2] Top Gainers in Pharmaceutical Sector - Notable gainers included: - Mindray Medical: up 0.09% with a capital flow of 371.57 million yuan [3] - International Medical: up 9.96% with a capital flow of 290.33 million yuan [3] - Haiwang Biological: up 9.97% with a capital flow of 242.73 million yuan [3] - Boji Pharmaceutical: up 19.96% with a capital flow of 241.23 million yuan [3] - Erkang Pharmaceutical: up 19.95% with a capital flow of 237.43 million yuan [3] Top Losers in Pharmaceutical Sector - Notable losers included: - Hainan Haiyao: down 4.82% with a capital outflow of 203.78 million yuan [5] - Huahai Pharmaceutical: down 3.60% with a capital outflow of 163.67 million yuan [5] - Sanbo Brain Science: down 3.93% with a capital outflow of 153.22 million yuan [5] - Xiangrikui: down 5.49% with a capital outflow of 147.26 million yuan [5] - Luyan Pharmaceutical: down 3.74% with a capital outflow of 110.10 million yuan [5]

Core Viewpoint - The article discusses the initiation of a Phase III clinical trial for HB0025, a drug developed by Huahai Pharmaceutical's subsidiary, Huatai, aimed at treating advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy [1][4]. Group 1: Clinical Trial Details - The clinical trial, registered under CTR20260016, is a randomized, double-blind, multi-center study named DUALIGHT-02, which will evaluate the efficacy and safety of HB0025 in comparison to pembrolizumab combined with chemotherapy [2][4]. - The trial aims to enroll 480 participants in China, with the primary endpoint being progression-free survival (PFS) assessed by blinded independent central review (BICR) according to RECIST v1.1 criteria [4]. - The drug HB0025 is an innovative PD-L1/VEGF dual-specific fusion protein designed to target both tumor immune evasion pathways and tumor angiogenesis pathways, providing a dual mechanism of action [4]. Group 2: Drug Development Status - HB0025 has reached Phase III clinical trials in China, while it is currently in Phase II globally for various cancers, including hepatocellular carcinoma and triple-negative breast cancer [5][9]. - The drug has shown promising results in earlier trials, with an objective response rate (ORR) of 83.3% in the squamous NSCLC cohort and 100% in the high PD-L1 expressing group, along with a disease control rate (DCR) of 95.8% [7]. - Huahai Pharmaceutical has invested approximately 326 million yuan in the development of HB0025 [9].

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the registration certificate of L-carnitine injection, which is used to treat complications arising from secondary carnitine deficiency in patients with chronic kidney failure undergoing long-term hemodialysis [1] Group 1 - The L-carnitine injection is indicated for symptoms such as cardiomyopathy, skeletal muscle disease, arrhythmia, hyperlipidemia, low blood pressure, and muscle cramps during dialysis [1] - The approval of L-carnitine injection enriches the company's product line and enhances its market competitiveness [1] - The product is classified as a Category 4 chemical drug, which is considered equivalent to passing the consistency evaluation according to national policies [1]

浙江华海药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的左卡尼汀注射液的《药品注册证书》， 现将相关情况公告如下： 一、药品的基本情况 药品名称：左卡尼汀注射液 剂型：注射剂 规格：5ml:1g 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2026-002 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 浙江华海药业股份有限公司 关于获得药品注册证书的公告 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个别及连带责任。 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符 合药品注册的有关要求，批准注册，发给药品注册证书。 二、药品其他相关情况 左卡尼汀注射液用于慢性肾衰长期血透病人因继发性肉碱缺乏产生的一系列 并发症状，临床表现如心肌病、骨骼肌病、心律失常、高脂血症，以及低血压和透 析中肌痉挛等。左卡尼 ...

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of L-carnitine injection, which is intended for patients with chronic renal failure undergoing long-term hemodialysis and suffering from secondary carnitine deficiency-related complications [1] Group 1 - The L-carnitine injection is used to address complications such as cardiomyopathy, skeletal muscle disease, arrhythmias, hyperlipidemia, low blood pressure, and muscle cramps during dialysis [1] - The company has invested approximately 4.69 million yuan in the research and development of the L-carnitine injection project [1]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the registration certificate of L-carnitine injection, which is used for complications arising from secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis [1] Group 1 - The L-carnitine injection is indicated for symptoms such as cardiomyopathy, skeletal myopathy, arrhythmia, hyperlipidemia, low blood pressure, and muscle cramps during dialysis [1] - The approval of L-carnitine injection enriches the company's product line and enhances its market competitiveness [1] - The product is classified as a chemical drug of category 4, which is considered equivalent to passing the consistency evaluation according to national policies [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of L-Carnitine Injection, which is intended for treating complications arising from secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis [1] Group 1 - The L-Carnitine Injection is classified as a Class 4 chemical drug, which is equivalent to passing the consistency evaluation, enhancing the company's market competitiveness [1] - The company has invested approximately 4.69 million yuan in the research and development of the L-Carnitine Injection project [1] - The projected domestic market sales for L-Carnitine Injection are estimated to reach approximately 508 million yuan in the first half of 2025 [1]

Group 1 - The core viewpoint of the news is that Zhejiang Huahai Pharmaceutical Co., Ltd. has undergone a site inspection by its sponsor, Zheshang Securities, which found that the company is operating well in terms of corporate governance, internal control, and compliance with regulations [1][12] Group 2 - The site inspection was conducted on December 30, 2025, and involved reviewing the company's governance documents, internal control systems, and financial practices [3][4] - The inspection confirmed that the company has a complete governance structure and that its internal control systems are effectively implemented [2][4] - The company has maintained independence from its controlling shareholders and has not engaged in any improper transactions with related parties [4][5] Group 3 - The use of raised funds was found to be compliant, with all funds stored in designated accounts and no evidence of misuse or unauthorized changes in fund allocation [5][6] - There were no violations related to external guarantees, related transactions, or significant external investments during the inspection period [5][6] Group 4 - The company's operational status remains stable, with no significant adverse changes in its business model or structure [6][12] - The company is advised to continue enhancing its corporate governance and risk management practices to ensure accurate and complete information disclosure [8]