Core Viewpoint - The innovative pharmaceutical stocks experienced a significant rebound, with Huahai Pharmaceutical and Kangchen Pharmaceutical both hitting the daily limit up, indicating strong market interest and investor confidence in the sector [1] Industry Summary - The National Medical Products Administration of China reported that the country's pharmaceutical industry ranks second globally, with approximately 30% of the world's innovative drugs currently under research [1] - Since the beginning of the 14th Five-Year Plan, a total of 387 pediatric drugs and 147 rare disease drugs have been approved for market, effectively addressing the medication needs of key populations [1] Company Summary - Huahai Pharmaceutical and Kangchen Pharmaceutical both reached the daily limit up, reflecting positive market sentiment towards their stock performance [1] - Other companies such as Puris, Duolai Pharmaceutical, Haoyuan Pharmaceutical, Huana Pharmaceutical, Medisi, Lifang Pharmaceutical, and Guangshengtang also saw stock increases, with some rising over 5% [1]

Core Viewpoint - Huahai Pharmaceutical announced the approval of its abbreviated new drug application (ANDA) for Dihydrocodeine Hydrochloride Tablets by the U.S. FDA, which is a significant milestone for the company [1] Group 1 - Huahai Pharmaceutical received notification from its subsidiary, Pulinsitong Pharmaceutical Co., Ltd., regarding the FDA approval [1] - The approved product is Dihydrocodeine Hydrochloride Tablets, which indicates the company's expansion into the U.S. generic drug market [1]

Core Viewpoint - Huahai Pharmaceutical's subsidiary has received FDA approval for a new drug application for Dicyclomine Hydrochloride Tablets, which is expected to enhance its market presence in the U.S. [1] Group 1: Company Developments - The subsidiary, Pulinsitong Pharmaceutical Co., Ltd., has successfully obtained approval for the abbreviated new drug application (ANDA) from the U.S. FDA [1] - The drug is primarily used for treating functional gastrointestinal disorders and was developed by ALLERGAN SALES LLC, first launched in the U.S. in 1984 [1] - The company has invested approximately 7 million RMB in research and development for this project [1] Group 2: Market Impact - The expected sales revenue for the drug in the U.S. market in 2024 is approximately 17.6 million USD [1] - The approval allows the company to sell the product in the U.S. market, which is anticipated to expand its sales and strengthen its product supply chain [1] - This development is expected to enrich the company's product portfolio and enhance its market competitiveness [1]

1、药物名称：盐酸双环胺片 6、申请人：普霖斯通制药有限公司（Prinston Pharmaceutical, Inc.） 二、药物的其他相关情况 盐酸双环胺片主要用于治疗功能性肠易激综合征。盐酸双环胺片由 ALLERGAN SALES LLC 研发，于 1984 年 10 月在美国上市。当前，美国境内， 盐酸双环胺片主要生产商有 ANNORA、AUROBINDO、BIONPHARMA 等。2024 年该药品美国市场销售额约 1,760 万美元（数据来源于 IQVIA） | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2025-096 号 | | --- | --- | --- | --- | | 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 关于制剂产品盐酸双环胺片获得美国 FDA 批准文号 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。 近日，浙江华海药业股份有限公司（以下简称"公司"）收到下属子公司普 霖斯通制药有限公司的通知，其向美国食品药 ...

26 August 2025 | 3:37PM CST Zhejiang Huahai Pharmaceutical (600521.SS): Earnings review: 1H25 results mostly in line; TP up to Rmb15 to reflect positive pipeline Huahai released its 1H25 results on Aug 25, 2025. Both its revenue (Rmb4,516mn, -12% yoy) and net profits (Rmb409mn, -45% yoy) were mostly in-line with GSe (Rmb4,748mn/398mn, respectively). We are positive on the company's pipeline progress (which all belong to the company's subsidiary, Huaota Biotech; see the company's latest pipeline in Exhibit 1 ...

Group 1 - The core point of the news is that Huahai Pharmaceutical (600521) has seen significant share pledges by its shareholder Zhou Minghua, with a total of 15 million shares pledged, accounting for 1.0% of the total share capital [1] - As of the announcement date, Zhou Minghua has cumulatively pledged 93.98 million shares, which represents 41.88% of his total holdings [1] - The cumulative pledged shares of the top ten shareholders of Huahai Pharmaceutical have been highlighted, indicating potential liquidity concerns [1] Group 2 - Huahai Pharmaceutical's financial data for the first half of 2025 shows a main revenue of 4.516 billion yuan, a year-on-year decrease of 11.93% [3] - The net profit attributable to shareholders decreased by 45.3% to 409 million yuan, while the net profit after deducting non-recurring items fell by 52.48% to 363 million yuan [3] - In Q2 2025, the company reported a single-quarter revenue of 2.148 billion yuan, down 18.32%, and a net profit of 112 million yuan, down 76.54% [3] - The company's debt ratio stands at 52.95%, with investment income reported at -12.09 million yuan and financial expenses at 97.59 million yuan, while the gross profit margin is 63.32% [3] Group 3 - Huahai Pharmaceutical specializes in the research, production, and sales of various dosage forms of generic drugs, biological drugs, innovative drugs, and specialty raw materials [4]

浙江华海药业股份有限公司（以下简称"公司"）5%以上股东周明华先生持 有公司股份总数为 224,418,890 股，占公司总股本的比例为 14.99%。本次部分 股份质押完成后，周明华先生处于质押状态的股份累计数为 93,980,000 股，占 其所持公司股份总数的 41.88%，占公司总股本的比例为 6.28%。 公司于近日收到 5%以上股东周明华先生关于其部分股份质押的通知，现将 具体情况公告如下： | 股东 | 是否为 | 本次质押股 | 是否 | 是否 | | | | 占其所持 | 占公司 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | 控股股 | 数 | 为限 | 补充 | 质押起始日 | 质押到期日 | 质权人 | 股份比例 | 总股本 | 质押融资资金用途 | | | 东 | | 售股 | 质押 | | | | | 比例 | | | 周明 华 | 否 | 15,000,000 | 否 | 否 | 2025.8.22 | 至办理解除 质押手续止 | 厦门国际银 行股份有限 公司上海分 | ...

Group 1 - Huahai Pharmaceutical (600521.SH) released its semi-annual report for 2025, showing that as of August 25, 2025, 31 institutional investors disclosed holding A-shares, totaling 144 million shares, which accounts for 9.62% of the total share capital [1] - The top ten institutional investors collectively hold 9.24% of the shares, with a 0.69 percentage point increase compared to the previous quarter [1] Group 2 - In the public fund sector, two funds increased their holdings, including China Europe Medical Health Mixed A and Southern CSI 500 ETF, with an increase ratio of 0.96% [2] - Two public funds decreased their holdings, namely Anxin Medical Health Stock A and Industrial Bank Medical Care A, with a decrease ratio of 0.19% [2] - A total of 22 new public funds were disclosed this period, including Guangda Baodexin Health Superior Mixed A and Huazhang Medical Innovation Mixed A [2] - One social security fund increased its holdings, specifically Guotai Fund Management Co., Ltd. - Social Security Fund 2103 Combination, with an increase ratio of 0.27% [2]

Group 1 - The company reported a total operating revenue of 4,516.35 million yuan, representing a year-on-year decrease of 11.93% [1] - The net profit attributable to shareholders of the listed company was 409.49 million yuan, down 45.30% year-on-year [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was 363.42 million yuan, a decline of 52.48% compared to the previous year [1] Group 2 - The company's total R&D investment amounted to 648.76 million yuan, accounting for 14.36% of its operating revenue [1] - R&D investment increased by 23.07% compared to the same period last year [1]

Core Viewpoint - Huahai Pharmaceutical reported a significant decline in both revenue and net profit for H1 2025, primarily due to falling product prices and increased R&D investments [1][2] Financial Performance - H1 revenue reached 4.516 billion yuan, a year-on-year decrease of 11.93% [1] - Net profit attributable to shareholders was 409 million yuan, down 45.30% year-on-year [1] - Non-recurring net profit was 363 million yuan, a decline of 52.48% compared to the previous year [1] - Operating cash flow for H1 was 370 million yuan, a drop of 71.52% year-on-year [2] Reasons for Decline - The decline in net profit is attributed to three main factors: 1. Continuous price drops due to intensified competition and domestic procurement policies, despite an increase in market share [1] 2. Accelerated R&D investments in biological innovation drugs [1] 3. Decreased foreign exchange gains due to currency fluctuations [1] R&D Progress - The product HB0034 (Ruxolitinib injection) has been prioritized for review by the National Medical Products Administration (NMPA) and is expected to be approved for market in Q2 2026 [3] - The key III phase clinical trial for HB0017 for moderate to severe plaque psoriasis is nearing completion, while the trial for ankylosing spondylitis is ongoing [3] - In the oncology pipeline, HB0025 for advanced or recurrent endometrial cancer has submitted a meeting request for confirmatory III phase clinical trials, and significant efficacy data for non-small cell lung cancer will be presented in early September [3]