Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has experienced significant stock price fluctuations despite facing substantial operational and financial challenges, including a 45.30% year-on-year decline in net profit for the first half of 2025 [2][3]. Financial Performance - For the first half of 2025, the company reported a revenue of 4.516 billion yuan, a decrease of 11.93% year-on-year, and a net profit attributable to shareholders of 2.409 billion yuan, marking the largest decline in net profit over the past decade [3]. - The decline in net profit is attributed to intensified domestic procurement policies, increased competition in the raw material drug industry, and the impact of US-China tariffs, despite an increase in market share [3]. R&D Progress and Challenges - Huahai Pharmaceutical's innovation platform, Shanghai Huatai Biopharmaceutical Co., Ltd., has not successfully launched any products in over a decade, with cumulative losses exceeding 1 billion yuan from 2022 to 2024 [4]. - The company is facing competition from earlier approved products in the market, particularly in the treatment of generalized pustular psoriasis and other indications [5][6]. - The HB0034 project, aimed at treating generalized pustular psoriasis, is nearing commercialization, with a formal application expected soon [4][6]. Market Competition - The competitive landscape is challenging, with other companies like Novartis and Eli Lilly having already launched similar products, which may affect the commercial prospects of Huahai's pipeline [6]. - The company is also advancing its HB0025 project for cancer treatment, which is entering critical clinical trial phases [6]. Future Outlook - The company has acknowledged the long and uncertain nature of the drug development process, highlighting the need for strategic adjustments in pricing and product structure in response to market conditions [7]. - There are questions regarding the company's plans to mitigate risks associated with its R&D pipeline and whether it will focus on niche therapeutic areas to reduce competition [7].

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has experienced significant stock price fluctuations despite facing substantial operational and financial challenges, including a 45.30% decline in net profit in the first half of 2025 compared to the previous year [1][2]. Financial Performance - In the first half of 2025, the company reported a revenue of 4.516 billion yuan, a decrease of 11.93% year-on-year, and a net profit attributable to shareholders of 2.409 billion yuan, marking the largest decline in net profit over the past decade [2]. - The decline in net profit is attributed to intensified domestic procurement policies, increased competition in the raw material drug industry, and the impact of US-China tariffs, despite an increase in market share for major products [2]. R&D Progress and Challenges - Huahai Pharmaceutical has established a subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., focused on innovative drug development, particularly in oncology and autoimmune diseases, but has yet to successfully launch any products [3]. - The subsidiary has reported cumulative losses exceeding 1 billion yuan from 2022 to 2024, with a net asset value of approximately -1.175 billion yuan as of the end of 2024 [3]. - The most advanced project, HB0034, for treating generalized pustular psoriasis, is expected to submit a formal application for market approval soon, with potential approval in the second quarter of 2026 [3][4]. Competitive Landscape - The competitive landscape for Huahai Pharmaceutical's products is challenging, with competitors like Boehringer Ingelheim and Novartis having already launched similar products, which may affect the commercial prospects of Huahai's pipeline [4][5]. - The company is also developing HB0025, a dual-target antibody for advanced or recurrent endometrial cancer, which is entering critical clinical trial phases [5]. Strategic Considerations - The company has indicated the need for potential adjustments in product pricing strategies and product structure optimization in response to declining revenues despite increased market share [6]. - There are questions regarding the company's risk management measures for its R&D pipeline and whether it will focus on more niche therapeutic areas to mitigate competition risks [6].

Core Viewpoint - The company experienced fluctuations in performance in the first half of 2025, with a significant focus on advancing its research projects and a notable increase in R&D investment. Group 1: Financial Performance - In the first half of 2025, the company achieved revenue of 4.516 billion yuan, a year-on-year decrease of 11.93% [1] - The net profit attributable to the parent company was 409 million yuan, down 45.3% year-on-year, while the non-recurring net profit was 363 million yuan, a decline of 52.48% [1] - The gross margin was 63.32%, an increase of 1.31 percentage points, and the net profit margin was 8.97%, a decrease of 5.74 percentage points [1] - The company revised its profit forecasts for 2025-2026, now expecting net profits of 1.164 billion yuan, 1.250 billion yuan, and 1.314 billion yuan for 2025, 2026, and 2027 respectively [1] Group 2: R&D Progress - The company invested 649 million yuan in R&D in the first half of 2025, representing a year-on-year increase of 23.07% and accounting for 14.36% of revenue [2] - Key clinical trial endpoints for HB0034 have been reached, and it has been included in the CDE priority review list, with a formal market application expected soon [3] - The HB0017 product is nearing the end of patient follow-up in its key Phase III clinical trial for moderate to severe plaque psoriasis, while the trial for ankylosing spondylitis is progressing rapidly [3] - The company is advancing its projects using AI and extensive biological information, with several new innovative projects in early clinical stages [3] Group 3: Expense Ratios - In the first half of 2025, the company's sales expense ratio was 20.93%, management expense ratio was 15.94%, R&D expense ratio was 11.58%, and financial expense ratio was 2.16%, with year-on-year increases of 1.29 percentage points, 3.23 percentage points, 3.00 percentage points, and 1.47 percentage points respectively [3]

华海药业（600521.SH） 2025 上半年业绩有所波动，在研项目快速推进 2025 年 09 月 02 日 投资评级：买入（维持） 医药生物/化学制药 | 日期 | 2025/9/1 | | --- | --- | | 当前股价(元) | 26.59 | | 一年最高最低(元) | 26.59/13.49 | | 总市值(亿元) | 398.12 | | 流通市值(亿元) | 387.18 | | 总股本(亿股) | 14.97 | | 流通股本(亿股) | 14.56 | | 近 3 个月换手率(%) | 232.99 | 股价走势图 数据来源：聚源 -30% 0% 30% 60% 90% 2024-09 2025-01 2025-05 华海药业 沪深300 相关研究报告 《2024 年前三季度业绩快速增长，在 研项目进展顺利—公司信息更新报 告》-2024.11.3 《2024 上半年业绩快速增长，国内制 剂业务强劲增长—公司信息更新报 告》-2024.9.3 余汝意（分析师） 阮帅（分析师） yuruyi@kysec.cn 证书编号：S0790523070002 ruanshuai@kysec.c ...

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]

Core Insights - The PD-1/VEGF dual antibody is currently a hot topic in innovative drug development, with significant collaborations and financial transactions highlighting its potential [1][2][3] Group 1: Industry Dynamics - Chinese biotech companies are emerging as key players in the global PD-(L)1/VEGF dual antibody development race, demonstrating advanced research progress and achieving international recognition through high-value business development (BD) deals [2][3] - Major collaborations include 12.5 billion USD upfront payment and 60.5 billion USD total deal value between 3SBio and Pfizer for SSGJ-707, and BioNTech's 15 billion USD upfront payment for BNT327 licensed to BMS, totaling over 90 billion USD [1][2] Group 2: Clinical Developments - The PD-(L)1/VEGF target gained traction after Kangfang Biotech's AK112 outperformed the benchmark drug, Pembrolizumab (K drug), in head-to-head trials, leading to increased interest from multinational corporations (MNCs) [3][4] - AK112 demonstrated a higher objective response rate (ORR) of 50% compared to K drug's 38.5% and a disease control rate (DCR) of 89.9% versus 70.5% in late-stage non-small cell lung cancer (NSCLC) trials [4][6] Group 3: Competitive Landscape - The success of AK112 has intensified competition among MNCs, with companies eager to capitalize on the potential of PD-(L)1/VEGF dual antibodies, as evidenced by Pfizer's strategic investments [9][10] - As of May 2025, there are 14 PD-(L)1/VEGF dual antibodies in clinical stages globally, with half originating from Chinese biotech firms, indicating a robust pipeline and potential for further BD opportunities [15][24] Group 4: Future Prospects - Companies like Junshi Biosciences, I-Mab, and Hualan Biological Engineering are actively pursuing PD-(L)1/VEGF dual antibodies, with significant investments and clinical trials underway [15][20][22] - The shift from merely imitating existing drugs to innovating new targets and technologies marks a significant evolution in the Chinese pharmaceutical industry, enhancing its international competitiveness [24][25]

Group 1 - The pharmaceutical and biotechnology index rose by 2.21%, outperforming the CSI 300 index by 3.30 percentage points and the ChiNext index by 2.00 percentage points, ranking second among 31 sub-industries [3] - Recent IND applications have been initiated for drugs such as BG-60366 from BeiGene and RFUS-949 from Renfu Pharmaceutical, while clinical applications for BGB-C354 and SSS55 injection have also been newly undertaken [4] Group 2 - The upcoming 2025 ASCO conference is expected to showcase Chinese innovative pharmaceutical companies, with a notable global licensing deal of $6.05 billion between 3SBio and Pfizer, enhancing the focus on PD-1 (PD-L1)/VEGF dual antibody products [5] - There are currently 14 PD-1 (PD-L1)/VEGF products in clinical stages globally, all associated with Chinese companies, with the fastest progress seen in the drug Ivorisumab from CanSino Biologics, which has been approved in China [5] Group 3 - Companies such as Zhenzhen Cell, Rongchang Biopharmaceutical, Junshi Biosciences, and Huahai Pharmaceutical have clinical products progressing quickly but have not yet established business development partnerships [6] - Huahai Pharmaceutical's HB0025 for endometrial cancer is expected to start Phase III clinical trials in the second half of 2025, while Zhenzhen Cell's SCTB14 has initiated Phase II/III clinical trials in March 2025 [6] Group 4 - The investment strategy for 2025 emphasizes structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: in-hospital payments, out-of-pocket payments, and overseas payments [7] - The strategy highlights three key directions: policy support for innovative drugs and devices, expanding public demand for blood products and home medical devices, and the upward cycle of overseas sales for products like heparin and respiratory-related treatments [7]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The PD-1 (PD-L1)/VEGF dual antibody concept is gaining significant attention, with Chinese innovative pharmaceutical companies leading the research and development efforts [2][20]. - The global market for dual antibodies is projected to exceed $80 billion by 2030, with PD-1 (PD-L1)/VEGF drugs expected to challenge the traditional PD-1/PD-L1 drugs in cancer treatment [20][21]. - The report highlights the importance of clinical data barriers and international expansion for companies in this sector, suggesting that these factors will create differentiated investment opportunities [3][26]. Summary by Sections Market Review - The pharmaceutical and biotechnology index rose by 2.21%, outperforming the CSI 300 index by 3.30 percentage points and the ChiNext index by 2.00 percentage points, ranking second among 31 sub-industries [11][12]. Clinical Progress - Notable advancements include the IND applications for BG-60366 by BeiGene and RFUS-949 by Renfu Pharmaceutical, as well as ongoing clinical trials for various drugs by companies like Hengrui Medicine and Stone Pharmaceutical [29][30]. Key Developments - The report notes that 14 PD-1 (PD-L1)/VEGF products are currently in clinical stages, all associated with Chinese companies, with the fastest progress seen in Ivonescimab by Kangfang Biotech, which has been approved in China [21][22]. Investment Strategy - The report emphasizes a structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: hospital payments, out-of-pocket payments, and overseas payments [4][26]. - Recommended companies include Hengrui Medicine, Mindray Medical, United Imaging Healthcare, and Yuyue Medical [4]. Company Announcements - Recent announcements include various companies receiving approvals for new drugs and medical devices, indicating ongoing innovation and regulatory progress within the sector [28][29].

Core Insights - Bristol-Myers Squibb (BMS) acquired BioNTech's PD-L1/VEGF dual antibody BNT327 for $9 billion, highlighting the increasing interest in Chinese biotech firms and their innovative drug pipelines [1][2] - The rapid financial success of BioNTech, which earned over $8 billion from the initial $55 million licensing deal with Chinese firm Pumice Biologics, raises questions about the pricing strategies of Chinese pharmaceutical companies in the global market [1][2][3] - The trend of multinational corporations (MNCs) aggressively acquiring Chinese dual antibodies is reshaping the global landscape of innovative drugs, with significant deals such as the $6.05 billion agreement between 3SBio and Pfizer [1][4] Group 1: Major Transactions - BMS's deal with BioNTech includes a $1.5 billion upfront payment, a record for oncology licensing agreements, along with additional milestone payments totaling $76 billion [2] - 3SBio's licensing of its PD-1/VEGF dual antibody SSGJ-707 to Pfizer for $6.05 billion, with an upfront payment of $1.25 billion, sets a new record for domestic innovative drug licensing [4][5] - Other notable transactions include Merck's $3.3 billion investment in LianBio and the anticipated $5 billion deal involving Shijiazhuang Yiling Pharmaceutical [5][6] Group 2: Market Dynamics - The surge in MNCs acquiring Chinese dual antibodies is driven by the expiration of patents for existing blockbuster drugs and the need for new products [6][7] - Chinese innovative drug companies benefit from lower development costs and a large patient pool, making them attractive targets for MNCs seeking to enhance their product pipelines [6][7] - The total value of outbound licensing deals for Chinese innovative drugs reached $45.5 billion since early 2025, with 42% of high-value projects coming from China [5][6] Group 3: Future Outlook - The ongoing trend of MNCs partnering with Chinese biotech firms is expected to bolster the confidence of domestic companies in pursuing research and development [7][8] - The ability of Chinese innovative drug companies to negotiate higher prices in licensing deals will depend on their negotiation skills and market positioning [8] - The need for a "pricing power revolution" in the Chinese pharmaceutical industry is emphasized, as companies face challenges from rising R&D costs and stringent domestic pricing policies [9]

证券研究报告 | 医药生物 | 2025年4月26日 www.hczq.com 华创医药投资观点&研究专题周周谈·第123期 华海药业创新研发进入收获期 本周周专题联系人：王宏雨 | 华创医药团队： | | | --- | --- | | 首席分析师 郑辰 | 执业编号: S0360520110002 邮箱: zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号: S0360520120002 邮箱: liuhao@hcyjs.com | | 医疗器械组组长 李婵娟 | 执业编号: S0360520110004 邮箱: lichanjuan@hcyjs.com | | 中药和流通组组长 高初蕾 | 执业编号：S0360524070002 邮箱：gaochulei@hcyjs.com | | 分析师 王宏雨 | 执业编号: S0360523080006 邮箱: wanghongyu@hcyjs.com | | 分析师 朱珂琛 | 执业编号: S0360524070007 邮箱: zhukechen@hcyjs.com | 本报告由华创证券有限责任公司编制 报告仅供华创证券有限责任公 ...