2025 年 12 月 09 日 晨会纪要 研究所： 证券分析师： 余春生 S0350513090001 yucs@ghzq.com.cn 证券研究报告 [Table_Title] 晨会纪要 ——2025 年第 209 期 观点精粹: 最新报告摘要 辛醇、硫酸价格上涨，关注反内卷和铬盐--行业周报 业绩稳定增长，后续管线丰富--华东医药/化学制药(000963/213701) 公司点评 超长债企稳了吗？--债券研究周报 隆培素上市在即，期待 TransCon 技术长效生长激素商业化空间--行业周报 固收买卖方怎么看待当前债市点位的配置价值？--债券研究周报 去产能迎来加速阶段，布局生猪底部--行业周报 节奏为先，革新求变——2026 年可转债年度策略--策略 PPT 1、最新报告摘要 1.1、辛醇、硫酸价格上涨，关注反内卷和铬盐--行业周报 分析师：李永磊 S0350521080004 分析师：董伯骏 S0350521080009 联系人：于畅 S0350124080008 2025 年 12 月 4 日，国海化工景气指数为 91.81，较 11 月 27 日上升 0.45。 投资建议： 日本首相高市早苗近期 ...

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The report emphasizes the importance of seizing opportunities following market corrections, particularly in anticipation of improvements in 2026. It notes that the pharmaceutical sector's fundamentals remain strong despite recent market fluctuations, and it is currently at a valuation bottom. The report suggests focusing on innovative drugs and companies with potential for operational improvements in 2025 [7][11]. Summary by Sections Industry Overview - The pharmaceutical sector consists of 498 listed companies with a total market capitalization of approximately 70,594.11 billion [2]. - The sector has experienced a decline of 6.88% recently, with various sub-sectors such as pharmaceutical commerce and biopharmaceuticals also facing downturns [11]. Market Dynamics - The report highlights a significant market correction, with the Shanghai Composite Index down by 3.77% and the pharmaceutical sector underperforming [11]. - It notes that the overall performance of the pharmaceutical sector has been positive since the beginning of the year, with a return of 13.69%, slightly outperforming the broader market [18]. Investment Opportunities - The report identifies key companies to watch, including: - CDMO leaders: WuXi AppTec, WuXi Biologics, and WuXi AppTec [11]. - Front-end CROs: Tigermed, ProPhase, and Zhaoyan New Drug [11]. - Medical devices: United Imaging Healthcare and HaiTai New Light [11]. - Biopharmaceuticals: I-Mab Biopharma and Hualan Biological Engineering [11]. - It also suggests focusing on companies with innovative drug pipelines and those that are transitioning from biotech to biopharma [11]. Company Performance - The report provides a list of recommended stocks, including: - WuXi AppTec (66.45), rated "Buy" - Three Life Pharmaceuticals (29.34), rated "Buy" - Tigermed (49.59), rated "Buy" - Xiansheng Pharmaceutical (12.85), rated "Buy" - Betta Pharmaceuticals (48.60), rated "Buy" [5][31]. Regulatory and Market Trends - The report discusses recent regulatory developments, including a call from the vaccine industry association to avoid low-cost bidding practices to stabilize profit margins for leading vaccine companies [11][12]. - It also notes significant acquisitions and advancements in drug development, such as Johnson & Johnson's acquisition of Halda Therapeutics for $30.5 billion [11].

Core Viewpoint - The announcement highlights that Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for the conversion of the conditional approval of the drug Mirvetuximab Soravtansine Injection (ELAHERE) to regular approval, marking a significant milestone in the drug's development process [1][4][9]. Drug Information - The drug is known as Mirvetuximab Soravtansine Injection, with a specification of 100 mg (20 mL) per bottle, and is classified as a Class 3.1 therapeutic biological product [1][5]. - It is indicated for adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy and are positive for folate receptor alpha (FRα) [1][4]. Development and Approval History - The drug was developed in collaboration with ImmunoGen, Inc., which is now acquired by AbbVie, and is the first and only approved antibody-drug conjugate (ADC) targeting FRα for treating platinum-resistant ovarian cancer in China, the U.S., and the EU [5][6]. - The drug received accelerated approval from the U.S. FDA in November 2022 and full approval in March 2024, with subsequent approvals in the EU in November 2024 [6][7]. Clinical Trial Results - The approval for the regular application was based on the results of the Phase III clinical trial MIRASOL, which demonstrated a 35% reduction in the risk of tumor progression or death (HR 0.65, p<0.0001) and a 33% reduction in the risk of death (HR 0.67, p=0.0046) compared to the control group [7]. - The trial also indicated that the treatment group experienced fewer severe adverse events and lower rates of treatment discontinuation [7]. Market Performance and Sales - The drug has been actively marketed in China, with sales exceeding 45 million yuan from January to September 2025, and it has been successfully launched in several hospitals [8][9]. - AbbVie reported global net revenue of $508 million for ELAHERE in the first three quarters of 2025, with $453 million coming from the U.S. market [8].

Core Viewpoint - The approval of the supplemental application for the drug Somatuzumab injection (brand name: ELAHERE) marks a significant milestone in the product's development process for the company [1] Company Summary - The company's wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the approval notice from the National Medical Products Administration for the supplemental application of Somatuzumab injection [1] - The company plans to actively promote the commercialization of ELAHERE in the Chinese market, aiming to provide better clinical treatment options for relevant patients [1]

Core Viewpoint - Huadong Medicine's subsidiary, Sino-American Huadong, received approval from the National Medical Products Administration (NMPA) for the supplemental application of Somatuzumab Injection, transitioning from conditional approval to regular approval [1] Group 1: Company Developments - The approved drug, Somatuzumab Injection (brand name: ELAHERE, R&D code: HDM2002), is indicated for adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy and are positive for folate receptor alpha (FRα) [1]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the supplemental application of the drug Somatuzumab Injection, transitioning from conditional approval to regular approval [1] Group 1 - The drug Somatuzumab Injection is marketed under the name ELAHERE® with the research code HDM2002 [1] - The approval signifies a significant regulatory milestone for Huadong Medicine, enhancing its product portfolio and market position [1]

Core Viewpoint - Huadong Medicine's subsidiary, Sino-American Huadong, received approval from NMPA for the conversion of the conditional approval of Somatuzumab injection to regular approval, applicable for specific ovarian cancer patients [1] Group 1: Product Approval - The product is an ADC innovative drug developed in collaboration with ImmunoGen, with Huadong Medicine holding exclusive rights in Greater China [1] - The approval was based on the results of a confirmatory Phase III clinical trial, and the product is already available in multiple locations [1] Group 2: Financial Performance - In the first three quarters of 2025, ELAHERE achieved sales revenue exceeding 45 million yuan, with global net revenue of 508 million USD [1] - The approval is expected to positively impact the company's future performance, although sales are influenced by various factors, leading to uncertainty [1]

Policy Developments - The National Medical Insurance Administration has initiated a pilot program for intelligent review of the entire process of medical insurance management, aiming to enhance the review capabilities and ensure the sustainable operation of medical insurance funds through the integration of AI technology [2]. Industry Developments - Chongqing has introduced measures to support high-quality development of innovative drugs, emphasizing the role of artificial intelligence in drug innovation and the establishment of a public service platform for "AI + pharmaceuticals" [3][4]. - Shanghai Pharmaceuticals has received FDA approval for its clopidogrel tablets, which are expected to generate approximately $1.284 billion in sales in the U.S. market in 2024, marking a significant opportunity for the company to expand its overseas market presence [6]. - NuoVation has obtained two medical device registration certificates for adenovirus antigen test kits, which are classified as Class III medical devices, indicating a step forward in the company's product offerings [7]. - Renfu Pharmaceutical has received approval for clinical trials of its HWH217 tablets, aimed at treating pulmonary arterial hypertension, with a total R&D investment of approximately 6 million yuan [8]. Capital Market - Pulsecare has successfully completed a financing round of over 100 million yuan, indicating strong investor interest in cardiovascular treatment technologies [10]. - Sunshine Nuohua has completed a share purchase plan by its associated company, acquiring 612,638 shares, which represents 0.55% of the total share capital, with an investment exceeding 28 million yuan [11]. Major Industry Events - The first batch of ovarian cancer treatment drugs has cleared customs in Beijing, marking a significant step in ensuring nationwide supply for this new treatment [13]. - Research from the Beijing Brain Science and Brain-like Research Institute has identified a new mechanism for treating depression, which could lead to the development of new antidepressant strategies with fewer side effects [14]. Regulatory Updates - Asia-Pacific Pharmaceutical has received a notification that its application for the consistency evaluation of diltiazem hydrochloride tablets has been rejected due to insufficient evidence supporting bioequivalence, indicating challenges in the drug development process [16].

Core Insights - The national medical insurance negotiation for 2025 has introduced a dual-directory system, marking a significant change in the negotiation process for innovative drugs and commercial insurance [1][2][15] - The negotiation process for innovative drugs has seen a price reduction range suggested by the National Medical Insurance Administration (NMIA) of 15% to 50%, with a focus on the CAR-T drugs [3][4] - The introduction of the innovative drug directory is expected to create a more sustainable market payment mechanism for new drugs, with companies needing to reassess their product positioning and market strategies [15] Summary by Sections National Medical Insurance Negotiation - The negotiation took place from October 30 to November 3, 2025, with the first three days dedicated to the national medical insurance directory and the last two days for the commercial insurance innovative drug directory [1] - This year marks the first introduction of an innovative drug directory, which has altered the negotiation dynamics for drug pricing [1][15] Price Negotiation Mechanism - The NMIA has introduced a new price negotiation mechanism for innovative drugs, allowing for price discussions between drug companies and commercial insurance [1][3] - Companies have been advised to consider a price reduction of 15% to 50% during negotiations, with some expressing skepticism about achieving reductions below 15% [3][4] CAR-T Drugs - CAR-T drugs have been a focal point in the negotiations, with successful negotiations reported for some products, such as the CAR-T drug from HeYuan Biotech priced at 999,000 yuan [3][4] - A limited number of CAR-T drugs are expected to be included in the innovative drug directory, with estimates suggesting around 20 drugs may be approved [1][3] Commercial Insurance Dynamics - The dual-directory negotiation allows companies to choose between reporting to the basic medical insurance directory, the innovative drug directory, or both, creating strategic options for different companies [2][10] - The commercial insurance market has shown limited interest in covering rare disease drugs due to their high costs and small patient populations, which may affect their inclusion in the innovative drug directory [14][15] Focus on ADC and Bispecific Antibodies - ADC (Antibody-Drug Conjugates) and bispecific antibodies remain key focus areas in the negotiations, with several innovative drugs vying for inclusion in the directories [8][10] - Companies are adopting varied strategies based on their market positioning, with some prioritizing the basic medical insurance directory for broader market access, while others focus on maintaining high-end product positioning through the innovative drug directory [10][11]

Core Insights - The company reported steady revenue and profit growth for the first three quarters of 2025, with total revenue reaching 32.664 billion yuan, a year-on-year increase of 3.77%, and net profit attributable to shareholders of 2.748 billion yuan, up 7.24% [1] - Significant investment in R&D was noted, with expenditures rising to 2.186 billion yuan, a 35.99% increase, indicating a strong commitment to innovation [1] - The company’s innovative products are increasingly contributing to revenue, with sales from innovative products reaching 1.675 billion yuan, a substantial growth of 62% year-on-year [2] Financial Performance - For the first nine months of 2025, the pharmaceutical industrial segment achieved revenue of 11.045 billion yuan, a growth of 11.10%, and net profit of 2.475 billion yuan, up 15.62% [2] - In Q3 2025, the segment reported revenue of 3.728 billion yuan, a 14.95% increase, and net profit of 894 million yuan, an 18.43% rise [2] - The company maintained a resilient operational performance despite increased R&D investments, with quarterly revenue and profit showing a consistent upward trend [1] Product Development and Innovation - The company has made significant advancements in its core therapeutic areas, including endocrine, oncology, and autoimmune diseases, with over 90 innovative drug pipeline projects underway [4] - The ADC drug pipeline has shown promising progress, with several candidates receiving IND approvals in both China and the U.S. [5] - The company is preparing for negotiations regarding national medical insurance and commercial insurance for three innovative products, aiming to enhance drug accessibility and drive sales growth [3] Market Position and Strategy - The company has established a strong market presence with its CAR-T product, achieving significant order volumes that exceed previous year's totals [2] - The company’s innovative drug candidates are positioned to address various conditions, including diabetes and cancer, with several products nearing market entry [6][7] - The industrial microbiology segment has also shown robust growth, with a 28.48% increase in revenue, indicating a diversified growth strategy [9] Future Outlook - The company aims to continue its focus on research-driven, patient-centered approaches to foster sustainable high-quality growth [11] - The medical aesthetics business is expected to enhance its brand effect and core competitiveness through a global product matrix [10] - The ongoing development of innovative products and the expansion of market access are anticipated to provide solid momentum for future performance [11]