Core Viewpoint - Huadong Medicine has received acceptance for the marketing authorization application of its innovative topical formulation Roflumilast Cream (ZORYVE) 0.3%, aimed at treating plaque psoriasis in patients aged 6 and above, which is expected to enhance the company's competitiveness in the autoimmune disease sector and provide breakthrough treatment options for psoriasis patients in China [1][4]. Market Opportunity - The active ingredient Roflumilast is a highly selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, approved by the FDA for treating various skin conditions, including plaque psoriasis, and is the first topical PDE4 inhibitor approved for this indication globally [2][3]. - The psoriasis market in China has shown significant growth, with the market size increasing from $604 million in 2018 to $1.436 billion in 2022, reflecting a compound annual growth rate (CAGR) of 24.2% [4]. - The Chinese psoriasis drug market is projected to reach ¥139 billion in 2023 and is expected to grow to ¥894 billion by 2032, with a CAGR of 59.1% [4]. Product Advantages - Roflumilast Cream demonstrates significant clinical advantages, including rapid onset of action, effective reduction of plaques, and significant relief from itching, while its unique HydroARQ technology enhances user comfort [2][3]. - The cream is non-hormonal, allowing for long-term use without restrictions, making it suitable for sensitive areas such as the face and underarms [2]. Company Strategy and Pipeline - Huadong Medicine is focusing on the autoimmune disease sector, which is experiencing rapid global growth, with the market expected to rise from $132.3 billion in 2022 to $176.7 billion by 2030 [5]. - The company has developed a diverse product pipeline in the autoimmune field, covering various conditions, and has over 20 innovative products in development [6]. - Huadong Medicine has established a "golden product combination" for psoriasis treatment, including monoclonal antibodies and both oral and topical formulations, aiming to provide comprehensive treatment options for patients [6]. Future Outlook - The acceptance of the Roflumilast Cream application marks the seventh marketing application milestone for Huadong Medicine in 2023, indicating a strong pipeline of innovative products [6]. - The company is expected to see multiple innovative drugs approved between 2025 and 2026, further solidifying its competitive position in the pharmaceutical market [9]. - Huadong Medicine aims to enhance its core competitiveness and market position by focusing on clinical needs and integrating global innovative resources [9].

Overview - The demand for Edaravone in China is driven by a large population of stroke patients, with sales peaking at 5.548 billion yuan in 2016 [1][8]. - The sales dropped significantly to 1.53 billion yuan by 2024 due to regulatory changes and market dynamics [1][9]. Development History - Edaravone was first approved in Japan in 2001 and introduced to China by Xiansheng Pharmaceutical in 2003 [3][4]. - The market demand grew rapidly from 2015 to 2018, establishing Edaravone as a key product in the neuropharmaceutical sector [3][5]. Market Dynamics - In 2019, Edaravone was included in the first batch of the National Key Monitoring Rational Drug Use Directory, leading to a decline in sales [4][5]. - The seventh batch of national drug procurement initiated in 2022 further impacted sales, with Edaravone being the only drug from the monitoring list to be included in the procurement [5][9]. Industry Chain - The upstream of the Edaravone industry includes raw materials, intermediates, packaging, and pharmaceutical equipment [6]. - The midstream consists of production companies, while the downstream includes hospitals and pharmacies, with hospitals being the primary distribution channel [7]. Market Background - Edaravone is primarily used for treating acute ischemic stroke, with its effectiveness linked to timely administration within 48 hours post-stroke [8]. - The aging population in China has led to an increase in stroke and other neurological disease incidences, with stroke patients reaching 27.461 million by 2024 [8]. Competitive Landscape - The Edaravone market in China is highly concentrated, with 54 approved products from 32 companies as of August 2025 [10]. - Xiansheng Pharmaceutical is the leading company, having launched the first Edaravone injection in China [10][11]. Company Profiles - Xiansheng Pharmaceutical reported a total revenue of 6.635 billion yuan in 2024, with a gross profit of 5.325 billion yuan and a gross margin of 80.25% [11]. - Jilin Boda Pharmaceutical, a key player, has a production capacity of 3 million 10ml and 2 million 20ml Edaravone injections annually, with a revenue of 733.38 million yuan in 2024 [12]. Future Trends - Innovations in Edaravone formulations are expected, including the development of oral tablets, which could enhance patient compliance [13]. - The expansion of insurance coverage and accelerated drug approvals are anticipated to increase market accessibility and demand, although cost control will be essential due to potential pricing pressures from insurance policies [13].

Group 1 - The core point of the article is that Huadong Medicine's new drug, Maihuatini tablets, is currently in the review stage for market approval and is expected to be approved by the end of this year if the review progresses smoothly [2] - The company is actively advancing the review process for Maihuatini tablets as per the procedures set by the National Medical Products Administration [2] - Other innovative drugs currently in the market review stage include Remabipine injection, the collaborative product IM19 CAR-T cell injection, modified new drug Edaravone tablets, and recombinant type A botulinum toxin for injection [2]

Summary of Huadong Medicine Conference Call Company Overview - **Company**: Huadong Medicine - **Industry**: Pharmaceutical Key Points and Arguments Business Strategy and Performance - Huadong Medicine focuses on maximizing efficiency rather than scale, which is reflected in its continuous growth in performance, particularly in the generic drug sales and innovation drug advancement [2][4] - The company's stock price is closely linked to its performance, recovering from a decline due to centralized procurement pressures since 2022, with a positive outlook for 2025 due to favorable policies and temporary procurement pauses in certain departments [2][7] Innovation and Product Pipeline - Significant progress has been made in the innovation drug sector, with a comprehensive pipeline established, particularly in oncology, autoimmune diseases, and metabolic disorders [3][11] - The company has a complete lineup in the endocrine metabolic field, including commercialized liraglutide and upcoming biosimilars of semaglutide, focusing on small molecule GLP-1 and dual-target/triple-target drugs in the weight loss market [2][19][25] Response to Market Challenges - Despite facing centralized procurement pressures, Huadong Medicine maintains a positive long-term growth outlook, especially with new products being launched and a strong sales capability in generics [5][10] - The company has effectively mitigated procurement pressures through a robust patent strategy, limiting competition in the short term [9] Financial Performance - The industrial segment has shown a return to double-digit growth since Q2 2022, indicating strong overall capabilities and resilience in traditional business areas [12] - The stock price has shown a recovery trend, with expectations for continued growth driven by performance recovery and favorable market conditions [7][40] Future Development Directions - The company’s future strategy focuses on four key areas: special raw materials (SRA), animal health, wellness, and medical aesthetics, with optimistic prospects in the medical aesthetics sector despite recent challenges [33][36] - The innovation drug sector is expected to see significant sales growth, with several products projected to reach over 1 billion in sales by 2025 [37] Collaborations and Acquisitions - Recent collaborations include projects in monoclonal antibodies and ADCs, enhancing the product line and market competitiveness [17][20] - The company has successfully introduced several products that complement existing treatments, indicating a strategic approach to expanding its portfolio [15] Market Position and Competitive Advantages - Huadong Medicine has established a strong competitive position in the autoimmune disease market through a diverse product range and differentiated capabilities in topical formulations [31] - The company’s diabetes treatment portfolio includes key drugs with annual sales exceeding 5 billion, showcasing its strong market presence [24] R&D and Management Changes - The R&D system has been restructured to enhance product development efficiency, led by experienced professionals from major pharmaceutical companies [13] - The company is actively pursuing innovative technologies such as ADCs and PROTACs, with several products entering clinical stages [22][38] Overall Market Outlook - The overall outlook for Huadong Medicine remains positive, with expectations for continued growth across various business segments, including pharmaceuticals and wellness products [8][34] - The company is well-positioned to leverage its strengths in innovation and market adaptability to drive future performance [40]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [4] Core Insights - The innovative drug sector has seen a significant increase in institutional interest, with the total heavy positions in Biotech innovative drugs reaching 80.371 billion yuan, a quarter-on-quarter growth of 39% [7][18] - The proportion of heavy positions in Biotech innovative drugs relative to the overall market has increased to 2.39%, up by 0.49 percentage points, indicating sustained enthusiasm from institutions towards the innovative drug sector [19][25] - The heavy positions in Biotech innovative drugs account for 24.93% of the total heavy positions in the pharmaceutical industry, reflecting a rise of 5.49 percentage points [19][25] Summary by Sections Weekly Review of New Drug Market - From July 28 to August 1, 2025, the top five companies in the new drug sector by stock price increase were: Zhongsheng Pharmaceutical (29.53%), WuXi AppTec (17.72%), CSPC Pharmaceutical Group (14.60%), Maiwei Biotech (12.08%), and Haizhi Pharmaceutical (11.76%) [14][15] - The top five companies by stock price decrease were: Kintor Pharmaceutical (-19.09%), Hualing Pharmaceutical (-16.19%), Junsheng Pharmaceutical (-13.24%), Kintor Pharma (-12.70%), and Yunding New Drug (-11.29%) [14][15] Key Analysis of New Drug Industry - The report analyzed the latest heavy positions of all funds in the innovative drug sector as of June 30, 2025, focusing on A-share and Hong Kong Biotech companies [18] - The heavy positions in Biotech innovative drugs accounted for 7.05% of the total market capitalization, an increase of 0.93 percentage points [23][28] New Drug Approval and Acceptance - This week, 13 new drug or new indication applications were approved, including drugs such as Risperidone orally disintegrating film and Nivolumab injection [33][34] - Additionally, 6 new drug or new indication applications were accepted, including drugs like Eptinezumab injection and Edaravone tablets [35][36] Clinical Application Approval and Acceptance - A total of 50 new drug clinical applications were approved this week, while 44 new drug clinical applications were accepted [37]

每经记者｜许立波 每经编辑｜魏官红 点评：最高人民法院驳回原告钟大放再审申请，意味着诺思格持续近两年的股权纠纷接近尘埃落定，尽 管公司称该诉讼案未对公司利润产生影响，但一定程度上对公司的外部声誉与投资者的信心造成了扰 动。 NO.3 华东医药：子公司依达拉奉片上市许可申请获受理 7月30日，华东医药公告称，公司全资子公司中美华东收到国家药品监督管理局签发的《受理通知 书》，由中美华东申报的依达拉奉片（研发代码：TTYP01）用于治疗急性缺血性脑卒中的上市许可申 请获得受理。依达拉奉是神经系统药物中的重磅品种，相对于院内给药14天的依达拉奉注射液，依达拉 奉口服片剂可以降低医药资源占用，适合患者自主长期给药。 点评：依达拉奉片如顺利获批上市，将进一步丰富华东医药心脑血管产品管线，在市场推广上有望与公 司现有产品形成有效协同。此外，尽管依达拉奉片为2.2类改良药，但剂型创新带来适应场景拓展，或 对原有注射剂市场形成部分替代，具备一定市场空间。 NO.4 南新制药：近期正筹划购买某一国内药品技术等资产组事项 丨 2025年7月31日 星期四 丨 NO.1 A股合成生物龙头华恒生物拟赴港上市 7月30日，华恒生物公告 ...

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a drug registration acceptance notice from the National Medical Products Administration (NMPA) for edaravone tablets, aimed at treating acute ischemic stroke [1][3]. Drug Information - Drug Name: Edaravone Tablets - Application: Domestic production drug registration and marketing license - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: To improve neurological symptoms and functional impairments caused by acute ischemic stroke (AIS) and enhance daily living capabilities [1]. R&D and Registration Status - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improving brain edema and tissue damage [3]. - The injectable form of edaravone has been approved in Japan and China for AIS treatment, but it requires intravenous administration, limiting patient compliance [3]. - The oral formulation, TTYP01, developed by Shanghai Aozong Biotechnology, is a modified new drug that allows for self-administration and room temperature storage, enhancing convenience and compliance [3][4]. - The clinical trial for TTYP01 was completed in June 2024, showing efficacy and safety comparable to the injectable form while improving patient adherence [3]. Impact on the Company - The approval of edaravone tablets is expected to enrich the company's cardiovascular product pipeline and create synergies with existing products [6]. - The drug is anticipated to meet the urgent clinical needs of stroke patients, potentially becoming a significant product in the treatment field [5][6]. - The company has invested approximately 100.81 million yuan in the development of edaravone tablets [5]. Future Considerations - Following the acceptance notice, the drug will undergo review by the NMPA's drug evaluation center, with the approval timeline and market competition remaining uncertain [6].

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a notice of acceptance from the National Medical Products Administration (NMPA) for the marketing authorization application of Edaravone Tablets, aimed at treating acute ischemic stroke (AIS) [1][2][3] Drug Information - Drug Name: Edaravone Tablets - Application Type: Domestic production drug registration and marketing authorization - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: Improvement of neurological symptoms and functional impairments caused by acute ischemic stroke, enhancing daily living capabilities [1] R&D and Registration Status - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improving brain edema and tissue damage while delaying neuronal death [1][2] - The oral tablet formulation (TTYP01) is a modified new drug that does not require professional medical personnel for administration, allowing for self-administration by patients and better storage conditions [2] - The clinical trial for TTYP01 was completed in June 2024, demonstrating efficacy and safety comparable to the injectable form while improving patient compliance [2][3] Impact on the Company - The approval of Edaravone Tablets is expected to enhance the company's cardiovascular product pipeline and create synergies with existing products [3] - The drug's unique oral formulation and extended treatment duration may address urgent clinical needs in stroke management, potentially positioning it as a significant player in the market [2][3] - The acceptance of the marketing authorization application is a critical milestone in the drug's development, although it will not have a significant immediate impact on the company's current performance [3]

Core Viewpoint - Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the Acceptance Notification from the National Medical Products Administration (NMPA) for the marketing authorization application of Edaravone Tablets (R&D code: TTYP01) for the treatment of acute ischemic stroke [1] Group 1 - The application for Edaravone Tablets has been officially accepted by the NMPA [1] - The acceptance of the application marks a significant step towards potential commercialization of the drug [1] - The drug is specifically aimed at treating acute ischemic stroke, indicating a focus on critical healthcare needs [1]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has received a notice of acceptance from the National Medical Products Administration for the marketing authorization application of Edaravone tablets for the treatment of acute ischemic stroke [1] Company Summary - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improve brain edema, tissue injury, and delay neuronal death [1] - The mechanism of Edaravone involves reacting with oxygen free radicals closely related to ischemic brain injury, providing protective effects against brain ischemic damage [1]