Core Viewpoint - The biopharmaceutical company Harmony Pharmaceuticals has submitted its prospectus to the Hong Kong Stock Exchange, aiming to address its financial pressures and advance its commercialization efforts for its drug pipeline, particularly Mufemilast, which is set to be approved in September 2025 [3][4]. Company Overview - Harmony Pharmaceuticals focuses on developing small molecule drugs for autoimmune diseases and tumors, with a pipeline that includes seven candidate drugs. However, only Mufemilast, aimed at treating moderate to severe plaque psoriasis, is expected to be approved by September 2025, while the others are still in clinical trials [4][12]. - The company has accumulated losses of 350 million yuan from 2023 to mid-2025 and has not yet achieved profitability due to the lack of product sales [4][18]. - Harmony Pharmaceuticals has raised a total of 950 million yuan through financing, with a post-E round valuation of 3.9 billion yuan [4][20]. Financial Situation - As of June 2025, the company has only 140 million yuan in cash and cash equivalents, with 77.94 million yuan in short-term debt, indicating a tight liquidity situation [20][22]. - The company has incurred significant R&D expenses, totaling 270 million yuan from 2023 to mid-2025, with 167 million yuan allocated to Mufemilast [18][19]. Ownership Structure - The majority of shares are held by founder Zhang Hesheng and his family, controlling approximately 46.51% of the voting rights. This includes Zhang's direct and indirect holdings through various entities [6][7]. - The company has established an employee stock ownership plan, but the majority of shares are concentrated among family members, raising concerns about talent retention and employee motivation [10][11]. Product Pipeline and Market Strategy - Mufemilast is positioned as a dual-action drug with a unique mechanism, but it faces competition from 17 other approved psoriasis treatments in China, including both small molecules and biologics [12][16]. - The company plans to set the annual treatment cost for Mufemilast between 52,700 and 119,900 yuan, which is higher than some competitors but lower than others, indicating a differentiated pricing strategy [16][22]. - Hemay022, another core product for treating advanced breast cancer, is currently in Phase III clinical trials, but patient recruitment has been slower than expected due to competition in the oncology space [17][22]. IPO and Future Prospects - The upcoming IPO is seen as a critical step for Harmony Pharmaceuticals to alleviate its financial constraints and support the commercialization of Mufemilast and the advancement of its pipeline [22][23]. - The company faces challenges in attracting talent and maintaining team stability due to its family-centric ownership and incentive structure, which may impact its long-term innovation capabilities [22][23].

Core Viewpoint - He Mei Pharmaceutical has submitted a prospectus to the Hong Kong Stock Exchange after the approval of its first new drug, Mufemilast, but faces significant challenges due to weak clinical data compared to competitors and limited market potential [1][2][11]. Company Overview - He Mei Pharmaceutical, established in 2002, focuses on discovering and developing small molecule drugs for autoimmune diseases and tumors [1][11]. - The company has completed several rounds of financing, with a post-investment valuation of 3.9 billion yuan after the E round [1][11]. Financial Performance - The company has not yet commercialized any products and has consistently reported losses, with projected losses of 156 million yuan, 123 million yuan, and 73 million yuan for 2023, 2024, and the first half of 2025, respectively [2][11]. - Cash reserves as of June 30, 2025, are approximately 73 million yuan, which may not sustain operations for a year based on historical cash usage [2][11]. Product Pipeline - He Mei Pharmaceutical has developed seven small molecule candidates, including Mufemilast, which has been approved for treating moderate to severe plaque psoriasis [2][11]. - Mufemilast's clinical efficacy data is significantly lower than that of comparable competitors, with PASI-75 and PASI-90 scores of 53.6% and 32.5% at week 16, respectively [4][14]. Competitive Landscape - The psoriasis treatment market is highly competitive, with 18 approved targeted drugs, including 13 biologics, and several others in clinical development [4][13]. - Mufemilast faces competition from established products with better clinical data and lower prices, which may limit its market entry and profitability [15][11]. Market Challenges - The pricing of psoriasis drugs has been significantly reduced due to national health insurance negotiations, putting pressure on Mufemilast's pricing and profit margins [15][11]. - The market for He Mei Pharmaceutical's unique indication for Mufemilast, treating Behçet's disease, is limited due to the low prevalence of the disease [10][18]. Additional Product Insights - Hemay022, another candidate for treating advanced breast cancer, is in phase III trials but targets a small patient population, which may limit its commercial potential [7][16]. - Clinical data for Hemay022 shows an objective response rate of 29.1% and a median progression-free survival (mPFS) of 9.0 months, which is lower than competitors [9][18].

Company Overview - Hemay Pharmaceutical Co., Ltd. (referred to as "Hemay") submitted its second prospectus to the Hong Kong Stock Exchange on December 1, 2025, aiming for a main board listing, with Guotai Junan Securities as the sole sponsor [1] - Established in 2002, Hemay focuses on the discovery and development of proprietary small molecule drugs for autoimmune diseases and tumors, maintaining a leading position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [1] Financial Performance - For the fiscal year ending December 31, 2024, Hemay reported other income of approximately RMB 0.05 billion and a net loss of RMB 1.23 billion, with a 20% year-on-year increase in net loss for the first half of 2025 [1][6] - In the first half of 2025, other income was RMB 0.04 billion, with a net loss of RMB 0.73 billion, reflecting a 26.93% year-on-year increase in net loss [7] - The company’s cash flow from operating activities was -RMB 0.52 billion as of June 30, 2025, with cash reserves of approximately RMB 0.73 billion at year-end [7] Product Pipeline - Hemay has developed seven small molecule drug candidates, including its core product Mufemilast, which has received NDA approval in China for the treatment of moderate to severe plaque psoriasis [2] - Hemay022, another candidate, is undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer [3] - Mufemilast is also being evaluated for Behçet's disease in a pivotal Phase III trial and has received orphan drug designation from the FDA [2] Market Potential - The psoriasis drug market in China is projected to reach RMB 18.2 billion by 2024, with a compound annual growth rate (CAGR) of 30.5% from 2019 to 2024, and is expected to grow to RMB 48.3 billion by 2028 [8] - The market for Behçet's disease drugs in China is anticipated to grow from RMB 490 million in 2019 to RMB 666.6 million by 2024, with a CAGR of 6.4% [12] Competitive Landscape - As of the latest data, there are 17 approved targeted therapies for psoriasis in China, including five small molecule drugs and twelve biologics, with some showing superior efficacy in head-to-head clinical trials [11] - Hemay's Mufemilast is positioned against established treatments like Apremilast, which has been recommended in clinical guidelines for Behçet's disease [15] Comparable Companies - Hemay's peer in the industry, Qianxin Biopharmaceutical-B (2509.HK), had an IPO on March 20, 2024, with a market capitalization of approximately HKD 4.397 billion [16]

Core Viewpoint - Ganzhou Hemei Pharmaceutical Co., Ltd. plans to go public on the Hong Kong Stock Exchange, focusing on the development of small molecule drugs for autoimmune diseases and tumors, with a product pipeline that includes seven candidates [1][3]. Company Overview - Founded by Dr. Zhang Hesheng in 2002, Hemei Pharmaceutical has evolved from a laboratory in Tianjin to a company with a comprehensive drug development system, including drug discovery, clinical development, and manufacturing [3][4]. - The company has undergone several transformations, including a name change in 2019 and a restructuring in 2023 to prepare for its IPO [3][4]. Product Pipeline - Hemei Pharmaceutical has developed a pipeline of seven small molecule candidates, including three for autoimmune diseases and four for tumors [1][11]. - The core product, Mufemilast, received approval from the National Medical Products Administration (NMPA) in September 2025 for the treatment of plaque psoriasis, marking it as the first domestic PDE4 inhibitor [1][11]. Funding and Financials - The company plans to use the funds raised from the IPO for the commercialization of Mufemilast, development of other key products, and general operational expenses [1][15]. - Hemei Pharmaceutical has completed seven rounds of financing, with a valuation of 3.9 billion yuan after the latest round [4][15]. - Despite the recent approval of Mufemilast, the company reported net losses of 156 million yuan, 123 million yuan, and 73 million yuan for 2023, 2024, and the first half of 2025, respectively [15][16]. Market Context - The psoriasis drug market in China is projected to reach 18.2 billion yuan in 2024, with a compound annual growth rate (CAGR) of 30.5% from 2019 to 2024 [11][12]. - However, the market is competitive, with 17 approved targeted therapies already available, including drugs with similar mechanisms to Mufemilast [12][13]. Strategic Positioning - Mufemilast's differentiation lies in its broader action range compared to single-cell factor-targeting biologics and its oral administration route, which enhances patient compliance [13][14]. - The company plans to establish a dedicated sales team to promote Mufemilast in major hospitals, focusing on rheumatology and oncology departments [13][14]. Research and Development - Hemei Pharmaceutical has established a comprehensive technology system for drug development, including platforms for pharmacological targeting, biomarker screening, and differentiated clinical design [7][9]. - The company has received significant support from local government initiatives aimed at fostering innovative pharmaceutical enterprises [15][16].

不过，记者注意到，Hemay022在III期临床试验中的患者入组速度低于预期，这主要是因为乳腺癌治疗 领域的患者招募竞争较为激烈。和美药业计划于2026年在中国完成III期临床试验，2027年提交NDA申 请（上市注册申请）。 E轮融资后估值39亿元 日前，总部位于江西赣州的赣州和美药业股份有限公司（以下简称和美药业）正式向港交所递交招股 书，拟在香港主板挂牌上市，国投证券融资（香港）有限公司担任独家保荐人。 《每日经济新闻》记者查询招股书获悉，和美药业成立于2002年，专注研发针对自身免疫性疾病和肿瘤 的小分子药物，目前已有一款已获批准的产品及多款进入临床阶段的管线药物。 不过，和美药业暂未实现盈利。招股书显示，和美药业2023年至2025年上半年累计净亏损超3.5亿元， 研发支出为主要支出。目前已完成7轮融资，最近一轮融资后估值为39亿元。 管线产品涵盖7个小分子候选药物 截至2025年6月30日，和美药业研发及临床试验团队共124人，核心研发人员由四名成员组成，涵盖化 学、生物学、药理学和医学领域。2023年至2025年上半年，和美药业研发开支分别为1.23亿元、0.97亿 元、0.53亿元，核心产品合 ...

Company Overview - He Mei Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Guotou Securities International as the sole sponsor [1] - The company focuses on the discovery and development of proprietary small molecule drugs targeting autoimmune diseases and tumors, with a pipeline of seven small molecule candidates [1] Core Products - The core product Mufemilast is a self-developed PDE4B expression blocker and PDE4 inhibitor, approved for new drug application (NDA) in September 2025 for the treatment of moderate to severe plaque psoriasis [1] - The second core product Hemay022 is a globally owned Class 1 small molecule inhibitor targeting both EGFR and HER2, with a Phase III clinical trial for advanced ER+/HER2+ breast cancer planned for NDA submission in 2027 [1] Technology and Market Potential - The company has established a comprehensive technical system covering the entire process of small molecule drug development, including modular compound library construction, biomarker animal model screening, tumor microenvironment activation combination chemotherapy design, and differentiated clinical design [2] - The global and Chinese autoimmune disease drug markets are showing significant growth trends, with the Chinese autoimmune disease drug market expected to reach USD 26.3 billion by 2032, and the psoriasis drug market projected to reach RMB 87.1 billion by 2032 [2]

智通财经APP获悉，据港交所12月1日披露，赣州和美药业股份有限公司(简称：和美药业)递表港交所主 板，国投证券国际为其独家保荐人。和美药业在识别、开发和商业化生物技术及其他候选药剂制品方面 做出了重大努力。其综合研发能力通过成功的往绩记录得到了验证，包括成功开发核心产品 Mufemilast，该药物已于中国获得NDA批准用于治疗中重度Ps。截至最后实际可行日期，公司已经开发 出一条由七种候选药物组成的强大产品管线。 招股书显示，和美药业成立于2002年，是一家生物制药公司，致力于发现和开发针对自身免疫性疾病和 肿瘤的自主研发小分子药物，并在Ps、BD和IBD和化学疗法开发方面拥有成熟的专业知识。 截至最后实际可行日期，和美药业已经开发包含七个小分子候选药物的产品管线(包括两种核心产品 Mufemilast及Hemay022)，涵盖多种具有未满足医疗需求的适应症。其中包括三个自身免疫候选药物和 四个肿瘤候选药物。 Mufemilast是一种自主研发的小分子PDE4B表达阻断剂和PDE4抑制剂，具有广泛的自身免疫性疾病治 疗潜力。根据弗若斯特沙利文，Mufemilast是一种具有双重作用机制的全球药物。Mufe ...

Core Insights - He Mei Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with Guotou Securities International as the sole sponsor [1] - The company, established in 2002, focuses on discovering and developing proprietary small molecule drugs for autoimmune diseases and tumors [1] - The product pipeline includes seven small molecule candidates, with two core products, Mufemilast and Hemay022, and Mufemilast has received NDA approval in China [1] Company Capabilities - He Mei Pharmaceutical has established a comprehensive technical system covering the entire process of small molecule drug development, from early research to industrialization [4] - The system includes a modular compound library construction platform focused on various pharmacological targets, an animal model screening platform driven by pathogen-related biomarkers for efficient candidate drug evaluation, a tumor microenvironment-activated combination chemotherapy drug design platform, and a differentiated clinical design platform to support effective clinical trials [4] - These capabilities enable the company to continuously advance its product pipeline and bring therapies to market to meet medical needs in China and other regions [4]

Core Insights - He Mei Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with Guotou Securities International as the sole sponsor [1] - Established in 2002, the company focuses on discovering and developing proprietary small molecule drugs for autoimmune diseases and tumors [1] - The company's pipeline includes seven small molecule candidates, with two core products, Mufemilast and Hemay022, and Mufemilast has received NDA approval in China [1] Company Capabilities - He Mei Pharmaceutical has developed a comprehensive technical system covering the entire process of small molecule drug development, from early research to industrialization [3] - The system includes a modular compound library construction platform focused on various pharmacological targets, a pathogen-driven biomarker animal model screening platform for efficient candidate drug evaluation, a tumor microenvironment-activated substructure combination chemotherapy drug design platform, and a differentiated clinical design platform to support effective clinical trials [3] - These capabilities enable the company to continuously advance its product pipeline and bring therapies to market to meet medical needs in China and other regions [3]

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Ganzhou Hemay Pharmaceutical Co., Ltd. 贛州和美藥業股份有限公司 (A joint stock company incorporated in the People's Republic of ...