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].

Core Viewpoint - Ganhua Hemei Pharmaceutical Co., Ltd. has submitted its prospectus to the Hong Kong Stock Exchange for an IPO, focusing on developing small molecule drugs for autoimmune diseases and tumors, despite not yet achieving profitability [1][4]. Company Overview - Established in 2002, Ganhua Hemei specializes in small molecule drugs targeting autoimmune diseases and tumors, with one approved product and several in clinical stages [1]. - The company has completed seven rounds of financing, with a recent valuation of 3.9 billion yuan [1][4]. Financial Performance - Ganhua Hemei reported cumulative net losses exceeding 350 million yuan from 2023 to the first half of 2025, primarily due to R&D expenditures [1][4]. - R&D expenses for 2023, 2024, and the first half of 2025 were 123 million yuan, 97 million yuan, and 53 million yuan, respectively, with core products accounting for 86.7% of total R&D spending [2]. - The company faces cash flow challenges, with negative net cash flows from operating activities of -141 million yuan, -91.25 million yuan, and -51.63 million yuan for the same periods [4]. Product Pipeline - Ganhua Hemei has seven small molecule drug candidates, with the first product, Mufemilast, expected to be approved for moderate to severe plaque psoriasis by September 2025 [2]. - Mufemilast is also undergoing clinical trials for other indications, including Behçet's disease and ankylosing spondylitis [2]. - Another product, Hemay022, focuses on late-stage breast cancer treatment and is currently in Phase III clinical trials, with plans for NDA submission in 2027 [3][4]. Market Context - In 2025, 23 biopharmaceutical companies have successfully listed on the Hong Kong Stock Exchange, indicating a favorable fundraising environment [5].

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]

Core Viewpoint - Ganzhou Hemei Pharmaceutical Co., Ltd. (Hemei Pharmaceutical) has submitted its application for listing on the Hong Kong Stock Exchange, with Guotou Securities International as its sole sponsor. The company has made significant efforts in identifying, developing, and commercializing biotechnology and other candidate drug products, validated by a strong track record in R&D, including the successful development of its core product Mufemilast, which has received NDA approval in China for the treatment of moderate to severe psoriasis [1][3]. Company Overview - Established in 2002, Hemei Pharmaceutical is a biopharmaceutical company focused on discovering and developing proprietary small molecule drugs for autoimmune diseases and tumors, with expertise in psoriasis (Ps), Behçet's disease (BD), and inflammatory bowel disease (IBD) [3]. - The company has developed a robust product pipeline consisting of seven small molecule candidates, including two core products, Mufemilast and Hemay022, targeting various unmet medical needs [3][4]. Product Details - Mufemilast is a proprietary small molecule PDE4B expression blocker and PDE4 inhibitor with broad therapeutic potential for autoimmune diseases. It has been approved for commercialization in China and is set to be launched for treating moderate to severe plaque psoriasis [3][4]. - Hemay022 is a class 1 small molecule inhibitor targeting both EGFR and HER2, currently undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer. The trial aims to evaluate the efficacy of Hemay022 in combination with aromatase inhibitors, with results expected to support an NDA submission to the Chinese National Medical Products Administration in 2027 [4][5]. Commercialization Strategy - Hemei Pharmaceutical plans to launch Mufemilast in China, with production facilities in Ganzhou. The commercialization strategy includes a dedicated team for marketing and sales, combining direct sales with partnerships with third-party contract sales organizations (CSOs) [6]. - The company aims to build a sales team of approximately 80-85 members within the first year of launch, focusing on 160-200 leading hospitals and key opinion leader institutions, with expansion goals set for 2026 and 2027 [6]. Financial Overview - For the fiscal year ending December 31, 2023, Hemei Pharmaceutical recorded other income of 4.05 million RMB, with projected other income of 5.298 million RMB for 2024 and 3.661 million RMB for the first half of 2025. This income primarily consists of government subsidies related to R&D activities [8]. - R&D expenditures are a core aspect of the company's operations, with expenses of 123.255 million RMB for 2023, 96.987 million RMB for 2024, and 52.597 million RMB for the first half of 2025. The company anticipates continued increases in R&D spending as it advances its clinical development [9]. - The company has not yet generated revenue from product sales, reporting net losses of 156.354 million RMB for 2023, 123.393 million RMB for 2024, and 72.641 million RMB for the first half of 2025, primarily due to R&D and administrative expenses [10]. Industry Overview - The global market for autoimmune disease drugs is projected to grow from $116.9 billion in 2019 to $143.1 billion by 2024, with a compound annual growth rate (CAGR) of 4.1%. It is expected to reach $179.5 billion by 2028 and $192.3 billion by 2032, with a CAGR of 5.8% from 2024 to 2028 [11]. - In China, the autoimmune disease drug market is expected to grow from $2.4 billion in 2019 to $4.6 billion by 2024, with a CAGR of 14.2%. Projections indicate it will reach $12.1 billion by 2028 and $26.3 billion by 2032, with a CAGR of 27.6% from 2024 to 2028 [11]. - The psoriasis drug market in China is anticipated to reach 18.2 billion RMB by 2024, with a CAGR of 30.5% from 2019 to 2024. It is estimated to grow to 48.3 billion RMB by 2028 and 87.1 billion RMB by 2032, with a CAGR of 27.6% from 2024 to 2028 [15].

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]

香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整 性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分內容而產生或因倚賴該等內容而引 致的任何損失承擔任何責任。 Ganzhou Hemay Pharmaceutical Co., Ltd. 贛州和美藥業股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 的申請版本 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證監 會」）的要求而刊發，僅用作提供資訊予香港公眾人士。 本申請版本為草擬本，其內所載資訊並不完整，亦可能會作出重大變動。 閣下閱覽本文件， 即代表 閣下知悉、接納並向贛州和美藥業股份有限公司（「本公司」）、其獨家保薦人、整體協 調人、顧問或承銷團成員表示同意： 倘於適當時候向香港公眾人士提出要約或邀請，有意投資者務請僅依據與香港公司註冊處處長 登記的本公司招股章程作出投資決定；招股章程的文本將於發售期內向公眾人士派發。 (a) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的。投資者不應根 據本文件中的資料作出任何投資決定； (b) 在聯 ...