Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for nine companies, including Hemei Pharmaceutical, which is seeking to list on the Hong Kong Stock Exchange. The CSRC is requesting detailed explanations regarding the company's previous A-share listing guidance and its future plans for A-share listing [1][2]. Group 1 - The CSRC has requested Hemei Pharmaceutical to clarify its previous A-share listing guidance and whether it plans to continue with the A-share listing, including any significant impacts on the current listing process [1][2]. - Hemei Pharmaceutical was established in 2002 and is an innovative biopharmaceutical company focused on discovering and developing 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 [2]. - As of May 21, 2025, Hemei Pharmaceutical has developed seven small molecule drug candidates targeting high unmet needs in autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages for twelve indications [2]. Group 2 - Hemei Pharmaceutical's core product, Mufemilast, is a novel small molecule phosphodiesterase 4B (PDE4B) protein expression blocker and PDE4 inhibitor, showing potential for treating a wide range of autoimmune diseases. According to Frost & Sullivan, Mufemilast may be a first-in-class drug with dual mechanisms of action [2].

Group 1 - The China Securities Regulatory Commission (CSRC) issued supplementary material requirements for nine companies, including Hemei Pharmaceutical, regarding their overseas listing applications [1][2] - Hemei Pharmaceutical is required to clarify its previous A-share listing guidance, plans for continuing the A-share listing process, and any significant impacts on its current listing [1][2] - The company was established in 2002 and focuses on discovering and developing small molecule drugs for autoimmune diseases and tumors, positioning itself at the forefront of the industry [2] Group 2 - As of May 21, 2025, Hemei Pharmaceutical has developed seven small molecule drug candidates targeting unmet needs in autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages for twelve indications [2] - The core product, Mufemilast, is a novel small molecule PDE4B protein expression blocker and PDE4 inhibitor, showing potential for treating a wide range of autoimmune diseases [2] - According to Frost & Sullivan, Mufemilast may be a first-in-class drug with dual mechanisms of action, blocking PDE4B protein expression and inhibiting PDE4 activity [2]

Group 1 - The China Securities Regulatory Commission (CSRC) issued supplementary material requirements for nine companies, including Hemei Pharmaceutical, regarding their overseas listing applications [1] - Hemei Pharmaceutical is required to clarify its previous A-share listing guidance and whether it plans to continue with the A-share listing process [1] - The company was founded in 2002 and focuses on discovering and developing small molecule drugs for autoimmune diseases and tumors, positioning itself at the forefront of the industry [2] Group 2 - As of May 21, 2025, Hemei Pharmaceutical has developed seven small molecule drug candidates targeting unmet needs in autoimmune and tumor diseases, with four candidates in clinical trials or NDA stages for twelve indications [2] - The core product, Mufemilast, is a novel small molecule PDE4B protein expression blocker and PDE4 inhibitor, showing potential for treating a wide range of autoimmune diseases [2] - According to Frost & Sullivan, Mufemilast may be a first-in-class drug with dual mechanisms of action, blocking PDE4B protein expression and inhibiting PDE4 activity [2]

Core Viewpoint - The rising public awareness of autoimmune diseases, particularly ankylosing spondylitis, has led to increased interest in the pharmaceutical sector, with Ganzhou Hemei Pharmaceutical Co., Ltd. filing for an IPO on the Hong Kong Stock Exchange to commercialize its drug Mufemilast, which targets conditions like psoriasis and ankylosing spondylitis [1][6] Company Overview - Hemei Pharmaceutical is a biopharmaceutical company planning to list under the Hong Kong Stock Exchange's 18A rules, characterized by high investment and potential [2] - The company has not yet generated revenue and relies on government subsidies and continuous financing to sustain operations [2][9] - Hemei Pharmaceutical has seven clinical-stage small molecule candidates focused on unmet medical needs in autoimmune diseases and oncology [2] Product Pipeline - Mufemilast is a novel small molecule drug that acts as a dual mechanism PDE4 inhibitor, aiming to reduce side effects associated with traditional PDE4 inhibitors [2][3] - The drug targets eight major indications, including psoriasis, Behçet's disease, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, chronic obstructive pulmonary disease, and Crohn's disease [3] - The psoriasis market in China has seen rapid growth, with a compound annual growth rate (CAGR) of 30.4% from 2019 to 2023, reaching a market size of 13.9 billion yuan in 2023, projected to soar to 89.4 billion yuan by 2032 [3] Competitive Landscape - The market for Mufemilast is highly competitive, with significant price reductions observed in similar drugs due to national procurement policies, such as a 93.6% price drop for Aplomast tablets [4][5] - There are currently five approved small molecule targeted therapies for psoriasis in China, with 37 more in clinical development, indicating a crowded market [4][5] - Mufemilast's commercial success will depend on its ability to navigate this competitive environment and demonstrate efficacy [5] Financial Status - Hemei Pharmaceutical has not yet commercialized any products, with reported losses of 156 million yuan and 123 million yuan for 2023 and 2024, respectively [9] - The company has relied heavily on financing, raising over 500 million yuan through multiple funding rounds since 2021, with a post-investment valuation of 3.9 billion yuan [9] - Research and development expenses constitute a significant portion of the company's expenditures, with 123 million yuan and 97 million yuan spent in 2023 and 2024, respectively [9] Leadership - The company is led by Zhang Hesheng, who holds approximately 46.51% of the voting rights and has over 20 years of experience in the biopharmaceutical industry [10]

Core Viewpoint - The rising public awareness of autoimmune diseases, particularly ankylosing spondylitis, has led to increased interest in the pharmaceutical company Ganzhou Hemei Pharmaceutical Co., Ltd. as it seeks to go public with its core drug Mufemilast targeting psoriasis and ankylosing spondylitis [1][6]. Company Overview - Ganzhou Hemei Pharmaceutical is preparing for an IPO under the Hong Kong Stock Exchange's 18A biotechnology rules, focusing on high investment and potential returns typical of biopharmaceutical companies [2]. - The company has not yet generated revenue and relies heavily on government subsidies and continuous financing to sustain operations [2][11]. Product Pipeline - The company has seven clinical-stage small molecule candidates aimed at addressing unmet medical needs in autoimmune diseases and oncology [2]. - Mufemilast is a dual-action PDE4 inhibitor that has entered the NDA priority review process, targeting multiple indications including psoriasis and ankylosing spondylitis [2][3]. Market Potential - The market for psoriasis drugs in China has seen rapid growth, with a compound annual growth rate (CAGR) of 30.4% from 2019 to 2023, reaching a market size of 13.9 billion yuan in 2023, projected to soar to 89.4 billion yuan by 2032 [3]. - The autoimmune disease drug market in China has expanded from $2.5 billion in 2019 to $4 billion in 2023, with expectations to reach $26.3 billion by 2032, reflecting a CAGR of 23.3% [6]. Competitive Landscape - The competitive environment for Mufemilast is intense, with existing competitors having undergone significant price reductions due to national procurement policies, with price drops exceeding 93% for some products [5]. - There are currently five approved small molecule targeted therapies for psoriasis in China, with 37 more in clinical development, indicating a crowded market for Mufemilast [5][8]. Financial Status - The company reported significant losses of 156 million yuan in 2023 and 123 million yuan in 2024, with minimal other income [11]. - The company has undergone multiple rounds of financing since 2021, raising over 500 million yuan to support its operations, with a post-investment valuation of 3.9 billion yuan [11]. Leadership - The founder and chairman, Zhang Hesheng, has over 20 years of experience in biopharmaceuticals and holds a significant voting power in the company [12].

Core Viewpoint - Ganfeng Pharmaceutical Co., Ltd. (referred to as "Ganfeng Pharma") has submitted a main board listing application to the Hong Kong Stock Exchange, seeking new funding avenues for its ongoing losses in research and development [1][4]. Financial Performance - Ganfeng Pharma reported losses of 156 million RMB and 123 million RMB for the years 2023 and 2024, respectively [3][4]. - The company has a net current asset value of only 4.5 million RMB by the end of 2024, with current liabilities reaching 25.5 million RMB by March 2025 [1][4]. - Cash flow remains negative, with net cash used in operating activities amounting to 141 million RMB and 91.3 million RMB for 2023 and 2024, respectively [4][5]. - The company has raised approximately 951 million RMB through multiple financing rounds, with a valuation of 3.9 billion RMB following the E-round financing in September 2024 [4][5]. Product Pipeline and Market Competition - Ganfeng Pharma's product pipeline includes seven small molecule candidates, with four in Phase II, III clinical trials, or NDA stages, targeting 12 indications [1][2]. - The core product Mufemilast is a novel small molecule PDE4B inhibitor, with an NDA submitted for psoriasis and expected approval in the second half of 2025 [1][2]. - The Chinese psoriasis drug market is projected to grow from 13.9 billion RMB in 2023 to 89.4 billion RMB by 2032, with increasing competition from existing therapies [2]. Research and Development Strategy - The company has invested heavily in R&D, with expenditures of 123 million RMB and 97 million RMB for 2023 and 2024, respectively, but has yet to generate revenue [4][5]. - Ganfeng Pharma plans to establish a commercialization team of about 80 members within a year of Mufemilast's launch [4]. Management and Governance - The company's ownership structure is highly concentrated, with the founders controlling approximately 46.51% of the voting rights [6]. - The CEO, Dr. Zhang Hesheng, has over 20 years of experience in biomedical research and management, with significant compensation tied to equity [6]. Challenges and Risks - The company faces significant cash flow pressures, with only 150 million RMB in cash and cash equivalents by the end of 2024, alongside 25.5 million RMB in current liabilities [4][5]. - There are concerns regarding the company's ability to successfully develop and commercialize its pipeline products, particularly given the lack of a marketed product [7].

Core Viewpoint - The recent approval of multiple innovative drugs in China and favorable policies have led to a surge in interest in the Hong Kong innovative drug sector, with several ETFs in the pharmaceutical space seeing gains of over 40% this year [1][2]. Company Overview - He Mei Pharmaceutical Co., Ltd. (referred to as "He Mei Pharmaceutical") has submitted an IPO application to the Hong Kong Stock Exchange, with a post-investment valuation of 3.9 billion RMB after completing six rounds of financing [1][2]. - The company, founded in 2002, focuses on developing small molecule drugs for autoimmune diseases and tumors, with a strong position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [1][2]. Financial Performance - As of the latest financial report, He Mei Pharmaceutical has not yet achieved profitability, with projected revenues of approximately 4.05 million RMB and 5.298 million RMB for 2023 and 2024, respectively, primarily from government subsidies [1][2]. - The company is expected to incur losses of approximately 156 million RMB and 123 million RMB for the same periods [1]. Product Pipeline - He Mei Pharmaceutical has developed seven small molecule drug candidates targeting unmet needs in autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages for 12 indications as of May 21, 2025 [2][3]. - The two core products include Mufemilast, a potential first-in-class treatment for psoriasis, and Hemay022, a dual-target EGFR/HER2 inhibitor for advanced breast cancer [4][8]. Mufemilast Details - Mufemilast is a novel PDE4B inhibitor with a favorable safety profile, showing potential for treating psoriasis patients with latent tuberculosis [4][5]. - The global psoriasis drug market is projected to reach 29.621 billion USD in 2024, with a compound annual growth rate of 9.19% from 2024 to 2029 [5][6]. Competitive Landscape - Despite Mufemilast's advantages, the psoriasis treatment market is highly competitive, with numerous new drugs entering the market, posing challenges for commercial success [8][11]. - Hemay022 is currently undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer, facing competition from existing EGFR/HER2 inhibitors [8][9]. Financial Pressure - The company anticipates significant financial pressure due to high R&D expenditures, with projected investments of 123 million RMB and 97 million RMB for 2023 and 2024, respectively [10]. - As of December 31, 2024, the company is expected to hold approximately 150 million RMB in cash and cash equivalents, indicating a tight financial situation [10]. Conclusion - Overall, while He Mei Pharmaceutical's core product for psoriasis shows rapid progress, the intense market competition and ongoing high R&D costs may hinder its ability to attract capital market interest [11].

Group 1: Company Overview - He Mei Pharmaceutical Co., Ltd. (和美药业) is an innovative biopharmaceutical company established in 2002, focusing on the discovery and development of small molecule drugs for autoimmune diseases and tumors [1][2] - The company has submitted an application for listing on the Hong Kong Stock Exchange, with Guo Zheng International as its exclusive sponsor [1] Group 2: Product Pipeline - He Mei Pharmaceutical has developed seven small molecule drug candidates targeting autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages [2][8] - The core product, Mufemilast, is a novel small molecule PDE4B inhibitor with potential applications in various autoimmune diseases, including psoriasis and inflammatory bowel disease [3][5] Group 3: Market Potential - The autoimmune disease drug market in China has grown from $2.5 billion in 2019 to $4 billion in 2023, with a compound annual growth rate (CAGR) of 12.5% [5] - The psoriasis drug market in China reached ¥13.9 billion in 2023, with a CAGR of 30.4% from 2019 to 2023, and is expected to grow to ¥89.4 billion by 2032, with a CAGR of 59.1% [5] Group 4: Clinical Development - Mufemilast is the only drug that can be directly used for psoriasis patients with latent tuberculosis infection, with its safety supported by Phase III clinical trials [3][5] - Hemay022, another core product, is a dual-target small molecule inhibitor for advanced breast cancer, currently undergoing a Phase III clinical trial [7] Group 5: Financial Overview - The company reported a pre-tax loss of ¥156.4 million in 2023 and ¥123.4 million in 2024, primarily due to R&D and administrative expenses [12][13] - As of the end of 2024, the company had cash and cash equivalents of ¥150 million, with a net cash outflow from operating activities of ¥141 million in 2023 [11][12]

Core Viewpoint - He Mei Pharmaceutical is seeking to list on the Hong Kong Stock Exchange under the 18A chapter, aiming to attract capital for its development of small molecule drugs targeting autoimmune diseases and tumors, despite currently having no revenue or profit [1][3]. Group 1: Company Overview - He Mei Pharmaceutical was established in 2002 and focuses on developing small molecule drugs for autoimmune diseases and tumors, with a strong position in the industry [1]. - The company is developing seven small molecule drug candidates, all in clinical stages, and relies on government subsidies and financing for sustainable operations [1][3]. Group 2: Financial Performance - In 2023 and 2024, He Mei Pharmaceutical reported other income of approximately 4.05 million and 5.298 million RMB, respectively, primarily from government subsidies [3][4]. - The company incurred losses of approximately 156 million and 123 million RMB in the same periods, with significant expenditures in research and development [3][4]. Group 3: Product Pipeline - The core product, Mufemilast, is a novel small molecule PDE4B inhibitor, currently undergoing critical clinical trials for various indications, including psoriasis and Behçet's disease [5][6]. - Mufemilast is positioned as a unique drug with a dual mechanism of action, potentially reducing central nervous system side effects [6][7]. Group 4: Market Potential - The psoriasis drug market in China is projected to grow from 13.9 billion RMB in 2023 to 89.4 billion RMB by 2032, with a compound annual growth rate of 59.1% from 2023 to 2032 [7]. - He Mei Pharmaceutical is preparing for comprehensive clinical development of Mufemilast across eight major indications, indicating a strategic approach to capture market share [10][11]. Group 5: Competitive Landscape - The market for psoriasis treatments is becoming increasingly competitive, with major pharmaceutical companies also developing small molecule targeted therapies [10]. - He Mei Pharmaceutical's limited industry influence and recognition may pose challenges in differentiating its products in a crowded market [10][11].