福建海西新藥創制股份有限公司（「本公司」）董事會（「董事會」）宣佈，本公司創新 藥物項目HXP056，即有望成為全球首款針對出血性視網膜疾病的口服藥物，已於 2025年7月初啟動中國濕性年齡相關性黃斑變性(wAMD)患者招募，目前已完成一 期臨床試驗中單次給藥劑量遞增(SAD)與多次給藥劑量遞增(MAD)階段的所有患者 招募工作，並在連續給藥四週後完成劑量限制性毒性(DLT)評估及藥代動力學(PK) 數據收集。初步療效評估亦同步進行中。2025年第四季度，本公司亦已啟動劑量擴 增的二期臨床研究。 人體免疫系統是涵蓋多重途徑與機制協同作用的複雜結構。本公司的小分子創新藥 物平台（MultiSel-Opt平台）專注於透過選擇性地鎖定多個蛋白質靶點來調節炎症與 免疫反應，並充分發揮小分子化合物的特性，用單一藥物分子實現多重機制協同作 用。MultiSel-Opt平台使我們能夠探索疾病治療的創新機制，以在創新藥物研發項 目中實現硬核創新，使得所產生的候選化合物在業界中同其他藥物比較不存在可 比擬性。此外，MultiSel-Opt平台的另一特色在於專注於優化藥物在疾病部位的分 佈，例如如何設計最佳藥物化合物以實現適當穿 ...

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Insights - The oral administration of drugs for retinal diseases shows promising prospects, particularly with a focus on HaiXi New Drug's developments [3][4] - The pharmaceutical market has seen a decline of 2.77% from March 16 to March 20, with innovative drugs showing signs of recovery, suggesting a potential valuation correction [5][27] - The global number of patients with eye diseases has increased from 1.7 billion in 2018 to 2.3 billion in 2023, with projections to reach 2.8 billion by 2032, indicating a growing market [8][20] - The market for wet age-related macular degeneration (wAMD) drugs is expected to grow from $5.8 billion in 2023 to $10.6 billion by 2032, reflecting a compound annual growth rate (CAGR) of 6.9% [11][20] - HaiXi New Drug's HXP056 aims to address the unmet needs in retinal disease treatment through oral administration, with clinical trials expected to start in June 2025 [20][24] Summary by Sections 1. Retinal Disease Oral Administration Prospects - The market for retinal diseases is expanding, with existing therapies showing low adherence due to the inconvenience of intravitreal injections [8][15] - The number of patients in China with eye diseases is projected to rise from 308.8 million in 2018 to 380.3 million by 2024, with a slower growth rate thereafter [8] - HXP056 is positioned to be the first oral treatment for wAMD, DME, and RVO, overcoming significant technical challenges [20][24] 2. Industry Perspective - The pharmaceutical index has experienced a decline of 2.77% recently, with a total decline of 2.90% year-to-date [27][36] - The report emphasizes a dual investment framework focusing on "technology innovation" and "performance/valuation recovery" for the year [46][47] - The report suggests that the Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with significant advancements in innovation and international market presence [46][47]

Group 1 - HaiXi Pharmaceutical (02637) saw its stock price rise over 10%, reaching a new high of HKD 145.9, which is nearly a 70% increase from its IPO price of HKD 86.4 [1] - As of the IPO disclosure date, HaiXi Pharmaceutical has 15 approved generic drug products, covering multiple therapeutic areas including digestive, cardiovascular, endocrine, and nervous systems [1] - The four core generic drugs, namely Anbili, Ruiantuo, Haihuitong, and Saixifu, are expected to contribute over 90% of the company's revenue, projected to reach CNY 425 million in 2024 [1] Group 2 - HaiXi Pharmaceutical is also developing an innovative drug pipeline, including C019199, an immunotherapy targeting CSF-1R/DDR1/VEGFR2, currently in I/II clinical stages for indications like osteosarcoma and tenosynovial giant cell tumor, with plans to start a Phase III trial in the second half of 2025 [1] - Another drug, HXP056, is an oral treatment for wet age-related macular degeneration, expected to complete its Phase I clinical trial by the end of 2025 [1]

Core Viewpoint - Haixi New Drug (02637) has seen a significant stock price increase, reaching a new high of 145.9 HKD, which is nearly 70% higher than its IPO price of 86.4 HKD [1] Company Overview - Haixi New Drug is a commercial-stage pharmaceutical company with 15 approved generic drug products covering various therapeutic areas, including digestive, cardiovascular, endocrine, and nervous systems [1] - Since 2021, four core generic drugs have been included in the national drug procurement program, contributing over 90% of the company's revenue, projected to reach 425 million CNY in 2024 [1] Research and Development Pipeline - The company is also developing innovative drugs, including C019199, an immunotherapy targeting CSF-1R/DDR1/VEGFR2, currently in I/II clinical stages for indications like osteosarcoma and tenosynovial giant cell tumor, with plans to start a Phase III trial in the second half of 2025 [1] - Another drug, HXP056, is an oral treatment for wet age-related macular degeneration, expected to complete its Phase I clinical trial by the end of 2025 [1]

Core Viewpoint - Haixi New Drug officially listed on the Hong Kong Stock Exchange on October 20, opening at HKD 102 per share, a rise of 18.06% from the issue price of HKD 86.4. The company's performance heavily relies on the national volume-based procurement (VBP) plan, with over 90% of revenue from this channel from 2022 to 2024, raising concerns about sustainability and profitability due to price pressures [2][6][8]. Revenue and Profitability - Revenue from Haixi New Drug is projected to be approximately RMB 212.5 million, RMB 316.6 million, and RMB 466.7 million for the years 2022, 2023, and 2024 respectively, with profits of about RMB 69.8 million, RMB 117.5 million, and RMB 136.1 million during the same period [4][6]. - The company faces significant price declines due to the VBP model, with the average price of its product Haihuaitong® dropping from RMB 3.56 to RMB 2.19, a decrease of 38.48%, and Anbili®'s price falling from RMB 1.16 to RMB 0.46 [6]. Dependency on Procurement - Haixi New Drug's revenue is highly dependent on a few products, with over 90% of revenue from procurement channels in 2022, 2023, and 2024. The two main products, Anbili® and Haihuaitong®, contributed 81.3%, 79.9%, and 72.2% of revenue respectively during these years [5][6]. - The procurement qualifications for Haihuaitong® and Anbili® will expire in 2025 and 2026 respectively, raising concerns about potential revenue disruptions if renewals are unsuccessful [6]. Innovation Pipeline - The company is attempting to pivot towards innovation with four drugs in the research pipeline targeting oncology, ophthalmology, and respiratory diseases. One notable drug, C019199, is in I/II clinical trials and aims to start a Phase III trial in late 2025 [7]. - However, the competition in the oncology space is intense, with several similar drugs already in development, posing risks to the success of Haixi's pipeline [7]. R&D Investment - R&D expenditures are expected to increase from RMB 34.82 million in 2022 to RMB 67.53 million in 2024, but this is still considered insufficient compared to the high costs associated with developing innovative drugs [7]. - The company needs to enhance its R&D efficiency and speed to compete effectively in the market [8].

Core Viewpoint - Haixi New Drug officially listed on the Hong Kong Stock Exchange on October 20, opening at HKD 102 per share, a rise of 18.06% from the issue price of HKD 86.4. The company's performance heavily relies on the national volume-based procurement (VBP) plan, with over 90% of revenue from this channel from 2022 to 2024, raising concerns about sustainability and profitability due to price pressures [1][5][6]. Group 1: Financial Performance - Revenue from 2022 to 2024 is projected to be approximately CNY 212.465 million, CNY 316.633 million, and CNY 466.683 million, respectively, with profits of about CNY 68.981 million, CNY 117.454 million, and CNY 136.079 million [4][5]. - The company’s net profit margin is expected to decline by 7.9 percentage points in 2024 compared to 2023, resulting in a net profit margin of 29.2% [5][6]. Group 2: Dependency on Procurement - Haixi New Drug's revenue is highly dependent on a few products, with over 90% of revenue from procurement channels in 2022, 2023, and 2024. The combined revenue contribution from Anbili® and Haihuitong® is 81.3%, 79.9%, and 72.2% for the respective years [5][6]. - The prices of key products have significantly decreased due to procurement, with Haihuitong® dropping from an average price of CNY 3.56 to CNY 2.19, a decline of 38.48% [5][6]. Group 3: Innovation Pipeline - The company is attempting to develop a "second growth curve" through its pipeline of innovative drugs, currently having four drugs in development targeting oncology, ophthalmology, and respiratory diseases [7][8]. - The innovative drug C019199 is in I/II clinical stages, with plans for a Phase III trial in late 2025, but faces intense competition from similar drugs globally [8]. - R&D expenditures are projected to increase from CNY 34.82 million in 2022 to CNY 67.525 million in 2024, but this may still be insufficient to support the high costs associated with innovative drug development [8][9]. Group 4: Market Perception and Challenges - The first-day performance of Haixi New Drug reflects short-term market recognition of its generics business and innovative drug potential, but long-term challenges include reducing reliance on procurement channels and accelerating the R&D process [9].

Core Viewpoint - The listing of Haixi Pharmaceutical (02637.HK) on the Hong Kong Stock Exchange has been delayed, originally scheduled for October 17, 2025, due to the need for additional time to finalize the announcement and obtain regulatory approval [2][3]. Group 1: Listing Delay Details - The company announced that the final announcement regarding the offering price and subscription levels must be published before 8:00 AM on October 17, 2025 [2]. - The company plans to issue approximately 11.5 million shares at a price range of HKD 69.88 to HKD 86.40, with a final cap set at HKD 86.40 per share [3]. - During the dark market trading phase, the stock price opened high but closed at HKD 107.6, reflecting a 24.54% increase, which may be linked to speculation about the delayed listing [3]. Group 2: Market Reactions and Speculations - There are rumors regarding irregularities in the international placement distribution, including issues with repeated applications and non-compliant participants, which may cast doubt on the effectiveness of dark market transactions [6]. - If the listing is merely delayed, completed dark market orders may still be valid; however, if the listing is ultimately canceled, all dark market transactions will be voided, although financing interest and fees typically are not refunded [7]. Group 3: Company Background and Financial Performance - Haixi Pharmaceutical has 14 approved generic drugs and four innovative drugs in development, with a dual-track approach of generics and innovative drugs [11][12]. - The company's revenue for the years 2022, 2023, 2024, and the first five months of 2025 were HKD 213 million, HKD 317 million, HKD 467 million, and HKD 249 million, respectively, with net profits of HKD 69 million, HKD 118 million, HKD 136 million, and HKD 90 million [12][13]. - The majority of the company's revenue comes from three products, which accounted for 98.2%, 92.9%, 82.6%, and 84% of total revenue during the respective reporting periods [14]. Group 4: Research and Development Pipeline - The company is developing several innovative drugs, including C019199, which targets multiple cancers, and HXP056, a potential oral treatment for eye diseases [16][17]. - C019199 has received IND approval and is undergoing various clinical trials, while HXP056 is expected to complete its Phase I trial by the end of 2025 [16][17]. - The combination of generics and innovative drugs has provided revenue and profit, but the generics segment may face future challenges due to market pressures [17].

Core Viewpoint - Fujian Haixi New Drug Creation Co., Ltd. is seeking to go public on the Hong Kong Stock Exchange (HKEX) after previously considering an A-share listing, highlighting its established position with 14 approved generic drugs and profitability [1][5]. Company Background - Founded in March 2012 by Dr. Kang Xinshan and Feng Yan, the company transitioned to a joint-stock company in November 2022, headquartered in Fuzhou, Fujian Province [1][4]. - The company is currently valued at approximately 1.948 billion yuan [4]. Shareholding Structure - The main controlling shareholders include Dr. Kang Xinshan, Feng Yan, and Tai Rui He Investment, holding about 41.17% of the issued share capital [2][3]. Business Model - Haixi New Drug operates a dual-track model, focusing on both generic and innovative drugs, with 14 approved generic drugs and 4 innovative drugs in the pipeline [5][7][11]. - The company’s generic drug portfolio addresses various therapeutic areas, contributing to over 25% of China's pharmaceutical sales in 2023 [8]. Financial Performance - Revenue growth has been observed, with reported revenues of 212 million yuan in 2022, 317 million yuan in 2023, and projected revenues of 467 million yuan in 2024 [19][21]. - The net profit for the same periods was 68.98 million yuan, 117.45 million yuan, and 136.08 million yuan respectively [19][21]. Product Portfolio - The company’s revenue is primarily derived from three products, which accounted for 98.2%, 92.9%, 82.6%, and 84% of total revenue in the respective years [22]. - The product "Haihui Tong" has achieved significant market share, reaching 59.3% in 2024 [22]. Challenges and Competition - The company faces pressure from national centralized procurement, with contracts for four products expiring between 2025 and 2026, which may impact future revenues [23][24]. - The innovative drug pipeline, particularly the C019199, faces intense competition from multiple companies developing similar agents for solid tumors [17][19].

Core Viewpoint - Haixi New Drug, the first pharmaceutical company in Fujian to obtain a drug production license, is advancing its IPO process on the Hong Kong Stock Exchange, showcasing significant revenue growth but facing various operational risks [1][2]. Financial Performance - Haixi New Drug's revenue surged from 2.12 billion in 2022 to 4.67 billion in 2024, with a net profit increase from 690 million to 1.36 billion during the same period, reflecting a compound annual growth rate (CAGR) of 48.2% for revenue and 40.5% for net profit [4]. - In the first five months of 2025, the company reported revenue of 2.49 billion and a net profit of 902 million [4][20]. Revenue Dependence and Risks - The company heavily relies on 13 approved generic drugs, with 4 included in the national volume-based procurement (VBP) program, leading to a significant dependency on VBP products, which accounted for 72.6% of revenue in 2024 [6]. - The top five customers contributed over 70% of total revenue, with the largest customer accounting for 44.5% [6]. - Key VBP products are approaching contract expiration, with two set to expire by the end of 2025 and others in subsequent years, raising concerns about future revenue stability [6][7]. Cash Flow and Financial Health - Despite impressive revenue growth, the company's cash flow is under pressure, with a cash balance of only 380 million at the end of 2024, covering just 21% of current liabilities [15][21]. - The operating cash flow has shown fluctuations, with a net cash flow of 1.64 billion in 2024, but a decline to 800 million in the first five months of 2025 [11]. Sales and Marketing Expenses - The sales expense ratio increased from 22% in 2022 to 35.5% in 2024, significantly higher than the industry average, which may erode profit margins [12][13]. - The rising sales costs are attributed to increased channel maintenance expenses and the need for additional marketing resources for newly included VBP products [12]. Innovation Pipeline - Haixi New Drug has four innovative drugs in development, but all are in early stages, with the first clinical trials just starting [17][19]. - The company’s R&D expenditure is relatively low, with rates below the industry threshold of 20%, which may hinder future innovation [19][23]. - The company plans to use funds from the IPO to support clinical development and expand its sales network, but faces competition from established products that are already ahead in the market [24]. Production Capacity Concerns - The company’s production facility in Chang Le has a designed capacity of 2 billion tablets per year, but actual sales in 2024 were only 460 million tablets, raising concerns about potential overcapacity [25].