Core Viewpoint - The recent investor communication by Weisheng Pharmaceutical (02561) highlighted the company's strong position in the growth hormone market, focusing on its innovative long-acting growth hormone product and its strategic approach to commercialization [1][2]. Growth Hormone Market Overview - The growth hormone market in China is valued at over 100 billion RMB, primarily driven by out-of-pocket expenses, with approximately two-thirds of the market covered by private hospitals and clinics [1][2]. - The market is expected to grow to 300 billion RMB by 2030, with long-acting formulations projected to dominate the market share [2]. Product Pipeline and Innovation - Weisheng's long-acting growth hormone product is recognized for its superior clinical data and is the only product to achieve favorable results in head-to-head trials against Japanese formulations [3][4]. - The product utilizes a temporary linkage technology that enhances stability and extends the drug's half-life, allowing for weekly injections while maintaining efficacy [4][6]. Competitive Landscape - The competition in the growth hormone sector is relatively mild, with high barriers to entry for long-acting formulations, making Weisheng's product a leader in the market [3][5]. - The current market is dominated by JinSai, which holds about 80% of the market share, primarily due to its established short-acting products [6][7]. Commercialization Strategy - Weisheng plans to leverage its experienced team to accelerate the transition from short-acting to long-acting products, focusing on key pediatric endocrinologists for efficient market penetration [7][8]. - The company has established global partnerships and strategic agreements to expand its market channels and enhance patient services [7][8]. Future Prospects - The company anticipates that its long-acting growth hormone product will receive approval by the second half of 2025, with a significant market potential targeting 100,000 patients to achieve a billion-level market scale [7][8]. - The introduction of supportive national policies aimed at increasing birth rates is expected to expand the target patient population for growth hormone treatments [22]. Additional Product Developments - Weisheng is also developing innovative therapies such as Navepitide for cartilage development disorders and Parotipide for parathyroid hormone deficiency, both of which are expected to generate substantial revenue due to their unique market positions [8][9].

Product Development and Clinical Trials - In 2024, Visen Pharma submitted a marketing authorization application for its core product, Long-Acting Growth Hormone, which has shown superior efficacy and comparable safety in clinical trials compared to short-acting growth hormones [10]. - The company completed the double-blind phase of its pivotal trial for Parathyroid Hormone for the treatment of hypoparathyroidism, achieving primary and key secondary endpoints [10]. - The core product, lonapegsomatropin, has completed Phase 3 trials in China for treating pediatric growth hormone deficiency (PGHD) and has shown statistically significant efficacy compared to short-acting growth hormones [19]. - Navepegritide, a candidate drug for treating achondroplasia, has completed the double-blind phase of its Phase 2 clinical trial in China, with key data indicating it has met its primary endpoint [21]. - Palopegteriparatide, another candidate drug for treating adult hypoparathyroidism, has completed the primary analysis of its Phase 3 trial in China, achieving its primary efficacy endpoint [21]. - The company anticipates submitting a New Drug Application (NDA) for navepegritide to the National Medical Products Administration in 2024 [16]. - The open-label phase of the navepegritide trial is expected to be completed by April 2024 [21]. - The company emphasizes the importance of clinical trial results in ensuring the successful development and marketing of its core products [22]. Financial Performance - The company reported a net loss of RMB 182,242,000 in 2024, a decrease from RMB 249,570,000 in 2023, representing a 27% improvement year-over-year [13]. - The basic and diluted loss per share improved to RMB 1.95 in 2024 from RMB 2.67 in 2023, indicating a positive trend in financial performance [13]. - The company achieved other income of RMB 9,864,000 in 2024, down from RMB 11,356,000 in 2023, highlighting a decline in non-operational revenue [13]. - The total employee cost for the year ended December 31, 2024, was approximately RMB 988 million, an increase from RMB 666 million for the year ended December 31, 2023, representing a 48.3% increase [36]. - The annual loss decreased by 27.0% from RMB 249.6 million in 2023 to RMB 182.2 million in 2024 [54]. - The company reported a net cash outflow from operating activities of RMB 140.9 million for the year ended December 31, 2024, primarily due to R&D costs and management expenses [62]. Research and Development - Research and development costs increased to RMB 90,521,000 in 2024 from RMB 57,690,000 in 2023, indicating a focus on advancing product pipelines [13]. - Total R&D expenditures increased from RMB 57.7 million in 2023 to RMB 90.5 million in 2024, reflecting a significant investment in product development [30]. - Research and development expenses for the year ended December 31, 2024, amounted to approximately RMB 90.5 million, with RMB 47.6 million for lonapegsomatropin, RMB 20.1 million for navepegritide, and RMB 22.8 million for palopegteriparatide [29]. - The R&D team consists of 30 full-time employees, with approximately 43% holding PhDs or MDs, and an average of over 14 years of experience in clinical development [28]. Commercialization and Market Strategy - The company plans to accelerate the commercialization process of its core products and enhance local production capabilities to benefit more patients [10]. - The company plans to enhance its commercialization team in anticipation of BLA approval for core products in the second half of 2025, including increasing sales and marketing personnel [32]. - The company aims to develop a pre-filled dual-chamber device for drug delivery, with commercialization expected to begin in 2028 following BLA approval [33]. - The company has established a product pipeline consisting of three candidate drugs targeting specific endocrine diseases, all licensed from Ascendis Pharma [110]. - The company aims to establish localized production capabilities to ensure supply for its core products and future candidates in the Chinese market [44]. Governance and Management - The board consists of nine directors, including one executive director, five non-executive directors, and three independent non-executive directors [77]. - The executive director and CEO, Mr. Lu Anbang, has over 31 years of global biopharmaceutical development experience [78]. - The company has a strong board with members holding advanced degrees from prestigious institutions, enhancing its strategic decision-making capabilities [100]. - The management team includes experienced professionals from leading pharmaceutical and consulting firms, contributing to the company's growth strategy [101]. - Independent directors are tasked with providing oversight and independent judgment to ensure corporate governance [92]. Legal and Compliance - The company has complied with all relevant laws and regulations without any significant violations as of December 31, 2024 [138]. - The company has not been involved in any significant litigation or arbitration during the reporting period [147]. - The company has not disclosed any new product or technology developments, market expansions, or mergers and acquisitions in the provided documents [74][75]. Shareholder Information - The company has issued a total of 113,926,864 shares [169]. - Ascendis Pharma A/S owns 41,136,364 shares, accounting for 36.11% of the total shares [168]. - Vivo Capital IX (Cayman), LLC. has a stake of 37,167,064 shares, which is 32.62% of the total shares [168]. - The board does not recommend the distribution of a final dividend for the fiscal year ending December 31, 2024 [128]. - The company has not generated any product sales revenue as of December 31, 2024, and does not expect to do so until one or more candidate drugs are commercialized [136]. Strategic Partnerships - A strategic collaboration with Ascendis Pharma has been established for technology transfer related to core product manufacturing, expected to be completed by 2027 [33]. - The company has entered into a strategic partnership with Huashan Medical to enhance treatment and service capabilities for children with growth-related medical needs [32]. - The company has established exclusive licensing agreements with Ascendis Pharma subsidiaries for the development and commercialization of specific products in China, effective from November 7, 2018, and valid indefinitely until patent rights expire [196].

Financial Results - Visen Pharmaceuticals reported preliminary financial results for the year ending December 31, 2024[2]. - The unaudited preliminary financial data is available in the prospectus appendix dated March 13, 2025[3]. Company Information - The company is listed under stock code 2561 on the Hong Kong Stock Exchange[2]. - The announcement was made by the Executive Director and CEO, Mr. Lu Anbang, on March 27, 2025[3]. - The board of directors includes both executive and non-executive members, ensuring diverse oversight[3].

Investment Rating - The report assigns a "Neutral" rating with a total score of 69 out of 100 [3][14]. Core Insights - The company has a promising pipeline with products that, if approved, could meet significant demand in the Chinese market, particularly for conditions like Pediatric Growth Hormone Deficiency (PGHD) and Hypoparathyroidism [2][8][10]. - The company is positioned as the first endocrine drug manufacturer in the Hong Kong market, which may provide a competitive edge [14]. Industry Outlook - PGHD is prevalent among children under 18, accounting for 41.5% of short stature cases in China, with only 5.3% treatment rate in 2023, indicating a substantial unmet need [2]. - The market for achondroplasia treatment is currently limited, with only two products in clinical trials, suggesting a strong first-mover advantage for the company's product, Navepegritide [6]. - The demand for drugs treating Hypoparathyroidism is expected to grow, with the patient population projected to increase from 410,100 in 2023 to 495,600 by 2030 [7]. Company Operations - The company has not yet launched any products, resulting in no sales revenue. The net loss for shareholders in 2023 was approximately 250 million RMB, a 13.5% reduction year-on-year [8]. - Research and development costs have decreased significantly, contributing to the reduced net loss, while cash flow from operating activities remains healthy with no bank loans [8]. - The company has a robust pipeline with core products already approved in Europe and the U.S., with expectations for approval in China by 2025 [5][10]. Valuation Level - The company's valuation is considered reasonable, with a market capitalization range of 77.0 to 84.6 billion HKD, slightly lower than comparable companies in the biotech sector [10][12]. - The price-to-book ratio for the company's IPO price is estimated at 18.3 to 20.2 times, which is competitive compared to peers [10]. Market Sentiment - The recent market atmosphere has improved, with a higher percentage of newly listed companies experiencing price increases on their debut [13]. - The presence of notable cornerstone investors, such as WuXi Biologics, indicates confidence in the company's research capabilities [14].

Investment Rating - The report assigns a "Neutral" rating with a total score of 69 out of 100 [3][14]. Core Insights - The company has a promising pipeline with products that, if approved, could meet significant demand in the Chinese market, particularly for conditions like Pediatric Growth Hormone Deficiency (PGHD) and others [2][6][8]. - The company is positioned as the first endocrine drug manufacturer in the Hong Kong market, which may provide a competitive edge [14]. Industry Outlook - PGHD is prevalent among children under 18, with 41.5% of the total short stature cases in this age group in China. The treatment rate for this condition is currently low at 5.3%, indicating a substantial unmet need [2]. - The company’s product, Lonapegsomatropin, is the first long-acting growth hormone approved in the US and Europe, with expectations for approval in China by 2025 [5][8]. - There is a lack of approved drugs for Achondroplasia in China, with only the company’s Navepegritide and Sanofi's SAR442501 in clinical trials, suggesting a strong first-mover advantage if successful [6]. - For Hypoparathyroidism, the market is expected to grow from 410,100 cases in 2023 to 495,600 by 2030, highlighting a significant demand for effective treatments [7]. Company Operations - The company has not yet launched any products, resulting in no sales revenue. The net loss for shareholders in 2023 was approximately 250 million RMB, a 13.5% decrease year-on-year, primarily due to reduced R&D costs [8]. - The company’s cash flow from operating activities has remained stable, with net cash used in operations of 270 million RMB in 2023 and 100 million RMB in the first half of 2024 [8]. - The company has no bank borrowings, indicating a healthy balance sheet despite the absence of product approvals [8]. Valuation Level - The company’s valuation is considered reasonable, with a market capitalization range of 77.0 to 84.6 billion HKD, slightly lower than comparable companies in the biotech sector [10]. - The price-to-book ratio for the company is projected to be between 18.3 and 20.2 times, which is competitive compared to peers [10]. Market Sentiment - Recent market conditions have improved, with 14 out of 19 newly listed companies experiencing price increases on their first trading day, indicating a favorable environment for new listings [13].