香港聯合交易所有限公司及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 性亦不發表任何聲明，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依賴該等內容而引致 的任何損失承擔任何責任。 Suzhou Zelgen Biopharmaceuticals Co., Ltd. 蘇州澤璟生物製藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （「本公司」） 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。本聆訊後資料集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、接納並向本公司、獨家保薦人、整體協調人、顧問或包銷團成員表示同意： 倘在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於香港公司註冊處處長註冊的本公 司招股章程作出投資決定。該文件的文本將於發售期內供公眾人士查閱。 (a) 本文件僅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) 在聯交 ...

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 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]

Core Viewpoint - The biopharmaceutical company Wangshan Wangshui (2630.HK) is launching an IPO from today until next Monday (November 3), aiming to raise up to HKD 598 million through the global offering of 17.5978 million H-shares, with a maximum offer price of HKD 34 per share [1] Group 1: IPO Details - The public offering in Hong Kong accounts for 10% of the total shares, while the remaining shares are allocated for international placement [1] - The entry fee for one lot of 200 shares is HKD 6,868.57, with trading expected to commence on November 6 [1] Group 2: Fund Allocation - The company plans to allocate 38% of the net proceeds for the research and development of core products, 27% for other candidate products, 10% for the construction of a factory in Qingdao, 15% to enhance sales and marketing capabilities, and 10% for working capital and other general corporate purposes [1] Group 3: Core Products - Wangshan Wangshui focuses on discovering, acquiring, developing, and commercializing small molecule drugs in strategic therapeutic areas, specifically neuropsychiatry and reproductive health [1] - The company has developed two core products: LV232 and TPN171 [1] Group 4: TPN171 - TPN171 is a PDE5 inhibitor approved for the treatment of erectile dysfunction (ED) in China and Uzbekistan, featuring a novel chemical structure with high activity, selectivity, and safety [1] - Compared to competing products like sildenafil and tadalafil, TPN171 shows significantly lower activity against other PDEs, providing better safety and efficacy [1] Group 5: LV232 - LV232 is a dual-target receptor modulator for treating major depressive disorder, specifically targeting 5-HTT and 5-HT3 receptors, enhancing antidepressant effects while reducing gastrointestinal side effects [2] - The company plans to initiate a Phase II clinical trial for LV232 in China for major depressive disorder in April 2025, with completion expected in the second half of 2026 [2]

Core Viewpoint - 旺山旺水-B plans to globally offer 17.5978 million H-shares, with a price range of HKD 32.00 to 34.00 per share, aiming for a listing on November 6, 2025 [1] Company Overview - 旺山旺水-B, established in 2013, is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule drugs in the fields of neuropsychiatry and reproductive health [1] - The company has two core products: LV232, a 5-HTT/5-HT3 receptor modulator for treating major depressive disorder, and TPN171, a PDE5 inhibitor for treating erectile dysfunction [1] Product Pipeline - In addition to the core products, the company has four candidate drugs in clinical stages and three in preclinical stages [1] Fundraising and Use of Proceeds - The expected net proceeds from the offering are approximately HKD 521.1 million, which will be allocated as follows: 38.0% for core product R&D, 27.0% for other candidate product R&D, 10.0% for the construction of the Qingdao factory, 15.0% for enhancing sales and marketing capabilities, and 10.0% for working capital [1]

Summary of CXO Industry Conference Call Industry Overview - The CXO industry is experiencing a marginal increase in domestic demand in Q2 2025, with leading indicators such as rising monkey prices and increased hiring validating the sustainability of order recovery, which is expected to drive price increases for CRO companies [1][2] - The overseas CDMO business is performing well, with an upward trend in small molecule orders and an increase in the number of effective Phase III clinical trials, indicating a positive outlook for small molecule CDMO orders over the next three years [1][4] Key Insights - The small molecule drug sector is being reassessed for its potential, with new technologies like molecular glue and ProTAC making previously non-druggable targets viable. This has led to significant production expansions in the second half of the year, with leading companies planning large-scale hiring [1][5] - The CDMO industry shows a strong growth trend, with high capacity utilization among leading companies and increased scheduling reflecting rising market demand. Price increases for monkeys in July and August 2025 indicate heightened demand for experimental animals [7] - Clinical trial activities are on the rise, with the number of newly announced clinical trials increasing by approximately 17% and 16% year-on-year in Q2 and Q3 2025, respectively. This trend is accompanied by a rise in CRO price discounts, alleviating budget pressures for biotech companies [8] Market Dynamics - The perception of the CXO industry has shifted significantly over the first three quarters of the year, with a focus on the recovery of overseas preclinical demand and the sustainability of performance for companies like WuXi AppTec [2] - The CRO sector is particularly focused on changes in demand from biotech companies, which have a high outsourcing ratio. Improved cash flow for large pharmaceutical companies positively impacts CRO business [10] - The small molecule drug demand is expected to be underestimated, with a notable increase in early pipeline activities transitioning to later stages, suggesting a substantial improvement in demand by 2026 [11] Future Outlook - There is optimism regarding potential price increases in Q4 2025 and a strong market performance anticipated for 2026, likely leading to further price hikes [12] - The impact of overseas policy uncertainties on the market is diminishing, with recent legislative proposals having limited actual effects on CRO companies [13] - The proposed 100% tariff on imported drugs by Trump is viewed as a negotiation tactic, with major pharmaceutical companies managing to secure favorable terms, thus limiting the proposal's market impact [14] Additional Considerations - The relationship between semaglutide and companies like WuXi AppTec is minimal, with potential indirect impacts on revenue from price fluctuations of related products. Current observations indicate no significant effects, but ongoing monitoring of government actions is advised [15][16]

Core Viewpoint - The report from China Merchants Securities Hong Kong initiates coverage on HeYue-B (02256) with a "Buy" rating, estimating a fair equity value of HKD 21 billion and a target price of HKD 32.5 for the next 12 months, highlighting the company's long-term growth potential and efficient small molecule development capabilities [1] Group 1: Product Development and Market Potential - HeYue's developed drug, Pimitinib, is positioned as the most effective CSF-1R small molecule globally and is set to launch in both China and the U.S., promising ongoing sales revenue for the company [1] - The company is actively targeting two significant families of important targets, FGFR and KRAS, with FGFR4 as a late-stage clinical asset expected to become a new targeted small molecule in the liver cancer field [1] - The global sales peak for Pimitinib is projected to reach USD 1.5 billion, providing a continuous cash flow for HeYue, with the drug being a key asset in Merck's pipeline [1] Group 2: Clinical Advancements and Pipeline - HeYue has demonstrated the best efficacy globally for TGCT in the development of CSF-1R inhibitors, with safety and response rates surpassing similar molecules [1] - The company has established a robust pipeline with 22 candidate drugs, including 12 in clinical stages and 10 in preclinical stages, showcasing its leading recognition of frontier targets and developing clinical capabilities [3] - The selective FGFR4 inhibitor, currently in pivotal Phase III trials, targets advanced liver cancer patients with FGF19 overexpression, marking a potential first in the global market if successful [2] Group 3: Strategic Focus on Targeted Therapies - The company has been focusing on the FGFR target for a decade, with a deep layout in selective FGFR4 inhibitors and FGFR2/3 inhibitors, addressing unmet needs in liver and gastric cancers [2] - The ongoing research on RAS targets, including early-stage molecules for G12D and pan-RAS, is expected to enhance the company's offerings in precision oncology [2] - The development of next-generation FGFR inhibitors and oral PD-L1 small molecules is anticipated to exceed market expectations through better data disclosure and potential business development transactions [3]

Summary of He Yu Pharmaceutical Conference Call Company Overview - He Yu Pharmaceutical is focused on the commercialization of its drug, Pimitinib, expected in the first half of 2026, which is anticipated to generate sustainable cash flow and has secured an upfront payment from Merck for operational funding [2][7]. Key Products and Market Potential - **Pimitinib**: Expected peak sales could reach $1 billion or more, with a combined peak sales potential of $2-2.5 billion for two indications [4][11]. - **ABSK061 (FGFR23 Inhibitor)**: Targeting ACH, with a market potential of $4-5 billion, competing against BioMarin, which had sales of approximately $500-600 million last year [2][4][5]. - **ABSK043 (Oral PD-L1 Inhibitor)**: Expected to have data by the end of the year in combination with third-generation EGFR, potentially leading to a competitive advantage due to fewer side effects compared to previous antibody treatments [5][11]. - **KRAS G12D and pan-KRAS Products**: Early-stage research shows best-in-class characteristics, indicating significant overall company value and potential for increased value through international collaborations [2][6]. Financial Performance - The company has shown a clear trend towards profitability, with a stable financial condition and strong cash flow [2][7]. - Market capitalization is projected to reach between 40-50 billion yuan upon market entry in 2026, driven by the pipeline of products including FGFR4 and PD-L1 inhibitors [8]. Future Development and Pipeline - Multiple important pipeline advancements are expected in 2025, including NDA submissions for projects 021 and 0,570, and a pivotal Phase III trial for liver cancer treatment [3]. - The FGFR4 inhibitor is anticipated to enter commercialization by late 2027 to 2028, further enhancing the company's product offerings [3]. Strategic Partnerships and Investments - The company has received investments from Allianz and other high-quality foreign investors, indicating recognition of its fundamental value [13]. - Active share buybacks reflect management's confidence in long-term growth and commitment to shareholder interests [13]. Market Dynamics and Competitive Landscape - The PD-L1 small molecule is positioned to address significant market needs in non-small cell lung cancer, with a potential peak sales of $5 billion [9][10]. - The company is also exploring opportunities in large molecules and non-oncology fields, such as ADCs, showcasing a broad development potential [12]. Conclusion - He Yu Pharmaceutical is strategically positioned with a robust pipeline and strong financial backing, indicating significant growth potential and investment opportunities in the biopharmaceutical sector.

Core Viewpoint - The company demonstrates strong financial performance with sustainable growth potential, driven by its core product, ABKS021 (Pimicitinib), and strategic partnerships, particularly with Merck [1][4] Financial Performance - In the first half of 2025, the company reported revenue of 657 million RMB (up 20% year-on-year) and a net profit of 328 million RMB (up 59% year-on-year) [1] - The company holds cash reserves of 2.3 billion RMB, providing a solid foundation for future R&D and operations [1] Product Development - Pimicitinib's global commercialization option was exercised by Merck, with an upfront payment of 85 million USD [1] - The NDA for Pimicitinib has been accepted in China and is expected to be submitted in the U.S. within the year, with potential approvals in both markets by mid-2026 [1] - Clinical trial data for Pimicitinib shows a 54% objective response rate (ORR) at week 25, significantly outperforming placebo and other similar products [1] Pipeline and Research - The company is advancing its pipeline with ABSK011, a potential first-in-class FGFR4 inhibitor, which has shown superior efficacy in preclinical studies compared to earlier entrants [1] - ABSK011 is currently in clinical trials for FGF19+ hepatocellular carcinoma, with promising early results [1] - The company is also developing ABSK043, an oral PD-L1 inhibitor, which has shown a 19.6% ORR in early trials for NSCLC [2] Market Position and Competitive Advantage - The company’s product ABSK061, an FGFR2/3 inhibitor, is positioned to compete with existing therapies due to its oral administration route, contrasting with the injectable nature of competitors [3] - The company has a rich pipeline including KRAS inhibitors and ADCs, indicating a well-structured approach to drug development [3] Shareholder Engagement - The company has been actively repurchasing shares, indicating a commitment to shareholder returns, with a total of 9.545 million shares repurchased by June 30, 2025 [3] - Notable foreign investors, including Allianz SE and Morgan Stanley, have increased their stakes, reflecting confidence in the company's growth prospects [4] Revenue and Profit Forecast - Revenue projections for 2025-2027 are 680 million RMB, 620 million RMB, and 790 million RMB, with net profits of 40 million RMB, 60 million RMB, and 80 million RMB respectively [4]