Core Viewpoint - The article discusses the divestment of a 17.87% stake in Tianmai Biotechnology by China Resources Pharmaceutical, marking a significant shift in strategy after a decade of investment in oral insulin, which has faced multiple setbacks and challenges in commercialization [5][9]. Group 1: Company Background and Investment History - China Resources Pharmaceutical began its investment in Tianmai Biotechnology in 2016, focusing on the development and commercialization of insulin and its analogs, particularly oral insulin [5]. - The initial optimism surrounding oral insulin was based on its potential to improve patient compliance by replacing injections with oral administration, thus expanding the user base [5][6]. Group 2: Challenges Faced - The development of oral insulin has proven to be extremely challenging due to the instability of insulin in the gastrointestinal tract and the difficulty in achieving stable bioavailability [6]. - Tianmai faced delays in obtaining necessary approvals for injectable insulin, and the introduction of centralized procurement in China significantly altered the market dynamics, leading to price reductions and increased competition from larger players [6][7]. Group 3: Recent Developments and Strategic Shift - In 2023, Oramed's failure to meet primary and secondary endpoints in Phase III trials for ORM-0801 posed a significant setback for the oral insulin narrative, leading to diminished investor confidence and uncertainty regarding future funding [9]. - Following these developments, China Resources Pharmaceutical opted to divest its stake in Tianmai, indicating a strategic pivot towards more certain and commercially viable products, such as a partnership with Borui Pharmaceutical for BGM0504 [10]. Group 4: Market Context and Future Outlook - The divestment reflects a broader trend in the pharmaceutical industry where large companies are increasingly focused on maximizing returns on capital and minimizing exposure to high-risk projects [11]. - Despite the withdrawal from oral insulin, the article suggests that there may still be potential for value in Tianmai, as the company explores new avenues such as GLP-1 analogs, although the competitive landscape has become significantly more challenging [10][11].

Core Viewpoint - The strategic collaboration between CSPC Pharmaceutical Group and AstraZeneca, valued at up to $18.5 billion, was met with unexpected market skepticism, leading to a significant drop in stock prices for both companies involved [2][4][7]. Group 1: Strategic Collaboration Details - CSPC Pharmaceutical Group announced a strategic partnership with AstraZeneca to co-develop innovative long-acting peptide drugs based on CSPC's drug delivery technology and AI discovery platform [3][4]. - The agreement includes a $1.2 billion upfront payment, up to $3.5 billion in research milestone payments, and $13.8 billion in sales milestone payments, along with a double-digit revenue share based on annual net sales [4][5]. - This deal surpasses the previous record of $11.4 billion set by Innovent Biologics and Takeda in 2025, marking a new high for outbound licensing in China's biopharmaceutical sector [4]. Group 2: Market Reaction and Concerns - Following the announcement, CSPC's stock fell by 9.82% to HKD 9.64 per share, while its closely related company, New Horizon Health, saw a drop of 15.72% [2][7]. - Analysts suggest that the market's negative reaction stems from concerns over the details of the deal and the companies' fundamentals, indicating that the perceived benefits may not align with the actual risks involved [7]. - The milestone payments are contingent on successful clinical trials and market performance, raising questions about the viability of CSPC's projects in a competitive landscape [7][8]. Group 3: Product and Competitive Landscape - The core asset in this collaboration is SYH2082, a long-acting weight management drug currently in Phase I clinical trials, targeting GLP-1R and GIPR receptors [8][9]. - The competitive landscape for GLP-1 drugs is intensifying, with major players like Eli Lilly and domestic companies rapidly advancing their own dual-target and multi-target drugs [9][10]. - CSPC's late entry into the clinical phase with SYH2082 presents challenges in efficacy differentiation and safety optimization, which will be critical for its future competitiveness [10]. Group 4: Financial Context and Implications - CSPC's decision to pursue this significant licensing deal comes at a time when its financial performance is under pressure, with a reported revenue decline of 12.32% year-on-year for the first three quarters of 2025 [11]. - New Horizon Health stands to benefit from the upfront payment, which will help alleviate its cash flow issues as it anticipates a significant net loss in 2025 due to high R&D expenditures [12].

Core Insights - 博瑞医药 has made significant progress in clinical trials for multiple core innovative drugs, showcasing its strong research and development capabilities [1][2][3] Group 1: Key Products - BGM0504, a core candidate drug, shows potential for treating metabolic diseases by activating GIP and GLP-1 pathways, aiding in blood sugar control, weight loss, and treatment of non-alcoholic fatty liver disease (NASH) [1] - BGM0504 injection is advancing in clinical trials across multiple regions, including China and Indonesia, with positive results in phase III studies [1] - The oral formulation of BGM0504 has received IND approval in China and the U.S., with the first subject dosed, indicating steady progress in global development and future commercialization [1] - BGM1812, another core product, is a novel long-acting Amylin analog designed to promote weight loss through multiple mechanisms, including activating brain satiety pathways [2] - BGM1812 has received clinical trial approval in both China and the U.S., with the first clinical enrollment successfully completed, positioning 博瑞医药 to capture a key advantage in the global weight loss drug market [2] - The combination formulation BGM2102, which integrates the advantages of dual-target agonists and Amylin analogs, aims to address the treatment needs of severely obese and precision weight loss patients [2] Group 2: Research and Development - 博瑞医药 is advancing other research projects, including peptide-based hypoglycemic drugs, anti-tumor drugs, and innovative developments in immune diseases, all progressing according to research plans [2] - The company is also deepening its technical platform for complex formulations, such as inhalation drugs, laying a foundation for future product pipeline expansion [2] - 博瑞医药 adheres to compliance in research and development, ensuring that all clinical trials follow international standards and relevant laws, with a commitment to timely and accurate disclosure of project progress [3]

Core Viewpoint - The article highlights the significant progress in the global weight loss and metabolic drug sector, particularly focusing on Roche's initiation of the Phase III clinical trial for its dual agonist RO7795068, marking a critical phase in the competitive landscape of GLP-1/GIP dual-target therapies [6][10]. Group 1: Clinical Development - Roche has officially launched the first Phase III clinical trial for RO7795068, a dual GLP-1R/GIPR agonist, involving approximately 1,600 participants, indicating a decisive step in the GLP-1 compound target field [6]. - The trial aims to validate the early efficacy observed in previous studies, with a primary endpoint of percentage change in body weight from baseline at 72 weeks, while also assessing long-term safety and tolerability [8]. Group 2: Efficacy and Competitive Landscape - Early clinical data for RO7795068 shows promising results, with a 24-week treatment leading to an average weight loss of 18.8% in non-diabetic obese or overweight participants, and a 100% response rate for weight loss exceeding 5% [8]. - In the diabetic obese or overweight population, RO7795068 demonstrated a 3.0 percentage point reduction in HbA1c and an 8.6% weight loss after 12 weeks, indicating its potential to compete with existing products in both weight management and glycemic control [8]. Group 3: Market Positioning - The competitive landscape for Phase III candidates includes various companies, such as Hengrui Medicine and Eli Lilly, indicating a shift from exploratory phases to a race for market leadership in the GLP-1/GIP dual-target space [9]. - Roche's entry into this market is significant due to its established capabilities in clinical development and long-term safety management, which may provide an advantage in balancing efficacy, tolerability, and adherence in a market projected to be worth trillions [9][10].

Core Viewpoint - 博瑞医药 is actively investing in innovative drug development to counteract declining revenues from its traditional business segments, particularly in the context of increasing market competition and pricing pressures [3][5][8]. Company Investment and Shareholding - 博瑞医药 held a shareholder meeting on December 1, 2023, where it approved a capital increase of 50 million yuan in 苏州极客基因科技有限公司, raising its stake from 4.0816% to 12.8015% [1]. - 极客基因 specializes in high-throughput omics data for cell fate regulation and has a new drug for advanced malignant tumors that has been approved for clinical trials in China [1]. Financial Performance - 博瑞医药's revenue has been under pressure, with a decline in net profit from 2.44 billion yuan in 2021 to an expected 1.89 billion yuan in 2024, indicating a trend of "increased revenue without increased profit" [3][5]. - In the first three quarters of 2023, the company reported a 10.50% decrease in revenue to 874 million yuan and a 71.64% drop in net profit to 50.32 million yuan [5]. R&D Focus and Product Development - 博瑞医药 is focusing on innovative drugs, particularly in the metabolic disease sector, with BGM0504 being a key product under development [5][6]. - BGM0504 is a dual agonist for GLP-1 and GIP receptors, with ongoing clinical trials for diabetes and weight loss indications in China and the U.S. [6][7]. - The company plans to submit a Phase III clinical trial application to the FDA by the end of 2023, with an expected enrollment of around 6,000 participants, significantly increasing R&D costs [6]. Market Performance and Stock Activity - 博瑞医药's stock has been volatile, with a significant increase of over 76% from the beginning of the year to the end of November, despite a sharp decline following disappointing half-year results [7]. - The company has faced scrutiny regarding its stock price fluctuations and has issued multiple warnings about potential investment risks [7]. Financial Challenges and Funding Strategies - 博瑞医药's R&D expenses reached 348 million yuan in the first half of 2023, accounting for 64.83% of its revenue, with a significant increase in investment in innovative drugs [8]. - The company has been exploring various financing options, including a terminated 500 million yuan private placement and a recent application for a listing on the Hong Kong Stock Exchange to enhance its international financing capabilities [8][9].

Core Viewpoint - 博瑞医药's subsidiary received approval for clinical trials of BGM1812, a new long-acting Amylin analog for weight management, marking a significant step in its drug development pipeline [1] Group 1: Drug Development and Clinical Trials - BGM1812 injection is designed to activate satiety pathways in the brain, suppress appetite, delay gastric emptying, and inhibit glucagon secretion, contributing to weight loss [1] - The drug has already received FDA approval for clinical trials in the U.S., with the first patient enrolled [1] - No similar targeted weight loss drugs have been approved globally as of the announcement date [1] Group 2: Financial and Market Strategy - 博瑞医药 plans to list on the Hong Kong Stock Exchange, aiming to enhance its global strategy and expand overseas markets [2] - The funds raised from the H-share issuance will support drug development, upgrade production and R&D facilities, and supplement working capital [2] - The company reported projected revenues of 1.017 billion, 1.164 billion, and 1.255 billion RMB for 2022, 2023, and 2024, respectively, with net profits of 211 million, 173 million, and 141 million RMB [3] Group 3: Product Portfolio and Market Presence - 博瑞医药 has a diverse product portfolio, including over 40 formulations and active pharmaceutical ingredients, focusing on unmet medical needs in metabolic and respiratory diseases [2] - The company has established a commercial network covering over 40 countries and regions globally [2] - BGM0504, another core candidate drug, is a GLP-1/GIP dual-target agonist showing promising results in Phase II trials for type 2 diabetes and obesity [3]

Core Viewpoint - 博瑞生物 is attempting to re-enter the capital market through a Hong Kong IPO amidst declining performance and regulatory scrutiny, aiming to enhance its international strategy and financing capabilities [5][26]. Cash Flow - 博瑞医药 has experienced a significant decline in net profit and revenue, with a sharp drop in gross margin and high short-term liabilities, leading to tightened cash flow and multiple regulatory warnings affecting its credibility [3][10]. Commercialization - The company's revenue heavily relies on raw materials, with innovative drugs not yet generating commercial returns, indicating a need for improved internal governance [4][8]. Investment Opportunities - 博瑞医药's core innovation pipeline, BGM0504, is positioned in the leading tier of global diabetes and obesity drug development, with the global GLP-1 market expected to grow significantly from $39 billion in 2024 to $140 billion by 2030, and the Chinese market projected to increase from 1 billion to 58 billion yuan during the same period [4][8]. Financial Performance - Revenue for 博瑞医药 from 2022 to 2024 is projected to grow slowly from 1.017 billion yuan to 1.283 billion yuan, while net profit is expected to decline from 240 million yuan to 189 million yuan. In the first three quarters of 2025, revenue fell by 10.5% year-on-year to 874 million yuan, and net profit plummeted by 71.63% to 50.32 million yuan [9][10]. Regulatory Issues - 博瑞医药 has faced multiple regulatory warnings due to improper management of raised funds and disclosure issues, with a history of at least four warnings in five years [14][15][25]. Financing History - Since its IPO in 2019, 博瑞医药 has completed three major financing rounds, but has struggled with fundraising due to regulatory issues and market conditions, leading to the termination of a planned A-share issuance [13][15]. Leadership and Ownership - 博瑞医药 is controlled by 袁建栋 and his mother, holding approximately 53% of the voting rights, with their combined share value nearing 10 billion yuan [19][20]. Market Sentiment - The company has a history of regulatory scrutiny and past performance issues, raising concerns about its ability to maintain investor confidence and achieve its ambitions in the international market [26].

Core Viewpoint - 博瑞生物医药's financial performance has significantly deteriorated in the first half of 2025, with a sharp decline in revenue and profit margins, raising concerns about its business model and future prospects [1][2][10]. Financial Performance - Revenue for the first half of 2025 was 524 million yuan, a decrease of 18.7% year-on-year [2] - Net profit plummeted to 1.657 million yuan, down 97.9% from 82.2 million yuan in the same period last year, resulting in a net profit margin of only 0.3% [1][2] - Gross margin fell to 49.3%, down 6.5 percentage points from the previous year, marking a continuous decline over three years [2] Business Structure - The company heavily relies on raw materials and intermediates, which accounted for 83.5% of total revenue in the first half of 2025, while formulation products contributed only 14.5% [3][4] - The core product, Oseltamivir phosphate, saw a 66.2% drop in sales due to inclusion in volume-based procurement, adversely affecting revenue growth [2][4] Supply Chain Risks - The concentration of suppliers has increased significantly, with the largest supplier accounting for 40.7% of total purchases, up from 6.3% in 2024 [5][6] - The top five suppliers now represent 52.3% of total purchases, indicating a heightened risk of supply chain disruptions [5][6] R&D Investment and Challenges - The company has invested 790 million yuan in R&D from 2022 to 2024, representing 21.4% of revenue, but has not seen significant returns [7][8] - The core product BGM0504 is still in Phase III clinical trials, with expected market entry in 2026, while competitors have already launched similar products [8] Governance and Financial Concerns - The controlling shareholder holds 38.53% of voting rights, raising concerns about governance and potential conflicts of interest, especially with high dividend payouts during critical R&D phases [9][10] - Cumulative dividends from 2022 to 2024 reached 405 million yuan, which is 35.7% of net profits, while R&D investment during the same period was only 790 million yuan [9][10] Market Position and Valuation - The company's gross margin of 49.3% is below the industry average of 61.2%, and its R&D investment ratio of 26.4% is also lower than the industry average of 31.5% [10][11] - The projected P/E ratio of 37 times for 2025 is significantly higher than the average of 28 times for the Hong Kong biotech sector, indicating potential valuation risks [10][11]

Core Viewpoint - 博瑞医药 has submitted an application for a Hong Kong IPO, aiming for a dual listing in both A-share and H-share markets, which is a significant step in its global strategy to enhance its international business foundation [1] Group 1: Financial Performance - 博瑞医药 has shown steady revenue growth, with projected revenues of RMB 1.017 billion, RMB 1.164 billion, and RMB 1.254 billion for the years 2022, 2023, and 2024 respectively [1] - The company's R&D expenditures are also on the rise, with amounts of RMB 207 million, RMB 249 million, and RMB 297 million for the years 2022, 2023, and 2024, representing 20.35%, 21.08%, and 23.19% of revenue respectively [1] - In the first half of 2025, R&D spending reached RMB 348 million, a year-on-year increase of 144.07%, accounting for 64.83% of revenue [1] Group 2: Product Pipeline and Market Potential - 博瑞医药 focuses on innovative treatments for metabolic diseases, with its lead candidate BGM0504 showing promising results in clinical trials, achieving a HbA1c reduction of -2.76% and weight loss of -19.78% in the 15mg dosage group [2] - The global market for T2DM patients is projected to reach 543 million by 2024, with obesity and overweight populations at 2.639 billion, indicating a substantial market opportunity for GLP-1 receptor agonists [3] - BGM0504 is among the leading GLP-1/GIP dual-target agonists in clinical development, with plans for a new drug application submission as early as 2026 [3] Group 3: Strategic Initiatives - The funds raised from the Hong Kong IPO will be allocated to R&D for existing and future innovative drug candidates, upgrading production and R&D facilities, and supplementing working capital [1] - 博瑞医药 is also expanding its pipeline into respiratory diseases, with seven ongoing projects targeting conditions such as COPD and asthma [3] - The company aims to deepen international collaboration and accelerate its global expansion, with the Hong Kong listing expected to enhance its capital structure and support overseas clinical advancements [3]

（於中華人民共和國註冊成立的股份有限公司） 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。 的申請版本 BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. 博 瑞 生 物 醫 藥（ 蘇 州 ）股 份 有 限 公 司 （「本公司」） 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、接納並向本公司、本公司的獨家保薦人、整體協調人、顧問或包銷團成員表示同意： 於本公司招股章程根據香港法例第32章《公司（清盤及雜項條文）條例》送呈香港公司註冊處處長註冊前，不 會向香港公眾人士提出要約或邀請。倘於適當時候向香港公眾人士提出要約或邀請，準投資者務請僅依據 與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。招股章程的文本將 ...