股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 公司名稱: 樂普生物科技股份有限公司(於中華人民共和國註冊成立的股份有限公司) 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 呈交日期: 2025年9月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02157 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,804,439,838 | RMB | | 1 RMB | | 1,804,439,838 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 1,804,439,838 | RMB | | 1 ...

Group 1 - The Hong Kong biotechnology stocks experienced a collective decline, with notable drops in several companies [1] - WuXi AppTec (02126) saw a decrease of 12.95%, closing at 4.840 [2] - BioNTech (06952) fell by 12.53%, with a latest price of 13.750 [2] Group 2 - Other companies such as Valiant (09887) and Beihai Kangcheng (01228) also reported significant declines of 9.93% and 9.75% respectively [2] - The decline extended to companies like Saint Noble (02257) and MIRXES (02629), which dropped by 9.64% and 8.43% [2] - Overall, the biotechnology sector is facing downward pressure, impacting multiple firms [1]

Investment Rating - The report assigns a "Buy-A" investment rating to the company, with a 6-month target price of HKD 11.92 [4]. Core Insights - The company reported a revenue of HKD 466 million and a net profit of HKD 42 million for the first half of 2025. The approval of EGFR ADC is highly anticipated, with multiple pipeline products advancing rapidly [1][2]. - The company expects to disclose significant data at the ESMO 2025 conference, including Phase II data for MRG003 in combination with PD-1 for head and neck cancer and nasopharyngeal cancer [1]. - Revenue projections for 2025 to 2027 are estimated at HKD 750 million, HKD 880 million, and HKD 1.79 billion, respectively, with net profits expected to be HKD -80 million, HKD 10 million, and HKD 290 million [2]. Financial Performance - The company achieved a revenue of HKD 225.35 million in 2023, with projections of HKD 367.79 million for 2024 and HKD 748.58 million for 2025 [6][11]. - The net profit for 2023 was HKD -30.30 million, with expectations of HKD -87.90 million in 2025 and a turnaround to HKD 329.31 million by 2027 [11][12]. - The gross margin is projected to improve from 87.45% in 2023 to 88% in 2027, indicating a positive trend in profitability [12]. Pipeline and Collaborations - The company has several products in its pipeline, including TF ADC MRG004A, which has entered Phase III clinical trials, and CG0070, which has completed Phase I enrollment in China [2]. - The company has established multiple external licensing collaborations, including the licensing of CDH17 ADC MRG007 and two TCE-related IP assets [2]. Market Performance - The stock price as of August 26, 2025, was HKD 9.41, with a 12-month price range of HKD 2.27 to HKD 10.18 [4]. - The company has shown significant stock performance, with a 12-month absolute return of 282.5% [5].

Core Viewpoint - Lepu Biopharma-B (02157) experienced a 6.16% increase in stock price, reaching 10.17 CNY per share with a trading volume of 200 million CNY as of August 22 [1] Company Overview - Lepu Biopharma focuses on biopharmaceutical research and development in the oncology treatment sector, particularly in targeted therapy and immunotherapy innovations [1] - The company possesses end-to-end capabilities in drug discovery, clinical development, CMC, and GMP-compliant production [1] - Lepu Biopharma has established a professional sales and marketing team to meet clinical needs and provide optimized and innovative drug solutions [1] Financial Performance - As of the mid-year report for 2025, Lepu Biopharma reported total revenue of 466 million CNY and a net profit of 41.75 million CNY [1] - The company's net profit attributable to shareholders for the fiscal year 2025 increased by 121.69% year-on-year, with basic earnings per share of 0.02 CNY [1]

Group 1 - The Hong Kong stock market saw a rise in innovative drug concepts on August 21, with notable increases in stock prices for several companies [1] - Lepu Biopharma (02157.HK) experienced a surge of over 9% [1] - Other companies such as Junshi Biosciences (01877.HK) and Rongchang Biopharma (09995.HK) also saw significant gains, with Junshi rising over 5% [1]

Group 1 - The Hong Kong stock market opened slightly higher on August 21, with the Hang Seng Index at 25,216 points, up 0.20%, while the Hang Seng Tech Index was at 5,528 points, down 0.23% [1] - Hong Kong Exchanges and Clearing (HKEX) reported record high revenue and net profit for the first half of 2025, with total revenue of HKD 14.076 billion, a year-on-year increase of 33%, and net profit of HKD 8.519 billion, up 39% [3] - The increase in trading volume in the cash market, derivatives market, and Stock Connect was attributed to the recovery of the Hong Kong stock market and growing global investor interest in non-USD assets [3] Group 2 - HKEX CEO Charles Li indicated that the exchange will explore a 24-hour trading mechanism, which positively impacted the stock price, reaching a high of HKD 447, up 1.31% [4] - Domestic brokerage stocks saw a significant rise, with Guotai Junan International up over 5% and Guotai Haitong up over 2%, while other firms like Zhongzhou Securities and China Galaxy also experienced gains [4] - Various cross-border ETFs, including the Hong Kong Stock Connect Innovative Drug ETF and Hong Kong Securities ETF, showed strong performance, with increases of over 1% [5]

Group 1: Hong Kong Stock Exchange Developments - Hong Kong Stock Exchange (HKEX) CEO Charles Li stated that HKEX will research a 24-hour trading mechanism, taking into account international experiences and local market conditions [1] - HKEX plans to enhance its competitiveness through strategic investments in data platform optimization and trading settlement system upgrades [1] - The exchange is also exploring shortening the settlement cycle for the cash market, with a potential T+1 settlement system supported by its technology by the end of this year [1] Group 2: Market Overview - The S&P 500 index fell for four consecutive days, with the index closing down 0.24% at 6395.78 points [2] - Major technology stocks mostly declined, with Intel dropping approximately 7% [2] - The Nasdaq China Golden Dragon Index rose by 0.33%, with notable gains from Tiger Brokers and JinkoSolar [2] Group 3: Financial Regulatory Updates - The National Financial Regulatory Administration is seeking public opinion on the draft of the "Commercial Bank M&A Loan Management Measures," which includes provisions for equity acquisition loans [3] Group 4: Federal Reserve Insights - The Federal Reserve's July meeting minutes indicated a moderate GDP growth in the first half of the year, with a focus on inflation risks over labor market concerns [4] - There was a notable dissent among Fed officials regarding interest rate decisions, marking a significant moment since 1993 [4] Group 5: Corporate Earnings Reports - Alibaba Group announced plans to spin off its subsidiary, Zhaima, for an independent listing on the Hong Kong Stock Exchange [5] - Baidu Group reported a total revenue of RMB 327.13 billion for Q2 2025, a year-on-year decrease of 4%, while net profit increased by 33% to RMB 73.22 billion [8] - Huazhu Group's total revenue for Q2 2025 was RMB 64.26 billion, with a net profit of RMB 15.44 billion, reflecting a 44.7% year-on-year increase [9] - China Oriental Group expects a net profit increase of no less than 70% for the first half of 2025, projecting at least RMB 2.20 billion [10] - Lijun Pharmaceutical reported a net profit of RMB 12.81 billion for the first half of 2025, a 9.4% increase year-on-year [11] - BOSS Zhipin reported a net profit of RMB 7.16 billion for Q2 2025, a 69.87% increase year-on-year [12] - New World Development reported a significant increase in net profit to HKD 887 million, a 1076% rise year-on-year [13] - Yimuyou Group expects a net profit of no less than RMB 2.6 billion for the first half of 2025, representing a growth of over 90% [14] - Yongsheng Medical reported a net profit of HKD 51.63 million, a 55.1% increase year-on-year [15] - Lepu Biopharma achieved a revenue increase of 249.59% for the first half of 2025, marking its first profit [16] - Huya Technology expects a net profit of USD 30 million to 38 million for the first half of 2025, a significant increase from the previous year [17] - Kingsoft reported a net profit of RMB 816 million for the first half of 2025, a 20.41% increase year-on-year [18] - Zhong An Online reported a net profit of RMB 668 million, a 1103.54% increase year-on-year [19] - Yaoshi Bang reported a net profit of RMB 78.12 million, a 258% increase year-on-year [20] - Crystal International reported a net profit of USD 98.27 million, a 17% increase year-on-year [21] - Ocean Group expects a turnaround with a projected net profit of RMB 9.5 billion to 11 billion for the first half of 2025 [22] - Kingsoft Cloud reported an adjusted EBITDA of approximately RMB 725 million, a 672.62% increase year-on-year [23] Group 6: Pharmaceutical Developments - Heyou Pharmaceutical's IND application for a combination therapy for NSCLC has been approved by the CDE [24] - Shengbela reported a net profit of RMB 327 million, marking a turnaround from a previous loss, with significant growth in various business segments [25]

Core Viewpoint - The article discusses the emergence of NewCo transactions in China's innovative pharmaceutical sector, highlighting a shift where Chinese investment firms, such as Sequoia China, are becoming buyers in these deals, leveraging China's clinical efficiency and cost advantages to enhance the global market value of targeted drugs [1][3][6]. Group 1: NewCo Transactions Overview - NewCo transactions have seen a significant increase in China, with 14 similar deals occurring since the beginning of 2024, primarily involving both large and small pharmaceutical companies [2][6]. - The first NewCo transaction led by a Chinese fund involved a $10 million upfront payment to Lepu Biopharma, marking a notable shift in the buyer landscape from predominantly foreign funds to domestic investors [2][4][6]. Group 2: Investment Strategy and Market Impact - Sequoia China's investment strategy focuses on identifying differentiated assets, particularly in the T-cell engager (TCE) space, which has limited competition in solid tumors compared to blood cancers [6][7]. - The transaction structure allows Lepu Biopharma to retain a 10% stake in the new company, Excalipoint, and potentially earn up to $848 million in milestone payments and sales royalties, indicating a strategic approach to funding and asset management [7][10]. Group 3: Clinical Development and Cost Efficiency - The new company will conduct Phase I clinical trials in China, utilizing local resources to expedite development, contrasting with previous models that prioritized overseas clinical trials [12][13]. - The cost of conducting clinical trials in China is significantly lower than in the U.S., with estimates suggesting a cost difference of five to seven times, which enhances the feasibility of early-stage drug development [13]. Group 4: Management and Operational Considerations - The success of NewCo transactions relies heavily on the experience of the management team, with a focus on ensuring seamless integration of core technologies and research strategies [9][10]. - The article emphasizes the importance of strong relationships with potential buyers and understanding their pipeline needs, which is crucial for the successful exit of NewCo assets [16]. Group 5: Market Perception and Future Outlook - Despite some skepticism regarding the low upfront payments typical of NewCo deals, they remain a vital funding avenue for innovative pharmaceutical companies facing financial pressures [17]. - The article suggests that as the market for innovative drugs recovers, more NewCo transactions are likely to emerge, providing opportunities for companies to secure funding while maintaining involvement in their drug pipelines [17].

Core Insights - The article discusses the emergence of NewCo transactions in the Chinese pharmaceutical industry, highlighting a shift where local investment firms, such as Sequoia China, are becoming buyers in these deals, previously dominated by foreign funds [2][3][5]. Group 1: NewCo Transactions - NewCo transactions involve smaller pharmaceutical companies focusing their resources on one or two drug candidates, often leading to strategic sales to larger firms for significant returns [2]. - In 2024, there have been 14 similar NewCo transactions in China's innovative drug sector, indicating a growing trend despite a challenging capital environment [2]. - The first NewCo transaction led by a Chinese fund involved a $10 million upfront payment to Lepu Biopharma, marking a significant shift in the buyer landscape [3][5]. Group 2: Market Dynamics - The entry of Chinese funds into NewCo transactions is expected to enhance the global market value of targeted drugs by leveraging China's clinical efficiency and cost advantages [3][9]. - The traditional model of NewCo transactions often involved moving assets overseas for development, but the new approach focuses on maximizing asset value within China [9][10]. Group 3: Financial Aspects - Lepu Biopharma's deal includes a $10 million upfront payment and potential future payments totaling $848 million, along with a 10% equity stake in the new company, Excalipoint [6]. - The funding for Excalipoint will be led by Sequoia China and other investors, injecting $41 million in Series A funding [6]. Group 4: Management and Operations - The management team for Excalipoint includes experienced professionals from Lepu Biopharma, ensuring continuity in research and development [7][8]. - The complexity of NewCo transactions requires careful coordination among the founding team, investors, and the original company, which is different from traditional equity financing [8]. Group 5: Cost Efficiency - Conducting Phase I clinical trials in China is significantly cheaper than in the U.S., with costs per participant being approximately 300,000 to 400,000 RMB compared to 200,000 to 300,000 USD in the U.S., highlighting the cost advantages of Chinese clinical trials [11][10]. Group 6: Future Outlook - Despite some skepticism regarding the NewCo model, it remains a vital funding avenue for innovative drug companies facing financial pressures [14]. - The article suggests that the understanding of NewCo transactions among Chinese pharmaceutical executives is still developing, with potential for long-term value creation through strategic partnerships [14].

Core Viewpoint - Lepu Biopharma has successfully turned a profit for the first time since its IPO, achieving a net profit of 29.3 million yuan in the first half of 2025, compared to a loss of 197 million yuan in the same period last year, driven by significant revenue growth and improved cash flow [1][2][14] Financial Performance - In the first half of 2025, Lepu Biopharma reported revenue of 466 million yuan, a 350% increase from 133 million yuan in the same period last year [1][2] - The company achieved a cash inflow from operating activities of 46.7 million yuan, a turnaround from a cash outflow of 115 million yuan in the previous year [2][14] Product Performance - The rapid growth of Lepu's first commercialized product, Pudilan (PD-1 monoclonal antibody), contributed significantly to the revenue, generating 151 million yuan in sales, a 58.8% increase year-on-year [3][14] - MRG003, a new product in the pipeline, is expected to be a key driver for future revenue, with its NDA for treating recurrent/metastatic nasopharyngeal carcinoma under priority review by the National Medical Products Administration [4][5] Clinical Development - MRG003 has shown promising clinical results, with an overall response rate (ORR) of 30.2% in a pivotal study, significantly higher than the chemotherapy group's 11.5% [4][5] - The company is also advancing other products in its ADC pipeline, including MRG004A and MRG006A, which target various cancers and have shown early signs of efficacy [8][10] Strategic Initiatives - Lepu Biopharma is pursuing a dual strategy of commercialization and business development (BD) to enhance its market presence and revenue streams, including global licensing agreements for its products [12][13] - The company has established a strong sales and marketing team to boost product awareness and drive sales growth [3][14] Future Outlook - The successful commercialization of MRG003 and CG0070, along with the ongoing development of other promising candidates, positions Lepu Biopharma for sustained growth and profitability in the coming years [10][14] - The company aims to evolve from a biotech to a biopharma entity, focusing on innovative therapies and expanding its global footprint [14]